GOVERNING BODY MEETING – a Meeting in Public

GOVERNING BODY MEETING – A meeting in public

Tuesday 4th October 2016

Birkenhead Town Hall, Assembly Room Mortimer Street Birkenhead Wirral CH41 5EU

1pm - 4pm

AGENDA

Ref No Time Item Action Papers No. GB16- 1. 1.00pm PRELIMINARY BUSINESS 17/0012 (Chair) 1.1 Apologies for Absence 1.2 Chair’s Announcements 1.3 Declarations of Interest 1.4 Comments/questions from members of the public (10 mins) 1.5 Minutes and Action Points of Last Meeting – 6th September 2016 DRAFT GB Minutes Copy of WCCG Action Points PUBLIC MEETING 06 09Formal GB Action Poin 1.6 Matters Arising

GB16- 2. COMMISSIONING DECISIONS 17/0013 2.1 Products of Limited Clinical To Value Prescribing Policy approve a Lorna Quigley (Director of decision Quality and Patient Safety) coversheet_plcvpolicy PLCV v3 - Governing _GB_060916.docx Body report 4th Octobe

Appendix 1 - Products of Low Clinical Priority 2.2 Self Care Prescribing Policy To Lorna Quigley (Director of approve a Quality and Patient Safety) decision coversheet_selfcarep Self Care Prescribing olicy_GB_060916.docxPolicy - GB Report 4_1

Appendix 1 - OTC-Survey Results.pd 2.3 Gluten Free Prescribing To Policy approve a Lorna Quigley (Director of decision Quality and Patient Safety) coversheet_glutenfre Gluten Free efoodpolicy_GB_06091Prescrbing Policy_GB_0

Agenda – Wirral Governing Body Meeting PUBLIC SESSION – 10th October 2016 Page 1 of 3 Ref No Time Item Action Papers No.

Appendix 1 - Current Appendix 2 - prescribing guidelines.Summary Survey Resu

Appendix 3 - Appendix 4 - BSG.pdf BSNA.pdf

Appendix 5 - Coeliac Appendix 6 - Gluten UK.pdf Free Products Breakdo

2.4 Homeopathy and Iscador To Service Review Nesta Hawker approve a (Director of Commissioning) decision coversheet- GOVERNING BODY Homeopathy-Iscador.dBOARD REPORT Home

Consultation on Homeopathy and Iscad

GB16- 3. GOVERNANCE 17/0014 3.1 Assurance Framework To assure (Paul Edwards, Director of Corporate Affairs) Cover Sheet - AF OctoberGoverning Assurance FrameworkBody - changes agreed

Wirral CCG Assurance Framework - Changes

3.2 Development of Wirral Health To note and Social Care System (Jon Develing, Chief Officer) Development of Wirral Health and Soci

GB16- 4. PERFORMANCE 17/0015 4.1 Presentation from Wirral To assure Hospitals on CQC Report (Lorna Quigley, Director of Quality and Patient Safety)

GB16- 5. RISK REGISTER 17/0016 Current Risk Register To Paul Edwards, Director of Corporate approve Affairs) MASTER Risk Resgister - Sept 16 QP

6. ANY OTHER BUSINESS 6.1

7. End DATE AND TIME OF NEXT FORMAL MEETING

Agenda – Wirral Governing Body Meeting PUBLIC SESSION – 10th October 2016 Page 2 of 3 Ref No Time Item Action Papers No. Date and time of Next meeting: Tuesday 1st November 2016 – 1pm – 4pm Nightingale Room OMH Please forward any apologies to [email protected]

Agenda – Wirral Governing Body Meeting PUBLIC SESSION – 10th October 2016 Page 3 of 3

WIRRAL CLINICAL COMMISSIONING GROUP GOVERNING BODY BOARD MEETING Minutes of Meeting – Public Session

Tuesday 6th September 2016 2pm Nightingale Room, Old Market House

Present: Dr Sue Wells (SW) (Chair) Medical Director/Acting Chair Jon Develing (JD) Chief Officer Mike Treharne (MT) Chief Financial Officer Nesta Hawker (NH) Director of Commissioning Paul Edwards (PE) Director of Corporate Affairs Lorna Quigley (LQ) Director of Quality & Patient Safety James Kay (JK) Lay Member (Patient Champion) Alastair Cannon (AC) Lay Member (Quality & Outcomes) Alan Whittle (AW) Lay Member (Audit & Governance) Dr Laxman Ariaraj (LA) GP Lead – Planned Care Dr Simon Delaney (SD) GP Lead – Primary Care Dr Paula Cowan (PC) GP Lead – Unplanned Care Dr Sian Stokes (SS) GP Lead – Long Term Conditions Dr Sean Magennis (SM) Chair of Members’ Council Dr Arpan Guha (AG) Secondary Care Doctor Graham Hodkinson (GH) Director of Department of Adult Social Services

In Attendance: Allison Hayes (AJH) Corporate Officer Richard Williams (RW) LMC Jacqui Harvey (JH) PWC Laura Middleton (LM) PWC

Ref Minute No. GB16- Preliminary Business 17/0009

1.1 Apologies for absence

Apologies were received from: Fiona Johnston and Lesley Doherty. 1.2 Chairs Announcements/Opening Remarks

Chair welcomed members and the public to the meeting.

Chair announced that Dr Peter Naylor has resigned from his position as Chair of the CCG on health grounds and gave thanks to Dr Naylor for his work and commitment.

Chair informed members that a discussion had taken place at the Quality, Performance and Finance Committee about how risk could be made more central to agenda times and asked that future papers highlighted key issues for the risk register that could be discussed with the item rather than just at the end of the meeting. Members supported this proposal.

Action - PE and AJH are to review the format of future agendas and papers to support this.

1.3 Declarations of Interest

Minutes of the WCCG –Governing Body Meeting – PUBLIC SESSION – 6th September 2016 Page 1 of 8

Ref Minute No. Chair reminded the Governing Body members of their obligations to declare any interest they may have on any issues arising at committee meetings which might conflict with the business of Wirral Clinical Commissioning Group.

Declarations declared by members of the Governing Body are listed in the CCGs Register of Interests. The Register is available either via the secretary to the Governing Body or the CCG website at the following link: https://www.wirralccg.nhs.uk/Downloads/AboutUs/WhosWho/Register%20of%20Interests%20Versio n%20Updated%20June%202016.pdf

There were no declarations of interest received at today’s meeting.

1.4 Comments/questions from members of the public

Three members of the public attended the meeting, none of whom requested to address the Governing Body.

1.5 Minutes & Action Points from previous meeting held on 5th July 2016

The minutes of the previous meeting held on 5th July 2016 were agreed as a true and accurate record notwithstanding grammatical/typographical errors which will be rectified.

Action Points:

Members provided an update of their current actions recorded on a separate action log. It was agreed that future action points would be assigned a numeric code to allow easier tracking.

Action – AJH to amend current action log to add numeric codes.

1.6 Matters Arising

PE updated that the implementation plan for Communications and Engagement is still in progress, as a resource paper had only recently been approved by the CCG’s executive team that has shaped the scale of ambition. He also said that a meeting to progress the ‘Your NHS in Wirral’ brand is not due to take place until later in the month and that discussions are still going on regarding engagement footprints (e.g. Wirral or wider STP population). He stated that the more detailed plan would be brought to November Governing Body.

Action – PE to bring Communications and Engagement implantation plan to November Governing Body

1.7 Patient Story

LQ informed members of a quality review which had been undertaken of the Medical Assessment Unit at Arrowe Park Hospital. LQ advised the Governing Body of the recommendations that had been made in order for the service to improve areas of complaints, long waits, care of deteriorating patients and lack of continuity and care. LQ informed members of feedback which had been received from a patient’s relative in relation to the unit and the positive impact and outcomes the recommendations have had on the service.

Members noted the patient story presented at today’s meeting. GB16- 2.0 Items for Assurance and Approval 17/0010

2.1 Chief Officer’s Update

JD advised the Governing Body that the NHS has been very much in the news over the summer Minutes of the WCCG –Governing Body Meeting – PUBLIC SESSION – 6th September 2016 Page 2 of 8

Ref Minute No. months with the announcement of a new round of junior doctor industrial action, now suspended in the short term with a view to enabling further negotiation, and increasingly difficult times for the NHS in terms of both performance and finances.

JD explained that CCGs are now subject to a more rigorous and extensive assessment regime and that the first meeting in this process for 2016/17 is due to take place in September. Last year’s overall assessment was ‘requires improvement’, largely based on the year-end financial position. JD stated that the financial position remained a challenge and the CCG would need to be seen to be taking all possible actions to address this.

JD highlighted pressures across the Cheshire & Merseyside system and how the CCG have been working on the development of the STP across that footprint which has the four key themes of:

• Managing demand • Reducing unwarranted variation • Collaborations as a means to reducing back office functions • Exploring different ways of working in respect of accountable care

These are present in the Healthy Wirral and within the Cheshire & Wirral plan which is becoming increasingly important as CCGs and Providers work increasingly closer on these areas.

With regard to Healthy Wirral, the CCG and partner organisations recently presented progress to Sam Jones, the National Director for Vanguard, who noted that we had continued to make significant progress in spite of not receiving expected funding on 2016/17. JD went on to report that the CCG is now beginning to see the outputs form the Cerner clinical registries for the first time and these are being piloted in a number of practices.

The Governing Body noted the Chief Officer’s update.

2.2 Director of Corporate Affairs’ Report

PE advised members that, on the assumption that his papers had been read, he would draw attention to the most salient elements of his report. Key areas included:

• Emergency, Preparedness, Resilience and Response (EPRR) • Commissioning Support • Communications and Engagement

PE advised that the Midlands and Lancashire Commissioning Support Unit has designed new service structures and has been consulting with staff as part of a formal organisational change process. PE informed members of the Governing Body that Directors and Heads of Service have been continuing to meet with key CCG staff to discuss service delivery moving forward and advised that, now the organisational change process has ended, formal monthly contract meetings have been arranged to monitor progress against performance indicators. It was agreed that PE would work with MLCSU to develop a performance dashboard highlighting and this would be reported Quality, Performance and Finance Committee (QPF).

Action – PE work with MLCSU to develop performance dashboard to be reported through QPF

PE highlighted that a health and economy wide workshop has been arranged for 25th August 2016 to progress scope a work plan and to develop the Communications and Engagement Strategy aims and objectives which was approved at the Governing Body meeting on 5th July.

PE advised that analysis data and information is still being gathered in relation to the recent Minutes of the WCCG –Governing Body Meeting – PUBLIC SESSION – 6th September 2016 Page 3 of 8

Ref Minute No. consultations and reviews regarding: Homeopathy, Gluten Free Foods, Over the Counter Medication and Procedures of Low Clinical Value and therefore these papers will now be presented at a formal Governing Body meeting scheduled to take place on 4th October.

Emergency Planning, Response and Resilience (EPRR) Compliance Assessment

PE presented a report to members of the Governing Body in relation to the EPRR compliance assessment and sought the Governing Body’s support and approval of the CCG being fully compliant. PE explained that the statement of compliance and action plan are completed against the required areas of NHS England’s core standards for EPRR. PE advised that the CCG has conducted a self-assessment process which demonstrated that the CCG are fully compliant against the core standards.

JK sought clarity around the specific test exercises and PE explained how on-call staff attend these throughout the year.

JD highlighted the benefits of members attending the following courses:

• Strategic Leadership in a Crisis • Surviving Public Enquiries

The Governing Body approved the paper presented today and the CCGs position of being fully compliant.

On a separate note, PE informed members that a new election process is now underway to replace Dr Naylor as Chair and explained the criteria regarding the assessment process agreed with the Local Medical Committee. PE advised that the process will take approximately 5 weeks to complete and the elected new chair will be announced in October. PE went on to advise that the election process is being conducted with the support of the LMC.

2.3 Director of Quality & Patient Safety’s Report

LQ presented a report to the Governing Body which highlights the statutory functions and duties that the Director of Quality and Patient Safety is responsible for. Key topics included:

• Safeguarding • Continuing Health Care (CHC) Joint Committee • Previously Unassessed Periods of Care (PUPoC)

LQ informed members that the total number of PUPoC applications received for consideration was 559. At the time of writing this report the outstanding cases that need to be reviewed stands at 67, of which 39 remain open. LQ advised that the CSU have assured the CCG that all cases will have been reviewed by 2nd September 2016. After this, LQ went on to explain that all complaints and subject access requests relating to PUPoC cases will be transferred to South Cheshire and Vale Royal CCG who manage the CHC joint service across and on behalf of the Cheshire and Wirral CCGs.

Children Looked After (CLA) Annual Report 2015/16

LQ introduced the Children Looked After Annual Report 2015/16. Chair thanked LQ and her team for their work and the Governing Body noted the contents of the report and accepted the assurance that the CCG is meeting its statutory responsibilities in relation to CLA.

Joint Committee for NHS Continuing Health Care, Funded Nursing Care (FNC) & Complex Care Minutes of the WCCG –Governing Body Meeting – PUBLIC SESSION – 6th September 2016 Page 4 of 8

Ref Minute No.

LQ presented the Joint Committee for NHS CHC, FNC and Complex care report and sought the Governing Body’s approval for ratifying the Terms of Reference.

LQ explained that due to the changes in the commissioning of Cheshire and Wirral CHC to a joint service hosted by South Cheshire CCG, the CCGs had initially amended their constitution to allow the formation of a joint committee to cover commissioning arrangements for CHC, FNC and Complex Health Care. LQ went on to explain that due to changes in guidance, there has been a need to work more collaboratively with the Local Authority and the terms of reference have been amended to reflect these changes.

The Governing Body approved the Terms of Reference

2.4 Director of Commissioning’s Report

NH presented the Director of Commissioning Report and highlighted key areas to be reported and discussed. These included:

• Transformation of Primary Care • Financial Recovery Delivery

NH reported that NHS England has now supported the release of £340k to the Wirral Health Economy to commission additional access to GP services during evenings and weekends. NH advised that the monies will be available from 1st October 2016 subject to a business case and service specification being approved by the PMCC (Primary Medical Care Co-Commissioning Committee) and highlighted that the CCG is working with both Wirral GP Federations to develop the service model that will increase access to primary care to Wirral residents and registered patients.

NH gave an update regarding recent practice visits which are being undertaken to support improving CCG Member Practice engagement and reported that 32 practices have been visited to date.

NH went on to advise that the Primary Care Transformation working group considered a project mandate on co-commissioning level 3 and had provided insight from GP, practice manager and lay perspectives. The Primary Medical Care Commissioning Co-Commissioning Committee will be discussing the process for a level 3 application at a meeting on 13th September.

With regards to the financial recovery delivery, NH advised that a new process to facilitate consistent applications of the CCGs Procedure of Low Clinical Priority has been devised, medicines management schemes are being developed with the aim to reduce wastage, and a formal public consultation will begin in mid-September to ask the public’s opinion on the options of further raising thresholds for particular interventions or not routinely providing some interventions.

NH advised that further details regarding the financial aspects of the plan are included in the Chief Financial Officer’s report.

The Governing Body noted the progress and the additional plans for the delivery of the financial recovery and the recent performance against the constitutional standards and improvement trajectories.

2.5 Chief Financial Officer’s Report

MT provided a report detailing the headline financial position for NHS Wirral CCG as at the end of July (Month 4) 2016/17.

MT advised that as at the end of July, NHS Wirral CCG has a reported deficit of £5.253m and Minutes of the WCCG –Governing Body Meeting – PUBLIC SESSION – 6th September 2016 Page 5 of 8

Ref Minute No. explained the operational overspend.

MT informed the Board that the deficit position reported includes little QIPP achievement to date and a number of operational overspends. MT reported that the forecasted outturn position of £394k surplus is still the CCG reported planned control total in line with NHSE reporting expectations.

MT presented the best and worst case scenarios and reported that the worst case assumes no further QIPP delivery, no use of 1% headroom and includes the FNC pressure. The best case assumes £5m QIPP delivery to achieve 1% deficit.

MT highlighted the current key risks with the QIPP plan which include:

• There is significant risk to the CCG with the delay or failure of QIPP schemes to deliver the planned savings • Further unexpected cost pressures or allocation reductions throughout the year • Unexpected cost pressures against the CCGs running cost allocation • Of the overall £19m target saving area, £1.9m has been identified recurrently which would mean that £11.7m has been found no recurrently in addition to the £5.4m worth of QIPP schemes yet to be identified.

MT advised that due to the sizable challenge the CCG faces, it is to be noted that the underlying position of the CCG finances is a significant deficit. To date the position is based on achieving little progress towards the QIPP gap with the exception of contingency and 1% headroom.

In conclusion MT asked the Governing Body:

• To note that the CCG cash balance at the end of July was £23k. This is in line with current NHSE guidance that CCGs aims towards 1.25% month end cash balance of the drawdown. • To note the month 4 operational overspend of £5.253m and if no QIPP is delivered there will be a £16.7m deficit as a minimum. • To note the current forecast reported to NHSE remains as £394k surplus at present until we have exhausted all possible avenues to recover the QIPP planning gap.

The Governing Body noted the Chief Financial Officer’s report.

Financial Recovery Plan Delivery

MT gave an update of the financial recovery plan and the meeting he had attended with JD with NHS England. MT explained that the financial recovery plan presents the forecast outturn position as at July and draws attention to a number of scenarios and a number of recovery saving initiatives. MT advised that the plan also demonstrate how these initiatives will return the CCG to compliance with its Resource Limit and statutory duty by 2017/18.

AW highlighted that the report is clear although he feels the numbers around transformational areas are very ambitious and that the CCG would need to give close consideration to 2017/18 as well as the current year.

SS raised concerns regarding duplication and double counting of schemes and it was agreed that MT would look into this.

Members discussed the recovery plan and JD advised that the CCG will be writing to providers and trusts that are over performing in order to get a firmer grip on contracts.

JD also informed the Governing Body will be considering bringing in a recovery director to support the CCG.

Minutes of the WCCG –Governing Body Meeting – PUBLIC SESSION – 6th September 2016 Page 6 of 8

Ref Minute No.

GH highlighted the recovery plans impact on other organisations and the issues around complex care need cases and the need to pool future resources.

Members went on to review the Recovery Plan Savings Initiatives which include:

• Referral management • Products of Low Clinical Priority • Service Restriction Policy • Urgent Care Transformation • MSK Transformation • NHS Rightcare • Medicines Management • Healthcare Packages • Frailty • QIPP Schemes • Audiology Procurement • Direct Access Diagnostics • Other schemes to be identified to achieve resource limit

The Governing Body approved the recovery plan and noted that this will need to be signed off by NHS England. Members also agreed that they are happy for JD and MT to take the recovery plan forward with NHS England.

Action – MT to review duplication of services. Action – JD & MT to take the recovery plan forward with NHS England.

Lessons Learnt Paper

MT asked members to note the action plan to address the lessons learnt following the reporting of an unplanned deficit in 2015/16 and to note the progress in implementing the action plan.

The Governing Body noted and acknowledged the lessons learnt paper, together with the associated action plan.

2.6 Medical Director’s Report

SW asked Governing Body to note the progress in the report of the following areas:

• Urgent Care activity • Planned Care activity • Primary Care • Long Term conditions

Members noted the Medical Directors Report and commented on the excellent training results for the Wirral and the results of the national GP survey.

GB16- 3.0 Items for Noting 17/0011

3.1 Chair’s Briefing Reports

Summary reports were presented for the following committees:

• Clinical Senate - August 2016 Minutes of the WCCG –Governing Body Meeting – PUBLIC SESSION – 6th September 2016 Page 7 of 8

Ref Minute No. • Finance Committee– August 2016 • QPF Committee– August 2016 – AC drew members attention to the following areas discussed at the last QPF meeting: o WUTH Bed Occupancy o Value Stream Analysis o NHS 11 o IAPT o Out of Hours o Risks o Individual Funding Requests

JD commented on the quality of the Performance Pack and how useful the content and narrative is. Members agreed that the pack provides good assurance for the CCG.

3.2 Subgroups for Noting

• QPF meeting from 28th June 2016

Members noted the minutes as detailed above. GB16- 4.0 Risk Register 17/0012

PE updated the Governing Body on the discussion at the last QPF meeting, where the Risk Register is discussed in detail; Members supported the updates and agreed that existing risks remained at the same level.

Chair advised that all future risks would be discussed at the time a paper is presented within the meeting.

The Governing Body noted the current risk register.

5.0 Any other business

There were no other items of business. 6.0 Date and Time of Next Meeting

The date and time of the next formal meeting is Tuesday 4th October 2016 in the Nightingale Room, OMH please contact [email protected] with any apologies or agenda items.

Board meeting ended at: 17:10pm

Minutes of the WCCG –Governing Body Meeting – PUBLIC SESSION – 6th September 2016 Page 8 of 8

GB Formal Meetings Action Log

No. Date of meeting Title of Item Agenda Ref ID Action Lead(s) Deadline Progress Update 7 01.03.2016 Equality Act LQ to present an update on Equality & Diversity LQ November LQ Working with CSU on this LQ to invite WUTH to a Governing Body meeting to take through their action plan Nurse Director now attending 10 03.05.2016 Quality & Patient Safety Report GB/16-17/0002 2.3 LQ October in relation to the CQC report informal GB 11 03.05.2016 Patient Story GB/16-17/0001 1.7 LQ to view the patient's video and respond on behalf of the CCG LQ ASAP Waiting for production of video 14 06.09.2016 Chair's Announcements GB16-17/0009 1.2 PE and AJH to review format of future agendas and papers PE/AJH Oct-16 15 06.09.2016 Action Points GB16-17/0009 1.5 AJH to amend current action log to reflect numerical recordings AJH Oct-16 16 06.09.2016 Director of Corporate Affairs GB16-17/0010 2.2 PE to develop a dashboard highlighting areas of concern in regarding the CSU PE Nov-16 17 06.09.2016 Financial Recovery Plan Update GB16-17/0010 2.5 MT to review duplication of services MT Oct-16 18 06.09.2016 Risk Register GB16-17/0012 4 PE to add an aspirational risk column to the risk register PE Oct-16 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34

GOVERNING BODY BOARD REPORT COVER SHEET

Products of Limited Clinical Value Prescribing Policy Agenda Item: 2.1 Reference GB16-17/0013 Public / Private Public Meeting Date 04.10.2016 Lead Lorna Quigley - Director of Quality & Patient Safety Officer/Author of paper Contributors Jonathon Horgan – Head of Medicines Management Barbara Dunton - Commissioning Support Manager

Link to CCG Strategic System 1 Patient and primary care centric and based on high quality primary care, Plan secondary and community services 2 Rigorously developed and agreed care pathways working together with patients to secure their help, understanding, ownership and support of the needed changes 3 Commissioned services which have a sound evidence base 4 Provides greater equality of access to all Link to current strategic 2 Enhance the quality of life for people with long term conditions objectives 4 Ensuring people have a positive experience of care 5 Ensuring people are treated and cared for in a safe environment and protected from avoidable Harm To Approve Yes To Note To Ratify Summary There are a number of products currently prescribed in Wirral that are proven to be of limited clinical value, on the basis of safety, efficacy and cost effectiveness of the product. This is a cost to the CCG of approximately £16,000 per annum. These are products and medicines are considered to be of limited clinical value following review of published clinical trials and national clinical guidance from organisations such as NICE.

The paper outlines for Governing Body members the outcome of the consultation and a proposal to develop a policy to cease the prescribing of these products of low clinical value. Comments N/A Next Steps/ • Note the process that has been undertaken Recommendations • To support option one: the CCG to develop a policy which will cease the prescribing of Products of Low Clinical Value.

What are the implications for the following (if not applicable please state why): Financial Does the report consider the financial impact? YES

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GOVERNING BODY BOARD REPORT COVER SHEET

Wirral currently spends £16k per year on products of limited value. If the policy was implemented, this would be a saving. If a policy was not implemented, Wirral health economy would continue to spend in the area of £16k on these products.

Value For Money Does the report consider value for money? YES

Throughout the process the CCG is maintaining its responsibility under the Health and Social Care act of 2012 by: Performing our duties efficiently and manage our resources effectively Promoting the values of the NHS and protect its future

Risk Is there a documented risk assessment? YES

A quality impact assessment has been undertaken. If approved, this policy will be under review, should any risks be identified during implementation, or new evidence is published in relation to these products.

Legal Are there any legal implications and has legal advice been obtained? NO

This process has been in line with the CCGs commissioning decisions policy and procedure which has undergone previous legal review.

The process has public consultation which is compliant with the duty to consult Patient and Public Does the report provide evidence whether there could be a positive or Involvement (PPI) negative impact on patients and public? YES

Each option for consideration within the consultation assesses impact on patients Equality & Human Does the report provide evidence of whether there could be a positive or Rights negative impact on protected groups (statutory duty for new / changes to services) YES

An equality impact assessment has been undertaken both before and following the consultation. Workforce Does the report provide evidence of whether there could be a positive or negative impact on the CCG or other NHS staff? NO

Patients requiring these products include patients within CCG or NHS staff

Partnership Working Does the report evidence a partnership working in its development? YES

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GOVERNING BODY BOARD REPORT COVER SHEET

Midlands & Lancashire CSU Medicines Management professional technical advice Local Pharmaceutical Committee involvement Performance Does the report indicate any relevant performance indicators for this item? Indicators NO

Not applicable as consultation did not have associated performance indicators Sustainability Does the report address economic, social and environmental sustainability (should be addressed for new / change projects)? YES

Consultation options take into account impact on patient group

Do you agree that this document can be published on the website?  (If not, please note that it may still be subject to disclosure under Freedom of Information - Freedom of Information Exemptions

This section gives details not only of where the actual paper has previously been submitted and what the outcome was but also of its development path i.e. other papers that are directly related to the current paper under discussion.

Report History/Development Path

Report Name Reference Submitted to Date Brief Summary of Outcome

Private Business

The Board may exclude the public from a meeting whenever publicity (on the item under discussion) would be prejudicial to the public interest by reason of the confidential nature of the business to be transacted or for other special reasons stated in the resolution. If this applied, items must be submitted to the private business section of the Board (Section 1 (2) Public Bodies (Admission to Meetings) Act 1960). The definition of “prejudicial” is where the information is of a type the publication of which may be inappropriate or damaging to an identifiable person or organisation or otherwise contrary to the public interest or which relates to the provision of legal advice (for example clinical care information or employment details of an identifiable individual or commercially confidential information relating to a private sector organisation).

If a report is deemed to be for private business, please note that the tick in the box, indicating whether it can be published on the website, must be changed to an x.

If you require any additional information please contact the Lead Officer.

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GOVERNING BODY BOARD REPORT

Report Title Products of Limited Clinical Value Prescribing Policy

Lead Officers Lorna Quigley - Director of Quality & Patient Safety Jonathan Horgan – Head of Medicines Management

Contributors Barbara Dunton - Commissioning Support Manager

Recommendations 1. Governing Body to review the findings of the public consultation 2. Governing Body to consider the two options included in the consultation in a wider context 3. Governing Body to decide if Wirral are to introduce any changes in the prescribing of products deemed to be of limited clinical value

1. INTRODUCTION

i. This paper outlines the drivers for change and the process Wirral CCG has undertaken in the development of a policy for Products of Low Clinical Value (PLCV), and that the Governing Body recommend the development of a policy to be implemented across Wirral.

ii. This paper provides the Governing Body members with a summary of the proposal to develop a stop prescribing policy which, if implemented would result in the cessation of the prescribing of these products on prescription.

iii. The proposal has been developed by Wirral CCG and has been subject to a formal 60 day consultation with stakeholders and the public. The results of this consultation are summarised in this report to enable members to make an informed decision.

2. BACKGROUND

iv. For the purpose of transparency and to ensure the public are aware of the suggested changes, Wirral CCG has decided not to make a change in the prescribing policy, as have other areas, without seeking the views of patients and public via a public consultation.

v. There are a number of products currently prescribed in Wirral that are proven to be of limited clinical value, on the basis of safety, efficacy and cost effectiveness of the product. These are products and medicines are considered to be of limited clinical value following review of published clinical trials and national clinical guidance from organisations such as NICE. These can be found below.

• Antioxidant supplements for age related macular degeneration (this does not include treatments such as Lucentis for Wet Macular Degeneration) - Evidence base does

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GOVERNING BODY BOARD REPORT

not show that lutein and other eye vitamins are beneficial. Products are food supplements and not licenced medicines. Reference - AMD Guidelines Group. The Royal College of Opthalmologists. Age Related Macular Degeneration. Guidelines for Management. (Chapter 6). September 2013. Available at https://www.rcophth.ac.uk/wp-content/uploads/2014/12/2013-SCI-318-RCOphth- AMD-Guidelines-Sept-2013-FINAL-2.pdf

• Lactase enzyme drops (for colic) - Colief is not considered to be a medicinal product suitable for prescribing on the NHS unless the criteria set out by the Advisory Committee on Borderline Substances (ACBS) are met. Infacol is denoted in the BNF as being less suitable for prescribing on the NHS. Evidence does not support use. Gripe water is not licenced for the treatment of infantile colic and should not be used.

• Supplements for joints (e.g. glucosamine) – The recommendation in NICE CG177.4 states “Do not offer glucosamine or chondroitin products for the management of osteoarthritis.” Ref: https://www.nice.org.uk/donotdo/the-use-of- glucosamine-products-is-not-recommended-for-the-treatment-of-osteoarthritis

vi. NHS Wirral CCG spend approximately £16,000 per annum on products of limited clinical value such as antioxidant supplements for age related macular degeneration, lactase enzyme drops (for colic) and supplements for joints (e.g. glucosamine). vii. The proposal is for the CCG to develop a prescribing policy to not prescribe products with little clinical evidence and deemed to be of limited clinical value. In developing this policy the CCG is maintaining its statuary responsibility under the Health and Social Care Act of 2012 by:

• Seeking to continuously improve services and reduce inequalities • Working with patients, carers and the public while making decisions • Partnering with other health and social care bodies in planning and delivery • Performing our duties efficiently and manage our resources effectively • Promoting the values of the NHS and protect its future viii. The medications being considered to be included in the policy are listed below:

• Antioxidant supplements for age related macular degeneration (this does not include treatments such as Lucentis for Wet Macular Degeneration). • Lactase enzyme drops (for colic) • Supplements for joints (e.g. glucosamine)

3. PROCESS

i. To enable the production of this paper and support the Governing Body’s decision making, the following process has been undertaken

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GOVERNING BODY BOARD REPORT ii. Wirral CCG undertook some pre-engagement at various patient and public engagement events and at our GP prescribing events around this prescribing policy. This engagement work identified a range of views from the public and GPs on the current policy and on the proposal to change. This feedback was valuable in developing the structure of the consultation. i. Stakeholder analysis was completed prior to the consultation which considered both protected stakeholder groups and other stakeholder groups, key findings include:

• Additional thought needs to be given to those in receipt of state benefits who would be adversely affected by this change in policy • Will particularly affect pregnant women and 1 year after delivery. • Documentation will need to be provided in multiple languages upon request ii. A commissioning decisions impact assessment was also completed prior to the consultation, keys findings include:

• A change from 90 day top 60 day consultation period was felt appropriate • The positive impact will release NHS resources to be spent in other areas • Those most likely to affect negatively are those currently in receipt of free prescriptions • This could affect patient with low incomes, therefore GPs will exercise clinical judgement when assessing clinical needs and signpost patients to other appropriate NHS commissioned service or self- care models e.g. puffel. iii. A 60 day public consultation was undertaken which ended on Sunday 14th August at midnight. This took a number of forms which included:

• Publication of the on the CCG’s Website • Public meetings • Presentation to Wirral CCGs Patient Voice Group • Wider presentation to public meeting • Fortnightly publication on Wirral CCG’s weekly bulletin to a health care professionals across Wirral vi. The consultation gave the following options:

For items where there is little clinical evidence to support the effectiveness, which of the following options would you support?

Option Select 1 option Option 1 Stop prescribing items deemed to be of limited clinical value Option 2 Continue prescribing items deemed to be of limited clinical value at a cost to the NHS

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4. KEY ISSUES/MESSAGES

i. Key demographic highlights and trends are detailed below: • 203 patients and public responded to the survey - This figure includes all of the responses received in writing which have been added onto the online survey for the purpose of aggregating results and are clearly indicated when they have been manually entered. These responses can be correlated back to the individual paper copy which is securely stored. • 132/134 comments made were by Wirral residents • 87% of respondents opted to support a prescribing policy which would stop prescribing the items listed above • 65% of respondents were classed as female • 35% of respondents were classed as male • The majority of respondents – 33% - were aged 50 - 64 • Out of the respondents who classed themselves as having an impairment, 51% of these were related to mobility • 92% of respondents classed themselves as British or mixed British • 52% of respondents classed themselves as in full time work • 89% or respondents classed themselves as Christian • 82% of respondents classed themselves as heterosexual • Full demographic details of respondents can be found in Appendix 1

5. Qualitative Analysis of Public Consultation free text comments can be found below, these have been collated into common themes, to contextualize some real examples of public comments are also included below.

Thematic analysis of comments in order of frequency

Go with the opinion of the experts – stop if not effective

“Prescribing items of limited clinical value on prescription is a total waste of GP time and NHS resources”

Limited – means some value to few – keep for them

“It states limited, not none. If there is a chance of some positive effects, then these should be given….at risk of the patient suffering more without them”

Patients should self-purchase

“If patients want these items which are of limited clinical value – they need to buy them themselves”

Patients will understand as long as message is communicated effectively – need more social prescribing

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“Although I have agreed to stop prescribing these items, the CCG has much more work to do in communicating with patients. If they are of little clinical value, why are GP’s prescribing them? There also needs to be much more active involvement by the CCG/GP in educating us about self-care”

Make savings from NHS staff salaries stop making cutbacks

“stop paying consultants and GPs ridiculous salaries like £375k plus per year and stop holding the gun to NHS heads then we wouldn’t be quibbling about £36k and jo public carrying the can like we did for the banks”

Waste of public money

“If they are of limited clinical value – why waste public monies on prescriptions”

Continue to prescribe

“Stop these cut backs and let us live our life in comfort and pain free”

Leave the decision to the prescribing GP

“Let the doctor decide. Do not tie the doctor’s hands when considering treatments for their patients. You don’t fight with one arm behind your back”

Patients should be offered alternatives if there are any “However, alternative evidence based medicines (if available) should be offered to patients” 6. IMPLICATIONS

i. Wirral CCG Prescribing of PLCV Products (Financial Year 15/16)

Product Group Total Items Total Actual Cost PLCV Colief 593 £8,093.96 PLCV Eye Vitamins 715 £7,017.48 PLCV Glucosamine 36 £674.41

7. CONCLUSION

i. Governing Body is asked to:

• Note the process that has been undertaken • To support option one: the CCG to develop a policy which will cease the prescribing of Products of Low Clinical Value.

ii. Wirral CCG would like to take this opportunity to than all of the respondents who shared their views and took part in this survey.

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8. APPENDICES

No. Title of Appendix 1 Public consultation results

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Products of limited clinical value consultation - Patients, carers and stakeholders SurveyMonkey

Q1 I am a:

Answered: 207 Skipped: 0

Member of the public in...

Member of the public

Medical professional...

Voluntary sector or...

Other (please specifiy)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Member of the public in Wirral 52.17% 108

Member of the public 3.86% 8

Medical professional/work in the NHS 38.65% 80

Voluntary sector or community group 3.86% 8

Other (please specifiy) 1.45% 3

Total 207

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Q2 For items where there is little clinical evidence to support the effectiveness, which of the following options would you support?

Answered: 203 Skipped: 4

Stop prescribing...

Continue prescribing...

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Stop prescribing items deemed to be of limited clinical value 87.19% 177

Continue prescribing items deemed to be of limited clinical value at a cost to the NHS 12.81% 26

Total 203

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Q3 Do you have any other comments you would like to make regarding this proposal?

Answered: 63 Skipped: 144

3 / 19 Products of limited clinical value consultation - Patients, carers and stakeholders SurveyMonkey

Q4 Equality Monitoring FormIf you could please spare a couple of minutes more by completing the quick questions below you will be helping us to look at how effective we are involving all sections of the Wirral community we serve.Answer as much or as little as you want. Whatever information you give, we will not be able to identify you as an individual, so your identity is safe - the information you share simply goes towards providing a large profile of the types of people that have commented so we can ensure that we are meeting the right needs of our community.Thank you for your time - it is greatly appreciated.

Answered: 2 Skipped: 205

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Q5 Please provide the first three characters of your postcode

Answered: 134 Skipped: 73

5 / 19 Products of limited clinical value consultation - Patients, carers and stakeholders SurveyMonkey

Q6 What is your gender?

Answered: 169 Skipped: 38

Male

Female

Prefer not to say

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Male 34.91% 59

Female 64.50% 109

Prefer not to say 0.59% 1

Total 169

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Q7 What is your age?

Answered: 168 Skipped: 39

Under 25

25 - 34

35 - 49

50 - 64

65 - 74

75 - 84

85 - 94

95+

Prefer not to say

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Under 25 0.00% 0

25 - 34 13.69% 23

35 - 49 29.76% 50

50 - 64 32.74% 55

65 - 74 13.10% 22

75 - 84 5.36% 9

85 - 94 2.38% 4

95+ 0.00% 0

Prefer not to say 2.98% 5

Total 168

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Q8 Are you a person with impairments?

Answered: 164 Skipped: 43

Yes

Prefer not to say

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Yes 25.61% 42

No 73.17% 120

Prefer not to say 1.22% 2

Total 164

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Q9 If yes, is your impairment related to:

Answered: 41 Skipped: 166

Learning

Vision

Deaf/hearing impairment

Mobility

Mental Health

A hidden impairment

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Learning 2.44% 1

Vision 7.32% 3

Deaf/hearing impairment 14.63% 6

Mobility 51.22% 21

Mental Health 7.32% 3

A hidden impairment 9.76% 4

Other (Please specify) 7.32% 3

Total 41

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Q10 Which group below do you most identify with?Please select only ONE box.

Answered: 163 Skipped: 44

British or Mixed British

English

Irish

Scottish

Welsh

Prefer not to say

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

British or Mixed British 42.33% 69

English 49.69% 81

Irish 1.23% 2

Scottish 1.23% 2

Welsh 1.84% 3

Prefer not to say 2.45% 4

Other (Please specify) 1.23% 2

Total 163

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Q11 Please select only ONE box from below

Answered: 141 Skipped: 66

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Bangladeshi

Indian

Pakistani

Any other Asian...

African

Caribbean

Any other Black...

Any other Chinese...

Asian and White

Black African and White

Black Caribbean an...

Any other Mixed ethnic...

White European background

White background

Any other ethnic...

Gypsy/traveller

Prefer not to say

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Bangladeshi 0.00% 0

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Indian 0.00% 0

Pakistani 0.00% 0

Any other Asian background 0.00% 0

African 0.00% 0

Caribbean 0.00% 0

Any other Black background 0.00% 0

Any other Chinese background 0.00% 0

Asian and White 0.00% 0

Black African and White 0.00% 0

Black Caribbean and White 0.00% 0

Any other Mixed ethnic background 0.71% 1

White European background 31.91% 45

White background 62.41% 88

Any other ethnic background 0.00% 0

Gypsy/traveller 0.00% 0

Prefer not to say 3.55% 5

Other (Please specify) 1.42% 2

Total 141

13 / 19 Products of limited clinical value consultation - Patients, carers and stakeholders SurveyMonkey

Q12 You can stop here if you wish, however, we have more questions that we would like you to answer. Some may seem personal, you can choose not to answer these, but the more you can answer the more it helps us. We have no way of identifying you as an individual, so your answers are anonymous.Which of these activities best describes your situation?

Answered: 160 Skipped: 47

Full-time work

Fully retired

Part-time worker

Self-employed

Full- time student

Unemployed and available to...

Unable to work due to...

Look after the home/family

Government training scheme

Prefer not to say

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Full-time work 51.88% 83

23.13% 37 Fully retired

Part-time worker 11.25% 18

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Self-employed 4.38% 7

Full- time student 0.63% 1

Unemployed and available to work 1.25% 2

Unable to work due to illness/disability 3.75% 6

Look after the home/family 1.25% 2

Government training scheme 0.00% 0

Prefer not to say 1.88% 3

Other (Please specify) 0.63% 1

Total 160

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Q13 Do you have a religion or belief?

Answered: 155 Skipped: 52

Yes

Prefer not to say

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Yes 54.19% 84

No 38.06% 59

Prefer not to say 7.74% 12

Total 155

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Q14 If yes, please select:

Answered: 87 Skipped: 120

Buddhist

Christian

Hindu

Jewish

Muslim

Sikh

Prefer not to say

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Buddhist 0.00% 0

Christian 88.51% 77

Hindu 0.00% 0

Jewish 1.15% 1

Muslim 0.00% 0

Sikh 0.00% 0

Prefer not to say 6.90% 6

Other (Please specify) 3.45% 3

Total 87

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Q15 What is your sexual orientation?

Answered: 151 Skipped: 56

Bisexual

Gay man

Gay woman/lesbian

Heterosexual/st raight

Prefer not to say

Other (please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Bisexual 3.31% 5

Gay man 3.31% 5

Gay woman/lesbian 1.99% 3

Heterosexual/straight 82.12% 124

Prefer not to say 8.61% 13

Other (please specify) 0.66% 1

Total 151

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Q16 Is your current gender identity the same as the one on your birth certificate?

Answered: 144 Skipped: 63

Yes

Prefer not to say

Not sure what this means

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Yes 94.44% 136

No 1.39% 2

Prefer not to say 4.17% 6

Not sure what this means 0.00% 0

Total 144

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GOVERNING BODY BOARD REPORT COVER SHEET

Self-Care Prescribing Policy

Agenda Item: 2.2 Reference GB16-17/0013 Public / Private Public Meeting Date 04.10.2016 Lead Lorna Quigley - Director of Quality & Patient Safety Officer/Author of paper Contributors Jonathan Horgan – Head of Medicines Management Barbara Dunton - Commissioning Support Manager

Link to CCG Strategic System 1 Patient and primary care centric and based on high quality primary care, Plan secondary and community services 2 Rigorously developed and agreed care pathways working together with patients to secure their help, understanding, ownership and support of the needed changes 3 Commissioned services which have a sound evidence base 4 Provides greater equality of access to all Link to current strategic objectives 2 Enhance the quality of life for people with long term conditions 4 Ensuring people have a positive experience of care 5 Ensuring people are treated and cared for in a safe environment and protected from avoidable Harm To Approve Yes To Note To Ratify Summary There are a number of medicines currently prescribed in Wirral for minor ailments that patients can purchase over the counter in pharmacies and/or retail outlets such as supermarkets including

. Pain killers (such as ibuprofen and paracetamol) for short term used to treat minor aches and pains . Ear wax removers . Lozenges, throat sprays, mouthwashes, gargles and toothpastes . Indigestion remedies for occasional use . Creams for minor scars . Hair removal creams . Threadworm tablets . Laxatives for short term use (<72 hrs) . Anti-diarrhoeal medication for short term diarrhoea (<72hrs) . Haemorrhoidal preparations e.g. Anusol . Moisturising creams, gels, ointments and balms for dry skin with no diagnosis

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. Head lice treatments . Hay fever remedies e.g. antihistamines, nasal sprays (patients >18yrs) . Medicated shampoos e.g. Alphosyl, Capasal . Sun creams - unless diagnosed photo-sensitivity as a result of genetic disorders . Vitamins, foods and supplements except where clinically indicated

The paper outlines for Governing Body members, the outcome of the consultation and a proposal to develop a self -care prescribing policy.

Comments N/A Next Steps/ 1. Governing Body to review the process that has been undertaken Recommendations 2. Governing Body to approve the development of a self-care policy for MINOR ailments which will cease prescribing over the counter products to patients in line with the findings of the public consultation

What are the implications for the following (if not applicable please state why): Financial Does the report consider the financial impact? YES

Wirral health economy spends £541K per year in this area of prescribing. By introducing this policy there would be a reduction to prescribing costs that could be spend differently. Not having a policy, the CCG would continue to spend in the area of £541k on these products.

Value For Money Does the report consider value for money? YES

Throughout the process the CCG is maintaining its responsibility under the Health and Social Care act of 2012 by:

Performing our duties efficiently and manage our resources effectively Promoting the values of the NHS and protect its future Risk Is there a documented risk assessment? YES

A quality impact assessment has been undertaken. If approved, the policy will have ongoing review for any further risks.

Legal Are there any legal implications and has legal advice been obtained? NO

This process has been in line with the CCGs commissioning decisions policy and procedure which has undergone previous legal review.

The process has undergone public consultation which is compliant with the duty to consult.

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Patient and Public Does the report provide evidence whether there could be a positive or Involvement (PPI) negative impact on patients and public? YES

Each option for consideration within the consultation assesses impact on patients. Equality & Human Does the report provide evidence of whether there could be a positive or Rights negative impact on protected groups (statutory duty for new / changes to services) YES

An equality impact assessment has been undertaken both before and after the consultation. Workforce Does the report provide evidence of whether there could be a positive or negative impact on the CCG or other NHS staff? NO

Patients needing these products include patients within CCG or NHS staff. This proposal will also promote the role of the community pharmacy.

Partnership Working Does the report evidence a partnership working in its development? YES

Midlands & Lancashire CSU Medicines Management professional technical advice. Local Medical Pharmaceutical Committee have been involved Performance Does the report indicate any relevant performance indicators for this item? Indicators NO

Consultation options take into account impact on patient group. A quality impact assessment has also been undertaken and included within the report.

Do you agree that this document can be published on the website?  (If not, please note that it may still be subject to disclosure under Freedom of Information - Freedom of Information Exemptions

Report History/Development Path

Report Name Reference Submitted to Date Brief Summary of Outcome

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Private Business

If a report is deemed to be for private business, please note that the tick in the box, indicating whether it can be published on the website, must be changed to an x.

If you require any additional information please contact the Lead Officer.

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GOVERNING BODY BOARD REPORT

Report Title Self-Care Prescribing Policy – Over the Counter Products (OTC)

Lead Officers Lorna Quigley - Director of Quality & Patient Safety Jonathan Horgan – Head of Medicines Management

Contributors Barbara Dunton - Commissioning Support Manager

1. INTRODUCTION

I. This paper outlines the drivers for change and the process Wirral CCG has undertaken to introduce a self-care policy to cease the prescribing of products for minor ailments on prescription which are available to purchase over the counter in pharmacies, supermarkets and local stores.

II. This paper provides the Governing Body members with a summary of the proposal to develop a Self-Care Prescribing Policy which, if implemented would result in the cessation of the prescribing of products on prescription which are available for purchase in pharmacies, supermarkets and local stores.

III. The proposal has been developed by Wirral CCG and has been subject to a formal 60 day consultation with stakeholders and the public. The results of this consultation are summarised in this report to enable members to make an informed decision.

2 CURRENT POSITION

There are a number of medicines currently prescribed in Wirral that patients can purchase over the counter in pharmacies and/or retail outlets such as supermarkets, including those listed below:

The medications being considered for this proposal include:

. Pain killers (such as ibuprofen and paracetamol) for short term used to treat MINOR aches and pains

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. Ear wax removers . Lozenges, throat sprays, mouthwashes, gargles and toothpastes . Indigestion remedies for occasional use . Creams for minor scars . Hair removal creams . Threadworm tablets . Laxatives for short term use (<72 hrs) . Anti-diarrhoeal medication for short term diarrhoea (<72hrs) . Haemorrhoidal preparations e.g. Anusol . Moisturising creams, gels, ointments and balms for dry skin with no diagnosis . Head lice treatments . Hay fever remedies e.g. antihistamines, nasal sprays (patients >18yrs) . Medicated shampoos e.g. Alphosyl, Capasal . Sun creams - unless diagnosed photo-sensitivity as a result of genetic disorders (see FAQ section for more information) . Vitamins, foods and supplements except where clinically indicated (to be determined by your GP)

*This list is not exhaustive

i. The medicines on the list above are usually prescribed on a short term basis for the treatment of minor health problems only. Where this is not the case and they are prescribed for a long standing health problem, where clinically appropriate, they will continue to be prescribed. ii. Wirral CCG spends approximately £2m per year on medicines and products that can be used for the treatment of minor ailments. Many of which are available to buy over the counter from community pharmacies and retail outlets such as supermarkets. Whilst a proportion of the medicines and products prescribed will be used in the management of long term medical conditions; it is estimated that approximately £541K per annum is spent on the treatment of short term, minor conditions. Examples of prescribing expenditure on commonly prescribed medicines during 2015/16 are outlined over:

Medication Total 2015/16 Estimated Prescribing Prescribing Expenditure linked to Minor Expenditure Conditions Analgesics (pain killers £603,208 (including £120,600 (estimated to be such as paracetamol prescribing for long term 20% of total prescribing) and ibuprofen) pain management) Indigestion remedies £271,319 (including £27,100 (estimated to be and antacids (e.g. prescribing for long term 10% of total prescribing) Gaviscon liquid and management of acid tablets and ranitidine) reflux and associated conditions) Emollient and £657,474 (including £32,850 (estimated to be 5% moisturising management of long term of total prescribing)

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preparations (e.g. E45 skin conditions, e.g. cream, Aqueous eczema and psoriasis) Cream and Oilatum) Head Lice £24,336 £24,336 Preparations Sore Throat products £13,707 £13,707 (e.g. lozenges and sprays) Ear Wax products £653 £653 Cough and Cold £7,771 £7,771 Treatments Antifungal treatments £72,444 £72,444 (e.g. for athletes foot and thrush) Allergy eye drops (e.g. £28,429 £28,429 for hay fever) Oral Antihistamines £76,240 £76,240 (e.g. oral hay fever remedies) Medicated Shampoos £54,046 £54,046 Antibacterial Eye £19,713 £19,713 Drops (e.g. to treat conjunctivitis) NSAID Gels (e.g. £96,490 £9,600 (estimated 10% of ibuprofen 5% gel) total prescribing) Haemorrhoids £43,229 £34,500 (estimated 80% of treatment (e.g. Anusol) total prescribing) Oral rehydration £19,713 £19,713 sachets (e.g. Dioralyte) Total £1,988,776 £541,702

I. In addition to the cost of the medication there are also prescribing and dispensing costs when these medicines are provided via the NHS. By not prescribing this there is a potential to reduce GP appointments requested for the prescribing of these items which would improve access for patients.

2. PROCESS

i. To enable the production of this paper and support the Governing Body’s decision making, the following process has been undertaken;

ii. Wirral CCG undertook some pre-engagement at various patient and public engagement events and at our GP prescribing events around the proposal to develop a self-care prescribing policy. This engagement work identified a range of views from the public and GPs on the current policy and on the proposal to change it. This feedback was valuable in developing the structure of the consultation.

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iii. Stakeholder analysis was completed prior to the consultation which considered both protected stakeholder groups and other stakeholder groups, key findings include:

• Additional thought needs to be given to those in receipt of state benefits who would be adversely affected by this change in policy • Will particularly affect pregnant women and 1 year after delivery. • Documentation will need to be provided in multiple languages upon request iv. A commissioning decisions impact assessment was also completed prior to the consultation, keys findings include:

• A change from 90 day to 60 day consultation period was felt appropriate • The positive impact will release NHS resources to be spent in other areas • Those most likely to affect negatively are those currently in receipt of free prescriptions • If the CCG were to stop prescribing these products, a review would also need to be undertaken of the Think Pharmacy scheme, as this would contradict the outcome. • This could adversely affect patient with low incomes, therefore GPs will exercise clinical judgement when assessing clinical needs and signpost patients to other appropriate services or to self-care model, e.g. an alternative method of head lice removal is “wet combing”.

v. A 60 day public consultation was undertaken which ended on Sunday 14th August at midnight. This took a number of forms which included:

vi. The following options were presented in the public consultation survey.

Do you think that the medicines listed above should be prescribed by a Doctor/Nurse (other than an exceptionality or where NOT a minor ailment)

Tick here Option 1 Continue with current prescribing of over the counter products at a cost to the NHS Option 2 Stop prescribing over the counter products to patients who are able to self-purchase

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3. KEY ISSUES/MESSAGES

i. Key demographic highlights and trend are detailed below: • 256 patients and public responded to the survey • 250 patients were Wirral residents – 6 were from out of the area • 69% of respondents were female, 30% were males and 1% preferred not to say • The highest amount of respondents were aged between 50-64 – 34% • Out of the respondents who classed themselves as having an impairment, 43% of these were related to mobility • 94% of respondents classed themselves as British and White British • 52% of respondents classed themselves as in full time work • 88% of respondents classed themselves as Christian • 82% of respondents classed themselves as heterosexual • Full demographic details can be found in Appendix 1

ii. 89% of respondents opted to support the development of a prescribing policy which limits the prescribing of over the counter medicines for patients who can afford to buy them over the counter. This figure includes all of the responses received in writing which have been added onto the online survey for the purpose of aggregating results and are clearly indicated when they have been manually entered. These responses can be correlated back to the individual paper copy which is securely stored.

iii. 11% of respondents opted to continue to prescribe items available over the counter for short term ailments.

iv. Whilst a proportion of the medicines and products prescribed will be used in the management of long term medical conditions; it is estimated that approximately £541K per annum is spent on the treatment of short term, minor conditions.

v. Qualitative Analysis of Public Consultation free text comments can be found below, these have been collated into common themes, to contextualize some real examples of public comments are also included below.

Thematic analysis of comments in order of frequency

Stop prescribing items which can be bought over the counter

“£1.6m is a huge amount of money to be spending on medication that can be purchased over the counter, if things like this continue we are in danger of losing our NHS”

Continue to support prescribing of these items for patients with long term

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conditions and under 18’s

“Continue in cases where use is on repeat. Where items are over a couple of pounds and to keep these items free for under 18’s”

Systems needs to be means tested for those who are unable to afford items

“Some OTC medicines are insanely cheap (paracetamol for 30p, for example) and everyone should be able to afford them - it is ridiculous that valuable resources are used to prescribe such medicines, but although some OTC medicines may be cheaper than a prescription, some patients may still find it a significant percentage from their living budget (esp if they need multiple packs, eg hayfever remedies for 3 children). We need to have a system where we support those who *truly* cannot afford to buy anything OTC (we do not want to tax illness) but at the same time it would need to be a system that could not be abused by those who *choose* not to buy anything. I don't know who this could be achieved, without making the poorest amongst us feel stigmatised.

Effective communications and advice on self-help and on alternatives to purchase

“There will be resistance to this for those who see free products as a right and the GP as a proxy shopping basket for simple remedies. I think that clinical systems may be equipped with scripts that direct primary care to offer and print a help-leaflet to suggest what they can buy and what price range they can expect to pay. It will also need a consistent approach across primary care and other prescribers that really should be hard-line. One issue might be the wide variety of packaging and forms of such medications, exemplified by nurofen cf. ibuprofen generic that represent very significant differences of cost. This initiative, if deployed should equip patients with the knowledge of what to seek in terms of cost-effectiveness”

Some items are not affordable to all to buy over the counter

If I was not able to get my children's eye drops for allergies and eczema cream on prescription it would put me in financial difficulty as I do not get benefits but am on a low income. Also getting children's painkillers on prescriptions to control fever etc has saved me becoming overdrawn. This would be a disaster for mine and may other families if this was no longer offered.

Prescribing of OTC products for under 18’s should continue

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I believe over the counter medicines should remain available for all children on prescription regardless of parental income (some parents may be embarrassed to admit they are struggling); however maybe there should be tighter restrictions in place for adults to prevent abuse of the system.

This policy would contradict the Think Pharmacy scheme

“GP surgeries had a policy which was blown out the water by the pharmacy ailment scheme, who give shed loads to anybody who wants it, because they get paid to do so!”

4. IMPLICATIONS

I. Governing Body is asked to consider the feedback from the public consultation as part of the decision making process

5. CONCLUSION

A summary of the main conclusions needs to be included that leads to the following points

i. Governing Body is asked to:

o Note the process that has been undertaken

o Support option two, to allow the CCG to develop a policy which will cease prescribing over the counter products to patients who are able to self-purchase in line with the findings of the public consultation.

o Wirral CCG would like to take this opportunity to than all of the respondents who shared their views and took part in this survey.

6. APPENDICES

No. Title of Appendix 1 Public consultation summary of results

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Over the counter medicines (OTC) Consultation - Patients, carers and stakeholders SurveyMonkey

Q1 I am a:

Answered: 266 Skipped: 1

Member of the public in...

Member of the public

Medical professional...

Voluntary sector or...

Other (please specifiy)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Member of the public in Wirral 58.27% 155

Member of the public 3.01% 8

Medical professional/work in the NHS 34.21% 91

Voluntary sector or community group 2.63% 7

Other (please specifiy) 1.88% 5

Total 266

1 / 19 Over the counter medicines (OTC) Consultation - Patients, carers and stakeholders SurveyMonkey

Q2 NHS Wirral Clinical Commissioning Group has considered 2 options relating to the future of NHS prescribing of over the counter medicinesIt will be the responsibility of NHS Wirral Clinical Commissioning Group's 'Governing Body' members to thoughtfully consider all information gathered, including the findings of this consultation and then decide a best way forward.The 2 options to be considered are described below. We would like you to read through these options:Option 1: General Practitioners and Nurses should be allowed to continue prescribing medicines which are available over the counter on NHS prescriptionsOption 2: A prescribing policy should be developed which limits the prescribing of medicines which are available over the counter, other than an exceptionality of where NOT a minor ailmentPlease select one option from the below:

Answered: 256 Skipped: 11

Continue to prescribe it...

Develop a prescribing...

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Continue to prescribe items available over the counter on NHS prescriptions 11.33% 29

Develop a prescribing policy which limits the prescribing of over the counter medicines for patients who can afford to buy them over the counter 88.67% 227

Total 256

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Q3 Do you have any other comments you would like to make regarding this proposal?

Answered: 106 Skipped: 161

3 / 19 Over the counter medicines (OTC) Consultation - Patients, carers and stakeholders SurveyMonkey

Answered: 9 Skipped: 258

4 / 19 Over the counter medicines (OTC) Consultation - Patients, carers and stakeholders SurveyMonkey

Q5 Please provide the first three characters of your postcode

Answered: 180 Skipped: 87

5 / 19 Over the counter medicines (OTC) Consultation - Patients, carers and stakeholders SurveyMonkey

Q6 What is your gender?

Answered: 213 Skipped: 54

Male

Female

Prefer not to say

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Male 30.05% 64

Female 68.54% 146

Prefer not to say 1.41% 3

Total 213

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Q7 What is your age?

Answered: 213 Skipped: 54

Under 25

25 - 34

35 - 49

50 - 64

65 - 74

75 - 84

85 - 94

95+

Prefer not to say

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Under 25 0.94% 2

25 - 34 13.62% 29

35 - 49 30.05% 64

50 - 64 34.27% 73

65 - 74 12.21% 26

75 - 84 5.16% 11

85 - 94 1.41% 3

95+ 0.00% 0

Prefer not to say 2.35% 5

Total 213

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Q8 Are you a person with impairments?

Answered: 212 Skipped: 55

Yes

Prefer not to say

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Yes 23.58% 50

No 73.11% 155

Prefer not to say 3.30% 7

Total 212

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Q9 If yes, is your impairment related to:

Answered: 46 Skipped: 221

Learning

Vision

Deaf/hearing impairment

Mobility

Mental Health

A hidden impairment

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Learning 4.35% 2

Vision 6.52% 3

Deaf/hearing impairment 19.57% 9

Mobility 43.48% 20

Mental Health 8.70% 4

A hidden impairment 8.70% 4

Other (Please specify) 8.70% 4

Total 46

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Q10 Which group below do you most identify with?Please select only ONE box.

Answered: 211 Skipped: 56

British or Mixed British

English

Irish

Scottish

Welsh

Prefer not to say

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

British or Mixed British 42.65% 90

English 50.71% 107

Irish 0.47% 1

Scottish 1.42% 3

Welsh 1.42% 3

Prefer not to say 3.32% 7

Other (Please specify) 0.00% 0

Total 211

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Q11 Please select only ONE box from below

Answered: 177 Skipped: 90

11 / 19 Over the counter medicines (OTC) Consultation - Patients, carers and stakeholders SurveyMonkey

Bangladeshi

Indian

Pakistani

Any other Asian...

African

Caribbean

Any other Black...

Any other Chinese...

Asian and White

Black African and White

Black Caribbean an...

Any other Mixed ethnic...

White European background

White background

Any other ethnic...

Gypsy/traveller

Prefer not to say

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Bangladeshi 0.00% 0

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Indian 0.56% 1

Pakistani 0.00% 0

Any other Asian background 0.00% 0

African 0.00% 0

Caribbean 0.00% 0

Any other Black background 0.00% 0

Any other Chinese background 0.00% 0

Asian and White 0.00% 0

Black African and White 0.00% 0

Black Caribbean and White 0.00% 0

Any other Mixed ethnic background 0.56% 1

White European background 32.20% 57

White background 62.15% 110

Any other ethnic background 0.00% 0

Gypsy/traveller 0.00% 0

Prefer not to say 3.39% 6

Other (Please specify) 1.13% 2

Total 177

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Answered: 203 Skipped: 64

Full-time work

Fully retired

Part-time worker

Self-employed

Full- time student

Unemployed and available to...

Unable to work due to...

Look after the home/family

Government training scheme

Prefer not to say

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Full-time work 51.72% 105

22.66% 46 Fully retired

Part-time worker 13.30% 27

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Self-employed 3.94% 8

Full- time student 0.99% 2

Unemployed and available to work 0.99% 2

Unable to work due to illness/disability 2.46% 5

Look after the home/family 0.99% 2

Government training scheme 0.00% 0

Prefer not to say 2.46% 5

Other (Please specify) 0.49% 1

Total 203

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Q13 Do you have a religion or belief?

Answered: 199 Skipped: 68

Yes

Prefer not to say

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Yes 52.26% 104

No 40.20% 80

Prefer not to say 7.54% 15

Total 199

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Q14 If yes, please select:

Answered: 104 Skipped: 163

Buddhist

Christian

Hindu

Jewish

Muslim

Sikh

Prefer not to say

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Buddhist 0.00% 0

Christian 88.46% 92

Hindu 0.96% 1

Jewish 0.96% 1

Muslim 0.00% 0

Sikh 0.00% 0

Prefer not to say 7.69% 8

Other (Please specify) 1.92% 2

Total 104

17 / 19 Over the counter medicines (OTC) Consultation - Patients, carers and stakeholders SurveyMonkey

Q15 What is your sexual orientation?

Answered: 194 Skipped: 73

Bisexual

Gay man

Gay woman/lesbian

Heterosexual/st raight

Prefer not to say

Other (please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Bisexual 2.58% 5

Gay man 2.06% 4

Gay woman/lesbian 1.03% 2

Heterosexual/straight 82.47% 160

Prefer not to say 10.31% 20

Other (please specify) 1.55% 3

Total 194

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Q16 Is your current gender identity the same as the one on your birth certificate?

Answered: 188 Skipped: 79

Yes

Prefer not to say

Not sure what this means

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Yes 94.68% 178

No 0.53% 1

Prefer not to say 4.79% 9

Not sure what this means 0.00% 0

Total 188

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GOVERNING BODY BOARD REPORT COVER SHEET

Gluten Free Prescribing Policy

Agenda Item: 2.3 Reference GB16-17/0013 Public / Private Public Meeting Date 04.10.2016 Lead Lorna Quigley - Director of Quality & Patient Safety Officer/Author of paper Contributors Jonathon Horgan- Head of Medicines Management Barbara Dunton - Commissioning Support Manager

Link to CCG Strategic System 1 Patient and primary care centric and based on high quality primary care, Plan secondary and community services 2 Rigorously developed and agreed care pathways working together with patients to secure their help, understanding, ownership and support of the needed changes 3 Commissioned services which have a sound evidence base 4 Provides greater equality of access to all Link to current strategic objectives 2 Enhance the quality of life for people with long term conditions 4 Ensuring people have a positive experience of care 5 Ensuring people are treated and cared for in a safe environment and protected from avoidable Harm To approve Yes To note To Ratify Summary NHS Wirral has had a Gluten free policy in existence since 2013; this was adopted following authorisation of the CCG and is due for review in 2016.

This paper outlines the drivers for change and the process Wirral CCG has undertaken in reviewing the gluten free prescribing policy, the options that have been considered and the decision required by Governing Body.

Comments N/A Next Steps/ Governing Body is asked to : Recommendations Note the process that has been undertaken in the review of this policy. Agree the way forward regarding the prescribing of gluten free products taking into account the options presented.

What are the implications for the following (if not applicable please state why):

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GOVERNING BODY BOARD REPORT COVER SHEET

Financial Does the report consider the financial impact? YES

Wirral Health Economy currently spends £162K per year in the prescribing of gluten free products in addition to a forecast of a further £90k over the next 2 years.

Value For Money Does the report consider value for money? YES

Risk Is there a documented risk assessment? YES

A quality impact assessment has been undertaken, if approved the policy will have ongoing review for any further risks. Legal Are there any legal implications and has legal advice been obtained? NO

This process has been in line with the CCGs commissioning decisions policy and procedure which has undergone previous legal review.

The process has included a public consultation which is compliant with the duty to consult

Patient and Public Does the report provide evidence whether there could be a positive or Involvement (PPI) negative impact on patients and public? YES

Patients requiring gluten free food include patients within CCG or NHS staff

Partnership Working Does the report evidence a partnership working in its development? YES

Midlands & Lancashire CSU Medicines Management professional technical advice Local Pharmaceutical Committee involvement

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GOVERNING BODY BOARD REPORT COVER SHEET

Performance Does the report indicate any relevant performance indicators for this item? Indicators NO

Consultation options take into account impact on patient group Do you agree that this document can be published on the website?  (If not, please note that it may still be subject to disclosure under Freedom of Information - Freedom of Information Exemptions

Report History/Development Path

Report Name Reference Submitted to Date Brief Summary of Outcome

Private Business

If a report is deemed to be for private business, please note that the tick in the box, indicating whether it can be published on the website, must be changed to an x.

If you require any additional information please contact the Lead Officer.

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GOVERNING BODY BOARD REPORT

Report Title Gluten Free Prescribing Policy

Lead Officers Lorna Quigley - Director of Quality & Patient Safety Jonathan Hogan – Head of Medicines Management

Contributors Barbara Dunton - Commissioning Support Manager

Recommendations 1. Governing Body to review the findings of the public consultation 2. Governing Body to consider the three options included in the consultation in a wider context 3. Governing Body to decide if Wirral are to introduce any changes in the prescribing of Gluten Free products provided on prescription

1. INTRODUCTION

i. This paper outlines the drivers for change and the process Wirral CCG has undertaken in reviewing the Gluten Free Prescribing Policy, the options that have been considered, and the decision required by Governing Body.

ii. This paper provides the Governing Body members with a summary of the proposal to change the current prescribing Policy for Gluten Free products which, if implemented would result in the cessation of the prescribing of products on prescription which are available for purchase in pharmacies, supermarkets and local stores.

2. BACKGROUND

iv. In the past, the availability of gluten free foods was low, therefore obtaining these products from community pharmacies via prescriptions improved access to them. However, with the increased awareness of coeliac disease and gluten sensitivity as well as a general trend towards eating less gluten, gluten free foods are now much easier and accessible to purchase. A wide and expanding range of gluten free foods are now available from supermarkets and online. In supermarkets some gluten free foods are more expensive than the gluten containing equivalents. However, the prices of many items are now similar to gluten containing equivalents. Also, the price paid by the NHS for gluten free foods on prescription is much higher than supermarket prices and in some cases it may be twice as expensive. As when prescribed there is the cost of GP time, community pharmacy

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dispensing fee and sometimes delivery charge when the pharmacy orders the food in from a wholesaler added to the cost of the gluten free food.

v. As displayed below, a number of items are available for similar cost to the gluten containing equivalent.

Products Reimbursement Supermarket price Supermarket price price by NHS on for for gluten- prescription gluten free product containing equivalent Loaf of bread (400 - 500g) £1.49 to £8.70 £1.99 to £3.00 £0.50 to £1.70 Plain flour (1kg) £2.95 to £14.70 £1.99 to £3.00 £1.00 to £1.89 Self-raising flour (1kg) £9.31 £1.99 to £3.00 £1.18 to £1.80 Bread mix (240g-250g) £1.04 to £4.48 £2.49 to £2.68 £0.75 to £1.20 Pizza base (each) £1.33 to £5.00 £0.90 to £1.00 £0.50 to £0.85 Pasta (500g) £2.72 to £11.25 £1.35 to £2.00 £0.29 to £2.40 Cake/pastry None in Drug Tariff £0.90 to £1.00 £0.12 to £1.00 Biscuits (200g) £2.09 to £3.82 £0.88 to £3.86 £0.39 to £1.50 500g oats £2.78 to £2.89 £2.25 to £3.00 £0.56 to £3.69 300g breakfast cereal £2.58 to £4.56 £1.50 to £3.25 £1.50 to £2.69

**NHS prices from MIMS March 2014 and Drug Tariff March 2014. Supermarket prices collected from www.mysupermarket.co.uk on 28th February and 1st March 2014. Supermarkets included: Tesco, Sainsbury’s, Asda and Morrison’s. No special offer prices included. Delivery/surcharges not included

3. Current Position

i. NHS Wirral has had a Gluten free policy in existence since 2013; this was adopted following authorisation of the CCG and was due for review in 2016 (Appendix1).

ii. In reviewing this policy, the CCG is maintaining its responsibility under the Health and Social Care act of 2012 by: 1. Seeking to continuously improve services and reduce inequalities 2. Working with patients, carers and the public when making decisions 3. Partnering with other health and social care bodies in planning and delivery 4. Performing our duties efficiently and manage our resources effectively 5. Promoting the values of the NHS and protect its future

This is also in line with the organsiation’s values and the approved and legally supporting commissioning Decisions Policy and Procedure.

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4. PROCESS

i. To enable the production of this paper and support the Governing Body’s decision making, the following process has been undertaken

ii. Wirral CCG undertook some pre-engagement at various patient and public Engagement events and at our GP prescribing events around the gluten-free prescribing policy. This engagement work identified a range of views from the public and GPs on the current policy and on the proposal to change gluten-free funding. This feedback was valuable in developing the structure of the consultation.

i. Stakeholder analysis was completed prior to the consultation which considered both protected stakeholder groups and other stakeholder groups, key findings include:

ii. A commissioning decisions impact assessment was also completed prior to the consultation, keys findings include:

• A change from 90 day top 60 day consultation period was felt appropriate • The positive impact will release NHS resources to be spent in other areas • Those most likely to affect negatively are those currently in receipt of free prescriptions • This could adversely affect patient with low incomes, therefore GPs are expected to exercise clinical judgement when assessing clinical needs and signpost patients to other appropriate NHS commissioned services.

iii. Following the consultation, the Equality Impact Assessment has been amended as particular care needs to be given to the provision of fresh bread (e.g: Juvela) which cannot be purchased from supermarkets, if these were to be stopped on prescription patients are however able to purchase directly from pharmacies only, however these products are very costly, excluding on costs the average cost to the NHS is £25 per loaf. See appendix 6.

iv. A 60 day public consultation was undertaken which ended on Sunday 14th August at midnight. This took a number of forms which included:

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The consultation asked stakeholders to consider the following options:

Would you support a further restriction on the prescribing of gluten free products, please select an option below:

Tick here Option 1 Continue with current prescribing of gluten free products on prescription Option 2 Develop further prescribing restrictions for certain gluten free products Option 3 Stop prescribing gluten free products on prescription all together

5. KEY ISSUES / MESSAGES

i. In total Wirral CCG received 645 responses to the consultation this figure includes all of the responses received in writing which have been added onto the online survey for the purpose of aggregating results and are clearly indicated when they have been manually entered. These responses can be correlated back to the individual paper copy which is securely stored.

ii. We also received 27 written responses from coeliac patients. We received 11 telephone calls from concerned patients. All were sent paper consultation documents and questionnaires for completion.

i. Key demographic highlights and trends are detailed below: • 203 patients and public responded to the survey - This figure includes all of the responses received in writing which have been added onto the online survey for the purpose of aggregating results and are clearly indicated when they have been manually entered. These responses can be correlated back to the individual paper copy which is securely stored. • 291/360 comments made were by Wirral residents – 69 comments made by non Wirral residents • 56% of patients who responded currently pay for prescriptions • 70% of respondents were classed as female • 29% of respondents were classed as male • The majority of respondents – 32% - were aged 50 - 64 • Out of the respondents who classed themselves as having an impairment, 44% of these were related to mobility • 92% of respondents classed themselves as British or mixed British • 45% of respondents classed themselves as in full time work • 90% or respondents classed themselves as Christian

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• 86% of respondents classed themselves as heterosexual • Full demographic details of respondents can be found in Appendix 2

RESULTS

6. RESULTS

The following results were collated from responses received.

i. 44% of respondents continue with current prescribing of gluten free products on prescription as per the 2013 guidelines

ii. 25% of respondents suggested to develop further prescribing restrictions for certain gluten free products

iii. 32% of respondents suggested stopping the prescribing of gluten free products on prescription all together

iv. Many coeliac disease patients can, and do, alter their diet and replace bread with other naturally gluten free foods such as rice or potatoes rather than trying to substitute with gluten free products, in which case, the incremental costs may be less.

v. Three national organisations also provided some feedback to be taken into account in the consultation process, these are summarized below, and the letters can be found in Appendix 3,4,5.

vi. British Specialist Nutritional Association Ltd (BSNA) – BSNA wish to alert the CCG that NICE are currently finalizing a quality standard on coeliac disease, due this Autumn, and wish to urge the CCG to defer any decision until this is complete and all those involved in coeliac care can consider the standard and coordinate a response which addresses patient needs in the most cost effective way.

• Suggest the CCG audit all patients currently receiving gluten free products on prescription in the area and check for eligibility – check patients are not exceeding the allowance. • Challenges some of the statements regarding using naturally gluten free products instead of bread • Demonstrates concern on affordability of products • Reviews research on the negative impact of restrictive prescribing policies of coeliac patients • Questions if the CCG will be implementing an impact assessment tool to monitor the impact of any change in service

vii. British Society of Gastroenterology (BSG) key points are: • Non adherence to the gluten-free diet is associated with an increased risk of long term complications, including osteoporosis, vitamin D deficiency and iron deficiency . These long term complications will impact upon quality of life for the patient and

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treating these complications are likely to result in financial implications for the NHS through other treatment costs or bed days

• As part of your review the BSG would urge that due regard is paid to the impact of any withdrawal of GFD prescriptions on patients and wider healthcare costs. Certainly the published evidence is that high street purchase of GFD products are three to four times the cost of equivalent gluten containing food

viii. Coeliac UK key points are:

• In your consultation document, you state that there has been a general trend towards eating less gluten. Unlike people with coeliac disease who have to follow a strict gluten-free for life, individuals who chose to eat less gluten with no medical basis are able to pick and choose when they follow a gluten-free diet.

• Gluten-free staple foods are not readily available to purchase in budget supermarkets and convenience stores. Therefore, it cannot be assumed that all people with coeliac disease will be able to purchase gluten-free foods in their local shop. Access to gluten-free food on prescription is especially vital for the most vulnerable such as the elderly or those with limited transport options.

• In your consultation, you state that gluten-free foods are accessible and available at prices similar to gluten containing equivalents. Please could you share the evidence behind these statements?

• The consultation document states that ‘GP prescribing of food products is not supported for other disease areas such as diabetes’. This statement is highly misleading as people with diabetes are recommended to follow a healthy, balanced diet and do not need to eliminate any specific foods additionally, national recommendations specifically recommend to not consume specialist diabetic products.

• We are concerned that the proposal to withdraw gluten-free food on prescription is not equitable and will have a disproportionate impact on the most vulnerable patients.

• As part of your policy review, we hope that you will consider alternative supply routes for gluten-free food which have been shown to produce cost savings as well as saving clinical time and also improving the patient experience. The Scottish Government has developed a Gluten-free Food Service for adults and children across Scotland. This centralised NHS gluten-free prescribing service is available through local pharmacies, and following an eighteen month trial period has been adopted as a permanent service within NHS Scotland since 1 October 2015.

*Full copies of these letters can be found in Appendix 3,4,5.

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ix. Qualitative Analysis of Public Consultation free text comments can be found below, these have been collated into common themes, to contextualize some real examples of public comments are also included below in order of frequency

Thematic analysis of comments in order of frequency

Gluten free products are more expensive

“There is an increased supply of gf products accessible to many - However costs are still significantly higher than non gf products. I accept due to the vast increase in available off the shelf products prescribe able items must be reviewed and prioritised. I do feel children diagnosed coeliac should have full access to prescribe able items and those on limited or reduced income. The likes of pizza bases and biscuits, crackers on prescription are not a necessity unlike bread and flour and a few other staple items these I do feel should remain on prescription. Please do be mindful although there is a vast increase in available products they are more expensive and when there is more than one gf individual in a family this can be extremely expensive and may well result in 'doing without'.”

“Identify the necessities from the niceties and there is your starting point. May I also request you hold talks and negotiations with suppliers and developers to discuss the options for reducing the costs of their products if more individuals relied upon supermarket access only. (You also need to bear in mind remote gf patients who rely heavily on their local chemists to provide their gf bread etc.)”

Keep bread and flour

“I feel the NHS give prescriptions FOC to out of work drug addicts. We are hardworking people, one of whom has a lifelong condition, we pay our NI and pay for our prescriptions. We understand taking away things considered to be luxuries (pizza bases/biscuits etc) but bread products and flours should be available. The implication of someone not following this diet would have more impact on the NHS due to other complications of this condition. I work in a sector that deals with the NHS and know there are savings to be made and cannot understand why the NHS is paying extortionate amounts for simple items (paracetamol etc) when they have procurement professionals able to negotiate contracts for these items”

A good variety can now be bought in supermarkets

“Very select group eligible for prescribed gluten free products. Other people buy

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it from the supermarket; price is now low and readily available. Should treat everybody equally, so is fair to take it off prescription. Money could be spent better elsewhere that could have a bigger impact on health eg mental health care.”

“I work in GP practices and the variety and quantity people get is ridiculous. I'm sure they're feeding the whole family. It is readily available now days so such be purchased from the shops.”

“Gluten free food is available in supermarkets at prices similar to non gluten free products. Prescriptions cost around £45 each to process; no brainer!!”

“Gluten free product are widely available in supermarkets my dad buys them he is 81.”

Keep bread only

“I was diagnosed with coeliac disease about 8 years ago. Coeliac disease is recognised and the medicine is gluten free food. I feel that people who suffer from other illnesses are prescribed medicine without question and feel that the proposed curtailment of prescriptions is discrimination of the most obvious and worst sort. My staple diet consists of gluten free bread. I have tried all the other gluten free breads and the only one that I can manage is 'Juvela Fresh White' I would be happy if the prescription allocation was confined to bread.”

NHS needs to negotiate deals with GF companies

“NHS could try & get a better deal from gf manufacturers! plus coeliac do not cost mega bucks in medication compared to diabetics! it's small change relatively to keep a large & growing group of people healthy & functioning”

“This is a procurement issue, revisit agreements with GF free food manufacturers about the costs of supplying these foods to the NHS, if NHS / pharmacies didn’t have to pay a premium for these products then this would reduce the cost to the NHS. NHS could reduce the money spent on GF products if a deal with the supermarkets to provide cheaper GF products was made. In comparison to what the shops charge for GF food I believe the NHS is charged much more for the GF products they provide. Despite the availability of GF products in the shops, the cost of these products to families may be prohibitive. Families with children who have coeliac disease should continue to get GF food on prescription.”

“I think this is more of an issue of suppliers of prescription foods abusing the system, NHS should be stronger in negotiating rather than penalising patients

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because prescription GF is more expensive than Supermarket GF. Also the prescription items are not as readily available, and the supermarket alternatives are not always of the same standard/usability (i.e. flour, etc.)”

Keeping to an allowance

“I think bread should continue to be prescribed as £2.30 for a loaf is too expensive for most people to afford and bread is an essential part of our diet. The difference in cost between ordinary bread and gluten free remains huge and a gluten free loaf is about one third the size of a standard loaf so you do need to buy more. (I get 5 loaves a month on prescription and buy the rest). If you have to make savings I think you should stop prescribing other gluten free products. Also I think it is unfair to compare coeliac to diabetics. While they may not get a food prescription they are usually prescribed medication which is also costly to the NHS. Finally can I just say what is going on with the purchasers in the NHS that they cannot get gluten free products supplied at a cheaper cost than a supermarket? As an organization you should be ashamed to admit this”

Policy change will penalize those on low incomes

“Should be based on individuals circumstances, and this should include other changes you are considering implementing, and the costs for the family i.e childrens charges etc, people on regular medication.”

“I work as a dietitian on the Wirral and regularly see patients who are newly diagnosed with Coeliac disease in my clinics. Many of the patients I see find the gluten free diet very challenging. A concern that is often expressed is the cost of gluten free alternatives. In addition many people shop in budget supermarkets where the availability of gluten free alternatives is limited. I believe that having access to gluten free products on prescription is essential in helping people to adhere to a lifelong gluten free diet. In addition it helps to ensure an adequate nutritional intake. If gluten free prescribing is discontinued I would be concerned that many will struggle to adhere to the diet. This could lead to an increase in related health complications such as osteoporosis, which would have an additional health burden for individuals and have cost implications for the NHS. A number of people I see choose not to get gluten free items on prescription because they prefer to buy their favoured products from the supermarket or on online, and they have the resources to enable them to do this. However, many are on low incomes and so rely on their gluten free prescriptions. To ensure access for those on lower incomes I believe it is important that gluten free products are available universally for anyone who is diagnosed with Coeliac disease.”

“I think it is important to protect vulnerable groups of patients. The cheapest GF

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GOVERNING BODY BOARD REPORT

bread listed is four times the price of the cheapest gluten containing one. For families on low incomes this is a real issue. Gluten containing products are not readily available in corner shops. I am a wheelchair user and unable to drive at present. There are two local convenience type shops I can get to in my wheelchair and neither stock GF staples such as bread, crackers or pasta. I am internet savvy and can do online shopping but in my practice (I am a retired health professional) I encountered older patients who did not have internet access and relied on the local corner shop - this made following a GF diet extremely challenging, without staples on prescription it would have been virtually impossible. I realise such individuals are few in number but they do exist. I object to the use of diabetes as a comparator condition to justify stopping staples on prescription - you are not comparing like with like!”

Can a voucher system be implemented?

“I am answering this on behalf of my 5 year old son who has coeliac disease and for his future. Gluten free products are very expensive and more difficult to find locally. They must be available on prescription to all people with coeliac disease who have no option but to follow a gluten free diet. It would be better I feel however to have supermarket vouchers or vouchers that could be used at a number of supermarkets for the purchase of gluten free foods. My shopping costs double even with the use of prescription. I am a working mum of 3 and do have to rely on some convenience food that can be quickly prepared. To buy this gluten free is very expensive. Gluten free food vouchers would be much much cheaper for the government than providing gf food on prescription and would give those with coeliac less restrictions”

Associated costs of GF products are high

“I have and always have paid for my prescriptions therefore it is important to make clear the gluten free food I receive is not free. I feel people lose sight of the fact that coeliac disease is a medical condition and controlled by food intake and is also potentially dangerous if not adhered to. The cost of shop bought food, bread especially, is extortionate and your table in the introduction to this consultation bears this out, with the cheapest loaf being over 3 times the cost of an equivalent bought in a supermarket. Additionally, using bread as an example the supermarket gluten free loaf is smaller in size/weight than a supermarket equivalent so you needed to have compared size (gram for gram) as well as cost and this will bear out the true cost. Almost all gluten free food specially produced e.g free from range is far more expensive such as breakfast cereal, pastas, sauces, pastries and these examples are not luxury foods. Bread, flour etc are staple foods and therefore important - pensioners and people on low income could not afford to buy bread etc regularly and therefore do without. Medical conditions should have help and support to be managed and if the help

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GOVERNING BODY BOARD REPORT

is withdrawn (as previously stated prescriptions are paid for) then the potential is for further ongoing problems which could cost more to the NHS if it is not managed. It is assumed that everyone has ready access to supermarkets. People who live away from supermarkets find that local shops generally stock hardly any gluten free products whereas prescriptions can be delivered to a local chemist. An option that doesn't seem to have been considered is to obtain cheaper suppliers of gluten free foods for NHS prescriptions thus reducing costs. Also it is the handling charges from pharmacies and suppliers that cost the NHS a lot. I would take issue with the statement made under the heading case for change - the amount of gluten free food prescribed is for limited units monthly and can not be described as significant. Is the same going to be proposed for other conditions where prescribed items are available at a lower cost over the counter? As with all medical conditions coeliac disease should be helped and controlled in order to obtain a healthy and balanced diet, this is not luxury just basic staple foods to help maintain health. It is unfair to target a vulnerable group of people who have no choice with this condition. Who knows what the cost to the NHS would be if this dietary management/support is withdrawn.”

“If companies didn't charge extortionate prices for GF products in the supermarkets this would be a start, we buy many GF products that we consider 'treats' i.e. Pizza bases, crackers etc but feel that bread and flour should be available on prescription. Someone who has been diagnosed Coeliac has to eat GF, it's not a lifestyle choice and the implications and potential cost to the NHS should they not and the illnesses long term would cost the NHS do much more. Knowing how procurement works, I would urge better negotiating with suppliers!!

Treat all conditions the same

“Lots of people have ailments and have to pay for prescriptions why treat some conditions differently to others. Gluten free foods are now available widely in supermarkets. Patients with allergies to other ingredients are unable to get their food prescribed.”

Coeliac disease not well understood

“I do not believe that coeliac disease is well understood, or well supported, by the NHS on Wirral. As a patient, I have always had to take the initiative - from original diagnosis (including referral to gastro-enterologist) to periodic status checks. The current proposal smacks of cost-cutting pure and simple. What exactly will the NHS on Wirral do for someone with coeliac disease?”

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Can we means test?

“Maybe some kind of means testing, my mother is retired and gets her food on prescription for financial reasons as it extortionately over priced in the supermarkets!”

Wrong to have foods on prescription

“I personally think it is wrong to have foods on prescription, there are a whole host of different conditions that people need to buy certain foods for (i.e egg allergy), why should Gluten free foods be supplied but nothing else. If someone with another intolerance took the NHS to the European courts the NHS could be providing food for all people with a food intolerance. Why should people with a gluten intolerance get their food supplied and someone with a lactose or nut intolerance not. I know the supply is historic before gluten free foods were available as easily in supermarkets but the cost to the NHS is amazing.”

“Gluten free products are not even needed in a healthy diet. Vegetables meats dairy fruits are fine alone. People with serious mental illnesses are being left here due to funding. No bread isn't going to kill anyone”

These are not free items – I pay for my prescriptions

“The price of Gluten Free options within the supermarket far out way the options available for people who don't medically suffer from an intolerance which would put them in hospital unless a strict diet of gluten free is adhered to. The prescription free food provides the essential (Bread and Cereal) required to maintain and control my health. If the argument we don't supply specialist food for diabetics is used then why do we supply free prescriptions of those deemed with a lifelong condition such as under active thyroids, plus those suffering from diabetics aren't controlled by what they eat. I pay £120.00 per year for an NHS pre-payment prescription card.”

“Bread is the only gluten free item I get on prescription as it is not widely available. This week asda never delivered me a loaf I ordered online as it wasn't available. I tried a little tesco and they didn't have a gluten free loaf in and the little sainsburys I tried didn't have any either. Why should I have to travel miles and miles just to find a loaf. I pay £110 a year for a prescription card to the NHS so I do not get my bread for free, I pay them for it.”

NHS prescribe medications to drug addicts and alcoholics

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GOVERNING BODY BOARD REPORT

“The cost for this is very minimal compared to the amount spent on supplying alcoholics with there grants being coeliac isn’t a lifestyle choice where as many things funded by the NHS are i.e methodone for heroin addicts this is there choice to do these drugs. There should be changes to how it is done for coeliac... An introduction of monthly vouchers for/towards gluten free food from supermarkets would be a good idea to replace prescriptions . the price of gluten free food is almost 3 times more expensive in most stores. It would also cut down in the waste of the prescription food as some foods often can go to waste mainly bread if you have nowhere to store it properly.”

Fresh bread not available in the shops

“Some items currently available on prescription are still not available in the shops, Fresh Bread for instance. All other products (with the exception of some cereals) are up to 4, or more, times more expensive than the gluten containing equivalent. This added to the higher cost of gluten free products that are not available on prescription make it very difficult to eat a healthy diet on a tight budget. This is especially difficult when multiple members of the household are affected by coeliac disease. Wirral already restricts the products on prescription beyond the nationally recommended guidelines, to restrict these even further will cause hardship and in some cases serious harm to many people who already struggle to avoid contaminated products. This move will cause additional costs to the NHS for the treatment of patients who come to harm from consuming gluten containing products due to financial difficulties. Once again, it will be those on lower incomes who will suffer from the proposed changes.”

IMPLICATIONS

i. If the CCG were to continue with option 1, no changes to the current prescribing of Gluten Free products on prescription, Wirral Health economy would continue to spend in the area of £162k on these products – there would be no impact to Wirral coeliac patients. This could potential increase to £212k dependent on annual CCG horizon scanning for increased prescribing costs in this area. A potential increase had been identified as part of this annual process of in the region of £50k.

ii. If the CCG were to develop further prescribing restrictions, for instance, limit the formulary to bread and flour only, then the CCG would reduce the current send on gluten free products across Wirral – this would have an impact on all coeliac patients who currently receive additional products on prescription, which they would then need to buy. However as detailed in appendix 6 - £147k is currently spent on these items, therefore restricting the formulary to bread and flour only would only yield in the region of £16k savings.

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GOVERNING BODY BOARD REPORT

iii. If the CCG were to stop prescribing gluten free products to all coeliac patients across Wirral significant prescribing costs will be reduced across Wirral, the impact would be significant on all coeliac patients who would then be forced to purchase all products which are gluten free.

CONCLUSION

7. The Governing Body is asked to:

i. Note the process that has been undertaken in the review of this policy.

ii. Note that 56% of respondents supported a change to the current guidelines, either by amending or stopping with 44% recommending no changes

APPENDICES

No. Title of Appendix 1 Wirral CCG current Gluten Free prescribing guidelines 2 Summary of results 3 Letter from British Specialist Nutritional Association 4 Letter from British Society of Gastroenterology 5 Letter from Coeliac UK 6 Financial spend of Gluten Free products Wirral CCG

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Gluten-Free Foods Prescribing Guideline

NHS Wirral Commissioning Policy December 2012 . Only bread, pasta, crackers, bread mix, flour mix and flour should be supplied on prescription. Pharmacies must order fresh bread via the Alliance wholesaler. Other food items can be purchased in supermarkets. . Prescribing of the basic food groups is limited to the cost-effective brands. . Recommended quantities should not be exceeded. The diet should be supplemented with carbohydrates that are naturally gluten free.

Unit Values for Basic Prescribable Foods 400g bread loaves 1 unit 500g flour, bread mix or flour mix 2 units 200g crackers 1 unit 250g pasta 1 unit

Monthly Units for Men Units for Women Units for Children

Aged 19-59 years 18 Aged 19-74 years 14 Aged 1-3 years 10

Aged 60-74 16 Aged 75+ 12 Aged 4-6 years 11

Aged 75+ 14 Breastfeeding 18 Aged 7-10 years 13

Pregnancy 3rd trim. 15 Aged 11-14 years 15

Aged 15-18 years 18

Cost Effective Brands Notes . Examples include Dietary Quantities are suggested only and may be decreased Specials® and Glutafin® where appropriate. Refer to the dietician service if necessary. . Juvela® products are expensive For high physical activity levels eg manual workers add 4 apart from bread units . Juvela® mix may be prescribed if Each prescription should be for one month’s supply of cheaper brands have been tried food. unsuccessfully Some children may be prescribed pizza bases if the GP . See MIMS or Appendix 6.1 in the considers this a necessary solution current BNF for current prices

Information obtained from Coeliac UK. For more . Scriptswitch will be updated with information, visit www.coeliac.org.uk current cost effective options

Version 3. Guideline written by: Helen Dingle, Prescribing Adviser, NHS Wirral

Approved by Medicines Clinical Guidelines Subcommittee of Wirral Drug and Therapeutics Committee: 1 February 2013 Review Date: 2016

Gluten free prescribing limitations consultation - Patients, carers and stakeholders SurveyMonkey

Q1 I am a:

Answered: 653 Skipped: 6

Member of the public in...

Member of the public

Medical professional...

Voluntary sector or...

Other (please specifiy)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Member of the public in Wirral 62.02% 405

Member of the public 11.49% 75

Medical professional/work in the NHS 22.51% 147

Voluntary sector or community group 1.53% 10

Other (please specifiy) 2.45% 16

Total 653

1 / 20 Gluten free prescribing limitations consultation - Patients, carers and stakeholders SurveyMonkey

Q2 You are asked to consider one of the following options in regards to the prescribing of gluten free products on prescription, please select an option below?

Answered: 646 Skipped: 13

Continue with current...

Develop further...

Stop prescribing...

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Continue with current prescribing of gluten free products on prescription 43.81% 283

Develop further prescribing restrictions for certain gluten free products 24.61% 159

Stop prescribing gluten free products on prescription all together 31.58% 204

Total 646

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Q3 Do you have any other comments you would like to make regarding this proposal?

Answered: 360 Skipped: 299

3 / 20 Gluten free prescribing limitations consultation - Patients, carers and stakeholders SurveyMonkey

Q4 Do you currently pay for prescriptions?

Answered: 631 Skipped: 28

Yes

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Yes 55.78% 352

No 44.22% 279

Total 631

4 / 20 Gluten free prescribing limitations consultation - Patients, carers and stakeholders SurveyMonkey

Q5 Equality Monitoring FormIf you could please spare a couple of minutes more by completing the quick questions below you will be helping us to look at how effective we are involving all sections of the Wirral community we serve.Answer as much or as little as you want. Whatever information you give, we will not be able to identify you as an individual, so your identity is safe - the information you share simply goes towards providing a large profile of the types of people that have commented so we can ensure that we are meeting the right needs of our community.Thank you for your time - it is greatly appreciated.

Answered: 26 Skipped: 633

5 / 20 Gluten free prescribing limitations consultation - Patients, carers and stakeholders SurveyMonkey

Q6 Please provide the first three characters of your postcode

Answered: 525 Skipped: 134

6 / 20 Gluten free prescribing limitations consultation - Patients, carers and stakeholders SurveyMonkey

Q7 What is your gender?

Answered: 599 Skipped: 60

Male

Female

Prefer not to say

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Male 29.22% 175

Female 69.45% 416

Prefer not to say 1.34% 8

Total 599

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Q8 What is your age?

Answered: 606 Skipped: 53

Under 25

25 - 34

35 - 49

50 - 64

65 - 74

75 - 84

85 - 94

95+

Prefer not to say

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Under 25 3.47% 21

25 - 34 14.36% 87

35 - 49 26.90% 163

50 - 64 32.18% 195

65 - 74 13.70% 83

75 - 84 6.44% 39

85 - 94 0.99% 6

95+ 0.00% 0

Prefer not to say 1.98% 12

Total 606

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Q9 Are you a person with impairments?

Answered: 597 Skipped: 62

Yes

Prefer not to say

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Yes 20.44% 122

No 75.38% 450

Prefer not to say 4.19% 25

Total 597

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Q10 If yes, is your impairment related to:

Answered: 125 Skipped: 534

Learning

Vision

Deaf/hearing impairment

Mobility

Mental Health

A hidden impairment

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Learning 2.40% 3

Vision 12.80% 16

Deaf/hearing impairment 12.80% 16

Mobility 43.20% 54

Mental Health 11.20% 14

A hidden impairment 5.60% 7

Other (Please specify) 12.00% 15

Total 125

10 / 20 Gluten free prescribing limitations consultation - Patients, carers and stakeholders SurveyMonkey

Q11 Which group below do you most identify with?Please select only ONE box.

Answered: 595 Skipped: 64

British or Mixed British

English

Irish

Scottish

Welsh

Prefer not to say

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

British or Mixed British 38.99% 232

English 52.94% 315

Irish 1.34% 8

Scottish 1.51% 9

Welsh 1.51% 9

Prefer not to say 2.18% 13

Other (Please specify) 1.51% 9

Total 595

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Q12 Please select only ONE box from below

Answered: 492 Skipped: 167

12 / 20 Gluten free prescribing limitations consultation - Patients, carers and stakeholders SurveyMonkey

Bangladeshi

Indian

Pakistani

Any other Asian...

African

Caribbean

Any other Black...

Any other Chinese...

Asian and White

Black African and White

Black Caribbean an...

Any other Mixed ethnic...

White European background

White background

Any other ethnic...

Gypsy/traveller

Prefer not to say

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Bangladeshi 0.00% 0

13 / 20 Gluten free prescribing limitations consultation - Patients, carers and stakeholders SurveyMonkey

Indian 0.81% 4

Pakistani 0.00% 0

Any other Asian background 0.61% 3

African 0.00% 0

Caribbean 0.00% 0

Any other Black background 0.00% 0

Any other Chinese background 0.00% 0

Asian and White 0.20% 1

Black African and White 0.41% 2

Black Caribbean and White 0.00% 0

Any other Mixed ethnic background 0.20% 1

White European background 25.61% 126

White background 66.67% 328

Any other ethnic background 0.00% 0

Gypsy/traveller 0.00% 0

Prefer not to say 3.86% 19

Other (Please specify) 1.63% 8

Total 492

14 / 20 Gluten free prescribing limitations consultation - Patients, carers and stakeholders SurveyMonkey

Q13 You can stop here if you wish, however, we have more questions that we would like you to answer. Some may seem personal, you can choose not to answer these, but the more you can answer the more it helps us. We have no way of identifying you as an individual, so your answers are anonymous.Which of these activities best describes your situation?

Answered: 573 Skipped: 86

Full-time work

Fully retired

Part-time worker

Self-employed

Full- time student

Unemployed and available to...

Unable to work due to...

Look after the home/family

Government training scheme

Prefer not to say

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Full-time work 45.03% 258

23.91% 137 Fully retired

Part-time worker 15.36% 88

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Self-employed 3.66% 21

Full- time student 1.57% 9

Unemployed and available to work 1.40% 8

Unable to work due to illness/disability 3.66% 21

Look after the home/family 1.05% 6

Government training scheme 0.00% 0

Prefer not to say 2.97% 17

Other (Please specify) 1.40% 8

Total 573

16 / 20 Gluten free prescribing limitations consultation - Patients, carers and stakeholders SurveyMonkey

Q14 Do you have a religion or belief?

Answered: 561 Skipped: 98

Yes

Prefer not to say

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Yes 51.16% 287

No 38.50% 216

Prefer not to say 10.34% 58

Total 561

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Q15 If yes, please select:

Answered: 294 Skipped: 365

Buddhist

Christian

Hindu

Jewish

Muslim

Sikh

Prefer not to say

Other (Please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Buddhist 0.34% 1

Christian 90.48% 266

Hindu 0.34% 1

Jewish 0.00% 0

Muslim 0.68% 2

Sikh 0.34% 1

Prefer not to say 5.10% 15

Other (Please specify) 2.72% 8

Total 294

18 / 20 Gluten free prescribing limitations consultation - Patients, carers and stakeholders SurveyMonkey

Q16 What is your sexual orientation?

Answered: 542 Skipped: 117

Bisexual

Gay man

Gay woman/lesbian

Heterosexual/st raight

Prefer not to say

Other (please specify)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Bisexual 2.21% 12

Gay man 1.11% 6

Gay woman/lesbian 0.74% 4

Heterosexual/straight 86.35% 468

Prefer not to say 8.86% 48

Other (please specify) 0.74% 4

Total 542

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Q17 Is your current gender identity the same as the one on your birth certificate?

Answered: 548 Skipped: 111

Yes

Prefer not to say

Not sure what this means

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Answer Choices Responses

Yes 95.80% 525

No 0.55% 3

Prefer not to say 2.92% 16

Not sure what this means 0.73% 4

Total 548

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Jonathan Develing Wirral CCG Old Market House Hamilton Street Birkenhead Wirral CH41 5AL 7 July 2016

Dear Mr Develing

RE: Withdrawal or reduction of gluten free diet (GFD) prescriptions

It has come to our attention that Wirral CCG is planning to reduce prescription units or withdraw prescriptions altogether for GFD.

This is an important issue for the British Society of Gastroenterology (BSG), as the removal of prescriptions for GFD has a very direct impact on the care of patients with Coeliac disease, as well as wider cost implications for the health economy. Our membership includes most of the consultants and specialists in gastroenterology in the UK that treat patients with Coeliac disease and we would like to put on record our support for Coeliac UK on this issue.

Please find below further detail and background to support your ongoing discussions on this matter. If you would like to consult further with the BSG specialist committee (Small Bowel and Nutrition) on this issue or speak to the regional representative of the BSG Clinical Services and Standards Committee we would be most happy to do so. It is vital that the views of patients and specialist clinicians are actively sought before any final decisions are made.

We would urge the CCG to consider these facts in their decision making process and we would recommend a formal consultation process which will allow necessary access to GFD products for patients that require them and examine alternative potentially cost-effective models such as pharmacy led services to be considered.

Yours Sincerely

Dr Ian Forgacs

President, British Society of Gastroenterology

The significance of the gluten-free diet

Coeliac disease is an autoimmune disease caused by a reaction to gluten, found in wheat, barley and rye. Adherence to the gluten-free diet remains the complete medical treatment and having coeliac disease therefore requires significant dietary modification. The use of gluten-free substitute staple foods facilitates the necessary dietary adaptation. Rates for adherence to the gluten-free diet can vary between 42-91% [1] and gluten-free staples on prescription have been related to adherence [2].

Non adherence to the gluten-free diet is associated with an increased risk of long term complications, including osteoporosis, vitamin D deficiency and iron deficiency [3]. These long term complications will impact upon quality of life for the patient and treating these complications are likely to result in financial implications for the NHS through other treatment costs or bed days.

In addition to facilitating dietary adaption, gluten-free staple foods contribute important nutrients to the diet. In the UK bread is an important source of energy, dietary fibre, vitamins and minerals. It provides more than 10% of our intake of protein, B vitamins and iron, and one fifth of our dietary fibre and calcium. Removing important staples from the diet may therefore have a significant effect on the nutrient content of the diet [4].

The consultation

The National Institute of Health and Care Excellence (NICE) quality standard on coeliac disease is currently under development and highlights that access to gluten-free food may be more difficult for people on low incomes and that these people may need more support. As part of your review the BSG would urge that due regard is paid to the impact of any withdrawal of GFD prescriptions on patients and wider healthcare costs. Certainly the published evidence is that high street purchase of GFD products are three to four times the cost of equivalent gluten containing food [5,6]. Furthermore access to GFD remains in large supermarkets and not corner shops which will clearly make purchase difficult for the old and infirm. [5,6].

[1] Hall, N.J. Rubin, G. & Charnock, A. (2009). Systematic review: adherence to a gluten-free diet in adult patients with coeliac disease. Alimentary Pharmacology & Therapeutics, 30, 315-330. [2] Hall, N. et al. (2013). Intentional and inadvertent non-adherence in adult coeliac disease. A cross-sectional survey. Appetite 68 56-62 [3] National Institute for Health and Clinical Excellence (2015) Coeliac disease: recognition, assessment and management 2015 [4] O’Connor A (2012) An overview of the role of bread in the UK diet. British Nutrition Foundation. Vol. 37, Issue 3, 193-212, Article first published online: 8 Sep, 2012 [5] Singh, J. & Whelan, K. (2011). Limited availability and higher cost of gluten-free foods. Journal of Human Nutrition and Dietetics, 24, 479-486. [6] Burden, M., et al., Cost and availability of gluten-free food in the UK: in store and online. Postgraduate Medical Journal, 2015:91;622-6.

Jonathan Develing Wirral CCG Old Market House Hamilton Street Birkenhead Wirral CH41 5AL 7 July 2016 Dear Mr Develing

We have been made aware of the review of gluten-free prescribing by Wirral clinical commissioning group (CCG). As the largest patient organisation representing over 60,000 Members we would like to submit a formal response to the review and have some questions regarding the consultation.

We are concerned that you are considering removing access to gluten-free food on prescription, a service providing essential NHS support and a safety net for the most vulnerable. As you will see from the enclosed letter, our concerns are shared by the British Society of Gastroenterology.

The significance of the gluten-free diet Coeliac disease is an autoimmune disease caused by a reaction to gluten, found in wheat, barley and rye. Adherence to the gluten-free diet remains the complete medical treatment and having coeliac disease therefore requires significant dietary modification. The use of gluten-free substitute staple foods facilitates the necessary dietary adaptation. Rates for adherence to the gluten-free diet can vary between 42-91% [1] and access to gluten-free staples on prescription can be related to adherence [2].

Non adherence to the gluten-free diet is associated with an increased risk of long term complications, including osteoporosis, ulcerative jejunitis, intestinal malignancy, functional hyposplenism, vitamin D deficiency and iron deficiency [3]. These long term complications will impact upon quality of life for the patient and treating these complications will result in financial implications for the NHS.

In your consultation document, you state that there has been a general trend towards eating less gluten. Unlike people with coeliac disease who have to follow a strict gluten-free for life, individuals who chose to eat less gluten with no medical basis are able to pick and choose when they follow a gluten-free diet. Additionally, in the UK, bread remains a staple food and is an important source of energy, dietary fibre, vitamins and minerals. It provides more than 10% of our intake of protein, B vitamins and iron, and one fifth of our dietary fibre and calcium. Removing important staples from the diet may therefore have a significant effect on the nutrient content of the diet [4].

Gluten-free staple foods are not readily available to purchase in budget supermarkets and convenience stores [5, 6]. Therefore, it cannot be assumed that all people with coeliac disease will be able to purchase gluten-free foods in their local shop. Access to gluten-free food on prescription is especially vital for the most vulnerable such as the elderly or those with limited transport options.

The consultation In your consultation, you state that gluten-free foods are accessible and available at prices similar to gluten containing equivalents. Please could you share the evidence behind these statements?

Research shows that gluten-free staple foods are 3-4 times more expensive than gluten containing equivalents [5, 6]. An example of the increased cost of gluten-free staple foods is gluten-free bread, recent data shows gluten-free white bread is still on average 6 times the cost of gluten-containing by volume, and has not reduced since 2008 (see Annex 1). Gluten-free staple foods on prescription therefore help to address the financial burden for patients and are essential for people on fixed or low incomes. The consultation also compares the price in supermarkets to the price charged to the NHS. While the cost to the NHS may be higher than in the supermarket, patients should not be penalised on the basis of poor procurement by the NHS.

The consultation document states that ‘GP prescribing of food products is not supported for other disease areas such as diabetes’. This statement is highly misleading as people with diabetes are recommended to follow a healthy, balanced diet and do not need to eliminate any specific foods additionally, national recommendations specifically recommend to not consume specialist diabetic products. It is also important to note that people with these conditions are able to access prescription medications in addition to dietary advice as part of their treatment. An example of a condition where the only treatment is a life-long strict diet is the management of phenylketonuria, where the NHS does support people by prescribing specialist low protein substitute foods. This may be a more appropriate comparison.

Equality Impact Assessment We are concerned that the proposal to withdraw gluten-free food on prescription is not equitable and will have a disproportionate impact on the most vulnerable patients. As part of the policy development, has an equality impact assessment been completed? Our concerns are reflected in the draft National Institute of Health and Care Excellence (NICE) coeliac disease Quality Standard equality impact assessment. The assessment recognises that access to gluten-free food is more difficult for people on low incomes and that these people should be given additional support with regard to gluten-free food on prescription to support adherence to the diet.

Alternative supply methods for gluten-free food As part of your policy review, we hope that you will consider alternative supply routes for gluten-free food which have been shown to produce cost savings as well as saving clinical time and also improving the patient experience. The Scottish Government has developed a Gluten-free Food Service for adults and children across Scotland. This centralised NHS gluten-free prescribing service is available through local pharmacies, and following an eighteen month trial period has been adopted as a permanent service within NHS Scotland since 1 October 2015. For further information, see http://www.gov.scot/Publications/2015/09/4234.

We understand the budgetary pressures on the NHS but rather than reduce the support to address budgetary challenges costs could be contained by redesigning the service and retaining the necessary support for patients with coeliac disease to maintain the treatment for their condition.

We look forward to hearing from you and would welcome the opportunity to discuss this further.

Kind Regards

Sarah Sleet, Chief Executive, Coeliac UK

[1] Hall, N.J. Rubin, G. & Charnock, A. (2009). Systematic review: adherence to a gluten-free diet in adult patients with coeliac disease. Alimentary Pharmacology & Therapeutics, 30, 315-330. [2] Hall, N. et al. (2013). Intentional and inadvertent non-adherence in adult coeliac disease. A cross-sectional survey. Appetite 68 56-62 [3] National Institute for Health and Clinical Excellence (2015) Coeliac disease: recognition, assessment and management 2015 [4] O’Connor A (2012) An overview of the role of bread in the UK diet. British Nutrition Foundation. Vol. 37, Issue 3, 193-212, Article first published online: 8 Sep, 2012 [5] Singh, J. & Whelan, K. (2011). Limited availability and higher cost of gluten-free foods. Journal of Human Nutrition and Dietetics, 24, 479-486. [6] Burden, M., et al., (2015) Cost and availability of gluten-free food in the UK: in store and online. Postgraduate Medical Journal, 2015: p. postgradmedj-2015-133395 [7] Total value of gluten-free substitutes foods (excluding specialist products) 2014 estimate, Mintel, Free Foods UK, November 2014 [8] Prescriptions Dispensed in the Community, England 2004/14, Health & Social Care Information Centre, July 15

Annex 1 - Historical price data – White bread gluten-free and gluten-containing comparison May 2016  Price data for gluten-free and gluten-containing products gathered through Brand View  Average of 30 gluten-free white breads, 38 gluten-containing white breads (sample of budget, own label and branded products)  Between July 2008 and May 2016 gluten-free white bread is consistently on average 6 times the cost of gluten-containing white bread (worked out on volume price per 100g for comparison)  Gluten-free white bread prices have not come down significantly over the last 8 years.

White bread - volume price

Gluten-free Standard

01-11-2008 01-03-2009 01-07-2009 01-11-2009 01-03-2010 01-07-2010 01-11-2010 01-03-2011 01-07-2011 01-11-2011 01-03-2012 01-07-2012 01-11-2012 01-03-2013 01-07-2013 01-11-2013 01-03-2014 01-07-2014 01-11-2014 01-03-2015 01-07-2015 01-11-2015 01-03-2016 01-07-2008

Wirral CCG - Gluten Free Products dispensed in 15/16 BNF Name Total Items Total Act Cost Gluten Free Bread (see detail for products) 4,898 £105,263.86 Gluten Free Mixes (see detail for products) 1,146 £22,281.36 Gluten Free/Wheat Free Pasta 1,727 £14,959.41 Gluten Free/Wheat Free Bread 550 £7,756.36 Gluten Free/Wheat Free Biscuits 935 £5,488.89 Gluten Free/Wheat Free Cereals 286 £1,417.48 Gluten Free/Wheat Free Mixes 115 £1,335.93 Gluten Free Biscuits 186 £1,129.00 Gluten Free Pasta 98 £839.49 Gluten Free Grains/Flours 128 £666.15 Gluten Free/Wheat Free Grains/Flours 20 £115.94 Gluten Free/Wheat Free Cooking Aids 1 £10.70 Gluten Free Cakes/Pastries 0 £0.00 Gluten Free Cereals 0 £0.00 Gluten Free Cooking Aids 0 £0.00 Gluten Free/Wheat Free Cakes/Pastries 0 £0.00 Gluten Free/Wheat Free Meals 0 £0.00 Gluten Free/Wheat Free Snacks 0 £0.00 Gluten Free/Wheat Free Sweet/Savoury 0 £0.00 Wheat Free Cakes/Pastries 0 £0.00 10,090 £161,264.58

Gluten Free Bread - Detailed Breakdown by Product BNF Name Total Items Total Act Cost Genius_G/F Bloomer 3 £62.92 Genius_G/F Bread Brown (Cut) 84 £1,607.56 Genius_G/F Bread Brown Sandwich (Cut) 74 £1,447.17 Genius_G/F Bread Wte (Cut) 39 £642.80 Genius_G/F Bread Wte Sandwich (Cut) 98 £1,808.49 Glutafin Select_G/F Fibre Loaf Brown(Cut 83 £1,364.78 Glutafin Select_G/F Fresh Loaf Brown(Cut 66 £1,333.18 Glutafin Select_G/F Fresh Loaf Wte (Cut) 171 £4,579.20 Glutafin Select_G/F Loaf Wte (Cut) 318 £7,800.41 Glutafin Select_G/F Seeded Loaf 170 £3,352.75 Glutafin_G/F Bread Roll x 4 Wte 52 £558.74 Glutafin_G/F Bread Roll x 4 Wte P/Bke 89 £1,359.00 Glutafin_G/F Fibre Bread (Cut) 111 £2,126.90 Glutafin_G/F Fibre Roll x 4 P/bake 76 £1,025.30 Glutafin_G/F Roll x 2 Wte Long P/Bke 34 £972.44 Glutafin_G/F Wte Bread (Cut) 92 £2,065.98 Juvela_G/F Bread Roll Wte 151 £1,947.22 Juvela_G/F Bread Roll Wte P/Bke 195 £3,346.38 Juvela_G/F Fibre Bread Roll 33 £767.92 Juvela_G/F Fibre Bread Roll P/Bke 81 £1,705.11 Juvela_G/F Fibre Loaf Brown (Cut) 684 £15,270.41 Juvela_G/F Fibre Loaf Brown (Ucut) 117 £2,639.98 Juvela_G/F Fibre Loaf P/Bke 129 £3,037.79 Juvela_G/F Fresh Fibre Loaf (Cut) 213 £5,375.88 Juvela_G/F Fresh Fibre Roll 8 £81.85 Juvela_G/F Fresh Loaf Wte (Cut) 517 £13,791.81 Juvela_G/F Fresh Roll Wte 59 £1,554.01 Juvela_G/F Loaf P/Bke 152 £3,826.49 Juvela_G/F Loaf Wte (Cut) 668 £14,120.91 Juvela_G/F Loaf Wte (Ucut) 45 £1,080.89 Juvela_G/F Pizza Base 123 £1,844.63 Lifestyle_G/F Bread Brown (Cut) 25 £521.93 Lifestyle_G/F Bread Wte (Cut) 19 £456.61 Warburtons_G/F Baguette 8 £145.05 Warburtons_G/F Bread Brown (Cut) 31 £683.72 Warburtons_G/F Bread Roll Brown 9 £103.68 Warburtons_G/F Bread Roll Wte 6 £35.47 Warburtons_G/F Bread Wte (Cut) 45 £673.21 Warburtons_G/F Thin Roll Wte 20 £145.32 4,898 £105,263.86 Possible products to restrict (bread rolls etc) BNF Name Total Items Total Act Cost Genius_G/F Bloomer 3 £62.92 Glutafin_G/F Bread Roll x 4 Wte 52 £558.74 Glutafin_G/F Bread Roll x 4 Wte P/Bke 89 £1,359.00 Glutafin_G/F Fibre Roll x 4 P/bake 76 £1,025.30 Glutafin_G/F Roll x 2 Wte Long P/Bke 34 £972.44 Juvela_G/F Fibre Bread Roll 33 £767.92 Juvela_G/F Fibre Bread Roll P/Bke 81 £1,705.11 Juvela_G/F Fresh Fibre Roll 8 £81.85 Juvela_G/F Fresh Roll Wte 59 £1,554.01 Juvela_G/F Pizza Base 123 £1,844.63 Warburtons_G/F Baguette 8 £145.05 Warburtons_G/F Bread Roll Brown 9 £103.68 Warburtons_G/F Bread Roll Wte 6 £35.47 Warburtons_G/F Thin Roll Wte 20 £145.32 Juvela_G/F Bread Roll Wte 151 £1,947.22 Juvela_G/F Bread Roll Wte P/Bke 195 £3,346.38 947 £15,655.04 Gluten Free Mixes (Bread Mixes) - Detailed Breakdown by Product BNF Name Total Items Total Act Cost Finax_G/F Flour Mix 5 £122.14 Glutafin Select_G/F Bread Mix 66 £1,275.72 Glutafin Select_G/F Fibre Bread Mix 18 £339.00 Glutafin Select_G/F Multipurpose Wte Mix 92 £1,214.44 Glutafin Select_G/F MultipurposeFibreMix 12 £129.45 Glutafin_G/F Multipurpose Wte Mix 151 £1,880.25 Glutenex_G/F White Bread Mix 1 £11.54 Heron_G/F Organ Bread Mix 1 £24.87 Juvela_G/F Fibre Mix 138 £2,856.36 Juvela_G/F Mix Wte 634 £14,131.53 Tritamyl_G/F Bread Mix Brown 24 £243.26 Tritamyl_G/F Flour Mix 4 £52.81 1,146 £22,281.36

GOVERNING BODY BOARD REPORT COVER SHEET

Homeopathy and Iscador Service Review

Agenda Item: 2.4 Reference GB16-17/0013 Public / Private Public Meeting Date 04.10.2016 Lead Nesta Hawker - Director of Commissioning Officer/Author of paper Contributors Norma Currie, Senior Commissioning Manager Lorraine Guy, Commissioning Support Manager Link to CCG Strategic System 1 Patient and primary care centric and based on high quality primary care, Plan secondary and community services 2 Rigorously developed and agreed care pathways working together with patients to secure their help, understanding, ownership and support of the needed changes 3 Commissioned services which have a sound evidence base 4 Provides greater equality of access to all Link to current strategic objectives 2 Enhance the quality of life for people with long term conditions 4 Ensuring people have a positive experience of care 5 Ensuring people are treated and cared for in a safe environment and protected from avoidable harm To Approve Yes. To make a decision in relation to the future commissioning arrangements for the homeopathy and Iscador service. To Note To Ratify Summary The Homeopathy and Isacdor service is commissioned by Wirral Clinical Commissioning Group.

A review of the service has been undertaken which highlights which has included a 90 day public consultation which ended on Friday 15 July 2016. Overwhelming consensus was to cease funding the Homeopathy and Iscador service. There is no current national recognised evidence to support the commissioning of this service.

Comments N/A Next Steps/ 1. Governing Body to review the findings of the service review report Recommendations 2. Governing Body to consider the three options included in the consultation 3. Governing Body to decide on one of three options outlined

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GOVERNING BODY BOARD REPORT COVER SHEET

What are the implications for the following (if not applicable please state why): Financial Does the report consider the financial impact? YES

The report shares the annual costs spent on the service.

Value For Money Does the report consider value for money? YES

Throughout the process the CCG is maintaining its responsibility under the Health and Social Care act of 2012 by:

Performing our duties efficiently and manage our resources effectively Promoting the values of the NHS and protect its future Risk Is there a documented risk assessment? YES

A post and pre risk assessment has been completed.

Legal Are there any legal implications and has legal advice been obtained? NO

This process has been in line with Wirral Clinical Commissioning Group’s ‘Commissioning Decisions Policy and Procedure 2016’ which has undergone previous legal review.

The process followed includes public consultation which is compliant with the duty to consult. Patient and Public Does the report provide evidence whether there could be a positive or Involvement (PPI) negative impact on patients and public? YES

Each option for consideration within the consultation assesses impact on patients and the provider. Equality & Human Does the report provide evidence of whether there could be a positive or Rights negative impact on protected groups (statutory duty for new / changes to services) YES

An equality impact assessment has been undertaken and is included within the report. Workforce Does the report provide evidence of whether there could be a positive or negative impact on the CCG or other NHS staff? YES

Two staff from the Provider organisation may be impacted as a result of the decision.

Partnership Working Does the report evidence a partnership working in its development? YES

The CCG has worked with the Provider of the service and other key stakeholders during the review. Performance Does the report indicate any relevant performance indicators for this item? Indicators YES

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GOVERNING BODY BOARD REPORT COVER SHEET

Service activity is indicated in the report with further information in Appendix 5. Sustainability Does the report address economic, social and environmental sustainability (should be addressed for new / change projects)? YES

Consultation options take into account impact on patient groups and an impact assessment has also been undertaken and included within the report.

Do you agree that this document can be published on the website?  (If not, please note that it may still be subject to disclosure under Freedom of Information - Freedom of Information Exemptions

Report History/Development Path

Report Name Reference Submitted to Date Brief Summary of Outcome

Private Business

If a report is deemed to be for private business, please note that the tick in the box, indicating whether it can be published on the website, must be changed to an x.

If you require any additional information please contact the Lead Officer.

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GOVERNING BODY BOARD REPORT

Report Title Homeopathy and Iscador Service Review Report

Lead Officer Nesta Hawker- Director of Commissioning, Wirral Clinical Commissioning Group. Contributors Norma Currie -Senior Commissioning Manager Lorraine Guy - Commissioning Support Manager Recommendations 1. Governing Body to review the findings of the service review report 2. Governing Body to consider the three options included in the consultation 3. Governing Body to decide on one of three options outlined

1. Introduction

1.1 This Homeopathy and Iscador service review report will provide information to support future commissioning decisions in relation to Homeopathy and Iscador service. Wirral Clinical Commissioning Group (CCG) is required to commission services which are safe, improve the quality and outcomes for our population, and represent efficiency and value for money.

1.2 The Cheshire and Merseyside Procedures of Lower Clinical Priority Policy 2014/15 (click here) indicated that the future commissioning arrangements for this service would be subject to review by Wirral CCG. During August 2015 approval was given by the CCG for the review, which would include a review of the service currently commissioned, and also a public consultation in order to capture the views of the public and key stakeholders.

1.3 The Homeopathy and Iscador service is provided for patients across the Wirral Clinical Commissioning Group footprint by Liverpool Medical Homeopathy Service (the “Provider”). The Provider has delivered the Homeopathy and Iscador service in Wirral since 2011.

1.4 The NHS Choices website (January 2016) states that Homeopathy is a 'treatment' based on the use of highly diluted substances, which homeopathy practitioners claim can cause the body to heal itself. Homeopathy is considered by the NHS to be complementary or alternative medicine.

1.5 Iscador is a type of anthroposophic medicine (using natural means to optimise physical and mental health and well-being) produced from mistletoe extract and can be provided as part of complementary cancer care, but is not a cure.

2. Key issues / Messages

2.1 Review methodology

2.1.1 In order to complete the review a number of key tasks were undertaken, which included a review of the current commissioned service, evidence review, public and stakeholder consultation, quality impact assessment, and equality impact assessment, both pre and post consultation. Wirral CCG representatives and the Provider worked collaboratively throughout the service review period.

2.1.2 The Midlands and Lancashire Commissioning Support Unit was commissioned to provide independent specialist equality advice, an equality summary assessment, and support with questionnaire design. A statutory consultation process was followed which is detailed further in this report and full details included within Appendix 1.

2.2 Service Review

2.2.1 The Homeopathy and Iscador service is commissioned to provide 42 Initial Consultations (new) and up to 160 follow-up sessions in 2016/17. Further detail on the service provided is included in Appendix 2. Actual patient activity is shown in Table 1 below:

Table 1

Homeopathy and Iscador patient demand 2013 to 2016

Contract year Patients New Follow up 2013-2014 48 29 19 2014-2015 51 41 10 2015-2016 46 32 14 2016* - April to 45* 8 37 July only Source: Providers Annual Reports - April 2013 to March 2016 Providers finance activity data - April 2016 to July 2016

2.2.2 A summary of patient activity in relation to Table 1 is provided below:

• 145 episodes of patient care were reported for the service between April 2013 to March 2016. • 102 patients reported as ‘new’ (70%). • 43 patients reported as ‘follow up’ (30%). • Average of 34 new patients per year (full years only). • Average of 14 follow up patients per year (full years only). • New patient demand decreased in 2015-2016 (from 2014-2015).

• Follow-up ratio following initial consultation of new patients is significantly lower than projected year on year. • Follow-up patient demand increased considerably between April 2016 to July 2016.

2.2.3 Homeopathy and Iscador service data has 12 different themed patient health conditions reported by the Provider over the past three year period. The top 3 health conditions reported were for pain, followed by psychiatric and cancer.

2.2.4 The Homeopathy and Iscador service is based on activity tariff for ‘first’ and ‘follow-up.’ The Iscador service is paid on a cost per patient case basis. The total contract value is £16,506 for both ‘new’ and ‘follow up appointments', which covers both Homeopathy and Iscador service costs for products and postage, room hire, Homeopathic Doctor and a two day per week administrator post.

2.2.5 Table 2 - Actual activity against contract cost

Contract year Actual Activity -/+ spend 2011/12 £17,707 - (contract commencement) 2012/13 £13,971 - -21% significantly less 2013/14 £14,967 48 -15% significantly less Contract value reduced to £16,506

2014/15 £16,641 51 +0.8% slightly over 2015/16 £13,604 46 -18% significantly less 2016/17*estimated £12,704 45 -23% significantly less

Based on spend activity provided in Table 2, the spend and activity for the service has reduced between 2011 and March 2016.

2.3 Evidence Review

2.3.1 From the desk top research undertaken (Appendix 6) the quality of evidence of clinical effectiveness has more strength for conventional healthcare than for homeopathy and Iscador.

2.3.2 The National Institute for Health and Care Excellence (NICE), which produces guidance on health technology and clinical practice in England and Wales, does not list the use of Homeopathy or Iscador in its guidance on the use of complementary and alternative treatments.

2.3.3 The NHS Choices website (August 2016) states in relation to homeopathy: “Does it work? There has been extensive investigation of the effective of homeopathy. There is no good-quality evidence that homeopathy is effective as a treatment for any health condition.”

2.4 Patient Experience

2.4.1 Patient experience information, from current and previous service users, is available at Appendix 3. Those patients who have provided feedback regarding their experience appear satisfied with the Homeopathy and Iscador service.

2.4.2 Quality considerations of the service are available at Appendix 4. The CCG is aware of one complaint reported regarding the service.

2.4.3 Please note the below information which captures patient audit responses with more information at Appendix 5:

2.4.5 Some patients have reported changes in their health condition and have value of using the service. Over the period from April 2013 to March 2016 a total of 145 patients had accessed the Homeopathy and/or Iscador services as either a new or follow up. Of those patients, 53 have provided feedback following their use of the service (37%). Of all patients that have used the service, the following results have been reported:

• 15 patients reported being back to normal (10% of all service users) • 19 reported feeling very much better (13% of all service users) • 12 moderately better (8% of all service users) • 3 slightly better (2% of all service users) • 4 no change (3% of all service users).

2.5 Consultation process

2.5.1 Wirral CCG initially commenced public consultation as part of the Homeopathy and Iscador review in February 2016, to engage the public and stakeholders regarding their views for funding Homeopathy treatment from NHS monies.

2.5.2 As part of the consultation, the CCG presented three options:

• Option 1: Extend the existing contract for a Homeopathy and Iscador service. • Option 2: Only fund the Homeopathy or Iscador service if the patient’s GP can prove that the patient is likely to derive greater benefit from the treatment than might normally be expected for patients with that condition (exceptional circumstance). • Option 3: Stop funding the service.

2.5.3 The consultation was challenged in April 2016 as some hyperlinks of Wirral Clinical Commissioning Group’s website consultation page had unfortunately developed some technical issues. Advice was sought and a re-run of the consultation was recommended as the best way forward as there was no distinct date on when the website issue occurred. No consultation responses from this initial consultation have been included as part of the subsequent and completed consultation that was held from 22 April 2016 to 15 July 2016.

2.5.4 The public consultation re-started on 22 April 2016 and ran for 12 weeks to 15 July 2016. Feedback provided through the following channels was reviewed and analysed:

• 1,518 public and stakeholder survey responses • 24 GP survey responses.

2.5.5 Stakeholder responses were received from: The Good Thinking Society and Merseyside Skeptics Society, The British Homeopathic Association, The Nightingale Collaboration and Liverpool Medical Homeopathy Service, (please note: this response was made in relation to the commissioning review and the consultation process).

2.5.6 Consultation events/meetings were held as follows:

• Patient and Carer Forum Event - Tuesday 26 April 2016, Old Market House, Hamilton Street, Birkenhead). • Public Forum meeting – Tuesday 10 May 2016, Old Market House, Hamilton Street, Birkenhead) • Women’s Cancer Support Group - 30 June 2016, Maggie’s Clatterbridge Cancer Centre • Colorectal Support Group – 7 July 2016 , Maggie’s Clatterbridge Cancer Centre

2.5.7 During the consultation a number of organisations for and against Homeopathy and Iscador provided their varying stances; these documents can be found in Appendix 1. Governing Body members are asked to note the following responses from the CCG in relation to some of the stakeholder responses received:

a) A frequently asked question document was produced for the consultation and lists the health conditions of people who use the complementary and alternative Homeopathy or Iscador service. An additional link to the NHS Choices website was provided for further information on health conditions. b) Wirral Clinical Commissioning Group has not failed to note that NICE has not reviewed homeopathy specifically, the options factually state that NICE in fact does not list the use of homeopathy or Iscador for any health condition. The Equality Act 2010, Public Sector Equality Duty, Gunning Principle 2 was followed: “sufficient reasons must be put forward for the proposal to allow for intelligent consideration and response”.

Survey Responses

2.5.8 Examples of feedback that is supportive of NHS funding for Homeopathy and Iscador are as follows:

• Users claim it has been more beneficial than conventional medicine/treatment • Suggestions that it is cheaper than conventional medicine • Placebo effect is valuable • Relieves pressure on NHS resources • Removal from the NHS restricts patient choice.

Survey respondent - “Always helps me. Fast, effective, safe, no side-effects. Helped with chronic conditions and have also used it for some sudden problems.”

Survey respondent - “This service provides options for people who might wish to supplement their treatment and should be continued.”

Survey respondent - “I have had homeopathy privately for over 40 years. I find it safe and effective and it has helped me either overcome or manage several complex chronic conditions with the minimum of drug therapy or visits to doctors. It has so much to offer so many and cost effectively.”

2.5.9 Examples of feedback that are against the commissioning of Homeopathy and Iscador are as follows:

• Does not work/clinically unproven/placebo effect only • Funding is a waste of NHS resources • NHS funding wrongly ‘legitimises’ homeopathy and Iscador • Could harm patients who need conventional treatments • NHS funds should be targeted on scientifically proven treatments, and should follow NICE guidance.

Survey respondent - “Homeopathy doesn't work. That has been comprehensively proven. When the NHS is short of money for actual medicine treatments it is criminal to be wasting it on supernatural nonsense.”

Survey respondent – “There is no reliable, demonstrable scientific evidence that homeopathy has any effect beyond placebo. Iscador is similarly dubious. For this reason it is immoral to encourage either 'treatments' to be used and to waste precious state funds in their support.”

Survey respondent - “It is absolutely ridiculous in these financially straitened times that services like this with no medical efficacy beyond the placebo effect are even considered for public funding.”

2.5.10 From the public survey, 1,291 stakeholders left a response in relation to which option they preferred. The findings are as below:

• Option 1: Extend the existing contract for a Homeopathy and Iscador service: 3.72% (48 responses). • Option 2: Only fund the Homeopathy or Iscador service if the patient’s GP can prove that the patient is likely to derive greater benefit from the treatment than might normally be expected for patients with that condition (exception circumstances): 1.47% (19 responses). • Option 3: Stop funding the service: 94.81% (1,224).

2.5.11 From the GP survey, 22 GPs left a response in relation to which option they preferred. The findings are as below:

• Option 1: Extend the existing contract for a Homeopathy and Iscador service: 4.55% (1response). • Option 2: Only fund the Homeopathy or Iscador service if the patient’s GP can prove that the patient is likely to derive greater benefit from the treatment than might normally be expected for patients with that condition (exception circumstances): 4.55% (1 response). • Option 3: Stop funding the service: 90.91% (20)

2.5.12 There is therefore overwhelming majority consensus from the consultation respondents to cease funding Homeopathy and Iscador in Wirral from NHS funds. Whilst reviewing the evidence of the review it is important for the CCG to consider the responses to the consultation, as part of the review findings.

3 Implications

3.1 If any decision was made to cease commissioning the service, or for the treatment to only be available due to patient exceptionality, two workers (the homeopathic Doctor and a two day per week administrator) may be affected by this decision. It is unclear how many hours the administrator position is solely funded by the Wirral CCG contract. The Doctor provides one morning session a week.

3.2 There are legal duties on Wirral CCG to have due regard to the promotion of equality (Equality Act 2010) and the reduction of health inequalities (Health and Social Care Act 2012) when making decisions or developing new or improved ways of working.

3.3 The overall impact/risk assessment undertaken before consultation was deemed to be low risk. The post Equality Impact Assessment has been completed following consultation and is contained within the Consultation Report; this is also deemed low risk activity for patients. There does not appear to be any equality impact assessment implications for patients at this stage. The quality impact assessment has identified a very low risk in terms of impact with some negative impact to workforce as aforementioned.

4 Conclusion

4.3 Of the 145 patients who have used the Homeopathy and Iscador service, some patients have expressed health benefits. Some patients state the use of complementary and alternative therapy can help with medication contraindications.

4.4 The Homeopathy and Iscador service is complementary and alternative, therefore mainstream services are available as another option for patients.

4.5 There is some strength of clinical opinion across Wirral, and the UK that Homeopathic and Iscador treatments should not be provided by the NHS, in line with the need to demonstrate treatments are supported by robust evidence as being clinically effective.

4.6 National drivers and local evidence clearly indicate the direction of travel that is required for a Clinical Commissioning Group to close the health and wellbeing gap, the care and quality gap and the funding and efficiency gap. The CCG is required to commission effective evidence based treatments. At present there is no nationally recognised robust clinical evidence to support the commissioning of homeopathy and Iscador.

4.7 There is an overwhelming majority consensus from the consultation respondents to cease funding Homeopathy and Iscador treatments in Wirral, from NHS funds.

5 Recommendations

There are three options to consider as part of this review:

The Governing Body is asked to support one of the three options above, based on the findings of the review.

6 Appendices (Must be copied below or available on request – do not embed)

Appendix 1 Consultation report

Appendix 2 Homeopathy and Iscador service overview

Appendix 3 Patient experience findings Quality Appendix 4 Appendix 5 Service Audit responses Appendix 6 Desktop Research Appendix 7 Quality Assessment

Appendix 1: Consultation report

Wirral CCG_ 25082016 PM - FINAL

This document is included in full at the end of the report after Appendix 7

Appendix 2: Homeopathy and Iscador service overview

1. The Homeopathy service is provided to patients aged 16 and over who are registered with a Wirral GP with any health condition that the referring GP assesses will benefit from homeopathic treatment;

2. Referral to the homeopathy service is made by Wirral GPs only. All patients referred by their GP will be offered an initial assessment with a homeopathic Doctor for their condition(s) and up to four further follow up appointments.

3. The first assessment can take up to one hour. If the Provider assesses that the patient is suitable for homeopathic treatment, a treatment plan will be agreed.

4. The Iscador service is accessible to patients aged 18 and over who are registered with a Wirral GP, with malignant disease that the referring GP assesses will benefit from Iscador treatment.

5. Referral to the Iscador service is made by Wirral GPs only. If the Provider assesses that the patient is suitable for Iscador treatment, a treatment plan will be agreed. A ‘follow up’ appointment will be arranged between the patient’s GP and patient at the end of the Iscador treatment to ensure full discussion of the patient’s progress.

6. In terms of response times, initial contact must be made with the patient within 1 week of the receipt of referral, with treatment commencing within 6 weeks of receipt of referral, unless otherwise requested by the patient.

7. The Provider will discharge patients who have received the maximum 4 ‘follow up’ appointments from the services back to their GP. The GP will re-refer some patients back to the homeopathy or Iscador service if and when required. A new episode of patient care is recorded by the Provider; therefore patients who are reported as new to the service are both ‘new - not used the service before’ and ‘new episode of care.’

Appendix 3: Patient experience findings

1. Liverpool Medical Homeopathy Annual Report 2013/2014. The Provider’s report contains several reasons why patients request referral to the homeopathy service:

a. “The commonest is that they are unable to take conventional drugs for their condition e.g. side effects from anti-inflammatory drugs or menopausal symptoms with a history of breast cancer so hormone replacement therapy is contraindicated.” b. “When there is no good conventional treatment available e.g. chronic fatigue syndrome, fibromyalgia, multiple chemical sensitivity or multiple sclerosis.” c. “Failure to respond to conventional treatment for their conditions e.g. patients with diverticulitis, irritable bowel syndrome and hypertension.” d. “Finally some patients prefer to take homeopathic remedies in preference to conventional treatment wherever possible. In the Merseyside region there are many patients who have had access to NHS homeopathic treatment since the Hahnemann hospital became part of the NHS in 1948. This is illustrated by one patient, a 97 year old man who does not take any conventional treatment and manages his various ailments with homeopathy.”

2. The report also contained 2 patient examples: “…Patients were invited to comment on the service in the questionnaire. Some of the comments are as follows:

Cancer patient a. “One patient with neck cancer has been receiving Iscador alone as she decided the side effects of the conventional treatment she was offered would be too great. She was given 3 months to live but has survived for over a year using only Iscador treatment and for all of this time she has lived independently with a good quality of life.” Carer b. A letter from the wife of another patient comments about the treatment her husband received from the Iscador & Homeopathy service during a long battle with cancer. “The Iscador treatment helped; I also gave him the homeopathic remedy, Arsenicum during his illness and I know that this provided him with a comfortable and peaceful death. I wish that conventional practitioners were more understanding of homeopathy.”

3. Liverpool Medical Homeopathy Annual Report 2014/2015. The Provider’s report again contains several reasons why patients request referral to the homeopathy service:

a. “The commonest is that they are unable to take conventional drugs for their condition e.g. side effects from anti-inflammatory drugs or menopausal symptoms with a history of breast cancer so hormone replacement therapy is contraindicated.” b. “When there is no good conventional treatment available e.g. chronic fatigue syndrome, fibromyalgia, multiple chemical sensitivity or multiple sclerosis.” c. “Failure to respond to conventional treatment for their conditions e.g. patients with diverticulitis, irritable bowel syndrome and hypertension.” d. “To help with side effects from unavoidable conventional treatment- e.g. side effects of chemotherapy during cancer treatment.” e. “Finally some patients prefer to take homeopathic remedies in preference to conventional treatment wherever possible. In the Merseyside region there are many patients who have had access to NHS homeopathic treatment since the Hahnemann hospital became part of the NHS in 1948. This is illustrated by one patient, a 99 year old man who does not take any conventional treatment and manages his various ailments with homeopathy.”

4. The Providers Annual Report also contains 4 patient examples and 1 GP example: “…Patients were invited to comment on the service in the questionnaire. Some of the comments are as follows:

“Homeopathic treatment has made my life much easier, not having nearly as much pain as in the past. It enables me to continue my a. lifestyle as before my diagnosis of osteoarthritis. I do not need any conventional treatment either.” (from a 80 year old patient with osteoarthritis).” “My treatment from the homeopath in my opinion is helping me and I b. would like to continue to come.” (from a patient with recurrent diverticulitis)” “Homeopathy has helped my insomnia, appetite control, my anxiety, c. ability to cope, mood swings and my night time pain levels. This has been alongside therapy and conventional medicine.” (from a patient with long standing chronic fatigue syndrome) “Energy levels back to normal, active and strong, but ability to eat d. large amounts diminished due to removal of stomach” (from a patient with stomach cancer) “having reviewed her response, she appears to have gained relief from homeopathic treatment ,without side effects, that she has been e. unable to achieve through conventional medicine, I would therefore

be grateful if she could continue to receive treatment from the homeopathic service.” (from the GP of a patient with fibromyalgia).

5. Liverpool Medical Homeopathy Annual Report 2015/16 – The Provider’s report contained 4 patient examples:

“Homeopathic treatment has made my life much more easy, not having nearly as much pain as in the past. It enables me to continue a. my lifestyle as before my diagnosis of osteoarthritis. I do not need any conventional treatment either” [from an 82 year old lady with osteoarthritis] “I have benefitted enormously from this treatment both physically and mentally. My immune system has improved greatly and the extra b. support it has given me has given me a far greater chance of healing more quickly” (a 62 year old lady with endometrial cancer receiving Iscador) “Homeopathy has kept joints pain free and reduced stiffness” (a 74 c. year old lady with osteoarthritis of both knees) “My general wellbeing has improved since starting homeopathic d. treatment. The service is excellent and the remedies arrive promptly. I hope to be able to continue this service on the Wirral” (a 60 year old lady with anxiety).

6. Patient Audit Questionnaire - The Provider’s annual reports states:

“Patients are asked to complete an Audit Questionnaire at their final visit to the clinic to assess their response to homeopathic treatment. We use a simple questionnaire with an outcome score devised initially by the Glasgow Homeopathic Hospital and used in several other homeopathy units in the U.K.

The questionnaire asks the patient whether since starting homeopathic treatment their condition has been better, worse or unchanged. They are asked to rate their improvement or deterioration on a scale varying from +1(slightly better) to +4(completely cured/back to normal), 0(indicating no change) to - 1(slight deterioration) to -4(disastrous deterioration). Of the 18 patients who have been audited to date, outcomes have been as follows.

7. Further information was requested from the Provider during the review period in relation to patient experience/outcomes; unfortunately no further patient experience information, other than the above was shared. No further information was submitted by the Provider in relation to patient equality monitoring information, therefore, the Equality Impact Assessment (found in the Consultation Report Appendix 1), provides the most up to date version (January 2016) of this information and is as follows:

a. Patient gender is pre-dominantly females in both Homeopathy (74%) and Iscador (73%), and patients receiving both Homeopathy and Iscador being 100% female. b. Patients by age; pre-dominantly patients over 65 years of age; 44%, with the combined ages for patients aged over 50 years at 74%, two thirds.

Appendix 4: Quality

1. One complaint in 2015-16 was received for the Homeopathy service over the past 3 years. This complaint was in relation to a later than agreed delivery of homeopathy to the patient’s home address. The Provider reported this was due to temporary reception cover and their understanding of the order to be sent to the pharmacist, which was resolved.

2. Wired PALS service and Wirral Healthwatch have informed that they had not received any complaints or compliments in relation to the Homeopathy or Iscador service. Wirral Clinical Commissioning Group’s corporate department have not received any complaints or compliments in relation to the homeopathy or Iscador service.

3. A GP is not regulated by the General Medical Council for the homeopathic Doctor’s practice; this is regulated by an independent organisation in the field of complementary or alternative medicine. The Provider is a registered member of The Faculty of Homeopathy for homeopathic practice. The Faculty of Homeopathy does not regulate Iscador practice which is Anthroscopic medicine.

4. According to The Faculty of Homeopathy’s website (August 2016), their professional organisation was founded in 1844 and is the registering body for statutorily regulated healthcare professionals who integrate homeopathy into their practice. No Code of Ethics Practice was listed on their website (August 2016).

5. There is no legal regulation of homeopathic practitioners in the UK. This means that anyone can practise as a homeopath, even if they have no qualifications or experience.

6. According to the NHS Choices website (July 2016) the practice of conventional medicine is regulated by laws for statutory professional regulation. Only two complementary and alternative treatment professionals are regulated in the same way; osteopathy and chiropractic. There is no statutory professional regulation of any other complementary or alternative practitioners, therefore homeopathy and Iscador practice is not regulated in line with conventional medicine.

Appendix 5: Service Audit responses

1. Some patients have reported changes in their health condition. Over the period from April 2013 to March 2016 a total of 145 patients had accessed the Homeopathy and/or Iscador service as either a new or follow up. • 15 patients reported being back to normal • 19 reported feeling very much better • 12 moderately better • 3 slightly better • 4 no change.

2. Homeopathy and Iscador patient audit responses 2013-2016. Table 1 Audit Responses 12 10 10 10

8 7 6 6 4 4 3 3 2 2 2 1 1 1 1 1 1

0 No change Slightly better Moderately Very much Back to normal better better

2013-2014 2014-2015 2015-2016

Audit Response Rate 80 70 60 50 40 48 51 46 30 20 10 17 18 18 0 2013-2014 2014-2015 2015-2016

Audit responses Total patients

3. The GP practices that referrals to the Homeopathy or Iscador service have been received from are as below:

Table 2 Homeopathy and Iscador referrals by Wirral GP Practice

Patients referred by GP Practice

WHETSTONE LANE MED CTR WEST WIRRAL GROUP PRACTICE Wallasey Village Group Practice VICTORIA PARK HEALTH CTR Upton Group Practice The Villa Medical Centre The Medical Centre West Kirby St.Georges Med Ctr ST HILARY GROUP PRACTICE Spital Surgery SILVERDALE MED CTR_HENNESSY TD Seabank Medical Centre Riverside Surgery MORETON CROSS GROUP PRACTICE Marine Lake Medical Practice Marine Lake Medical Practice Heswall Medical Centre HEATHERLANDS MED CTR Grove Road Surgery Greenway Surgery Greasby Health Centre Field Road Health Centre Eastham Group Practice Dr Oates & Partners Commonfield Road Surgery Civic Medical Centre Church Road Medical Practice CAVENDISH MEDICAL CENTRE ALL DAY HEALTH CENTRE

0 1 2 3 4 5

Jan 16 - Aug 16 Jan 15 - Dec 15

GP referral data for the period January 2015 to August 2016; 29 GP practices made a referral. The highest number of referrals was from Civic Medical Centre Practice with 4 referrals, the second highest was Marine Lake with 3.

A full breakdown of patient health conditions ever treated by the Provider is listed below. The highest number of different health conditions treated was 69 in 2013- 2014.

Table 3 Homeopathy and Iscador patient health conditions – March 2013 to March 2016

Learning difficulties - Anger management Cancer - Neck Cancer - Endometrium Cancer - Non-Hodgkin’s lymphoma Cancer - Stomach Psychiatric - Nightmares Psychiatric - Stress Psychiatric - Depression Cardiac - Chronic oedema Skin - Lymphodema Skin - Psoriasis Skin - Lichen planus Respiratory - Tracheal stenosis Urology - Incontinence

Urology -Benign prostatic hypertrophy 13/14 Others - Lymphoedema 14/15 Others - Chemical sensitivity 15/16 Others - Multiple allergies Gynae - Menorrhagia Gynae - Breast Pain Gynae - Menopause Neuro - Multiple Sderosis Neuro - Headache Gastro - Hepatitis Gastro - Chronic hepatitis Gastro - Irritable bowel syndrome ENT - Chronic sinusitis ENT - Rhinitis Pain - Pubic symphysis diastasis Back pain Pain - Osteoarthritis 0 2 4 6 8 10 12 14 16 18 20

Table 4

Total patient reported health conditions April 2013 to March 2016

Patient health condition 2013- 2014- 2015- Total Average 2014 2015 2016 1. Pain 15 12 16 43 14 2. Psychiatry 15 11 10 36 12 3. Cancer 7 14 7 28 9 4. Gastroenteritis 5 7 4 16 5 5. Other conditions 8 2 5 15 5 6. Skin 7 4 4 15 5 7. Ear, nose, throat 5 3 3 11 4 8. Gynaecological 0 5 4 9 4 9. Cardio 4 2 2 8 3 10. Urology 1 2 3 6 2 11. Neurological 0 3 2 5 2 12. Respiratory 1 1 1 3 1 Source: Providers Annual Reports April 2013 to March 2016

Appendix 6: Desktop Research

1. The National Institute for Health and Care Excellence (NICE) who provides the national guidance and advice to improve health and social care in England, does not presently list the use of Homeopathy or Iscador in its guidance on the use of complementary and alternative treatments.

2. Currently, the NHS Choices website (January 2016) states that the National Institute for Health and Care Excellence (NICE) only recommends the use of a complementary and alternative treatment in a limited number of instances, including: Alexander Technique (teaches improved posture and movement) for Parkinson's disease - Ginger and acupressure for reducing morning sickness - Acupuncture and manual therapy, including spinal manipulation, spinal mobilisation and massage for persistent low back pain.

3. The National Institute for Health and Care Excellence (NICE) does not list Homeopathy or Iscador treatments in the above limited number of instances for the use of complementary or alternative treatment.

4. Further information:

NHS Choices

The NHS Choices website (August 2016) states in relation to homeopathy: a. “Does it work? There has been extensive investigation of the effective of homeopathy. There is no good-quality evidence that homeopathy is effective as a treatment for any health condition (see What can we conclude from the evidence?).” The British Homeopathic Association

The British Homeopathic Associations website (August 2016) states in relation to homeopathy: “How does it work? The honest answer is that we really don’t know exactly how homeopathic medicines work. But this is not b. unique – there are many conventional medicines that have no established mechanism of action and there are even uncertainties about common medicines like paracetamol. All we can say is that the medicines assist the body in responding to symptoms to bring a person back to their own individual state of “wellness” (click here)” The Department of Health c. On 09 December 2015, The Department of Health sent a letter to ask the Secretary of State for Health when the Government plans to undertake its public consultation on whether or not homeopathic products should be available through NHS prescriptions (click here).

President of the Faculty of Homeopathy

In response to The Department of Health planning the above consultation

d. on whether to include homeopathic products in Schedule 1, Dr Helen Beaumont, President of the Faculty of Homeopathy issued the following statement: “It’s disappointing that at a time when the NHS is facing a funding crisis the Department of Health (DH) is embarking on a costly consultation that could prevent highly skilled clinicians prescribing a course of treatment that benefits thousands of patients each year. If the DH were serious about saving money surely it should be looking at SSRIs, prescribed for mild to moderate depression in vast quantities at considerable cost to the NHS, but which studies have found to be ineffective for those conditions? (click here) The Faculty of Homeopathy

The Faculty of Homeopathy website (July 2016) reports on safety and cost h. benefits of a survey in France and cost per care being 15% less than the cost of treatment provided by conventional physicians. The available evidence suggests that homeopathy has the potential to generate savings through reduced conventional prescribing and demand for other services, the document is available here: (click here)

The British Homoeopathic Association (August 2016) m. The British Homoeopathic Association reports on its website that there is a growing body of clinical evidence to show that homoeopathy has a positive effect. This includes reference to results of randomised controlled trials, systematic reviews and feedback from patients (click here).

Appendix 7 – Quality Impact Assessment

Wirral Clinical Commissioning Group: Quality Impact Assessment Tool v2

Overview

This tool involves an initial assessment (stage 1) to quantify potential impacts (positive or negative) on quality from any proposal to change the way services are commissioned and/or delivered. Where potential negative impacts are identified they should be risk assessed using the risk scoring matrix to reach a total risk score.

Quality is described in 6 areas, each of which must be assessed at stage 1. Where a potentially negative risk score is identified and is greater than (>) 8 this indicates that a more detailed assessment is required in this area. All areas of quality risk scoring greater than 8 must go on to a detailed assessment at stage 2.

Scoring

A total score is achieved by assessing the level of impact and the likelihood of this occurring and assigning a score to each. These scores are multiplied to reach a total score.

The following tables define the impact and likelihood scoring options and the resulting score: -

LIKELIHOOD IMPACT Risk Category IMPACT

1 RARE 1 MINOR score 1 2 3 4 5

2 UNLIKELY 2 MODERATE / LOW 1 - 3 Low risk (green) 1 1 2 3 4 5 OD

3 MODERATE 3 SERIOUS 4 - 6 Moderate risk (yellow) 2 2 4 6 8 10 / POSSIBLE LIKELIHO

4 LIKELY 4 MAJOR 8 - 12 High risk (orange) 3 3 6 9 12 15

5 ALMOST 5 FATAL / CATASTROPHIC 4 4 8 12 16 20 CERTAIN 15 - 25 Extreme risk (red) 5 5 10 15 20 25

A fuller description of impact scores can be found at the end of the document

Please take care with this assessment. A carefully completed assessment should safeguard against challenge at a later date.

Stage 1

The following assessment screening tool will require judgement against the 6 areas of risk in relation to Quality. Each proposal will need to be assessed whether it will impact adversely on patients / staff / organisations. Where an adverse impact score greater than 8 is identified in any area this will result in the need to then undertake a more detailed Quality Impact Assessment ( Stage 2) This will be supported by the Quality and Patient Safety Team.

Title and lead for scheme:

Homeopathy and Iscador service review.

Brief description of scheme:

Wirral CCG commission a complementary and alternative homeopathy and Iscador service.

The Homeopathy service is provided to patients aged 16 and over who are registered with a Wirral GP with any health condition that the referring GP assesses will benefit from homeopathic treatment. The Iscador service is accessible to patients aged 18 and over who are registered with a Wirral GP, with malignant disease that the referring GP assesses will benefit from Iscador treatment.

Answer positive/negative (P/N) in each area. If N score the impact, likelihood and total in the appropriate box. If score greater than 8 insert Y for full assessment. If Not Applicable please add N/A

Area of Quality Impact question P/N Impact Likelihood Score Full Assessment

required

Duty of Could the proposal impact positively or negatively on any of the following N 1 1 2 No Quality - compliance with the NHS Constitution, partnerships, safeguarding children or adults and the duty to promote equality?

Patient Could the proposal impact positively or negatively on any of the following N 1 1 2 No Experience - positive survey results from patients, patient choice, personalised & compassionate care?

Patient Safety Could the proposal impact positively or negatively on any of the following N/A N/A – safety, systems in place to safeguard patients to prevent harm, including infections?

Clinical Could the proposal impact positively or negatively on evidence based N 1 1 2 No Effectiveness practice, clinical leadership, clinical engagement and/or high quality standards?

Prevention Could the proposal impact positively or negatively on promotion of self- N/A N/A care and health inequality?

Productivity Could the proposal impact positively or negatively on - the best setting to N 1 1 2 No and deliver best clinical and cost effective care; eliminating any resource Innovation inefficiencies; low carbon pathway; improved care pathway?

Vacancy Could the proposal impact positively or negatively as a result of staffing P 1 1 2 No impact posts lost?

Resource Could this proposal impact positively or negatively with regard to estates, N/A N/A Impact IT resource, community equipment service or other agencies or providers

e.g. Social care/voluntary sector/District nursing

Please describe your rationale for any positive impacts here:

There is a GP Homeopathic Practitioner who provides one session per week. There is a two day a week administration post, but it is not known what support is provided solely from this role to the WCCG commissioned service.

Signature: Designation: Date:

Lorraine Guy Commissioning Support Manager August 2016

Stage 2

Relevant sections in Quality Impact Assessment (Stage 2) to be completed where any adverse impact score greater than 8 is identified in any area this will result in the need to then undertake a more detailed

Mitigation strategy and

Indicators monitoring arrangements Impact Likelihood SCORE What is the impact on the organisation’s duty to secure continuous improvement in the quality of the healthcare that it

provides and commissions. In accordance with Health and Social Care Act 2008 Section 139?

Does it impact on the organisation’s commitment to the public

to continuously drive quality improvement as reflected in the

rights and pledges of the NHS Constitution?

Does it impact on the organisation’s commitment to high quality workplaces, with commissioners and providers aiming

to be employers of choice as reflected in the rights and pledges of the NHS Constitution?

What is the impact on strategic partnerships and shared risk?

What is the equality impact on race, gender, age, disability, sexual orientation, religion and belief, gender reassignment,

pregnancy and maternity for individual and community health, access to services and experience of using the NHS (Refer to

What impact is it likely to have on self reported experience of patients and service users? (Response to national/local surveys/complaints/PALS/incidents) CCG Equality Impact Assessment Tool?

Are core clinical quality indicators and metrics in place to review impact on quality improvements?

Will this impact on the organisation’s duty to protect children, young people and adults?

How will it impact on choice?

Does it support the compassionate and personalised care agenda?

How will it impact on patient safety?

How will it impact on preventable harm?

Will it maximise reliability of safety systems?

How will it impact on systems and processes for ensuring that the risk of healthcare acquired infections is reduced?

What is the impact on clinical workforce capability care and skills?

How does it impact on implementation of evidence based practice?

How will it impact on clinical leadership?

Does it support the full adoption of Better care, Better Value metrics?

Does it reduce/impact on variations in care?

Are systems for monitoring clinical quality supported by good information?

Does it impact on clinical engagement?

Does it support people to stay well?

Does it promote self-care for people with long term conditions?

Does it tackle health inequalities, focusing resources where they are needed most?

Signature: Designation: Date:

Does it ensure care is delivered in the most clinically and cost effective way?

Does it eliminate inefficiency and waste?

Does it support low carbon pathways?

Will the service innovation achieve large gains in performance? PRODUCTIVITY AND INNOVATION

Does it lead to improvements in care pathway(s)?

Does the proposal involve reducing staff posts? If so describe the impact this will

have

Is the loss of posts likely to impact on remaining staff morale?

Can arrangements be made to prioritise

VACANCY IMPACT and manage workload effectively?

Are vacancies likely to impact on patient

experience?

Will services be negatively impacted by the loss of posts for a short term, medium term or longer term?

Impact / Consequence score (severity levels) and examples of descriptors

1 2 3 4 5

Negligible Minor (Green) Moderate (Yellow) Major (Orange) Catastrophic (Red)

Informal Formal complaint (stage 1) Formal complaint (stage 2) Multiple complaints/ independent Gross failure of patient safety if complaint/inquiry complaint review findings not acted on

Local resolution Local resolution (with potential to Low performance rating Inquest/ombudsman inquiry go to independent review)

Single failure to meet internal Repeated failure to meet internal Critical report Gross failure to meet national standards standards standards

Minor implications for patient Major patient safety implications if safety if unresolved findings are not acted on

Reduced performance rating if unresolved

Short-term low staffing Low staffing level that reduces Late delivery of key objective/ Uncertain delivery of key Non-delivery of key level that temporarily the service quality service due to lack of staff objective/service due to lack of objective/service due to lack of staff reduces service quality staff (< 1 day) Unsafe staffing level or Unsafe staffing level or Ongoing unsafe staffing levels or competence (>1 day) competence (>5 days) competence

Low staff morale Loss of key staff Loss of several key staff

Poor staff attendance for Very low staff morale No staff attending mandatory mandatory/key training training /key training on an ongoing basis

No staff attending mandatory/ key training

No or minimal impact Breech of statutory legislation Single breech in statutory duty Enforcement action Multiple breeches in statutory duty

on breech of guidance/ Reduced performance rating if Challenging external Multiple breeches in statutory duty Prosecution statutory duty unresolved recommendations/ improvement notice

Improvement notices Complete systems change required

Low performance rating Zero performance rating

Critical report Severely critical report

Rumours Local media coverage – Local media coverage – National media coverage with <3 National media coverage with >3 days service well below days service well below reasonable reasonable public expectation public expectation. MP concerned (questions in the House)

short-term reduction in public long-term reduction in public confidence confidence

Potential for public Elements of public expectation Total loss of public confidence concern not being met

Insignificant cost <5 per cent over project budget 5–10 per cent over project budget Non-compliance with national 10– Incident leading >25 per cent over increase/ schedule 25 per cent over project budget project budget slippage Schedule slippage Schedule slippage Schedule slippage Schedule slippage

Key objectives not met Key objectives not met

Small loss Risk of Loss of 0.1–0.25 per cent of Loss of 0.25–0.5 per cent of Uncertain delivery of key Non-delivery of key objective/ Loss claim remote budget budget objective/Loss of 0.5–1.0 per cent of >1 per cent of budget of budget

Claim less than £10,000 Claim(s) between £10,000 and Claim(s) between £100,000 and Failure to meet specification/ £100,000 £1 million slippage

Purchasers failing to pay on time Loss of contract / payment by results

Claim(s) >£1 million

Loss/interruption of >1 Loss/interruption of >8 hours Loss/interruption of >1 day Loss/interruption of >1 week Permanent loss of service or facility hour

Minimal or no impact Minor impact on environment Moderate impact on environment Major impact on environment Catastrophic impact on environment on the environment

Likelihood score

1 2 3 4 5

Rare Unlikely Possible Likely Almost certain

This will probably Do not expect it to Might happen or recur occasionally never happen/recur happen/recur but it is possible it Will probably happen/recur but it is Will undoubtedly happen/recur, may do so not a persisting issue possibly frequently

Consultation on Homeopathy & Iscador Independent Report of Findings on behalf of Wirral Clinical Commissioning Group August 2016

Table of Contents

Page

Introduction 4

Background 4

Consultation Options 5

Consultation Approach 6

Communications and Engagement 8

Review of Findings 12

Appendices

• Appendix 1- Consultation Strategy • Appendix 2 - Commissioning Decision Impact Assessment • Appendix 3 - Response from The Good Thinking Society • Appendix 4 - Response from The British Homeopathic Association • Appendix 5- Response from The Nightingale Collaboration • Appendix 6 - Response from Liverpool Medical Homeopathy Service • Appendix 7 - Notes of Patient, Carer and Stakeholder involvement meetings • Appendix 8 - Summary survey results • Appendix 9 - Post-consultation Equality Impact Assessment

Introduction

This report has been produced by NHS Midlands and Lancashire Commissioning Support Unit (CSU) on behalf of Wirral Clinical Commissioning Group to provide an independent report of the findings of the consultation on Homeopathy and Iscador.

Background

NHS Wirral Clinical Commissioning Group re-started its public consultation as part of a wider review on the future funding of the Homeopathy and Iscador treatments, currently provided by the Liverpool Medical Homeopathy Service.

The 12-week period of consultation engaged patients, carers and stakeholders to hear what people think about whether Homeopathy and Iscador treatment should continue to be funded for some patients from NHS money.

Wirral Clinical Commissioning Group regularly reviews the services that it funds for local people because it needs to achieve the best health gain from NHS money spent on services to the wider community.

The current service

The contract cost paid to Liverpool Medical Homeopathy Service between April 2013 to March 2015 for Homeopathy and Iscador treatments was £31,608; broken down as £20,540 for Homeopathy and £11,068 for Iscador.

At the time of the Wirral Clinical Commissioning Group’s Equality Impact Assessment, there were 77 patients receiving the service.

The contract with Liverpool Medical Homeopathy Service was due to expire in September 2015 but has been extended. A decision on the continued funding of the service will be subject to the outcome of commissioning review.

About homeopathy and Iscador

The National Institute for Health and Care Excellence carries out a public sector role to improve outcomes for people who use the NHS and other public health and social care services, and issues guidance.

The National Institute for Health and Care Excellence does not list the use of Homeopathy or Iscador in its guidance on the use of complementary and alternative treatments; they state there is a lack of evidence about the benefits for patients.

The NHS Choices website (January 2016) states that Homeopathy is a 'treatment' based on the use of highly diluted substances, which homeopathy practitioners claim can cause the body to heal itself. Iscador is a form of complementary therapy produced from mistletoe extract in herbal product form that might be provided alongside cancer treatment by homeopathic practitioners for patients, but is not a cure.

Nesta Hawker, Director of Commissioning for NHS Wirral Clinical Commissioning Group said: “This is a consultation and not a 'vote'. We are really keen to hear what people think and I would encourage them to take part in the consultation.”

Consultation Options

The National Institute for Health and Care Excellence (NICE) believes there is a lack of evidence about the patient benefits for Homeopathy and Iscador treatment, and NHS Wirral Clinical Commissioning Group is committed to achieving the best health gain from NHS money spent on services to the wider community. NHS Wirral Clinical Commissioning Group has considered 3 options relating to the future of NHS funded homeopathy services in Wirral. It will be the responsibility of NHS Wirral Clinical Commissioning Group's Governing Body members to thoughtfully consider all information gathered, including the findings of this consultation and then decide a best way forward.

Wirral Clinical Commissioning Group presented three options:

Option 1: NHS Wirral Clinical Commissioning Group should not follow the advice of The National Institute for Health and Care Excellence (NICE) guidelines.

Option 2: NHS Wirral Clinical Commissioning Group continues to fund the Homeopathy and Iscador services but only on an exceptional basis. This means that the GP (Doctor) who refers a patient would have to prove exceptional circumstances to receive Homeopathy or Iscador treatment, meaning: "The patient is likely to derive greater benefit from the treatment than might normally be expected for patients with that condition."

This option could result in an additional financial burden on NHS Wirral Clinical Commissioning Group who funds these Individual Funding Requests and there should be a cap on costs and this would not follow the advice of the National Institute for Health and Care Excellence (NICE).

Option 3: In light of the National Institute for Health and Care Excellence (NICE) guidelines, advising the NHS on proper use of treatments and who do not list that Homeopathy or Iscador should be used in the treatment of any health condition, Wirral Clinical Commissioning Group stops funding the Homeopathy and Iscador treatments.

The 3 options to select would be:

Option 1: Extend the existing contract for a Homeopathy and Iscador service.

Option 2: Only fund the Homeopathy or Iscador service if the patient's GP can prove that the patient is likely to derive greater benefit from the treatment than might normally be expected for patients with that condition (exceptional circumstance).

Option 3: Stop funding the service.

The Clinical Commissioning Group offered local people a variety of methods for participating in the consultation process.

• Completing the questionnaire online

• In hard copy and by post

The document could also be requested in alternative formats and printed from the Clinical Commissioning Group website.

The Clinical Commissioning Group also held a number of public events and meetings with specific groups to gather their views.

Consultation Approach

Aims and objectives

NHS Wirral Clinical Commissioning Group would undertake a pro-active approach to consultation which aims to ensure the patients, public, clinicians and other stakeholders were aware of the proposals and have the opportunity to comment on them. Specifically this would involve:

• Pro-actively publicising the consultation process through a range of channels • Providing details on the options and further information about Homeopathy and Iscador • Ensure arrangements are in place to provide information in different formats and languages to promote inclusiveness and reduce barriers to participation • Explaining the reasons and impact ( for example financial, numbers of people affected) of the proposed changes • Ensuring patients, wider public, clinicians and other stakeholders have the opportunity to comment on the proposals and are encouraged to provide feedback • Making information available about the options through a range of channels • Keeping all stakeholders informed of the consultation process

Legal requirements

The Clinical Commissioning Group is legally required to have in place arrangements to ensure that members of the public are involved at all stages of the commissioning process, including in the development and consideration of proposals for changes to services.

Where a proposed service change is considered to be a substantial variation the Clinical Commissioning Group must consult the Local Authority Health and Overview Scrutiny Committee (HOSC) (Public Health, Health and Wellbeing Boards and Health Scrutiny Regulations 2013).

Given the sensitivity of the proposals and the potential for a significant level of interest from patients, and interest groups (both for and against NHS funding of Homeopathy and Iscador), Wirral Clinical Commissioning Group decided this should be considered a substantial variation and communicated this to Wirral Metropolitan Borough Council in February 2016 before an initial consultation process was launched.

In the event, the consultation period initially commenced on 2 February 2016 and was to have run until 26 April 2016. However, it was suspended because the online survey could not be accessed for a period of time. This was announced by way of a press release, on the Clinical Commissioning Group’s website and communicated to Wirral Metropolitan Borough Council, patient and public forums and the Clinical Commissioning Group’s stakeholder list.

The consultation re-started on 22 April and ran for 12 weeks to 15 July 2016.

Public Sector Equality Duty (PSED)

When the Clinical Commissioning Group is proposing policy changes that will affect a large number of patients who are in groups which have a “protected characteristic”, it must have “due regard” to the need to:

- Remove or minimise the disadvantage suffered by persons who share relevant protected characteristics (such as race, age, disability, or sexual orientation) - Take steps to meet the needs of those who share such characteristics - Encourage participation of those who share such characteristics

This duty – to “have regard” to these needs – must be met before or at the time any policy is being considered.

This duty does not mean that the NHS cannot take changes that adversely affect, for example, the access that disabled people have to local services. It does mean that those who take the decision need to have a proper understanding of how their decisions will impact on disabled people and take those factors into account when taking the final decision.

To fully understand the likely impact of the options under consideration, the Clinical Commissioning Group undertook an Equality Impact Assessment (EIA) prior to commencing consultation (Appendix 2). A copy of the Consultation Strategy (Appendix 1) includes Annex A containing the Gunning Principles, Annex B: the proposed consultation period (NB: originally planned to commence 21 April-14 July 2016 but, in fact, commenced 22 April and ended on 15 July 2016) and Annex C the Commissioning Decision Impact Assessment. A post-consultation Equality Impact Assessment has since been undertaken (see Appendix 9).

This concluded that, in relation to the Equality Risk, there should be little or no impact and little risk involved; little chance of a Human Rights breach and little chance of a privacy breach. Communications and Engagement

The communications plan developed to support the consultation set out a range of activities to support the consultation. The Clinical Commissioning Group adopted a pro-active approach to consultation to ensure the patients, public, clinicians and other stakeholders were aware of the proposals and had the opportunity to comment on them.

Stakeholder communication: To support the plan a detailed stakeholder map was developed identifying those groups/individuals likely to have an interest in the consultation (See list below).

In addition, the Clinical Commissioning Group arranged meetings with certain local support groups and voluntary organisations, as part of their commissioning review process.

Name Group Type Age Wirral Older Peoples Parliament Older people Age UK (Wirral) Older people Wirral Executive Youth Board Young People Alcohol /substance Misuse Wirral Ways to recovery Alcohol / substance Misuse Phoenix Recovery Services Alcohol / substance Misuse Wirral Spider Project Alcohol / substance Misuse BME Wirral Multicultural Centre BME Wirral Change BME Carers WIRED Carers service Carers

Wirral carers Association Carers Family Tree Carers Action with young carers Barnardos Wirral service Carers

Community Wirral Women’s Enterprising Breakthrough Community “Wirral Well” Health and Well Being Services Community Citizens Advice Wirral Community Voluntary Community Action Wirral Community Wirral CVS Community

Involve North West (former Tranmere Alliance) Community

North Birkenhead Devcelopment Trust Community

Leasowe Community Trust Community YMCA Wirral Community Magenta Living Community / Housing Disability Merseyside Society for the Deaf Disability

Wirral Society for the Blind and Partially Sighted Disability

WIRED ( Wirral Information Resource for Equality and Disability Diversity) Wirral DISC ( Disabled Integrated Social Club) Disability

Faith groups

Merseyside Council of Faiths Faith Gender Wirral Women’s and Children’s Aid Gender

International Women’s Group Gender

Cheshire Federation of Women’s Institutes (North Wirral) Gender

HealthWatch Healthwatch Wirral Healthwatch Learning Disability Wirral Mencap Learning Disability

Wirral Independent Living and learning Learning Disability

Long term conditions/ Conditions currently using Homeopathy Support Groups Local Solutions (Wirral) Support Groups

Wirral Alzheimers Society Support Groups

Wirral Holistic Care Services Support Groups

The British Lung Foundation Support Groups

Maggie's Merseyside at Clatterbridge Support Groups

Sundowns Support Groups

Stick n step Support Groups Diabetes UK Wirral branch Support Groups

Alzheimers Society Support Groups Sahir House (HIV) Support Groups Parkinsons Disease Society Support Groups

Mersey Region Epilepsy Association Support Groups Wirral Heartbeat Support Groups National Kidney federation Support Groups Breathe Easy Wirral Support Groups Multiple sclerosis Society (Wirral Branch) Support Groups Stroke Association Support Groups National Eczema Society Support Groups IBS Merseyside Support Group Support Groups Fibromyalgia Support group Support Groups Wirral Arthritis Support Group (WASPS) Support Groups Dystonia Society (Liverpool and Merseyside group) Support Groups Infertility Network Support Groups Chester ME support Group - includes Wirral (Chronic Support Groups fatigue Syndrome ) Headway (Acquired brain injury) Support Groups

Mental health

AMMO (military veterans) Mental Health Cheshire and Wirral Partnership Mental Health Mental Health Foundation Trust Inclusion Matters Wirral Mental Health Wirral Mind Mental Health

Advocacy in Wirral Mental health Wirral pathfinders Mental Health Sexual Orientation Wirral LGBT network Sexual Orientation Trans Wirral Sexual Orientation Special Interest Groups

Liverpool Medical Homeopathy Service Merseyside Skeptics Society Interest Groups

North West friends of Homeopathy Interest Groups

British Homeopathic Association Interest Groups

Good Thinking Society Interest Groups

Local Public Bodies and NHS Trusts Wirral Metropolitan Borough Council Public Sector

Wirral University Teaching Hospital (WUTH) NHS Health organisation Foundation Trust

Wirral Community NHS Trust Health organisation

Website: the core channel for the consultation was a dedicated area on the Clinical Commissioning Group’s website. The website included information about the proposals, further information about Homeopathy and Iscador, details about consultation events and access to the online survey. In order to reflect differing points of view on complementary and alternative therapies, the Clinical Commissioning Group signposted people to information both supportive and not supportive of homeopathy. Further information from the NHS Choices website was also provided including the health conditions which patients are seen for.

Social Media: a schedule of social media activity was created that generated 28 website hits.

Media: The Clinical Commissioning Group issued press releases to promote the consultation and encourage feedback via the online survey.

Consultation materials: the Clinical Commissioning Group published full and summary versions of its consultation document with a supporting briefing. As well as being posted on the Clinical Commissioning Group’s website, hard copies also made available. This information was also offered in a range of formats and languages.

Co-production of the Questionnaire

In order to ensure the survey questionnaire was accessible and generated the maximum- possible response, the Clinical Commissioning Group enlisted the help of the Wirral-based “Together All Are Able” disability group who as a “critical friend” in its design and content.

Publicity materials: The Clinical Commissioning Group distributed a flyer promoting the consultation process to Wirral GP practices for display on noticeboards and TV screens.

Patient focused meetings: A number of meetings were held to enable discussion with the public and other stakeholders. These are listed below.

Meeting Date Attendees Patient engagement event, Clinical Commissioning 26 April 8 Group offices, Old Market House, Hamilton Street, Birkenhead Public meeting, Clinical Commissioning Group offices, 10 May 33 Old Market House, Hamilton Street, Birkenhead Women’s Support Group, Maggie's Merseyside at 30 June 6 10

Clatterbridge Colorectal Support Group, Maggie's 07 July 11

To ensure the views of current or previous users of the service were taken into account, the Clinical Commissioning Group worked with the Liverpool Medical Homeopathy Service to inform all previous patients, current patients and carers. Patient questionnaires were sent out with a stamped, addressed envelope to all previous patients, current patients and shared with members of the Forum.

The Clinical Commissioning Group also briefed all Clinical Commissioning Group staff, encouraging them to raise awareness of the process within their professional and patient- focussed networks and to inform the consultation process project lead of any potential impacts in relation to any of the options under consideration.

Review of Findings

Feedback provided through the following channels was reviewed and analysed:

• 1,518 public and stakeholder survey responses • 24 GP survey responses • Stakeholder responses were received from: The Good Thinking Society and Merseyside Skeptics Society, The British Homeopathic Association, The Nightingale Collaboration and Liverpool Medical Homeopathy Service.(Please note: this response was made in relation to the commissioning review and the consultation process).

Events/meetings: • Patient and Carer Forum Event - Tuesday 26 April, Old Market House, Hamilton Street, Birkenhead). • Public Forum meeting – Tuesday 10 May 2016, Old Market House, Hamilton Street, Birkenhead) • Women’s Support Group - 30 June, Clatterbridge Cancer Centre • Colorectal Support Group – 7 July, Clatterbridge Cancer Centre

NB: Notes of the Patient, Carer and Stakeholder involvement meetings are provided at Appendix 7.

Themes that emerged:

Supportive of NHS funding for Homeopathy and Iscador:

• Users of Homeopathy and Iscador say it works • Users claim it has been more beneficial than conventional medicine/treatment • Cheaper than conventional medicine • Placebo effect is valuable • Relieves pressure on NHS resources • Removal from the NHS restricts patient choice. 11

Sample of comments:

Survey respondent - “Always helps me. Fast, effective, safe, no side-effects. Helped with chronic conditions and have also used it for some sudden problems.” Survey respondent - “This service provides options for people who might wish to supplement their treatment and should be continued.”

Participant – colorectal support group – “Cancer treatment caused huge fatigue and GPs should provide more help. Side-effects could be difficult to manage and it was understandable why some would use the service”

Participant at Patient Forum – “To me the very small cost of homeopathy to the NHS is so fractional that keeping it will save the NHS in the long run. In general homeopathy appeals to health minded individuals.”

Against Homeopathy and Iscador

• Does not work/clinically unproven/placebo effect only • Funding is a waste of NHS resources • NHS funding wrongly ‘legitimises’ homeopathy and Iscador • Could harm patients who need conventional treatments • NHS should follow NICE Guidance • NHS funds should be targeted on scientifically proven treatments

Survey respondent - “£31,000 could be spent to employ a diabetes support specialist to visit patients to educate and inform patients and staff about the reality of this den astatine condition which is now epidemic on the Wirral”

Which option would the public choose?

Patient, Carer and Stakeholder Survey

Which option would GPs choose?

GP Survey

Themes and comments from survey respondents:

• “OMG - there is no money in the NHS and I can’t believe how long it is taking to stop funding something with no evidence to show anything other than a placebo effect!! Enough consulting and just stop”

• “May help patient- but suspect due to increased consultation times rather than Rx”

• Previous experience seems to offer short term benefit? From a patient gets attention/placebo effect but no lasting gain ever seems to have been achieved”

Summary of Stakeholder responses

The Good Thinking Society and Merseyside Skeptics Society

• There was no proof that homeopathy was effective and it was absurd to offer patients an intervention that was known not to effectively treat any condition.

• NHS funding legitimised homeopathy as a treatment and this was dangerous for patients who may need conventional treatment.

• The funds spent on homeopathy could be spent, more effectively, on evidence-based treatment.

• The threat of legal challenge should not deter the Clinical Commissioning Group from making healthcare decisions in the best interests of patients following a properly- conducted consultation process.

• The Clinical Commissioning Group commissioned Iscador as a treatment for managing the side-effects of cancer treatment and not as a treatment for cancer itself. It should be distinguished from homeopathy as it was derived from mistletoe (an active ingredient). However, the Clinical Commissioning Group could not continue to spend limited resources on treatments including Iscador that had not been shown to be effective.

The British Homeopathic Association

• Patients with complex problems had benefitted from the homeopathy service.

• NICE had not reviewed homeopathy specifically.

• The way the Clinical Commissioning Group had described the consultation options was biased and based on erroneous claims.

• If homeopathy was funded by exceptional case only, it would be more expensive to treat those patients who would otherwise receive homeopathy services.

• Expert opinion was flawed and the literature review on which to drawn informed conclusions was “non-systematic, scanty and lacking in scholarly process;” omitting some important studies and biased negatively in favour of others.

The Nightingale Collaboration

• Supported Option 3 and urged the Clinical Commissioning Group to cease funding of Homeopathy and Iscador. In summary, there were three main problems with homeopathy:

• There was no reason to suppose it should work, as like does not cure like.

• Its doctrines and practices were fundamentally inconsistent with all relevant scientific knowledge.

• There was no high-quality evidence that it did work (including three Government-level reviews) and criticism of these reviews did not withstand scrutiny.

• Iscador was not a homeopathic preparation. Nevertheless, it was difficult to see how it could be recommended.

Liverpool Medical Homeopathy Service

• Option 2 (Individual Funding Request Model): This could, potentially, be a low referral model which would be both time-consuming for GPs and not cost- effective and not a sustainable business model for the Service. Most patients would have to ask their GP to access the service, rather than it being routinely offered.

• Evidence was increasing for the efficacy of homeopathy (example shared with Clinical Commissioning Group)

• Re: Option 3: NICE had made explicit reference to homeopathy in only five conditions out of the thousands of medical conditions that existed, making option 3 is misleading.

• If a decision was made to stop NHS funding for the service, patients would have to either stop their treatment (from which he had seen many benefit) or fund their treatment privately which was not affordable for many patients.

• Iscador was widely used across Europe to help with side-effects and improve the quality of life for patients with cancer. One patient, in his late seventies, was still alive some five or six years later after being diagnosed with mesothelioma.

• It would be “a tragedy” if homeopathy was no longer available via the NHS. Patients could no longer access a service that works for them which could, in the long run, cost the NHS more money. Current service-users were very anxious about the current service review.

• The Service also submitted to the Clinical Commissioning Group a copy of a letter previously sent to Liverpool Clinical Commissioning Group to draw their attention to the “strong evidence base for the effectiveness of homeopathy” and critical of the “flawed” House of Commons Science and Technology Committee’s homeopathy review of 2010. Please see Appendix 7

Full survey results

The full survey results are provided at Appendix 9

Appendix 1

CONSULTATION STRATEGY FOR HOMEOPATHY & ISCADOR Wirral Clinical Commissioning Group

BACKGROUND & CONTEXT

NHS Wirral Clinical Commissioning Group (Clinical Commissioning Group) has a duty to ensure that the services we commission are high quality, safe, local, accessible and good value for money.

As part of the Clinical Commissioning Group’s review of contract requirements for 2015/16, and in line with published Procedures for Low Clinical Priority Policy, which came into effect on 1st May 2015, it was agreed that complementary therapy services would be subject to commissioning review in 2015-16.

As a result, the contract for Homeopathy and Iscador treatment (remedies) by the provider Liverpool Medical Homeopathy Service is being reviewed. This will include a public consultation to seek patient and public opinion as to whether the service should continue to be commissioned

The current service

The contract with Liverpool Medical Homeopathy Service was due to expire in September 2015 but has been extended and a decision on the continued funding of the service will be subject to the outcome of commissioning review.

Options for consultation

The Clinical Commissioning Group proposes to consult on three options:

Option 1: NHS Wirral Clinical Commissioning Group should not follow the advice of The National Institute for Health and Care Excellence (NICE) guidelines.

The 3 options to select would be:

Option 1: Extend the existing contract for a Homeopathy and Iscador service.

Option 3: Stop funding the service.

APPROACH TO CONSULTATION

The approach to consultation will ensure Wirral Clinical Commissioning Group meets its obligations under the Duty to Involve the public, the Public Sector Equality Duty and guidance from NHS England guidance.

Legal context

There is no statutory obligation on Clinical Commissioning Groups to conduct formal public consultations when bringing forward proposals to change services. The legal requirement is for the Clinical Commissioning Group to have in place arrangements to ensure that members of the public are involved at all stages of the commissioning process, including in the development and consideration of proposals for changes to services. Consultation is one method only of involving the public.

Where the proposed service change is considered to be a substantial variation the Clinical Commissioning Group must consult the Local Authority (Public Health, Health and Wellbeing Boards and Health Scrutiny Regulations 2013). Substantial variation is, however, not defined and whether or not any of the proposed changes amount to a substantial variation needs to be determined in discussion.

Given the sensitivity of the proposals and the potential for a significant level of interest from patients, and interest groups (both for and against NHS funding of Homeopathy and Iscador) Wirral Clinical Commissioning Group will ensure the Local Authority Health Overview and Scrutiny Committee (HOSCs) is fully briefed and aware of the proposals and consultation process. Keeping the HOSC informed will reduce the possibility of a challenge to the proposals.

As Wirral Clinical Commissioning Group is undertaking a 12 week consultation, this satisfies a key requirement for the HOSC and consultation.

Public Sector Equality Duty (PSED)

When the Clinical Commissioning Group is proposing policy changes that will impact a large number of patients who are in groups which have a “protected characteristic”, it must have “due regard” to the need to:

This duty – to “have regard” to these needs – must be met before or at the time any policy is being considered.

The Clinical Commissioning Group needs to fully understand the likely impact of any 19

proposed changes to local NHS services on disabled people, the elderly, racial minorities or any other group that has a protected characteristic under the Equality Act. It is considered good practice to undertake an Equality Impact Assessment (EIA) prior to any consultation on whether to alter or stop a particular service. A further Equality Impact Assessment should be undertaken following the completion of consultation.

Guidance from NHS England

The latest guidance from NHS England – Planning, assuring and delivering service changes for patients, highlights good practice as well as the legal duties the Clinical Commissioning Group needs to adhere to meet its obligations and ensure it actively and positively engages with local people.

Gunning Principles

The legal context is further underpinned by the Gunning Principles, developed following a legal challenge to a consultation. These gunning principles are:

1. When proposals are still at a formative stage

Public bodies need to have an open mind during a consultation and not have already made the decision, but have some ideas about the proposals.

2. Sufficient reasons for proposals to permit ‘intelligent consideration'

People involved in the consultation need to have enough information to make an intelligent choice and input in the process. Equality Assessments should take place at the beginning of the consultation and be published alongside the document.

3. Adequate time for consideration and response

Timing is crucial – is it an appropriate time and environment, was enough time given for people to make an informed decision and then provide that feedback, and is there enough time to analyse those results and make the final decision?

4. Feedback must be conscientiously taken into account

Think about how to prove decision-makers have taken consultation responses into account.

A consultation report should be published detailing respondents and comments. The consultation report should detail the main themes/ comments and responses.

The risk of not following these principles could result in a Judicial Review. A number of public bodies across the UK have been taken to Judicial Review and deemed to have acted unlawfully in their Public Sector Equality Duty – usually linked to the four Gunning Principles.

A matrix showing how the consultation strategy meets each of the Gunning Principles is included at Annex 1.

APPROACH TO CONSULTATION

Aims and objectives

NHS Wirral Clinical Commissioning Group will undertake a pro-active approach to consultation which aims to ensure the patients, public, clinicians and other stakeholders are aware of the proposals and have the opportunity to comment on them. Specifically this will involve:

• Pro-actively publicising the consultation process through a range of channels • Providing details on the options • Ensure arrangements are in place to provide information in different formats and languages to promote inclusiveness and reduce barriers to participation • Explaining the reasons and impact e.g. financial, nos. of people affected) of the proposed changes • Evidence to support any preferred option • Ensuring patients, wider public, clinicians and other stakeholders have the opportunity to comment on the proposals • Making information about the proposals available through a range of channels • Keeping all stakeholders informed of the consultation process

COMMUNICATIONS PLAN

Pre-consultation

Prior to consultation starting in February 2016, Wirral Clinical Commissioning Group will ensure key stakeholders have been briefed about the proposals. These include:

- HOSC - GPs within Wirral Clinical Commissioning Group - Healthwatch - MPs - Liverpool Medical Homeopathy Service.

Communications Plan

A communications plan has been developed to support the consultation. The communications plan will deploy a spectrum of activities and channels to ensure awareness of the consultation and to invite feedback.

The plan has been informed by the pre-Equality Impact Report and Stakeholder Analysis.

Pre Equality Impact Assessment

The law requires that any new service, significant change in service, reduction or removal of service has an equality analysis report to see if there are negative impacts, i.e. direct or indirect discrimination on particular people because of their protected characteristic, relating to the action. If there are negative impacts, then we (NHS Wirral Clinical Commissioning Group) must be cognisant of our Public Sector Equality Duty (PSED) when making decisions with a view to mitigating the impact or in extenuating circumstances explaining why we 21

cannot. In order to demonstrate consideration of the PSED in relation to the Homeopathy and Iscador services a Pre Equality Analysis report will: • Set out the detail of the change in relation to the equality legislation. • Identify in the proposal any inherent indirect discrimination • Identify any barriers or detriments connected to protected characteristics in transferring services • Ensure that all relevant patients, public and groups are suitably consulted on the proposal The report alerts officers within Wirral Clinical Commissioning Group to any potential barriers/discrimination in developing proposals or policy and presenting them to the public. This pre-equality assessment is concerned with highlighting potential barriers to the consultation and will be making recommendations to steer this process, via Wirral Clinical Commissioning Groups Senior Management Team and officers responsible for the consultation. The Pre-Equality Impact is at annex 3.

Final Equality Analysis Report Post consultation we will draw on the results of the consultation and engagement exercise (specific responses from people with relevant protected characteristics) carried out as a result of the review and the findings and recommendations of the Pre EA document and aim to: • Analyse the input from interested parties and consultation • Identify any concerns and worries related to equality issues and mitigations of the proposal • Establishes whether the Public Sector Equality Duty (PSED) is met • Propose recommendations for committees to consider prior to a decision being made. Stakeholder Map

A detailed stakeholder map has been produced to identify groups likely to have a particular interest in the consultation, for example patient support groups. Wirral Clinical Commissioning Group will ensure these groups are proactively informed of the consultation and invited to participate.

Provision of information

Information will be made available to enable people to understand the proposals and provide feedback. A range of channels to distribute information will be used. Information to be made available in various formats will include:

• The case for change - why Wirral Clinical Commissioning Group is putting forward the proposals including supporting evidence • The proposed changes and an explanation of the impact on patients • Details of the consultation process - timescales, methods for providing feedback , further information 22

• Publicising details of events being held including adequate notice of dates • Pre – consultation Equality Impact Assessment • Where need is for example through the Stakeholder Analysis and Pre-Equality Impact Assessment, provide targeted information to particular groups which might be impacted by the proposed change.(e.g. in languages other than English?)

All existing channels and mechanisms used by Wirral Clinical Commissioning Group to support communications should be utilised.

This will include a contact point for enquiries and where to submit questions or obtain further information.

Channels for information & feedback

Information will be made widely available through a range of channels, in different formats and feedback can be submitted through different mechanisms:

• Published material, including a literature search • Dedicated consultation Website • Social Media • Events/presentations: pre-planned and on request (If there is demand, Wirral Clinical Commissioning Group will consider holding additional focus groups to explore some of the issues raised during the consultation process • Dedicated consultation Website • Online surveys – patients/publics and GPs • Patient surveys in the provider.

Media

Wirral Clinical Commissioning Group will take a pro-active approach to media handling and should ensure it can respond to media enquiries on the proposals in a timely manner during the consultation process.

Pro-active releases should be issued at ley points during the consultation period, for example, reminders, publicising meetings.

Given the sensitive nature of the subject, and the existence of relatively vocal supporters and opponents, arrangements need to be in place to respond to media/public comment. There is, for example, the likelihood of claims and counter claims relating to information being put in the public domain, particularly by interest groups.

KEY ISSUES TO BE ADDRESSED DURING THE CONSULTATION

The cessation of funding for Homeopathy and Iscador will be contentious with vocal supporters and opponents. There is considerable debate about the evidence of the effectiveness of Homeopathy or Iscador. For example:

- Friends of Homeopathy are a nationally vocal group promoting its use as a treatment; - The Good thinking society, a group promoting rational thinking in science are calling nationally for funding of Homeopathy to be stopped. They have been active recently

in Liverpool asking the Clinical Commissioning Group to reconsider its funding of services - National Institute for Health and Care Excellence (NICE) doesn’t recommend the use of Homeopathy for the treatment of any health condition - British Homeopathic Association claims a growing body of evidence demonstrating a positive effect on patients - A majority of patients report a positive experience in terms of improvements to their health from Homeopathic treatment - In 2010 the House of Commons Science and Technology Committee found there was no evidence that Homeopathy is an effective treatment for any health condition and asked for it not be funded by the NHS.

Recent experience in Liverpool demonstrated a significant level of interest in the funding of Homeopathy and Iscador. The Good Thinking Society challenged Liverpool Clinical Commissioning Group to reconsider its position on funding Homeopathy. Wirral Clinical Commissioning Group has also received a request to cease funding of Homeopathy.

Recent experience in Liverpool and elsewhere will inevitably mean that Wirral Clinical Commissioning Group will come under scrutiny. Particular key issues that will need to be addressed during the consultation are:

• Evidence for and against the clinical effectiveness of Homeopathy and Iscador • The proposed changes and impact on current and future patients e.g. restricting patient choice • Patients reporting positive impact/benefits: feedback in local audits show a majority of patients report improvements in their condition.

The following high level messages should run throughout the consultation process:

• Wirral Clinical Commissioning Group reviews all its commissioned services to ensure they continue to be clinically effective, meet patients’ needs and provide value for money; • New evidence, for example, becomes available which might change clinical effectiveness and prompt a review of a service • NICE doesn’t recommend the use of Homeopathy or Iscador in the use of any health condition • Other Clinical Commissioning Groups have removed funding for Homeopathy or Iscador based on lack of evidence and there is likely to be a national consultation to determine if homeopathy should continue to be made available on the NHS • Wirral Clinical Commissioning Group welcomes the views of local people to help it decide what the future arrangements for Homeopathy and Iscador should be.

CONSULTATION REPORT

A detailed consultation report will be prepared following the end of the consultation period. This will include a detailed review of all the consultation responses.

A post consultation Equality Impact Assessment report will also be undertaken to examine any further issues raised in relation to protected characteristics. This will provide a final analysis of any potential equality impacts and whether or not the proposals meet Public 24

Sector Equality Duties (Equality Act 2010, s149). The final results of the consultation must be written up and submitted to the Clinical Commissioning Group Governing Body Board as part of their decision making process for thoughtful consideration prior to their final commissioning decision.

The outcome of the consultation will be made publicly available and explain the rationale for the recommended decision.

The Report should also include an evaluation of the consultation.

ANNEX 1: ENSURING EFFECTIVE ENGAGEMENT - MEETING THE GUNNING PRINCIPLES

Principle Activities supporting the principles

1. When proposals are still at a Make information available on how the proposals were developed. E.g. formative stage • Pre-consultation work • Pre-consultation Equality Impact Assessment Public bodies need to have an • Evidence used to support the proposals. open mind during a consultation and not already made the decision, but have some ideas about the Tone of consultation material will emphasise the Clinical Commissioning proposals. Group is open to comments and ideas and values feedback as part of making a positive contribution to the decision-making process.

The Clinical Commissioning Group will provide options for change rather than a single proposal.

2. People involved in the Details of the case for change will be made available and the evidence consultation need to have used to support this. Information made available will include: enough information to make an intelligent choice and input in • Explanation of proposals (consultation document) and the process. supporting evidence • Summary (easy – read version offered) • Website – updated to reflect comments • Frequently Asked Questions Equality Assessments should take • Equality Impact Assessments place at the beginning of the • Online survey. consultation and be published alongside the document.

3. Adequate time for Consultation period will run for 12 weeks minimum 22 April – 15 July consideration and response 2016 Timing is crucial – is it an appropriate time and environment, Sufficient notice for any events to be held. was enough time given for people to make an informed decision and Consultation report should detail issues/themes raised and response to then provide that feedback, and is these should be published. there enough time to analyse those results and make the final decision.

4. Feedback must be A consultation report will be published and final recommendations will conscientiously taken into highlight any changes that have taken place as a result of the account consultation and reasons why ideas/suggestions have not been accepted. Think about how to prove decision- makers have taken consultation responses into account. The final decision of the Clinical Commissioning Group should be publicised e.g. via a press release.

Annex 2 : Consultation Plan – Homeopathy and Iscador

Consultation Period: Thursday 21 April 2016 – Thursday 14 July 2016

April 2016 May 2016 June 2016 July 2016 August 2016 September 2016

Thursday 14 April 2016

Closure and Pre-planning. Consultation on-going. Consultation on-going. Thursday 14 July 2016 Review the Tuesday 6 September Consultation Report 2016 Consultation closes. and produce Review Report for Governing Attend Governing Body Monday 18 April 2016 Tuesday 10 May 2016 Media and social Body. Board meeting (1pm- media continue to 4pm, Nightingale Room). Closure briefings ready: Public Event held at promote the OMH: consultation. 1. Consultation closure Preparation of Prepare final versions and re-run briefings for 1. Clinical consultation report by of above Reports for HOSC – report on media and stakeholders Commissioning CSU. Clinical Ops to ratify. consultation. agreed. Group Targeted drop ins 2. Scheme of work introduction; continue to be held. completed ready for 2. Public opportunity actions to commence to share views; Final Equality Analysis Tuesday 16 August consultation 19 April 3. Engagement of report by CSU. 2016 2016. interested parties. Final draft papers sent to Clinical Ops Tuesday 19 April 2016 Media and social media for ratification. continue to promote the Consultation decision ratified: consultation.

1. Clinical Commissioning Tuesday 23 August Group Clinical 2016 Operations members Targeted drop ins confirm closure of continue to be held. Final ratified version current and re-run of sent for Governing consultation. 27

Body Agenda.

Thursday 21 April 2016

Consultation closure actions:

2. Clinical Ops response; formal notification corresponded to Provider; 3. GP bulletin update briefing circulated; 4. Update briefing circulated to stakeholder list (include Healthwatch CVS, Special Interest and reach to circa 1,000+ contacts). Re-run consultation actions:

1. Dedicated Clinical Commissioning Group webpage go live; 2. Online public survey to start; 3. Online GP survey to start; 4. LMHS patient surveys to be re-sent; 5. Social media programme starts (Twitter) to publicise consultation; 6. Consultation circulated to stakeholder list; 7. Update sent to HOSC; 8. Wirral Globe press release to announce 28

closure due to technical issues, re-run dates announced. Tuesday 26 April 2016

Patient/carers meeting

1. Patient/carers meeting held at OMH to gather views; 2. IT set up in Duncan Room for online survey completion; 3. Printed versions with stamped addressed envelopes available. *Media and social media activity will continue throughout consultation period to promote the consultation. ** Website should be updated and will be monitored throughout the consultation period in response to activity and developments.

APPENDIX 2

Commissioning Decision Impact Assessment

Service Considered: Annual Contract Value: Approx. number of patients currently Homeopathy and Iscador. Value noted in this paper. receiving the service: 77 (seventy seven). Provider: Liverpool Medical Homeopathy Service. This document forms part of the auditable document trail for the commissioning decision which may be legally challenged, therefore it must be completed factually, objectively and diligently. Commissioning a health service will have both positive and negative impact. It is critical that any adverse impact on patients and on the wider health economy are understood and documented.

1a. Background – Information on Service:

Homeopathy treatment is a form of complementary therapy/alternative medicine which uses highly diluted substances for a wide range of health conditions through the body’s immune system. Iscador treatment is form of complementary therapy/alternative medicine from mistletoe extract in herbal product form that is provided as part of cancer treatment (not a cure).

Homeopathy and Iscador Services are provided to Wirral residents by Liverpool Medical Homeopathy Service. The Service was commissioned by Wirral Primary Care Trust (PCT) and has been in place for a number of years, although the exact date is not known.

The contract cost paid to Liverpool Medical Homeopathy Service on patient activity between April 2013 to March 2015 for Homeopathy and Iscador treatments was £31,608; broken down as £20,540 for Homeopathy and £11,068 for Iscador.

This highlights a 143% cost increase for Iscador treatment and a 25% cost decrease in Homeopathy treatment in 2014/15; with an overall 11% Service cost increase:

Iscador Homeopathy Annual total paid 2013/2014 £3,227 £11,740 £14,967 2014/2015 £7,841 £8,800 £16,641 2 year spend £11,068 £20,540 £31,608

The contract with Liverpool Medical Homeopathy Service was due to expire in September 2015 but has been extended to September 2016 by Wirral Clinical Commissioning Group and a decision on the continued funding of the Service would be subject to the outcome of formal review.

The Service is delivered from St Catherine's Health Centre in Birkenhead and provided to patients who are registered with a Wirral GP. The Service is accessible to patients aged 18 and over for Iscador and aged 16 and over for Homeopathy treatment. 30

Referrals to the Service may be made by GPs only, based on health illness/conditions (listed in Appendix 1) that the referring GP assesses the patient will benefit from Homeopathy or Iscador treatment. Referred patients will be offered an initial assessment for the health condition(s) and the opportunity to have up to four further follow up appointments.

Evidence and demographic

April 2015 to December 2015 demographic data received from Liverpool Medical Homeopathy Service (received on 11-01-2016) captured the gender and age of one hundred and sixteen (116) patients who had either received Homeopathy or Iscador treatment, or both.

Table 1 below highlights Service patient gender is pre-dominantly females in both Homeopathy (74%) and Iscador (73%), and patients receiving both Homeopathy and Iscador being 100% female:

Gender Homeopathy Iscador Both Male patients 22 3 0 Female patients 77 8 6 Total patients 99 11 6 04/2015 – 12/2015 total patients: 116

Table 2 below highlights patients by age; pre-dominantly patients over 65 years of age; 44 %, with the combined ages for patients aged over 50 years at 74%, two thirds:

Table 2 Patient age Receiving Receiving Receiving Total by Homeopathy Iscador Homeopathy age & Iscador Under 25 7 0 0 7 25 - 34 years 4 0 0 4 35 – 49 years 15 0 0 15 50 – 64 years 26 8 3 37 Over 65 years 47 3 3 53 Total patients 116

The April 2014 to March 2015 activity report sent to Wirral Clinical Commissioning Group from Liverpool Medical Homeopathy Service states: “There are several reasons why patients request referral to the homeopathy service:

• The commonest is that they are unable to take conventional drugs for their condition e.g. side effects from anti-inflammatory drugs or menopausal symptoms with a history of breast cancer so hormone replacement therapy is contraindicated.

• when there is no good conventional treatment available e.g. chronic fatigue syndrome, fibromyalgia, multiple chemical sensitivity or multiple sclerosis

• Failure to respond to conventional treatment for their conditions e.g. patients with 31

diverticulitis, irritable bowel syndrome and hypertension.

• To help with side effects from unavoidable conventional treatment-e.g. side effects of chemotherapy during cancer treatment.

• Finally some patients prefer to take homeopathic remedies in preference to conventional treatment wherever possible. In the Merseyside region there are many patients who have had access to NHS homeopathic treatment since the Hahnemann hospital became part of the NHS in 1948. This is illustrated by one patient, a 99 year old man who does not take any conventional treatment and manages his various ailments with homeopathy.”

This report also states: “Patients are asked to complete an Audit Questionnaire at their final visit to the clinic to assess their response to homeopathic treatment. We use a simple questionnaire with an outcome score devised initially by the Glasgow Homeopathic Hospital and used in several other homeopathy units in the U.K… The results of the audit show that the majority of the patients attending the Wirral service have had an improvement in their condition following homeopathic treatment. This is in line with other outcome studies looking at patient reported outcomes from homeopathy treatment which show that around 70% of patients have a moderate or significant improvement in their condition as a result.”

The report continues with patient feedback: “Patients were invited to comment on the service in the questionnaire. Some of the comments are as follows:

“Homeopathic treatment has made my life much easier, not having nearly as much pain as in the past. It enables me to continue my lifestyle as before my diagnosis of osteoarthritis. I do not need any conventional treatment either.” (from a 80 year old patient with osteoarthritis)

“My treatment from the homeopath in my opinion is helping me and I would like to continue to come.” (from a patient with recurrent diverticulitis)

“Homeopathy has helped my insomnia appetite control, my anxiety, ability to cope, mood swings and my night time pain levels. This has been alongside therapy and conventional medicine.” ( from a patient with long standing chronic fatigue syndrome)

“Energy levels back to normal, active and strong, but ability to eat large amounts diminished due to removal of stomach” ( from a patient with stomach cancer)

“having reviewed her response, she appears to have gained relief from homeopathic treatment ,without side effects, that she has been unable to achieve through conventional medicine, I would therefore be grateful if she could continue to receive treatment from the homeopathic service.” (from the GP of a patient with fibromyalgia).”

A total of 66 health conditions were treated during 2014-15 and 66 during 2013-14, with the most common conditions treated being cancer (14), pain (12) and psychiatric (11). Liverpool Medical Homeopathy Service receives different cost tariff for each patient which is based on how many health conditions are being treated. A breakdown by type of cancer has not been provided to date, but requested from Liverpool Medical Homeopathy Service.

1b. Background- Policy Context and/or principle driver for commissioning decision:

The proposed commissioning decision is regarding potential Service change proposals to cease the current arrangement between Wirral Clinical Commissioning Group for Homeopathy and Iscador treatment provided by Liverpool Medical Homeopathy Service.

HM Treasury Managing Public Money

Proposed Service change would contribute to Wirral Clinical Commissioning Group carrying out its prescribed duties in that it acts as a responsible and efficient organisation, in accordance with the principles outlined in the HM Treasury Managing Public Money guidance (first publication 2007, second publication July 2013, revisions August 2015).

NHS Five Year Forward View

The funding and efficiency gap for the NHS is highlighted in the NHS Five Year Forward View (October 2014:7), explaining: “if we fail to match reasonable funding levels with wide-ranging and sometimes controversial system efficiencies, the result will be some combination of worse services, fewer staff, deficits, and restrictions on new treatments.

(October 2014: 33)…NHS England already has a £15m a year programme, administered by NICE, now called “commissioning through evaluation” which examines real world clinical evidence in the absence of full trial data. At a time when NHS funding is constrained it would be difficult to justify a further major diversion of resources from proven care to treatments of unknown cost effectiveness.”

Delivering the Forward View: NHS Planning Guidance (December 2015) includes for three interdependent and essential tasks from commissioners in line with NHS Spending Review;

• first, to implement the Five Year Forward View; • second, to restore and maintain financial balance; • third, to deliver core access and quality standards for patients.

It is anticipated for allocated NHS resources to contribute to closing the health and wellbeing gap, the care and quality gap and finance and efficiency gap.

Proposed Service change would contribute to ensuring that Wirral Clinical Commissioning Group business is transitioning in the direction of travel of the NHS Five Year Forward View commissioning vision; fit for purpose as a sustainable and transformational NHS organisation in the best interests of their patients.

National Institute for Health and Care Excellence

Alongside Wirral Clinical Commissioning Group reviewing commissioned contracts, the National Institute for Health and Care Excellence (NICE) who advises the NHS on the proper use of treatments does not currently recommend that homeopathy or Iscador treatment should be used in the treatment of any health condition, nor fund it from the NHS. Proposed Service change would contribute to Wirral Clinical Commissioning Group 33

following guidance from the National Institute for Health and Care Excellence and acting as a responsible and efficient public sector organisation.

Procedure of Lower Clinical Priority Policy

Wirral Clinical Commissioning Group has a duty to ensure that the services it commission are high quality, safe, local and accessible and also provide value for money; having reviewed its contract requirements for 2014/15 and in line with their published ‘Procedures of Low Clinical Priority Policy’, which came into effect on 1st May 2015, it was agreed that complementary therapy services would be subject to commissioning review in 2015- 2016.

Proposed Service change would contribute to Wirral Clinical Commissioning Group is following guidance in line with National Institute for Health and Care Excellence and acting as a responsible and efficient public sector organisation.

NHS England – Planning, Assuring and Delivering Service Change for Patients guidance

NHS England Planning, Assuring and Delivering Service Change for Patients (November 2015 publication, c2013) are good practice guidance for commissioners on the assurance process for major service changes and reconfigurations. It is to support commissioners to consider how to take forward their proposals, including effective public involvement, enabling them to reach robust decisions on change in the best interests of their patients.

This guidance is built on Cabinet Office principles for public consultation and illustrates how commissioning proposals will need to meet the four tests laid down by the Secretary of State for Health in the Mandate through:

1. Strong public and patient engagement; 2. Consistency with current and prospective need for patient choice; 3. Clear clinical evidence base to support the proposals; 4. Support for the proposals from clinical commissioners.

Proposed Service change would contribute to Wirral Clinical Commissioning Group transitioning in the direction of travel of the NHS Five Year Forward View commissioning vision; fit for purpose as a transformational and sustainable NHS organisation in the best interests of their patients through clear evidenced based proposals supported by clinical commissioners.

Healthwatch England– What are people’s biggest health and care issues priorities (2015/16) Healthwatch England consulted with local populations regarding: “What are people's biggest health and care issues for 2015?” The findings from this consultation was published via their website on 31-12-2014; ensuring people are properly engaged and involved in discussions around changes to local services was highlighted as the number three priority.

Healthwatch England consulted with local populations regarding: “What are people's biggest health and care issues for 2016?” The findings from this consultation was published via their website on 31-12-2015; access to and the quality of mental health services was raised as a priority by more than half of local

Healthwatch, making it the number one issue for 2016.

Priority number four was services working better together, people told local Healthwatch that they would like to see health and social care services working better together so that they receive a more seamless service. Proposed Service change would contribute to Wirral Clinical Commissioning Group engaging in crucial conversations around changes to local health care services about options for the future are co-designed and sustainable services. House of Commons Science and Technology Committee Report (2010)

The 2010 House of Commons Science and Technology Committee Report on Homeopathy, found that “there is no evidence that homeopathy is effective as a treatment for any health condition” and that “homeopathic remedies perform no better than placebos.” Proposed Service change would contribute to Wirral Clinical Commissioning Group acting as a responsible and efficient public sector organisation.

The British Homeopathic Association

According to reports on the British Homeopathic Association website (January 2016) there is a growing body of clinical evidence to show that homoeopathy has a positive effect for patients (http://www.britishhomeopathic.org/what-is-homeopathy).

The website includes reference to results of randomised controlled trials, systematic reviews and feedback from patients; the website also states: “Homeopathic research is still in its infancy. The body of evidence that exists shows that much more investigation is required – 44% of all the randomised controlled trials carried out have been positive, 5% negative and 47% inconclusive.” http://www.britishhomeopathic.org/evidence/

North West Friends of Homeopathy

According to the North West Friends of Homeopathy organisational website (January 2016): “Homeopathy is relevant today as more and more people see the value of a ‘holisitc’ approach to their health issues. There is great concern about the use of conventional drugs and their side effects, especially where:

A counteraction drug is then needed. There is a deeper anxiety about the repeated use of antibiotics. There is disquiet about the numbers developing allergies, asthma, eczema etc.

…The Friends work hard for the continuation and preservation of the highly acclaimed service we have today and we know that our work and support is valued by both doctors and patients.”

Liverpool Medical Homeopathy Service

According to statements on the Liverpool Medical Homeopathy Service website (January 2016), homeopathy is a safe, natural, gentle way of treating a wide range of medical conditions, it states: “It can be used in conjunction with conventional treatment or for those who are failing to respond to conventional medicines. It can also be effective for patients where mainstream remedies produce unacceptable side effects or are just not appropriate their particular case.” Proposed Service change would look to engage with interested parties during Wirral

Clinical Commissioning Groups formal consultation process, ensuring thoughtful consideration to final commissioning review decision.

Snapshot of Wirral population profile

Wirral Local Authority and Wirral Clinical Commissioning Group is co-terminus (they have the same geographical boundaries). The Wirral Joint Strategic Needs Assessment website highlights the Indices of Deprivation for Wirral in 2015, (also known as the Index of Multiple Deprivation) which is a measure of relative deprivation at a small area level covering all 32,844 Lower Super Output Areas in England:

• Wirral was the 66th most deprived authority (of 326 authorities) in England according to the 2015 figures (1 the being most deprived, 326 the least deprived). Wirral ranked 60th in the previous 2010 figures. • This ranking of 66, means Wirral is no longer classified as being one of the 20% most deprived authorities in England (as it was previous). This could mean that relative to other authorities, Wirral has become less deprived, or that other authorities in England have become more deprived (this is a relative Index, areas are always judged in relation to one another, they are not compared historically) • Although Wirral overall is no longer in the 20% most deprived of areas in England, many of the Lower Super Output Areas within Wirral are classed as being amongst the most deprived in the country (and Wirral is only just outside the 20% most deprived, as the cut off was the 65th ranked authority, Wirral was 66th) • There are 10 Wirral Lower Super Output Areas which are classed as being in the 1% most deprived in England. Eight of these were in Birkenhead Constituency, 2 were in Wallasey Constituency.

Wirral GP Registered Population by 5 year age group Wirral Clinical Commissioning Group, 2014. Age Group Total

0-4 15,307

5-9 19,097

10-14 17,998

15-19 18,593

20-24 18,462

25-29 20,575

30-34 19,746

35-39 18,658

40-44 20,923

45-49 23,662

50-54 25,007

55-59 22,472

60-64 20,074

65-69 20,823

70-74 15,621

75-79 12,811

80-84 9,709

85+ 10,360

Grand Total 329,898

Source: Health and Social Care Information Centre – Wirral Council Compendium of Statistics 2015, Wirral Joint Strategic Needs Assessment website, January 2016.

The Wirral Joint Strategic Needs Assessment website highlights future projections by age; an increase of the population aged 65 years+ is expected to increase over the next decade by an estimated 17% and the population aged over 85+ by 30%.

The Wirral Joint Strategic Needs Assessment website highlights the key Issues (July 2015) relating to cancer as:

• Cancer caused 1 in 4 deaths annually in Wirral (up to 2012); • There were 274,000 new cancers diagnosed in England (excl. C44*), a 30% increase since 1993. In Wirral this is a 25% increase with 2,018 cancers diagnosed in 2011 compared with 1,620 in 1993; • Although there are lower rates of cancer in some male and female populations’ such as West Indian, South Asian and East/West African for certain cancers there are equally a number of ethnic population groups in which there are higher rates of certain cancers; • In Wirral breast, lung, bowel and prostate cancer account for half, of all new cancers diagnosed; • The two most commonly diagnosed cancers in Wirral are prostate and lung (in men) and breast and lung (in women); • More than two-thirds of people diagnosed with cancer survive beyond the first year after diagnosis; • Almost half (46%) of all people diagnosed with cancer now survive for at least 5 years and 92% rated their cancer care as either excellent or very good; • Wirral’s breast screening coverage is slightly higher than the national average at 77.2% in12/13; • Bowel screening uptake is 52.65%% within the Merseyside & North Cheshire Screening Centre area (2012/13). The national target is 60%; • The full economic cost of cancer has been estimated at £15.8bn for the UK which based on the ratio of cancer incidence (Wirral has 0.592% of UK cancer cases) would equate to around £93.5million per annum for Wirral.

A report on Wirral’s Lesbian, Gay, Bisexual and Transgender Needs Assessment April 37

2012, highlights the increased rates of sexual ill-health, certain cancers and lifestyle- related issues (including drinking, smoking, drug use and obesity) amongst the Lesbian, Gay, Bisexual and Transgender population in UK (Chin-Hong 2005, Roberts 2006, DH 2007, HPA 2008, Keogh et al 2009).

This assessment also highlights: higher rates of mental ill-health and suicide ideation in Lesbian, Gay Bisexual people compared to heterosexual people (King et al 2003). Suicide and attempted suicide rates are even higher in transgender population (Haas 2010).

The Wirral Joint Strategic Needs Assessment website (December 2013 data) highlights the key Issues relating to Wirral’s Black & Minority Ethnic population issues:

• Information relating to ethnicity in Wirral is limited. Wirral is by no means unique in this respect; many other areas are faced with this issue due to the limitations and relative inconsistencies in the recording of Black & Minority Ethnic population data; • This possible lack of local data on the health and wellbeing needs of the increasing range of Wirral Black & Minority Ethnic communities can in part be addressed by reviewing national data as it is likely to present a similar picture for Wirral residents; • More Black and Minority Ethnic residents live in Birkenhead and Tranmere ward than any other part of Wirral followed by Claughton, Rock Ferry and Hoylake & Meols; • Census 2011 shows us an increase in the Black & Minority Ethnic population, from 3.46% in 2001 to 5.03% in 2011 (From 10,900 people in 2001 to 16,101 people in 2011).

The Wirral Joint Strategic Needs Assessment website (2015 data) highlights Wirral has largest inequalities in ‘Disability Free Life Expectancy’ (years spent free from illness and disease) of all local authorities in England.

2. Positive Impact (Benefit) of Commissioning Decision: The prime benefit from commissioning decision e.g. improved safety, simplified pathway, better value money, better outcomes, market improvement, opportunity for reinvestment.

Impact/risk assessment (tick one and include notes as required) □None RLow □Medium □High

Prime commissioning benefits need to be underpinned by clear clinical evidence and alignment with safe, simplified clinical guidance and national good practice regarding managing public money for public sector organisations.

Financial accountability to ensure better value for money through a clinically driven outcome, in line with national context, guidance and drivers for NHS evidenced, sustainable commissioning models of delivery.

Proposed Service change would give potential beneficial outcomes regarding the opportunity for reinvestment, freeing up financial resources for other priority health resources that are evidenced as NHS proven care treatments.

In general, it is noted that nationally and locally the users of healthcare services tend to be people from older age groups, lower income distribution and those with disabilities or long 38

term conditions; providing NHS proven care treatments is imperative to meeting the local profile of the Wirral population. A decision on the continued funding of the Service and positive benefits to be achieved would be subject to the outcome of formal review.

3. Risks of not proceeding with the proposed commissioning decision: Impact to patient care, pathway, CCG reputation etc. Impact/risk assessment (tick one and include notes as required) □None □Low □Medium R High

National policy context, guidance and principle drivers for commissioning decisions for Wirral Clinical Commissioning Group necessitates the duty to respond as an accountable body in line with HM Treasury Managing Public Money, NHS Five Year Forward View, National Institute for Health and Care Excellence, local Procedure of Lower Clinical Priority Policy and NHS England – Planning, Assuring and Delivering Service Change for Patients guidance.

There are two key groups lobbying homeopathy/complementary therapy aspects on the Wirral; the North West Friends of Homeopathy, who are supporters of homeopathic treatments and The Good Thinking Society, a charity that was established in 2012 to promote rational thinking in science, particularly in relation to healthcare, who have asked Wirral Clinical Commissioning Group to review on-going spending on homeopathy services.

The Good Thinking Society, have contacted NHS Wirral Clinical Commissioning Group in 2015, to highlight their stance in regard to the funding of homeopathic treatment from NHS money.

4. Adverse Impact on the Patient: Continuity of on-going care for those within service, pathway of care, access, distance travelled, is there another provider representing reasonable choice. Likelihood of public concern at change of service delivery, loss or perceived loss. Impact on CCG’s reputation.

Impact/risk assessment (tick one and include notes as required) □None RLow □Medium □High

There could be some public concern with loss of service if a decision on the continued funding of the Service, subject to the outcome of formal review decides to cease funding. The Service is complementary therapy/alternative medicine, therefore looking at other main stream options available to support people with their health condition; reasonable choice would need to be further considered and public views engaged.

To mitigate impact, Wirral Clinical Commissioning Group would need to ensure a formal consultation is commenced, with an emphasis on public and patient engagement regarding commissioning proposals outlined in this paper and that it complies with legal requirements and duties.

As part of its thoughtful consideration process Wirral Clinical Commissioning Group has to consider:

1. Regarding further consultation and evidence gathering; consider how the protected characteristics would be engaged through commissioning review process. 2. As a result of the consultation, if the public recommend withdrawal of funding and Wirral Clinical Commissioning Group accepts this; might there be any discriminatory forces in play.

3. Mitigation of risk to patient/public, and equality issues for Wirral Clinical Commissioning Group is included below:

Protected Issue 1: Characteristic Ensure consultation is inclusive Remedy/Mitigation Age Ensure participation of spectrum of Make sure that the consultation ages. process and methodology can capture different protected characteristics. High proportion of older citizens Ensure views of those aged over using service. 50 (74% of users) are engaged in the consultation. Disability/ Ensure information is available in Develop methods of inclusion Learning easy read formats. covering different types of Disability/ communication medium and Sensory support. Work with disability Impairment support groups ‘focus session’ events to maximise inclusion.

Ensure information is in Costs cannot be passed on to the different formats (Braille/audio if disabled community for requested). production of specialised information mediums.

Ensure that positive engagement Lack of voice. /consultation with Disabled Groups / patients. Gender Ensure participation. Include in stakeholder analysis. reassignment Pregnancy and Ensure participation. Include in stakeholder analysis. maternity Race Ensure participation across the Include in stakeholder analysis. spread of the community. Religion and Ensure participation. Include in stakeholder analysis. belief Sex (male or Ensure participation. Include in stakeholder analysis. female) Please note; high numbers of patients are female. Sexual Ensure participation. Include in stakeholder analysis. orientation Issue 2: The service has always been an Protected Removal of service. ‘alternative’ provision; therefore Characteristic Is there a discriminatory impact? there are other main stream

options available to support people with illness. Age Presumed no. Finalise when results of consultation are received. Cross reference against this protected characteristic Please note; high numbers of patients over the age of 65 years. Disability Presumed no. Finalise when results of consultation are received. Cross reference against this protected characteristic. Please note; provider stated ‘yes’ to disability without supporting activity numbers. Gender Presumed no. Finalise when results of reassignment consultation are received. Cross reference against this protected characteristic. Pregnancy & Presumed no. Finalise when results of maternity consultation are received. Cross reference against this protected characteristic. Race Presumed no. Finalise when results of consultation are received. Cross reference against this protected characteristic. Religion and Presumed no. Finalise when results of belief consultation are received. Cross reference against this protected characteristic. Sex Presumed no. Finalise when results of consultation are received. Cross reference against this protected characteristic. Sexual Presumed no Finalise when results of orientation consultation are received. Cross reference against this protected characteristic.

Due to the limited information that has been collected to date/received from Liverpool Medical Homeopathy Service regarding the demographic data of current patients receiving either Homeopathy or Iscador treatment, it is of vital importance that equality monitoring by protected characteristic is collected in relation to the consultation and the choice of commissioning options are outlined to ensure any proposed service change is clearly explained.

5. Adverse Impact on CCG Finance: Non recurrent impact/ one off decommissioning cost contractually borne by commissioner e.g TUPE, Non-recurrent impact replacement service overlapping with 41

decommissioned service. Recurrent gross cost (cost of this service) recurrent net cost (cost of this service less cost of any replacement or movement in demand) transactional costs of commissioning. Impact/risk assessment (tick one and include notes as required)

□NoneR Low □Medium □High

Potential low risk consideration due to low number of patients accessing, not viewed as a sustainable and affordable recurring cost Service that is deemed by the National Institute for Health and Care Excellence guidance as a NHS proven care treatment option; Service activity costs for Iscador highlight a cost increase of 143% and Homeopathy with a 25% cost decrease, overall contract Service increase of 11% based on 2014/15 activity.

Potential low risk due to the Service being complementary therapy/alternative medicine if a decision on the continued funding of the Service, subject to the outcome of formal review is to cease funding.

6. Adverse Impact on Provider: Does the loss of this service/contract element compromise the provider’s economic or physical ability to deliver other services? Fixed cost dilution, sub-critical mass etc Does the provider have capacity to provide new services? Impact/risk assessment (tick one and include notes as required) □None R Low □Medium □High

It is anticipated there could be an impact to staff employed by Liverpool Medical Homeopathy Service and potential running cost economic considerations, however, the extent of this impact is unknown and further information will need to be gathered during the consultation process and included in the final commissioning decision paper.

Potential low risk due to the Service being complementary therapy/alternative medicine, if a decision on the continued funding of the Service, subject to the outcome of formal review is to cease funding.

7. Adverse impact on Health Market Economy: Overall supply/demand balance, on upstream and downstream elements of care pathway, knock on to the other providers, gap in provision, market diversity, loss of clinical skill, training opportunities etc Impact/risk assessment (tick one and include notes as required) □None R Low □Medium □High

Potential low risk pathway. There could be some low impact for cancer support networks and other related services for cancer, pain and psychiatric health conditions; reasonable choice would need to be further considered and public views engaged.

During the consultation, Wirral Clinical Commissioning Group will undertake transparent and constructive communication with wider networks; commissioners and local agencies must ensure they disseminate with staff any potential impact from proposed changes if a decision on the continued funding of the Service, subject to the outcome of formal review is to cease funding.

It will be important for front-line clinicians who are the referral pathway to the Service and could be affected by the proposed changes to be involved in the consultation. Wirral Clinical Commissioning Group website (January 2016) highlights fifty six (56) GP Practices in Wirral to engage in consultation, clinicians being powerful advocates and playing an important role in communicating the benefits of change to a wider community; in line with NHS England – Planning, Assuring and Delivery Service Change for Patients good practice guidance.

The consultation will seek to gather information regarding the 143% increase in patient referrals by local GPs to the Iscador Service, in aim to further mitigate impact if a decision on the continued funding of the Service, subject to the outcome of formal review is to cease funding.

8. Adverse impact on Performance: Does the cessation of service adversely affect any vital sign commitment eg cancer access, health inequalities, 18 week access etc. Will the new/re-design service impact on performance elsewhere?

Impact/risk assessment (tick one and include notes as required) □None R Low □Medium □High

9. Adverse Impact on Equality: Is there an equality implication to the commissioning decision? Impact/risk assessment (tick one and include notes as required) □None R Low □ Medium□High

Yes/ No

Currently there is no information available on the specific users of Homeopathy or Iscador patient’s regarding their religion, sexual orientation or marital status. Wirral Clinical Commissioning Group recognises there is limited data as a ‘yes’ response for patients in the Service regarding their disability. The proposals may affect people living with a disability, if a decision on the continued funding of the Service, subject to the outcome of formal review is to cease funding. 43

The consultation would seek to identify issues that might affect lesbian, gay, bisexual, transsexual people in Wirral if the Service changes. The consultation would seek to identify issues that might affect people with regard to their disability in Wirral if the Service changes.

The consultation would aim to engage with specific equalities groups outlined in this paper, Section 4 - Adverse Impact on the Patient, to mitigate any adverse impact on equality, if the Service changes. Stakeholder analysis has been planned and a consultation matrix produced to support the consultation which includes protected characteristics and potential impacts on equality.

10. Adverse Impact on Rurality: Does initiation/ cessation of service represent unequal treatment or a barrier to access to service users in a rural location – if yes how will this be mitigated?

Impact/risk assessment (tick one and include notes as required) □None R Low □ Medium □High

The Service is delivered from St. Catherine’s Health Centre in Birkenhead. Potential low risk due to the Service being complementary therapy/alternative medicine if a decision on the continued funding of the Service, subject to the outcome of formal review is to cease funding.

11. Engagement : To what degree is patient and public involvement (including, where appropriate, consultation) required.

All sections in this paper outline aforementioned patient and public involvement requirements. Further pre-consultation information is aimed to go live on the Wirral Clinical Commissioning Group website starting 21 April 2016, for 12 week consultation. Consultation will be carried out with:

a) Current user of the Homeopathy service in Wirral;

b) Previous user of the Homeopathy service in Wirral;

c) Current user of Iscador service in Wirral;

d) Previous user of Iscador service in Wirral;

e) Never used the service;

f) GPs as the referrer;

g) Community Action Wirral networks (circa 1,080 organisations’ on their database);

h) Identified stakeholder analysis participants which include Healthwatch and special interest groups.

Wirral Clinical Commissioning Group would look to consult with interested parties during the 12 week consultation period. Stakeholder briefing, media response, frequently asked questions, links to further information/ literature review, key messaging for Twitter posts, dedicated page on Wirral Clinical Commissioning Group website and questionnaires on Survey Monkey for completion. Liverpool Medical Homeopathy Service has been approached to work as a collaborative partner in the process.

As part of the consultation period, a public engagement event, venue and date to be confirmed, would be held with intention of being an opportunity for open discussion with interested parties on the proposed Service change options.

12. Recommendations: Recommendation to CCG e.g. commission, not to be decommissioned, decommission with stipulated conditions (state them)

Commissioning review

Formal consultation must take place before a final analysis of any potential equality impacts and whether or not the proposals meet Public Sector Equality Duties (Equality Act 2010, s149). The final results of the consultation will be written up and submitted to Wirral Clinical Commissioning Group Governing Body Board as part of the commissioning process for thoughtful consideration prior to final commissioning decision.

It would be the responsibility of NHS Wirral Clinical Commissioning Group's Governing Body members to thoughtfully consider all information gathered, including the findings of the consultation and then decide a best way forward.

The three options to be considered are described below:

Option 1: NHS Wirral Clinical Commissioning Group should not follow the advice of The National Institute for Health and Care Excellence (NICE) guidelines.

The 3 options to select would be:

Option 1: Extend the existing contract for a Homeopathy and Iscador service.

Option 3: Stop funding the service.

Overall impact/risk assessment (tick one and include notes as required, including contingency/mitigation plans) □None R Low □Medium □High

Completed by : Date: Lorraine Guy 15-04-2016 Commissioning Support Manager Partnerships Team Wirral Clinical Commissioning Group

Appendix 1

Contract specification referral conditions for Homeopathy or Iscador treatment:

a) Allergies,

b) Angina and palpitations,

c) Anxiety,

d) Asthma,

e) Benign prostatic hypertrophy (enlarged prostrate),

f) Chronic back pain,

g) Chronic fatigue syndrome,

h) Crohn’s disease and ulcerative colitis,

i) Depression,

j) Hay fever and catarrh,

k) Headaches and neurological diseases, 46

l) Hypertension (high blood pressure),

m) Infertility and the menopause,

n) Irritable bowel syndrome,

o) Malignant disease, (Iscador treatment only)

p) Premenstrual tension,

q) Problems with the menstrual cycle including painful irregular periods,

r) Recurrent chest infections,

s) Recurrent urinary tract infections,

t) Skin diseases – eczema, psoriasis, acne, arthritis.

Appendix 3:

The Good Thinking Society’s submission to NHS Wirral Clinical Commissioning Group, regarding homeopathy funding

Dear Wirral Clinical Commissioning Group

I am writing to you in my joint capacity as the Project Director of the Good Thinking Society, as Vice President of the Merseyside Skeptics Society and as a Merseyside resident of over 14 years.

The Good Thinking Society is a registered charity set up to encourage curiosity and promote rational thinking. In February 2015 we filed a Judicial Review to NHS Liverpool Clinical Commissioning Group, which resulted in the Clinical Commissioning Group revisiting and recently overturning their previous decision to continue funding homeopathy. In November 2015 our legal correspondence with the Department of Health resulted in the upcoming consultation as to whether the DoH shall add homeopathic remedies to Schedule 1 of the 2005 Prescription of Drugs Regulations - AKA “The Blacklist”.

The Merseyside Skeptics Society is a non-profit community group whose goal is the promotion of scientific skepticism on Merseyside, around the UK and internationally. What little funding we receive comes directly from the community, and we represent up to 200 members of the rationalist community of Merseyside, a large proportion of whom (including the President of the organisation) are patients and stakeholders of NHS Wirral Clinical Commissioning Group.

This document comprises our concerns over the provision of homeopathy by NHS Wirral Clinical Commissioning Group, the position of the leading experts in the field, a brief view on the consensus of the scientific literature, a note on potential legal cases that may follow a decision to withdraw funding and an analysis of the movement by the rest of the NHS over the last few years to cease homeopathy funding.

Yours sincerely

Michael Marshall

Project Director, Good Thinking Society

Vice President, Merseyside Skeptics Society

Overview

In evidence submitted to the House of Commons’ Science and Technology Committee’s 2010 Evidence Check on homeopathy, the point was made by homeopaths that efficacy is not the be-all and end-all when it comes to treatment modalities such as homeopathy. We agree: patient choice and cost-effectiveness are also clear and important factors in deciding whether or not to fund any particular treatment. However, cost-effectiveness and patient choice in isolation cannot provide a solid base for the provision of a certain treatment. Fundamentally, as a baseline, it is vital that any proposed treatment actually works. Without proof that a treatment works, cost-effectiveness becomes a moot point. After all, how cost-effective can a clinically- ineffective treatment be?

Supporters of homeopathy argue that a removal of funding would be a restriction of patient choice. However, without reliable evidence that a treatment can actually work, the notion of patient choice is nonsensical. It is absurd to offer patients the choice of an intervention which is known not to effectively treat any condition. That homeopathy is even available as a publicly- funded option constitutes an implicit endorsement of it as an intervention. Patients do not expect to be offered ineffective treatments by the NHS; the understandable assumption will be that if the NHS funds it, it must work. At best, this is misleading; at worst, it fatally undermines the notion of informed consent, which is one of the very foundations of modern medicine.

It is also our fear that the tacit endorsement of homeopathy by the NHS’s continued funding legitimises it as treatment. At the recent HS Liverpool Clinical Commissioning Group consultation on homeopathy, Dr Sue de Lacy, one of the two service providers at the Liverpool Medical Homeopathy Service through which the Wirral Clinical Commissioning Group’s homeopathy service is delivered, said of a stage 4 breast cancer patient “that it was important that this patient came to LMHS because she could be treated with homeopathy.”1 There is no evidence that homeopathy has any role to play in the treatment of stage 4 cancer, and to claim such is highly disturbing.

Furthermore, claims like these, and the legitimacy afforded to them by NHS support and funding, encourage and embolden lay homeopaths (who are in the most part lacking any training in medicine, and at times relatively scant training in homeopathy), who then use the legitimacy afforded by the reputation of the NHS to further convince patients to use homeopathy for serious illnesses. Unfortunately, this fear does not seem to be unfounded: at the same public consultation by NHS Liverpool Clinical Commissioning Group there were 26 attendees who were supportive of homeopathy. Discounting the several of these attendees who work at the Liverpool Medical Homeopathy Service, five people stated during discussions that homeopathy can be used to treat cancer, at least two of whom claimed to have treated cancer themselves using homeopathy exclusively. Similar claims were made at the public meeting held by NHW Wirral Clinical Commissioning Group in May.

Such dangerous claims could be seen as persuasive to a public led by the NHS to believe that homeopathy is anything other than a placebo. It is hard to think of a clearer illustration of the potential for harm of homeopathy than this.

As for efficacy or effectiveness, the evidence from clinical studies is clear: homeopathy does

1 https://secure.membra.co.uk/Attachments/homeopathyconsultationfinalreportjune2016_20166711216.pdf NHS Liverpool Clinical Commissioning Group Homeopathy Consultation, page 34 49

not work above the placebo effect. In fact, looking at the literature, a pattern is clear: where studies are objectively and independently assessed as being the fairest tests with the best methodologies, the effect of homeopathy diminishes to zero. Were a pharmaceutical drug to have the history of shoddy research and weak evidence that homeopathic remedies have thus far shown, it rightly would not be considered for funding by the NHS. Homeopathy does not warrant special privilege, it should abide by the same standards as the rest of medicine.

It is worth highlighting that an end to homeopathy on the NHS would not be a ban on homeopathy entirely. Patients who feel that these inert sugar pills are something they really do want can still buy them from their local high street pharmacy at very small costs. In fact, if proponents of homeopathy were able to reliably demonstrate that their remedies have genuine effects, they would even be free to argue for NHS funding in the future. But as yet, after hundreds of years of searching, such proof hasn’t been forthcoming. The 2010 House of Commons’ Science and Technology Select Committee’s Evidence Check on Homeopathy stated, as to future research on homeopathy: “There has been enough testing of homeopathy and plenty of evidence showing that it is not efficacious. Competition for research funding is fierce and we cannot see how further research on the efficacy of homeopathy is justified in the face of competing priorities... It is also unethical to enter patients into trials to answer questions that have been settled already”.2

We are in an age of austerity, with severe budgetary pressures felt throughout the NHS. The money spent on homeopathy can be far better spent on treatments which are proven to work, and proven to offer a benefit to patients. Several GPs have told us of their frustration in being unable due to budgetary reasons to provide a treatment known to be effective for conditions such as painful varicose veins. While we are not experts on medical budgeting, it’s clear that the potential recipients of treatments that could be funded with the saved resources could not have been identified and therefore could not join the consultation to argue that the resources be used for their benefit. Similarly, if the resources were allocated to public health measures to tackle, for example, smoking, alcohol addiction or obesity, it’s likely the number of beneficiaries of such services would be reasonable.

Now is the time to remove funding for the treatments – such as homeopathy – which are at best unproven, and at worst comprehensively disproven. Expert opinion

It is the position of every credible expert in the field of medicine in the UK that homeopathic remedies are no better than placebo, and should not be provided on the NHS. Experts to have spoken out on the issue include:

• The House of Commons’ Science and Technology Select Committee in 2010 undertook an extensive review of the evidence for and against homeopathy, including testimony from many key stakeholders on all sides of the debate. In their conclusion, they highlighted that “homeopathic products perform no better than placebos.” And stated: “The Government should stop allowing the funding of homeopathy on the NHS. We conclude that placebos should not be routinely prescribed on the NHS. The funding of homeopathic hospitals—hospitals that specialise in the administration of placebos—

2 http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/45/4504.htm (paragraphs 77, 78) 50

should not continue, and NHS doctors should not refer patients to homeopaths.”3, 4 • West Kent PCT conducted an extensive review of the cost-effectiveness of homeopathy, including a systematic review of the highest quality evidence base, a consultation document and questionnaire sent to a random sample of 1000 of the PCT’s registered patient population, a series of public meetings and an audit of all GPs in West Kent. 5 The review concluded in its results that homeopathy did not represent value for money. The House of Commons’ Science and Technology Select Committee commented in 2010: “We were impressed with NHS West Kent’s review of the commissioning of homeopathy and consider that it provides a good model for other commissioning organisations, particularly those that fund homeopathic hospitals. We recommend that the Department of Health circulate NHS West Kent’s review of the commissioning of homeopathy to those PCTs with homeopathic hospitals within their areas. It should recommend that they also conduct reviews as a matter of urgency, to determine whether spending money on homeopathy is cost effective in the context of competing priorities.” 6 • The Australian National Health and Medical Research Council conducted an extensive review of the evidence base for homeopathy, concluding in March 2015: “There are no health conditions for which there is reliable evidence that homeopathy is effective.”7 • The British Medical Association, who in June 2010 described homeopathy as “nonsense“ and argued that the NHS should stop funding the treatment, explaining that it “can do harm by diverting patients from conventional medical treatments."8 • The Chief Medical Officer, Dame Sally Davies, in January 2013 said: ‘I’m very concerned when homeopathic practitioners try to peddle this way of life to prevent malaria or other infectious disease. I am perpetually surprised that homeopathy is available on the NHS.”9 • The Government’s Chief Scientific Advisor, Sir Mark Walport, said in April 2013: “"My view scientifically is absolutely clear: homoeopathy is nonsense, it is non-science. My advice to ministers is clear: that there is no science in homoeopathy. The most it can have is a placebo effect – it is then a political decision whether they spend money on it or not."10 • The NHS Choices website highlights that, “There has been extensive investigation of the effectiveness of homeopathy. There is no good-quality evidence that homeopathy is effective as a treatment for any health condition” and explains: “There is no evidence for the idea that substances that can induce certain symptoms can also help to treat them. There is no evidence for the idea that diluting and shaking substances in water can turn those substances into medicines. The ideas that underpin homeopathy are not accepted

3 http://www.theguardian.com/science/blog/2010/feb/22/mps-verdict-homeopathy-useless-unethical 4 http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/45/4504.htm#a18 5 http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/45/45.pdf (EV34, HO 39, page 95) 6 http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/45/45.pdf (para 86, page 27) 7 https://www.nhmrc.gov.au/health-topics/complementary-medicines/homeopathy-review 8 http://www.bbc.co.uk/news/10449430 9 http://www.telegraph.co.uk/news/health/news/9822744/Homeopathy-is-rubbish-says-chief-medical- officer.html 10 http://www.telegraph.co.uk/news/health/news/10003680/Homeopathy-is-nonsense-says-new-chief- scientist.html 51

by mainstream science, and are not consistent with long-accepted principles on the way that the physical world works.”11 • The Secretary of State for Health, Mr Jeremy Hunt MP, who in September 2014 said: “When resources are tight we have to follow the scientific evidence and spend the NHS’s money on what works and what the scientific evidence says works”12

• The Royal Pharmaceutical Society of Great Britain, who in June of this year clarified: “The Royal Pharmaceutical Society does not endorse homeopathy as a form of treatment. In its reference guide on homeopathic and herbal products, the RPS makes it clear that there is no evidence of the clinical efficacy of homeopathic products, beyond a placebo effect, and no scientific basis for the practice.”13 • The Royal Pharmaceutical Society of Northern Ireland in April 2010 proposed that patients be told that homeopathic products do not work, other than having a placebo effect and, having reviewed the evidence base for homeopathy, concluded it was "not an efficacious form of treatment."14 • Chair of the Health Select Committee, Dr Sarah Wollaston MP, who said earlier this year: “There can be no excuse for wasting NHS resources or deliberately deceiving patients with ‘treatments’ which have been shown to have no benefit.”15 • Professor Edzard Ernst, Professor of Complementary Medicine, who said earlier this year: “Homeopathy is not supported by evidence — it is implausible, disproven, wasteful and often dangerous. Enthusiasts of homeopathy tend to quote ‘patient choice’ as an argument to have it on the NHS, but this notion is as bogus as homeopathy itself. Patient choice must always be a choice between treatments that are backed by evidence; if not ‘choice’ degenerates into little more than ‘arbitrariness’.”16

The scientific evidence

Despite the protestations of some homeopaths and homeopathy lobby groups, the scientific consensus on homeopathy is uncontroversial by this stage. As such, we will not dedicate too much space in this response outlining the overwhelming support for the view that homeopathic remedies perform no better than placebo in any fair and unbiased test.

However, we would direct the Clinical Commissioning Group to pay close attention to a number of key evidence summaries, including that of the House of Commons’ Science and Technology Select Committee; the Australian Government’s National Health and Medical Research Council’s comprehensive review from earlier this year17; and the submission to this Clinical Commissioning Group made by the Nightingale Collaboration – whose analysis of studies for and against homeopathy, as well as responses to common criticisms of each study, we find to be wholly informative.

11 http://www.nhs.uk/Conditions/Homeopathy/Pages/Introduction.aspx 12 http://www.lbc.co.uk/watch-jeremy-hunt-live-on-lbc-from-7pm-96835 13 http://www.rpharms.com/what-s-happening-/news_show.asp?id=2632 14 http://news.bbc.co.uk/1/hi/northern_ireland/8640582.stm 15 http://goodthinkingsociety.org/projects/nhs-homeopathy-legal-challenge/ 16 http://goodthinkingsociety.org/projects/nhs-homeopathy-legal-challenge/ 17 https://www.nhmrc.gov.au/health-topics/complementary-medicines/homeopathy-review 52

Potential legal challenges to a cease of funding

Over the last decade, there have been a small number of occasions whereby a decision by a Clinical Commissioning Group or PCT to cease funding for homeopathy has resulted in a Judicial Review, brought about by the British Homeopathic Association or similar homeopathy lobbyist group. There is a possibility that a decision by this Clinical Commissioning Group to cease funding for homeopathy may result in a similar challenge. The most notable of such challenges were to the NHS West Kent PCT decision of 2007, the NHS Wirral PCT decision of 2010 and the NHS Lothian decision of 2014.

In the case of the NHS West Kent PCT decision, the Judicial Review was unsuccessful after the courts found the original consultation process to be sufficient18. Similarly, in 2015 the challenge to the NHS Lothian decision was rejected after the court found the consultation process to have been carried out correctly, ruling “reduction of the Board’s decision of 26 June 2013 would result only in a waste of time and public funds as it would inevitably result in exactly the same decision being taken by the Board”19.

Conversely, as you are doubtlessly aware, in the case of NHS Wirral PCT the decision to cease funding for homeopathy was overturned in August 2011 after a Judicial Review successfully argued that part of the consultation had been held in private, rather than it being open to the public20. This was clearly a challenge based not on the credibility of homeopathy, but on the PCT’s failure to adhere to the correct consultation procedure – something I’m sure the Clinical Commissioning Group has been very cautious to consider in designing the consultation process, and therefore would likely not leave grounds for a similar successful challenge.

It’s important to highlight that the threat of a potential legal challenge to a decision should not be sufficient to deter the Clinical Commissioning Group from carrying out its duty to make healthcare decisions that are in the best interests of the many thousands of patients the Clinical Commissioning Group represents. Moreover, the successful challenge to NHS Wirral PCT should be instructive on how best to avoid an insufficient consultation process. Indeed, the examples of the NHS West Kent PCT and the NHS Lothian decisions ought to demonstrate that when consultations are carried out correctly and with proper consideration for the need to be publicly accountable, decisions to cease homeopathy funding can withstand a legal challenge. NHS trends around the country

Of the 211 Clinical Commissioning Groups in existence during the 2013/14 NHS year, 31 responded to FOI requests made by Good Thinking to confirm their funding for homeopathy. This meant that at that time, 180 Clinical Commissioning Groups – 85% of the country – already did not fund homeopathy.

Comparing the results of the 2013/14 FOI requests with the data in the 2010 Science and Technology Select Committee: Evidence Check 2, it is clear that many of the former PCTs with

18 http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/memo/homeopathy/ucm3902.ht m 19 http://www.scotcourts.gov.uk/search-judgments/judgment?id=f086e9a6-8980-69d2-b500-ff0000d74aa7 20 https://www.leighday.co.uk/News/2011/August-2011/Wirral-patient-stops-NHS-commissioning- decisions-b 53

high levels of reported funding during the years 2006/07-2009/10 had ceased all funding by 2013/14:

• NHS Kensington PCT spent an average of £100,000pa from 2006/07-2009/10; by 2013/14 their equivalent Clinical Commissioning Group had ceased all funding. • NHS Bath and North East Somerset PCT spent an average of £48,000pa from 2006/07- 2009/10; by 2013/14 their equivalent Clinical Commissioning Group had ceased all funding. • NHS Sefton PCT spent an average of £35,000pa from 2006/07-2009/10; by 2013/14 their equivalent Clinical Commissioning Group had ceased all funding. • NHS Bromley PCT spent an average of £56,000pa from 2007/08-2009/10; by 2013/14 their equivalent Clinical Commissioning Group had ceased all funding.

Furthermore, many more former PCTs had dramatically reduced their funding:

• NHS Liverpool PCT spent an average of £202,000pa from 2006/07-2009/10; in 2013/14 their equivalent Clinical Commissioning Group spent £34,050 (a fall of 83%). • NHS South Gloucestershire PCT spent an average of £57,000pa from 2006/07-2009/10; in 2013/14 their equivalent Clinical Commissioning Group spent £24,169 (a fall of 55%). • NHS North Somerset PCT spent an average of £52,000pa from 2006/07-2009/10; in 2013/14 their equivalent Clinical Commissioning Group spent £24,765 (a fall of 44%). • NHS Bristol PCT spent an average of £252,000pa from 2006/07-2009/10; in 2013/14 their equivalent Clinical Commissioning Group spent £145,420 (a fall of 44%).

Finally, the developments of the last 24 months shed even further light on the subject. Of the 31 Clinical Commissioning Groups who reported homeopathy funding in June 2014, more than a third have now ceased all funding for homeopathy:

• NHS Central Manchester Clinical Commissioning Group • NHS Dorset Clinical Commissioning Group • NHS Halton Clinical Commissioning Group • NHS Harrow Clinical Commissioning Group • NHS Knowsley Clinical Commissioning Group • NHS Liverpool Clinical Commissioning Group • NHS Gateshead Clinical Commissioning Group (now part of NHS Newcastle and Gateshead Clinical Commissioning Group) • NHS Newcastle North and East Clinical Commissioning Group (now part of NHS Newcastle and Gateshead Clinical Commissioning Group) • NHS Newcastle West Clinical Commissioning Group (now part of NHS Newcastle and Gateshead Clinical Commissioning Group) • NHS South Tyneside – ceased all funding for homeopathy • NHS Sutton Clinical Commissioning Group • NHS Wandsworth

We also understand a number of other Clinical Commissioning Groups are currently undertaking a review of their homeopathy funding: 54

• NHS Bristol Clinical Commissioning Group • NHS North Somerset Clinical Commissioning Group • NHS South Gloucestershire Clinical Commissioning Group

In summary, of the 209 Clinical Commissioning Groups currently in existence in England, only 18 now fund homeopathic services. 13 fall within the London area, with only 5 Clinical Commissioning Groups outside of London funding homeopathy services. Four of those six are currently reviewing their policy or consulting on the end of their homeopathy funding.21

It is therefore unequivocally clear that the NHS is moving with great momentum toward the end of homeopathic funding in England. We invite this Clinical Commissioning Group to take this opportunity to bring itself up to date with the overwhelming majority of the country.

Iscador

Somewhat uniquely across the country, NHS Wirral Clinical Commissioning Group currently funds Iscador therapy – an alternative treatment derived from mistletoe and used in the treatment of cancer. While NHS Wirral Clinical Commissioning Group appears to provide the treatment specifically for the alleviation of pain and nausea associated with conventional cancer treatment, it is notable that Iscador is promoted by many proponents as a direct treatment for cancer. Indeed, it was invented for this very use by Rudolf Steiner, who decided mistletoe must be capable of curing cancer given that it grows on trees and devours the host organism in much the same way (to Steiner’s mind) as cancer does. It ought to be apparent to all that there is no sound basis for this belief, and it ought to be no surprise that the medical literature does not support this conclusion.

There are a number of aspects about NHS Wirral Clinical Commissioning Group’s funding of Iscador or Mistletoe Therapy which are troubling and highly problematic, not least of which is the absence of any reliable evidence for the use of this therapy in treating any condition. If the Clinical Commissioning Group wishes to maintain a commitment to evidence-based practice, it cannot continue to spend limited resources on treatments that have not been shown to have any effectiveness, which certainly includes Iscador.

Beyond the lack of evidence, we are concerned as to the manner in which Iscador is currently provided to cancer patients in the Wirral. While NHS Wirral Clinical Commissioning Group commissions the service for management of side effects related to conventional cancer treatment, the service provider at the Liverpool Medical Homeopathy Service clearly believes the effectiveness of Iscador extends to directly treating cancer, in line with the original intended use of the treatment by its founded Rudolf Steiner. As we highlighted to the Clinical Commissioning Group via email on March 24th, Dr Hugh Nielsen was involved in a police inquest into the death of one of his private patients, who had been given Iscador by Dr Nielsen in order to treat her breast cancer, to which she ultimately succumbed.

During the inquest, Dr Nielsen stated that he believes Iscador has “direct anti-cancer effects causing death of tumour cells” and that it can cause “occasional regression of the tumour”.

21 http://goodthinkingsociety.org/projects/nhs-homeopathy-legal-challenge/nhs-homeopathy-spending/ 55

Given the severity of this case, we urge the Clinical Commissioning Group to seek assurances from Dr Nielsen that he recognises the seriousness of these statements and acknowledges that there is no evidence that Iscador has the properties he claimed during the inquest. We also urge the Clinical Commissioning Group to end funding for this service, so that vulnerable cancer patients are no longer referred to the Liverpool Medical Homeopathy Service for this therapy.

During the public consultation held in Birkenhead on May 10th, there appeared to be some confusion in the minds of both the public and the representatives of the Clinical Commissioning Group as to the nature of Iscador, with one of the Clinical Commissioning Group representatives stating that Iscador is considered a homeopathic treatment, or is grouped in with homeopathic treatments. This shows a clear misunderstanding either of what Iscador is, or of what homeopathic treatments are, or both. For the avoidance of doubt, the Iscador service commissioned by the Clinical Commissioning Group involves the administration of products which are derived from mistletoe in identifiable dosages, in stark contrast to homeopathic remedies which definitionally contain no active ingredient at all.

The persistence of this misunderstanding amongst the Clinical Commissioning Group and its patients is concerning where the issue of continued funding is concerned, as it is important that opinions on these matters come from an informed position. That Dr Nielsen, as the provider of both the homeopathy service and the (quite distinctly different) Iscador service apparently did little either before or during the consultation to disabuse the Clinical Commissioning Group and its stakeholders of the misunderstanding is disappointing.

During the public consultation, the Clinical Commissioning Group highlighted an important paragraph from the Procedures of Low Clinical Priority:

“Wirral will continue to commissioning (sic) homeopathy as at present but this service will be subject to review. All other complementary therapies are not routinely commissioned unless recommended by NICE guidance.” 22

In the meeting this excerpt was used to explain why both homeopathy and Iscador was currently funded. However, given that Iscador is not a homeopathic treatment, it appears that according to this policy Iscador should have been one of the complementary therapies that was not commissioned since this policy came into effect.

It is clear that Iscador therapy is based on a highly dubious philosophy and is not supported by any reliable evidence, is often confused for a homeopathic treatment, yet it carries with it some rather extraordinarily dangerous claims which, as best as can be told from sworn testimony at an inquest, the service provider appears to support. For all of these reasons, we believe the Clinical Commissioning Group should not continue funding the Iscador service, and should decommission it along with the homeopathy service.

22 https://www.wirralccg.nhs.uk/Downloads/AboutUs/Policies/PLCP%20Wirral%20CCG.pdf Cheshire & Merseyside Commissioning Policy, Wirral Variation 2014/15, Page 7

Appendix 4

Appendix 5:

NHS Wirral Clinical Commissioning Group Homeopathy and Iscador® treatment consultation

Alan Henness Maria MacLachlan Director Director

15 July 2016

www.nightingale-collaboration.org [email protected]

The Nightingale Collaboration Limited is a private company limited by guarantee.

Registered office: 7 St John’s Road, Harrow HA1 2EY. Registered in England and Wales. Company number 07406649.

The Nightingale Collaboration

The Nightingale Collaboration challenges questionable claims made to the public by healthcare practitioners on their websites, in adverts and in their promotional and sales materials by bringing these to the attention of the appropriate regulatory bodies. The vast majority of these claims are made by practitioners of alternative therapies.

We also strive to ensure that organisations representing healthcare practitioners have robust codes of conduct for their members that protect the public and that these are enforced.

Note

We use the term ‘homeopathic medicine’ to be consistent with the language used in various EU Directives and therefore by the Medicines and Healthcare products Regulatory Agency (MHRA). However, we believe this phrase and the word ‘remedy’ — as frequently used by homeopaths — are misleading terms, implying as they do, that they have medicinal or remedial effects when we understand there is no good evidence for any such effects. Such products are only considered medicines for the purposes of regulation by the MHRA because they are “presented as having properties of preventing or treating disease in human beings”,[1] not because there is any evidence they actually have such properties. We believe this is consistent with the stance of the MHRA on the evidence and the official policy of the Department of Health, as stated on the NHS Choices website.[2]

Contents

1 Introduction ...... 5 2 Homeopathy services provided ...... 5 3 Evidence reviews ...... 6 3.1 House of Commons Evidence Check ...... 6 3.1.1 Criticisms ...... 7 3.1.2 Conclusions ...... 8 3.2 NHMRC report ...... 8 3.2.1 Criticisms ...... 9 3.3 Swiss homeopathy report ...... 9 3.4 Mathie et al ...... 10 3.4.1 Jacobs 1994 ...... 11 3.4.2 Jacobs 2001 ...... 11 3.4.3 Bell 2004 ...... 11 3.4.4 Conclusion ...... 12 3.4.5 Criticisms ...... 12 3.4.6 Overall conclusions ...... 13 3.5 Other reviews of homeopathy ...... 13 3.5.1 Kleijnen et al. 1991 ...... 14 3.5.2 Boissel et al. 1996 ...... 14 3.5.3 Cucherat et al. 2000 ...... 14 3.5.4 Linde et al. 1997 ...... 15 3.5.5 Shang et al. 2005 ...... 15 3.5.6 Systematic review of systematic reviews ...... 15 3.5.7 Conclusion ...... 16 4 Other considerations ...... 16 4.1 Positive vs non-conclusive vs negative trials ...... 16 4.2 Specific and non-specific effects ...... 17 4.3 Anecdotal evidence ...... 17 4.4 Patient satisfaction surveys ...... 18 4.5 Integrating homeopathy with conventional medicine ...... 18 4.6 Safety of homeopathy ...... 18 4.6.1 Indirect harm ...... 19 4.7 Cost-effectiveness ...... 19 3

4.8 Usage of homeopathy in the UK ...... 20 4.9 False legitimacy ...... 20

4.10 Lack of funds for trials ...... 21 5 Iscador® ...... 21 6 Miscellaneous ...... 22 6.1 Homeopathy for babies and animals ...... 22 6.2 India ...... 23 6.3 Consumer choice ...... 23 6.4 Fallacious arguments ...... 23 6.4.1 Tu quoque ...... 24 6.4.2 Argumentum ad populum ...... 24 6.4.3 Appeal to (inappropriate) authority ...... 24 7 Conclusions and recommendations ...... 24 8 References ...... 24

1 Introduction We would like to respond to your consultation on homeopathy. We believe that the provision of homeopathy by the NHS gives an undeserved and false imprimatur to homeopathy, leading homeopaths and the public to believe that homeopathy is an officially recognised medical system[3] and one that: …can support and complement conventional medicine, working alongside GPs, the NHS and other health professionals or provide a gentle alternative.[4] Broadly there are three main problems with homeopathy: 1. There is no reason to suppose it should work, as like does not cure like. 2. There is no way it can work, its doctrines and practices such as potentisation are fundamentally inconsistent with all relevant scientific knowledge. 3. There is no high quality evidence it does work, since all clinical results are fully consistent with the null hypothesis. Claims and assertions of proponents of homeopathy primarily try to address point 3, occasionally seek to provide some partial evidence for point 2, and address point 1 only by stating as a fundamental axiom that ‘like cures like’, an idea for which there is simply no evidence at all. We do not believe it is necessary to address the first two: since there is no high quality evidence that homeopathy has specific effects over placebo, speculations of how it might work if the evidence was different, or considerations of what homeopaths believe, are unnecessary. We will therefore mainly concentrate our submission on the scientific evidence for homeopathy, particularly evidence that is erroneously cited as being firmly positive for homeopathy. Ioannidis shows that the chances of a positive result being false increase when the treatment is implausible (before doing the study).[5] This is the essence of Bayesian methodology and a fundamental of science-based medicine. Some trials of homeopathy — even those with a robust methodology — may give a positive outcome. This is to be expected. However, because homeopathy has no prior plausibility whatsoever, the Bayesian approach means that any such trials must be considered false positives. Instead of cherry-picking these and holding them up to be exemplars of homeopathic efficacy, they should be considered only within the totality of evidence and not in isolation. We have also taken the opportunity to address what we believe some proponents of homeopathy will provide in their submissions. We are aware that there are many arguments used to support homeopathy, but we believe that many are based on misunderstandings of the evidence and on unsound and fallacious reasoning. We hope you find our submission useful.

2 Homeopathy services provided We note that you currently provide homeopathy via the Liverpool Medical Homeopathy Service to patients with the following conditions: • Allergies • Angina and palpitations • Anxiety • Asthma • Benign prostatic hypertrophy (enlarged prostrate) • Chronic back pain • Chronic fatigue syndrome • Crohn's disease and ulcerative colitis • Depression • Hay fever and catarrh • Headaches and neurological diseases • Hypertension (high blood pressure) • Infertility and the menopause • Irritable bowel syndrome • Premenstrual tension • Problems with the menstrual cycle including painful irregular periods • Recurrent chest infections • Recurrent urinary tract infections • Skin diseases - eczema, psoriasis, acne, arthritis As you clearly lay out in your further information document,[6] there is little evidence of effectiveness for homeopathy for any condition, never mind those for which homeopathy is currently provided. It is interesting to note that if these conditions were advertised in relation to homeopathy treatment, they could be in breach of the UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (CAP Code).[7,8] In view of this lack of any good evidence for specific effects, listing homeopathy as an exception in your policy on Procedures of Low Clinical Priority is an anomaly that we recommend is corrected so it aligns with the best available scientific evidence. We note that a similar step was recently taken by your colleagues in NHS Liverpool Clinical Commissioning Group, whose homeopathy service was delivered via the same provider.

3 Evidence reviews Your Evidence Review Summary Sheet gives details of a number of trials of homeopathy, meta- analyses, systematic reviews, etc but this represents only a small proportion of the literature. Because many of these trials are of low quality and suffer from various methodological defects, it’s important to give precedence to the higher quality evidence in meta-analyses and systematic reviews. We believe we have covered the main ones below.

We believe that other papers will be provided in support of homeopathy, so we have listed the ones we believe are most likely to be mentioned in submissions together with some analysis and rebuttal of them. We hope this helps you in your decision. There have also been three Government-level reviews of homeopathy — the United Kingdom, Australia and Switzerland — all of which conclude that there is no good evidence that homeopathic treatment works better than placebo. There have been a number of systematic reviews and meta analyses of homeopathy. We would like to consider the more recent ones first, but we include several older ones below because they are still frequently cited as being in favour of homeopathy.

3.1 House of Commons Evidence Check This is listed in your Evidence Review Summary Sheet. This was a comprehensive review:

Our task was to determine whether scientific evidence supports government policies that allow the funding and provision of homeopathy through the NHS and the licensing of homeopathic products by the MHRA.[9] They concluded: 110. The Government’s position on homeopathy is confused. On the one hand, it accepts that homeopathy is a placebo treatment. This is an evidence-based view. On the other hand, it funds homeopathy on the NHS without taking a view on the ethics of providing placebo treatments. We argue that this undermines the relationship between NHS doctors and their patients, reduces real patient choice and puts patients’ health at risk. The Government should stop allowing the funding of homeopathy on the NHS. 111. We conclude that placebos should not be routinely prescribed on the NHS. The funding of homeopathic hospitals—hospitals that specialise in the administration of placebos—should not continue, and NHS doctors should not refer patients to homeopaths. [Original emphasis] We believe this is an evidence-based view and one that must inform the Clinical Commissioning Group’s decision. Although there has been some new papers published since this report such as Mathie et al. (see below) we do not believe that changes the report’s conclusions, even ignoring the many problems with Mathie et al.

3.1.1 Criticisms The report has been criticised by some homeopathy proponents but they do not withstand scrutiny. One argument is that the Government rejected the report. They did not, instead saying: 8. We agree with many of the Committee’s conclusions and recommendations. However, our continued position on the use of homeopathy within the NHS is that the local NHS and clinicians, rather than Whitehall, are best placed to make decisions on 7

what treatment is appropriate for their patients - including complementary or alternative treatments such as homeopathy - and provide accordingly for those treatments.[10] That is, they simply delegated the decision to local NHS and clinicians such as yourselves, allowing you to make the decision through consultations such as this one. Another argument is that the report was only passed by three members of the Science and Technology Select Committee and that they were biased against homeopathy. It should be noted that Nadine Dorries was a member of the Committee and a supporter of homeopathy and homeopathic hospitals[11] yet did not attend any Committee meetings and did not vote on the final report.[12] The Government in its response did not express any concerns over the legitimacy of the Committee, the process or the final report.[10] Another criticism is that the committee was biased and ignored evidence from homeopaths. A quick look through the report at the many contributions from homeopathy proponents gives lie to that criticism. The Committee held three hearings and the 12 witnesses included: • Mr Robert Wilson, Chairman, British Association of Homeopathic Manufacturers (BAHM) • Dr Peter Fisher, Director of Research, Royal London Homeopathic Hospital • Dr Robert Mathie, Research Development Adviser, British Homeopathic Association The hearings have been criticised by some because they included scientists and medical practitioners known to have evidence-based and science-based views of homeopathy, such as Edzard Ernst, Professor of Complementary Medicine at the University of Exeter, and Dr Ben Goldacre, but it is unclear why they believed the voice of non-homeopaths should not have been heard. Overall, there were 66 written evidence submissions from 56 individuals and organisations; these were all considered and included in their report. This included submissions from the following organisations representing homeopaths or supporting homeopathy: • Alliance of Registered Homeopaths (ARH) • British Association of Homeopathic Manufacturers (BAHM) • British Homeopathic Association • European Central Council of Homeopaths • European Committee for Homeopathic Medicine in Europe • Homeopathy Research Institute • Homeopathy: Medicine for the 21st Century (H:MC21) • Liga Medicorum Homoepathica Internationalis (LMHI) • Northern Ireland Association of Homeopaths • Prince’s Foundation for Integrated Health • Society of Homeopaths The individuals submitting written evidence included the following homeopaths and homeopathy researchers: • Dr Clare Relton • Dr Hugh J Nielsen • Dr Jean Munro • Dr Peter Fisher • Dr Peter Julu • Dr Sara Eames 8

• Professor George Lewith • Professor Harold Walach We estimate that, overall, around 50% of submissions were from homeopaths or organisations representing or supporting homeopaths. It is therefore difficult to understand the criticism that the Committee failed to take account of the views of homeopaths.

3.1.2 Conclusions We therefore believe that the criticisms of the Evidence Check do not withstand scrutiny and that the report was comprehensive and evidence-based in its conclusions. However, even if any or all of the criticisms was valid, that does not invalidate the conclusions of the Evidence Check report.

3.2 NHMRC report

This is listed in your Evidence Review Summary Sheet. In March 2015 the Australian National Health and Medical Research Council (NHMRC) published its report on the most extensive investigation into homeopathy carried out to date. The Council set out to answer the question: Is homeopathy an effective treatment for health conditions, compared with no homeopathy, or compared to other treatments? The work was overseen by a Homeopathy Working Committee established by the NHMRC with collective expertise in evidence-based medicine, study design, and complementary and alternative medicine research. It commissioned a professional research group OptumInsight (Optum) to do a thorough search of published research to find systematic reviews of studies (prospective, controlled studies) that compared homeopathy with no homeopathy or with other treatments and measured effectiveness in patients with any health condition. Studies were considered to be of sufficient size where N>150 (ie those studies categorised as ‘medium’ sized or larger). Systematic reviews analysed numbered 58, containing 176 individual controlled studies covering 61 clinical conditions. We believe this was the most comprehensive and thorough review of the evidence for homeopathy. Additional information was submitted to the NHMRC by homeopathy interest groups and the public. The NHMRC also commissioned an independent organisation with expertise in research methodology (The Australasian Cochrane Centre) to review the methods used in the overview and ensure that processes for identifying and assessing the evidence were scientifically rigorous, consistently applied, and clearly documented. Their conclusions included: Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective. Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. [Emphasis added]

3.2.1 Criticisms

There have been a number of criticisms from homeopathy proponents.[13] However, we believe these have been addressed by the NHMRC.[14] In particular, there was some criticism of the n>150 threshold for trial inclusion, but it is never made clear in that criticism why including smaller and less reliable trials would be beneficial in improving the quality of the analysis.

3.3 Swiss homeopathy report This is not listed in your Evidence Review Summary Sheet. This is frequently — and erroneously — referred to as the Swiss Health Technology Assessment (HTA).[15] It was not a Health Technology Assessment, which is a very specific, comprehensive and broad- ranging type of assessment, but simply a limited review of some homeopathy studies for a few medical conditions. Indeed, the Swiss Government felt it necessary to correct this false and misleading impression.[16] Further, the published document wasn't even the same as that submitted to the Programm Evaluation Komplementärmedizin (PEK) set up by the Swiss Government to review reimbursement for homeopathy in their state health insurance scheme. It was an unofficial English translation of the report that had been added to by the authors. Again, the Swiss Government had to clarify that it was published 'without any consent of the Swiss government or administration'.[16] In their evaluation of the evidence for homeopathy, the authors chose to 're-interpret' the conclusions of the original studies, making them more favourable to homeopathy. When the PEK reviewed the report, they had to downgrade the conclusions to achieve a more balanced view of the evidence, saying, 'Even less skeptical academic doctors will regard many interpretations as very optimistic and not scientifically convincing.'[17] (Note that this references a blog post written by Alan Henness and Sven Rudloff with translations from Swiss- German by Sven Rudloff. However, all original documents are cited, so the veracity of translations (and other information) can be fully verified.)

The report has been heavily criticised elsewhere[18], with some going as far as to call it ‘research misconduct’.[19] The report only looked specifically at evidence for upper respiratory tract infections and allergic reactions, so even if their conclusions had been valid, they cannot be extrapolated to the homeopathic treatment of any other condition. Also, homeopathy had not been found cost- effective because it had not been found effective. As a direct result of the Swiss homeopathy report, the Government removed the previous temporary reimbursement of homeopathy from its national health insurance scheme. However, after campaigning by homeopaths and their supporters, a referendum was held in which 67% of those voting voted for homeopathy (and other alternative treatments) to be included for reimbursement. The Swiss Government was in a difficult situation because, 10

although the results of referendums are binding, their law only allows reimbursement for treatments that meet requirements of 'efficacy, appropriateness and cost-effectiveness'. Since none of these therapies met the requirements, the Government has allowed temporary reimbursement until 2017 and this will only be extended if homeopaths provide good scientific evidence by 2015. It should be noted that the Shang et al. analysis mentioned below was part of the same review commissioned by the Swiss Government.

3.4 Mathie et al. Mathie et al. [20] is not listed in your Evidence Review Summary Sheet although an earlier preparative paper is listed.[21] This has been hailed recently as the definitive evidence review for homeopathy, particularly since it considered individualised homeopathic treatments. It is also the most recent and was conducted by the British Homeopathic Association, supported by a grant from the Manchester Homeopathic Clinic. Note that it has been claimed (eg by Dr Peter Fisher [22]) that this was an analysis by the Robertson Centre for Biostatistics at the University of Glasgow. However, although two of the authors were affiliated with that institution, they only provided the statistical analysis of the data provided by the British Homeopathic Association. Published in December 2014, Mathie et al. conducted a systematic review of randomised placebo-controlled trials (RCTs) of individualised homeopathic treatments and conducted a meta analysis where appropriate data were available: Thirty-two eligible RCTs studied 24 different medical conditions in total. Twelve trials were classed ‘uncertain risk of bias’, three of which displayed relatively minor uncertainty and were designated reliable evidence; 20 trials were classed ‘high risk of bias’. Twenty-two trials had extractable data and were subjected to meta-analysis; OR = 1.53 (95% confidence interval (CI) 1.22 to 1.91). For the three trials with reliable evidence, sensitivity analysis revealed OR = 1.98 (95% CI 1.16 to 3.38). It should be noted that the review’s hypothesis was not a null hypothesis, but one that sought confirmation: We tested the hypothesis that the outcome of an individualised homeopathic treatment approach using homeopathic medicines is distinguishable from that of placebos. If they had more properly considered a null hypothesis — eg that the outcomes of an individualised homeopathic treatment approach was not distinguishable from that of placebo — and sought to falsify it, they would have to provide significant evidence to overcome the inherent lack of the prior plausibility for homeopathy. We cannot accept that a small number of randomised controlled trials of not very high quality and with obvious methodological flaws sufficient to overcome this necessary hurdle. However, even with their alternative hypothesis, they found no trials that had low risk of bias in all seven domains they assessed. In the next lower category, they identified just 12 that 11

had uncertain risk of bias in some domains and low risk of bias in all other domains. The rest were identified as having a high risk of bias in some domains. Of the 12 with uncertain risk of bias, they singled out just three that they concluded were of ‘reliable evidence’. These are Jacobs 1994 (referenced as A19 in Mathie et al.), Jacobs 2001 (A20) and Bell 2004 (A05). We will briefly look at each of these.

3.4.1 Jacobs 1994 This was a small study (n=81) of children with a history of acute diarrhoea given either homeopathy or re-hydration treatment plus homeopathy.[23] It should be noted that Mathie et al. claim: We conducted a systematic literature search to identify RCTs that compared individualised homeopathy with placebos… It is therefore not clear why they chose to include this trial because it fails this: the control arm was not a placebo, but was an active treatment to which was added the homeopathy treatment. This is an A+B versus B trial design and these will always generate positive results (unless the treatment in question does actual harm). However, it concluded: The statistically significant decrease in the duration of diarrhea in the treatment group suggests that homeopathic treatment might be useful in acute childhood diarrhea. Further study of this treatment deserves consideration. Although Mathie et al. regarded this as reliable evidence, it has been criticised on a number of grounds.[24]

3.4.2 Jacobs 2001 The paper itself describes this as a preliminary trial (n=75) of homeopathy vs placebo for otitis media.[25] It concluded: These results suggest that a positive treatment effect of homeopathy when compared with placebo in acute otitis media cannot be excluded and that a larger study is justified.

3.4.3 Bell 2004 This was a test of increasing LM dilutions (starting at 1:50,000) in alcohol (n=62), of homeopathy vs placebo for fibromyalgia.[26] Note that the dilutions started as a 1:50,000 but was repeatedly serially diluted in the same ratio for each subsequent dose. A total of 41 different homeopathic preparations were used: Homeopathic remedy choices over the whole sample were highly individualized to the same degree in both groups (homeopaths prescribed 41 different remedies for 62 participants) (supplementary data, Table 3). Only two remedies, Calcarea carbonica and Rhus toxicodendron, each were chosen for four patients. 12

The actual preparations used are identified in the supplemental data to the paper, but there is no analysis of outcome measure vs each preparation. Note that the authors state: This study was designed as a feasibility or pilot study rather than a definitive clinical trial It concluded: This study replicates and extends a previous 1-month placebo-controlled crossover study in fibromyalgia that pre-screened for only one homeopathic remedy. Using a broad selection of remedies and the flexible LM dose (1/50 000 dilution factor) series, the present study demonstrated that individualized homeopathy is significantly better than placebo in lessening tender point pain and improving the quality of life and global health of persons with fibromyalgia.

3.4.4 Conclusion All these three trials had various and significant methodological flaws, yet they were the best identified by Mathie et al. It is not clear why the many criticisms of these trials were not fully addressed by Mathie. It is worth emphasising the number of participants in these three trials (81, 75 and 62 participants) and that Jacobs 2001 self-describes as ‘preliminary’ and Bell 2004 as ‘a pilot study’. It is difficult to understand why he chose to categorise as being ‘reliable evidence’. This ignores the very serious problem highlighted by Ioannidis of prior probability and false positive results.[5] However, taking these three and then adding in many other even poorer quality trials, Mathie concluded: Medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation. [Emphasis added]

Moreover, he emphasised: The overall quality of the evidence was low or unclear, preventing decisive conclusions. It’s difficult to understand how this could be viewed as compelling evidence for the use of homeopathy.

3.4.5 Criticisms This paper has been roundly criticised.[27] The main criticism levelled at it is in the selection of the outcome measure for each trial it considered. Although Mathie could have chosen the outcome measure or measures as declared by the authors of the original studies (ie that for which the trial was designed), he chose to ignore them and use World Health Organisation ICF Classification System for Levels of Functioning Linked to Health Condition.[28]

Moreover, the WHO intend it as an ‘international standard to describe and measure health and disability’ especially for the purposes of policy formation. The system provides a method of classification, but does not provide a means of ranking health conditions and it does not appear to have been validated for such use. They do not classify it as a method of ranking importance of outcomes in clinical trials. In using the WHO’s Classification, Mathie has, in some cases, stated that a trial’s declared primary outcome to be of lesser importance than a secondary outcome. It is unclear why this has been done or what benefit, if any, it offers in terms of the evaluation of the evidence.

However, Prof Ernst has surmised that this has led to a trial he co-authored[29] being excluded from Mathie’s analysis: Why did they do that?

The answer is simple: in their methods section, they specify that they used outcome measures “based on a pre-specified hierarchical list in order of greatest to least importance, recommended by the WHO“. This, I would argue is deeply flawed: the most important outcome measure of a study is usually the one for which the study was designed, not the one that some guys at the WHO feel might be important (incidentally, the WHO list was never meant to be applied to meta-analyses in that way).

By following rigidly their published protocol, the authors of the meta-analysis managed to exclude our negative trial. Thus they did everything right – or did they? Well, I think they committed several serious mistakes. • Firstly, they wrote the protocol, which forced them to exclude our study. Following a protocol is not a virtue in itself; if the protocol is nonsensical it even is the opposite. Had they proceeded as is normal in such cases and used our primary outcome measure in their meta-analyses, it is most likely that their overall results would not have been in favour of homeopathy. • Secondly, they awarded our study a malus point for the criterium ‘selective outcome reporting’. This is clearly a wrong decision: we did report the severity- outcome, albeit not in sufficient detail for their meta-analysis. Had they not committed this misjudgment, our RCT would have been the only one with an ‘A’ rating. This would have very clearly highlighted the nonsense of excluding the best-rated trial from meta-analysis.[27] There are similar concerns over another trial, Walach et al.[30] (A37 in Mathie et al.) being not classified as reliable evidence. The conclusions of Mathie et al. must therefore be treated with extreme caution.

3.4.6 Overall conclusions However, even if the evidence from the three trials are taken as if they did constitute ‘reliable evidence’ and that, overall, the evidence was decisive and compelling, they would only provide evidence for homeopathy for children with acute diarrhoea, otitis media and fibromyalgia for the specific preparations used (where known). As there appears to be no coherent, scientific or evidential basis for the notion that the successful use of one homeopathic preparation in one person in some way implies that other completely different preparations (whose only similarity is the amount it has been diluted), would be similarly 14

successful in another person, it’s difficult to see how these results could be extrapolated to cover any circumstances other than those specifically trialled. However, it is clear that these three trials do not even provide compelling evidence for the specific medical conditions of those trials. Mathie et al. also provide no suggestions as to how their conclusions could be extrapolated to other patient groups (eg adults) or any other medical condition. At best, and in the interests of providing the best healthcare, it would be prudent to do as Mathie concludes: await new high-quality research that might allow a more decisive conclusion.

3.5 Other reviews of homeopathy There are a number of meta-analyses and systematic reviews of homeopathy that are cited frequently in support of homeopathy. The British Homeopathic Association states: Systematic reviews

The most solid evidence for a treatment comes from critically assessing more than one RCT in a carefully defined way. This is known as a systematic review.[31] They continue: Six out of seven major systematic reviews of RCTs in homeopathy have concluded (with important caveats) that homeopathy has an effect greater than placebo. They then refer to the website of the Faculty of Homeopathy who make a different claim about reviews:

Systematic reviews of randomised controlled trials (RCTs) of homeopathy

Four of five major comprehensive reviews of RCTs in homeopathy have reached broadly positive conclusions.[32] They cite the reviews given below but it’s difficult to understand why they categorise them as all being ‘broadly positive’ when there are so many important and critical caveats. It is easy to select single RCTs that have a positive conclusion. Such a result can be caused by many factors including, bias, lack of a robust protocol and random chance. We therefore agree with the British Homeopathic Association that systematic reviews must be the arbiters of the evidence. These are best dealt with by quoting their individual conclusions in full.

3.5.1 Kleijnen et al. 1991 This is not listed in your Evidence Review Summary Sheet. This was a meta-analysis of 107 trials, concluding:

At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials.[33] [Emphasis added]

3.5.2 Boissel et al. 1996 This is not listed in your Evidence Review Summary Sheet. Critical literature review commissioned by the European Commission Homeopathic Medicine Research Group, 184 trials. Boissel controversially combined p-values of the highest quality trials to arrive at this conclusion: From the available evidence it is likely that among the tested homoeopathic approaches some had an added effect over nothing or placebo….but the strength of this evidence is low because of the low methodological quality of the trials. [Emphasis added]

3.5.3 Cucherat et al. 2000 This is not listed in your Evidence Review Summary Sheet. This used the same data as Boissel et al. 1996 but with the addition of at least two more trials. Boissel was one of the four-strong research team and authored the report, which concluded: There is some evidence that homeopathic treatments are more effective than placebo; however, the strength of this evidence is low because of the low methodological quality of the trials. Studies of high methodological quality were more likely to be negative than the lower quality studies. Further high quality studies are needed to confirm these results.[34] [Emphasis added]

It is worth noting what Boissel told reporter Martin Robbins of the Guardian: I spoke to Jean-Pierre Boissel, an author on two of the four papers cited (Boissel et al and Cucherat et al), who was surprised at the way his work had been interpreted. “My review did not reach the conclusion ‘that homeopathy differs from placebo’,” he said, pointing out that what he and his colleagues actually found was evidence of considerable bias in results, with higher quality trials producing results less favourable to homeopathy.[35]

3.5.4 Linde et al. 1997 This is not listed in your Evidence Review Summary Sheet. A meta-analysis of 89 trials, concluded:

The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition. Further research on homeopathy is warranted provided it is 16

rigorous and systematic.[36] [Emphasis added]

Linde produced a follow-up paper in 1999, which concluded: The evidence of bias [in homeopathic trials] weakens the findings of our original meta- analysis. Since we completed our literature search in 1995, a considerable number of new homeopathy trials have been published. The fact that a number of the new high- quality trials… have negative results, and a recent update of our review for the most “original” subtype of homeopathy (classical or individualized homeopathy), seem to confirm the finding that more rigorous trials have less- promising results. It seems, therefore, likely that our meta-analysis at least overestimated the effects of homeopathic treatments.[37] [Emphasis added]

3.5.5 Shang et al. 2005 This is not listed in your Evidence Review Summary Sheet. It should be noted that the Shang et al. analysis was part of the review commissioned by the Swiss Government (see above). Eight homeopathy trials selected from 110 were compared against 6 trials of conventional medicine selected from 110 for similar conditions. This concluded: Biases are present in placebo-controlled trials of both homoeopathy and conventional medicine. When account was taken for these biases in the analysis, there was weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions. This finding is compatible with the notion that the clinical effects of homoeopathy are placebo effects.[38] [Emphasis added]

A frequent objection to Shang et al. is that Shang didn’t identify the eight trials. Although it was not at all obvious in the paper published in The Lancet, he corrected this in a letter a few issues later.[39] It is also frequently pointed out that the homeopathy trials were of higher quality than those of the conventional treatments. This occurred because of the limited number of medical conditions trialled for homeopathy so he had to find conventional treatments to match to the available homeopathy trials. If he had tried to do this the other way round (ie try to find trials of homeopathy for conditions that he had already identified good evidence of conventional treatments), he would have been severely restricted in the number he could have compared. It can be seen that whilst some of these do show that there might be some findings compatible with the notion that the clinical effects of homoeopathy are not placebo effects, they are not compelling.

3.5.6 Systematic review of systematic reviews This is not listed in your Evidence Review Summary Sheet.

In 2002, Prof Ernst analysed these and other papers in his ‘systematic review of systematic reviews of homeopathy’. This included the above reviews and several others. He concluded: …the hypothesis that any given homeopathic remedy leads to clinical effects that are relevantly different from placebo or superior to other control interventions for any medical condition, is not supported by evidence from systematic reviews. Until more compelling results are available, homeopathy cannot be viewed as an evidence-based form of therapy.[40]

3.5.7 Conclusion These reviews are damning of the evidence for homeopathy. While some proponents of homeopathy cherry pick quotes from these reviews, an impartial and disinterested observer cannot fail to be wholly unconvinced by the totality of this evidence. In terms of any relevant null hypothesis, the evidence is clearly negative. (See below for further discussion on this.)

4 Other considerations 4.1 Positive vs non-conclusive vs negative trials

Organisations such as the Faculty of Homeopathy, the Homeopathy Research Institute and the British Homeopathic Association make much of their analysis of RCTs, stating: Of the 104 papers in total, 43 (41%) reported positive findings; 5 (5%) were negative; 56 (54%) were non-conclusive.[31,41,42] The Society of Homeopaths give similar figures.[43]

This misunderstands the role of the null hypothesis in science. Prof Ernst put it thus: The efficacy or effectiveness of medical interventions is, of course, best tested in clinical trials. The principle of a clinical trial is fairly simple: typically, a group of patients is divided (preferably at random) into two subgroups, one (the ‘verum’ group) is treated with the experimental treatment and the other (the ‘control’ group) with another option (often a placebo), and the eventual outcomes of the two groups is compared. If done well, such studies are able to exclude biases and confounding factors such that their findings allow causal inference. In other words, they can tell us whether an outcome was caused by the intervention per se or by some other factor such as the natural history of the disease, regression towards the mean etc. A clinical trial is a research tool for testing hypotheses; strictly speaking, it tests the ‘null-hypothesis’: “the experimental treatment generates the same outcomes as the

treatment of the control group”. If the trial shows no difference between the outcomes of the two groups, the null-hypothesis is confirmed. In this case, we commonly speak of a negative result. If the experimental treatment was better than the control treatment, the null-hypothesis is rejected, and we commonly speak of a positive result. In other words, clinical trials can only generate positive or negative results, because the null- hypothesis must either be confirmed or rejected – there are no grey tones between the black of a negative and the white of a positive study.[44] [Original emphasis] Thus, inconclusive trials are negative because they do not refute the null hypothesis. So, those trials labelled as inconclusive must be more correctly designated as negative, changing the above statement to read:

Of the 104 papers in total, 43 (41%) reported positive findings and 61 (59%) were negative.

This gives a very different — and more scientifically accurate — picture of the evidence. Even then, this does not take trial quality — and prior probability — into account, hence the need for the reviews as given above, to examine the quality — and totality — of the evidence.

4.2 Specific and non-specific effects It is important to distinguish the specific effects of a treatment from the non-specific effects. The specific effects of a homeopathic treatment are those specific to the actual homeopathic preparation itself, removed from any other influencing factors; the non-specific effects encompass everything else including the consultation, how long it lasts, the practitioner’s attitude, the surroundings, the cost of the consultation, etc. There is little doubt that the non-specific effects can be helpful and that they are appreciated by patients. A study by Brien et al. showed that homeopathy had clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process (the non-specific effects) but not to the homeopathic remedy (the specific effects).[45] These benefits might be a feeling of relaxation or relief that someone has taken the time to listen to them and there is little doubt that some patients are helped by this.[46] However, this does not mitigate the need for robust evidence for the specific effects of that treatment. In the case of homeopathy, the specific effects are those generated by the homeopathic preparation itself. We note the conclusions of Brien et al.: Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable [rheumatoid arthritis]. 19

4.3 Anecdotal evidence Homeopaths frequently claim that there is more than 200 years of evidence for the use of homeopathy. Other than the fact this evidence doesn’t seem to have been collated anywhere, extreme caution must be taken in accepting unverified and unverifiable anecdotes as reliable evidence. This problem of anecdotal evidence was clearly stated by the Australian National Health and Medical Research Council:

It is not possible to tell whether a health treatment is effective or not simply by considering individuals’ experiences or healthcare practitioners’ beliefs. One reason personal testimonials are not reliable is that people may experience health benefits because they believe that a treatment is effective. This is known as the ‘placebo effect’. Another reason is that healthcare practitioners cannot always tell whether changes in a person’s health condition are due to the treatment or some other reason. For these reasons, medicines must be tested in a planned, structured scientific research project designed to prevent these kinds of experiences giving the false impression that a medicine is more or less effective than it really is.[47]

4.4 Patient satisfaction surveys The two most commonly cited examples of patient satisfaction studies are the Northern Ireland Study [48] and the Bristol Homeopathic Hospital Study.[49] There is little doubt that those seeking homeopathy treatments could be predisposed and receptive to it. It is therefore unsurprising that some surveys of patient satisfaction report high rates of satisfaction. (See also above on specific/non-specific effects and anecdotes). That cannot, however, be interpreted as evidence that homeopathic treatments are effective. Additionally, such surveys would only be useful when compared to similar surveys about patients of conventional medicine. The Northern Ireland survey is little more than a customer satisfaction survey and tells us nothing about the efficacy of homeopathy. The Bristol Homeopathic Hospital study can similarly be dismissed in the context of examining the evidence for the efficacy of homeopathy. We note the results of the Liverpool Medical Homeopathy Service’s survey mentioned in your further information document. While some patients report feeling better after treatment, this tells us nothing about whether any reported improvements were due to any homeopathy treatment received. It is important to note that the data provided represents only a small sample (n=18), covering April 2014 to March 2015. Your consultation document states a total of 99 patients received either homeopathic or Iscador® treatment between April 2013 and March 2015. Assuming these were distributed evenly between these two years, this sample of 18 represents just 36% of the total number of patients. Because data were not collected on the remaining 64% — including those who dropped out, perhaps because they were unhappy with the treatment — the results of the survey are highly unreliable and can be given little credence as a measure of patient satisfaction, never mind effectiveness of treatment.

4.5 Integrating homeopathy with conventional medicine The argument is sometimes used that instead of homeopathy being an alternative and a replacement to conventional treatments, it can integrated alongside conventional treatments. We would argue that if homeopathy were to be used alongside conventional, then compelling evidence that it improved outcomes when used with specific conventional treatments would have to be provided. We note that none of the reviews we have highlighted above cover this situation and therefore cannot be used to substantiate homeopathy integrated with conventional treatments.

4.6 Safety of homeopathy If homeopathic preparations are manufactured according to Good Manufacturing Practice (GMP),[50] according to their MHRA authorisation (National Rules Scheme) or registration (Simplified Scheme) and are sufficiently diluted, then it is unlikely patients would suffer any direct harm. Having said that, some trials of homeopathic products obtained from Helios Homeopathy Ltd and Ainsworths Homeopathic Pharmacy could be interpreted to conclude that some of the initial material remains even after dilution to 1:10050 000.[51] An inspection report by the US Food and Drugs Administration (FDA) ‘identified significant violations of Current Good Manufacturing Practice’ by A Nelson & Co Ltd. This included glass fragments on the production line and sugar pills that did not receive a dose of the water they were supposed to under homeopathic principles. The FDA go on to state: These violations cause your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP. These drugs are also misbranded under Sections 503 and 301 of the Act. We have reviewed your firm’s response of December 07, 2011, and note that it lacks sufficient corrective actions.[52] One study, Posadzki et al., highlighted a number of concerns about harms caused by both specific and non- specific effects, concluding: Homeopathy has the potential to harm patients and consumers in both direct and indirect ways. Clinicians should be aware of its risks and advise their patients accordingly.[53] However, even if the registered and authorised products were manufactured safely and correctly, there is no such guarantee for the vast majority of homeopathic products on sale in the UK. This is because, other than the 19 authorised products and the 235 registered products,[54] there are thousands of unlicensed homeopathic products on sale from any of several homeopathy manufacturers in the UK.[55–58] These products may well be manufactured in the same manufacturing plant and to the same GMP as registered and authorised products, but they have no MHRA Public Assessment Report (PAR) or a Summary of Product Characteristics (SPC). The safety of these products cannot, therefore, be known.

4.6.1 Indirect harm

As well as possible direct harms, the indirect harms of the idea that homeopathy is effective and that it can be used for a wide range of medical conditions must also be noted. It is to be hoped that GPs, even though they prescribe homeopathy, would ensure that their patients receive conventional treatments when required. Overall, however, we believe that the idea that homeopathy is in any way an alternative medical system or complementary —or even an alternative — to conventional treatments could lead patients to rely on homeopathy from practitioners who are not medical doctors.

4.7 Cost-effectiveness Much has been said about the cost-effectiveness of homeopathy, particularly when used as an adjunctive treatment. For a treatment to be cost-effective, it must first be effective. As shown above, homeopathy fails this criterion. But even if homeopathy had specific effects, it does not follow that healthcare costs would be reduced. Looking at the healthcare records of 44,500 patients in Germany, a study by Ostermann et al. to compare the health care costs for patients using adjunctive homeopathic treatment with the costs for those receiving usual care, concluded: Compared with usual care, additional homeopathic treatment was associated with significantly higher costs. These analyses did not confirm previously observed cost savings resulting from the use of homeopathy in the health care system.[59] Therefore, even if homeopathy was effective, it is not cost-effective and does not reduce healthcare costs.

4.8 Usage of homeopathy in the UK It is frequently claimed that homeopathy is used by 10% of the UK population. This figure may originate from the oral evidence given by Prof Kent Woods, the then Chief Executive of the Medicines and Healthcare products Regulatory Agency, to the House of Commons Science and Technology Select Committee: From the point of view of evidence, certainly from a regulatory perspective, it is very important evidence that something like ten per cent of the population have used a homeopathic remedy or have gone to a homeopath in the previous 12 months, and that I think is a starting point for deciding what is the public health significance of this phenomenon.[9] It is not known how this figure is arrived at and we are not aware of any data that would substantiate it. Additionally, we do not believe that this necessarily means that 10% are in any way relying on homeopathy for healthcare needs, because it does not tell us how often the 10% used homeopathy: it seems likely that many will have tried it only once, perhaps by buying a product is their high street chemist or health food shop, and then abandoning it. This figure therefore tells us nothing about ongoing reliance on homeopathy or about its efficacy. It has been stated that use of homeopathy is increasing in the UK at the rate of 20% pa. We don’t know the source of this but we are aware that a survey conducted by Global TGI in 2008 found 15% of the population of Britain trusted homeopathy, falling to 12% in 2013.[60]

4.9 False legitimacy The NHS is a highly respected institution and one that is trusted and valued for the services and treatments it provides. We believe that the provision on the NHS of homeopathy lends it a false legitimacy that could cause harm. For example, on their UK website, Weleda state: Homeopathic treatment today

Today there are four [sic] homeopathic hospitals offering treatment under the National Health Service - in London, Glasgow, Liverpool and Bristol. There are also numerous homeopathic clinics, more than 400 homepathic [sic] doctors in Britain and simple self- help guides freely available to guide families on remedies for every-day ailments. Homeopathy is now one of the most widely used and trusted alternative systems of medicine in the world. It’s still the only alternative medicine incorporated into the NHS. An act of parliament in 1952 responded to the success and reputation of homeopathy and secured, by law, the provision of homeopathy within the NHS[61] Similar text can be found repeated on the websites of lay homeopaths, for example: Homeopathy is one of the most extensively used and trusted complementary system of medicine in the UK. Homeopathy remains the only alternative medicine incorporated into the NHS. This was brought about by an act of parliament in 1952 due to the unparalleled success and reputation homeopathy gained in treating epidemic diseases. The results were so impressive that the Act was passed with the subsequent establishment of 5 NHS Homeopathic hospitals. This Act secures, by law, the provision of homeopathy within the NHS. A 1986 survey by the British Medical Journal showed that 42% of doctors referred patients for homeopathic treatment. A 1990 survey of British pharmacists found that 55% if them considered homeopathic remedies useful.[62] One other claim about the provision of homeopathy on the NHS has been the subject of an adjudication by the Advertising Standards Authority.[63] The advertiser claimed that homeopathy was ‘sanctioned by the UK government and has been an integral part of the National Health Service (NHS) since it was founded in 1948’. The ASA ruled that the advertiser had not substantiated the claim that it was sanctioned by the UK government and the claim was therefore misleading and told the advertiser not to repeat the claim. However, this stands as an example of how the provision of homeopathy within the NHS is used in advertising to the general public. We appreciate that misleading statements made by others are not the responsibility of the Clinical Commissioning Group, but they serve as examples of the way in which the provision of homeopathy by the NHS gives it false imprimatur: the ending funding by the Clinical Commissioning Group will help diminish that legitimacy.

4.10 Lack of funds for trials The lack of money is frequently cited as a reason why good homeopathy research has not been forthcoming or why trials only include relatively small numbers of participants. This is misleading: homeopathy is a multi-billion pound global business and the funding could easily be made available from manufacturers or from homeopaths themselves. 23

Boiron, a multinational homeopathy manufacturer who has a number of licensed products in the UK, has a market capitalisation value of €1.43 billion and made a profit before tax of

€354 million in 2014.[64] Weleda AG had net sales of €364 million in 2014.[65] A Nelson and Company Limited had a turnover of just under £44 million in 2014.[66] There are other manufacturers in the UK, but homeopathy should not be seen as a small cottage industry that cannot afford to conduct robust clinical trials.

Additionally, there are over 3,000 homeopaths in the UK alone.[67] A few assumptions about number of clients, cost of a consultation, etc have to be made, but for illustration, if it is assumed that, on average, these 3,000 have four clients a day, just four days a week, 40 weeks a year and that they charge £50 per client, then a 1% levy on each client — just 50p — would raise an annual levy of just under £1 million.[68] If these conservative assumptions are low, then considerably more than £1 million could easily be raised for research each and every year. This could make a considerable contribution to research if the will was there.

5 Iscador® Iscador® is the brand name for several proprietary products manufactured by Weleda AG and the brand stated to be used by the Liverpool Medical Homeopathy Service. Although frequently associated with homeopathy and homeopathy practitioners, it is not a homeopathic preparation (nor considered such by the MHRA) but is one of a range of anthroposophic medicines, prepared from a fermented extract of the European mistletoe (Viscum album). The normal route of administration is by subcutaneous injection. The basis of the mistletoe preparations for the treatment of cancer was in the supernatural beliefs of mystic Rudolf Steiner. Observing that mistletoe grew on trees like a cancer, his reasoning concluded that therefore mistletoe could be used to treat cancer. Mistletoe is a semiparasitic plant that grows on leaf-bearing and coniferous trees throughout Europe, Asia and North Africa: Interestingly, the chemical properties of the plant vary according to the type of host tree. Iscador derived from mistletoe grown on apple trees is described as Iscador M, on the oak, Iscador Q and on pine, Iscador P. Mistletoe from a specific host tree will be selected for use with a specific kind of primary cancer. Under normal circumstances, mistletoe berries are, of course, highly toxic to people.[69] It is not clear what the pharmacodynamic and pharmacokinetic differences are, but it cannot be assumed that any clinical trials on one product automatically are applicable to the other.

Unlike homeopathy, there is at least some plausibility for Iscador® as a treatment and there have been a number of trials for some specific cancers as listed on your Evidence Review Summary Sheet. As with homeopathy, it’s important that systematic reviews and meta-analyses of the evidence are considered rather than any individual trial. A 2003 systematic review concluded: Most of the studies had considerable weaknesses in terms of study design, reporting or both. Some of the weaker studies implied benefits of mistletoe extracts, particularly in terms of quality of life. None of the

methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy. [70]

A 2015 review looked at 18 controlled clinical trials (CCTs) for a number of mistletoe products including Iscador® concluded: Based on 18 controlled clinical trials (CCTs), there is reasonably good evidence that mistletoe preparations improve quality of life during chemotherapy. Seven out of 14 CCTs also show improvement of survival. Because of heterogeneity and shortcomings of the studies no firm conclusions can be drawn.[71]

With that caveat and the difficulty in applying the conclusions to Iscador® specifically (rather than any of the other mistletoe products covered by the review) and to the variants used by the Liverpool Medical Homeopathy Service in particular, it is difficult in our view to see how Iscador® could be recommended.

6 Miscellaneous We would like to briefly address several other claims made by proponents of homeopathy in case these appear in other consultation responses.

6.1 Homeopathy for babies and animals Use of homeopathy in animals is often cited as evidence of its efficacy because it is asserted that animals are free of placebo effects. However, this is quite untrue. Owners and practitioners are responsible for reporting outcomes for animal patients and their observations are prone to all the usual biases that are rolled into so-called placebo effects. Similar arguments can be made against the evidence cited for the use of homeopathy for babies. Also, parents, pet owners or farmers sympathetic to homeopathy may perceive that there has been more of an improvement than there really has been. The child or animal may also have been given increased care and attention or there may have been other changes, for example to their diet. The parent or pet owner may feel calmer and more in control, which may, in turn, help the animal or child to feel better, and may convey an expectation of improvement. In many cases, regression to the mean is a more plausible explanation for the effects observed. Improvements that would have happened without any treatment are likely to be attributed to homeopathy. Trials that do not adequately control for these many well understood biases can only ever produce results that seem more positive that they are.

There have been some trials of homeopathy in animals, but we are not aware of any high-quality studies that substantiate the existence of remedy-specific effects in animals. Many of the studies do not have good randomisation and do not adequately blind the parents/herdsman/owners and therefore results must be treated with caution. Overall, there is no good evidence that withstands scrutiny that homeopathy is effective for babies or animals.

However, even if there was good evidence for some homeopathic preparations for some conditions in animals, it is not clear how those results could be extrapolated to treating humans with different homeopathic preparations for different conditions.

6.2 India India is frequently held up as a shining example of a country where homeopathy is valued, widely used, highly successful and an integral and vital part of their healthcare system. Two facts give lie to such assertions: 1. Homeopathy is generally grouped with other alternative therapies: Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH). The National Sample Survey Office of the Indian Government, in its survey on Social Consumption: Health, conducted between January to June 2014 and covering all of India, including urban and rural sectors, stated: 3.2.2 Clearly a higher inclination towards allopathy treatment was prevalent (around 90% in both the sectors). Only 5 to 7 percent usage of ‘other’ including AYUSH (Ayurveda, Yoga or Naturopathy Unani, Siddha and homoeopathy) has been reported both in rural and urban area.[72] Clearly, homeopathy is not as prevalent in India as some seem to claim. In fact, homeopathy might even be trusted less in India than in the UK.[60]

2. The life expectancy at birth in 2013 was 81 years in the UK, but only 66 years in India.[73] Since homeopathy is not identified separately but included under the banner of AYUSH, it is not known how many use it — all that can be stated is that less than 7% use homeopathy. While this indicates that a number as high as 87 million could be using homeopathy, that still means that 1,164 million do not. However, even if homeopathy was widely used in India or anywhere else, that does not alter the lack of any good scientific evidence that it has specific effects over placebo.

6.3 Consumer choice Much is made about patient choice. But, with homeopathy, it is simply a choice of something for which there is no good evidence. Proponents of homeopathy may well believe homeopathy confers benefits to patients, but, as we have seen, there is no good evidence to support that view. As such, it cannot be a ‘healthcare choice’.

6.4 Fallacious arguments We are sure we do not need to remind the Clinical Commissioning Group of the many fallacious arguments sometimes used by proponents of homeopathy, but, for completeness, we would like to briefly mention a few here. None of them alters the lack of good evidence for specific effects of homeopathy and therefore should not influence the Clinical Commissioning Group’s decision.

6.4.1 Tu quoque These fallacious arguments usually reference problems with conventional medicines, iatrogenic harms, vaccines, problems with trials, problems with pharmaceutical companies, etc. These are irrelevant to the question of the evidence for homeopathy. 26

6.4.2 Argumentum ad populum It is frequently stated that homeopathy is popular in some countries. It may well be that homeopathy is more prevalent in some other countries but that is irrelevant to the question of the evidence for homeopathy.

6.4.3 Appeal to (inappropriate) authority This frequently appears in the guise of the assertion that the Queen (or someone other well- known personality or celebrity) uses homeopathy, therefore, because she could choose whatever healthcare she wanted, homeopathy must be effective. We have no information as to whether she does, but also note that she certainly does not use it exclusively.[74] Additionally, even if she does rely on it, that does not alter the scientific evidence for homeopathy. A variation on this is the use of the name of a Nobel laureate who won the prize because of his/her work in an unrelated area of science. This is equally fallacious.

7 Conclusions and recommendations The NHS Five Year Forward View[75] highlights three widening gaps in provision that present challenges to the NHS:

• the health and wellbeing gap • the care and quality gap • the funding and efficiency gap. In view of: • the lack of any compelling evidence that homeopathy has specific effects over placebo • the lack of compelling evidence for Iscador® • the false legitimacy the endorsement of homeopathy and Iscador® by the NHS gives • the additional costs that providing those treatments incur …homeopathy and Iscador® cannot have a role in prevention, cannot have a role in improving quality and safety of care and cannot contribute to efficiency savings, they cannot be a part of any solution to these challenges.

We urge you to cease the funding of homeopathy and Iscador® and choose option 3 as highlighted on your consultation. Concomitant with that decision is a revision of your Procedures of Low Clinical Priority to remove the exception for homeopathy. Given this, it cannot be the case that there can ever be exceptional clinical circumstances whereby a patient should be granted an Individual Funding Request for homeopathy.

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Appendix 6

Copy of letter from Liverpool Medical Homeopathy Service to Liverpool Clinical Commissioning Group

Dear Dr Fazlani and Colleagues,

As a Liverpool GP and member of Liverpool Clinical Commissioning Group I wish to bring to your attention the strong evidence base for the effectiveness of homeopathy contrary to the statement made by you in the Liverpool Echo of 28th November 2015.

“There is little evidence that homeopathy has a clinical benefit so, as a governing body, our preferred option would be to stop commissioning this service.” Comments in the same vein appear on the Liverpool Clinical Commissioning Group consultation website about the homeopathy service quoting extensively from the House of Commons Science and Technology Committee’s homeopathy review of 2010.( 1)

However this is a flawed document and one that should not be relied on to make any decisions about homeopathy. In deciding on the effectiveness or otherwise of any therapeutic intervention one needs to assess evidence from ALL sources. Professor Sir Michael Rawlins first Chairman of NICE in the Harveian oration of 2008 to the Royal College of Physicians about the nature evidence stated: (2)

“The notion that evidence can be reliably placed in hierarchies is illusory. Hierarchies place RCTs [randomised controlled trials] on an undeserved pedestal for, as I discuss later, although the technique has advantages it also has significant disadvantages. Observational studies too have defects but they also have merit. Decision makers need to assess and appraise all the available evidence irrespective as to whether it has been derived from RCTs or observational studies, and the strengths and weaknesses of each need to be understood if reasonable and reliable conclusions are to be drawn.”

This is something the Science &Technology homeopathy report most certainly did not do.

For example they ignored observational studies and focused almost solely on RCTs. At the time there had been 5 meta- analyses of homeopathy trials; 4 of those found in favour of homeopathy (3, 4, 5, 6) one against (the Shang 2005 meta- analysis) (7). However the committee ignored the first four studies and concentrated on the Shang review which purported to show proof that homeopathy was no more effective than placebo.

The Shang study compared 110 trials of homeopathy treatment with 110 trials of conventional treatment. They then narrowed down the trials to 8 of homeopathy and 6 of conventional therapy and compared them. They found that according to their research homeopathy came out as no better than placebo. However the 8 trials they selected did not involve individualised homeopathy: if a legitimately different set of trials are selected then a completely different result comes out – that homeopathy is more effective than placebo. (8,9)

The S&T Committee’s conclusions seem to have been derived from this flawed analysis and the opinion solely of the negatively minded witnesses they asked to give evidence. Only 3 out of the 14 members of the S&T committee voted in favour of the report, 1 voted against, the rest abstained which is not exactly a resounding endorsement of the document. Shortly after the report was published an early day motion expressing reservations about the report was signed by 70 MPs from across the political spectrum.

Their criticisms were:

• Limited number of witnesses called including two noted anti- homeopathy campaigners who had no experience of homeopathy

• No evidence heard from Doctors who use homeopathy in a primary care setting

• No evidence heard from other relevant organisations e.g. Society of Homeopaths

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• That the Committee ignored a reported 120 peer-reviewed RCTs comparing homeopathy with placebo, of which 52 reported homeopathic treatments were effective.

• That evidence should have been considered from:

• - Countries such as France and Germany, where provision of homeopathy is far more widespread than in the UK, • - India, where it is part of the health service

After the report was published the UK government rejected the committee’s recommendations.

In summary this is a flawed document that should not be used to make any decision about commissioning homeopathy treatment.

Also on the Clinical Commissioning Group website is the document prepared by Mr Kieran Lamb, librarian. This is another flawed and unreliable document for making any judgement about the effectiveness of homeopathy. It makes the same mistake that the House of Commons S&T report made i.e. being too selective with the evidence. There is no mention in the report about any inclusion or exclusion criteria: indeed the entire document is superficial and imprecise. The small selection of papers presented seems completely arbitrary which leads one to wonder if they have been cherry-picked.

Plus it makes no mention of the observational studies in homeopathy e.g. A service evaluation at Bristol Homeopathic Hospital recorded the outcome of homeopathic treatment in over 6,500 consecutive patients over a 6 year period. At follow- up, 70% of patients reported an improvement in their health, including 50% who reported ‘major improvement’.(10)

• A study involving 3,981 patients looked at the long-term outcome for patients receiving homeopathic treatment in 103 German and Swiss primary care practices. The results showed that treatment by a homeopath leads to marked and sustained improvements in disease severity and quality of life.(11)

• A 500-patient survey at the Royal London Homeopathic Hospital showed that many patients were able to reduce or stop conventional medication following homeopathic treatment. (12)

Again no mention of the previously cited meta-analyses of homeopathy, which are now 5 to 1 running in favour of homeopathy being more effective than placebo – see below.

There is no mention of placebo controlled RCTs.

In a more refined review of placebo-controlled trials published between 1950 and 2014 (13) there were 104 eligible RCT papers published in homeopathy. Only 32 RCTs (31%) of the 104 papers have studied individualised homeopathy; each of the other 72 papers (69%) has studied non-individualised homeopathy (i.e. selected a single homeopathic medicine for investigation).

Of the 104 papers in total, 43 (41%) reported positive findings; 5 (5%) were negative; 56 (54%) were non-conclusive. The 104 papers represent placebo-controlled research in a total of 61 different medical conditions.

There is no mention of the latest meta-analysis of homeopathy trials published by Mathie et al in 2014 of individualised homeopathic treatment. (13) The results of this meta-analysis – including trials with reliable evidence – showed that homeopathic medicines ("remedies"), when prescribed during individualised treatment, consistent with the usual care provided by homeopaths in a real-world clinical context, are almost twice as likely to have a beneficial effect as placebo. In other words, the RCT evidence including the most reliable trials of individualised homeopathic treatment shows that remedies can have specific and detectable beneficial effects beyond placebo. In terms of statistical ‘effect size’, the order of magnitude of the treatment effect of individualised homeopathy was similar to that of a number of conventional interventions: for example thrombolysis in acute stroke (14); statins in cardiovascular events (15); ACE inhibitors in chronic heart failure (16), inhaled corticosteroids in COPD exacerbations (17), and paroxetine in acute depression (18).

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Finally, Mr Kieran Lamb’s document mentions the Australian National Health and Medical Research Council report into homeopathy. This suffers from the same methodological flaws as the UK S&T report. Consequently, in September 2015, the NHMRC agreed to undertake a formal internal review of its processes to address alleged procedural irregularities, bias and methodological flaws. It doesn’t mention the Swiss government Health Technology Assessment report, published in 2006 and translated into English in 2011, which concluded by saying, “In summary, it can be said that there is sufﬁcient evidence for the preclinical effectiveness and the clinical efﬁcacy of homeopathy and for its safety and economy compared with conventional treatment. As a consequence of this report the Swiss Government took the decision to include homeopathy on the list of services covered by the Swiss statutory health insurance scheme.

In summary this librarian review provides no basis on which to draw any informed conclusions about clinical research evidence in homeopathy. It is a biased, inaccurate and misleading document of such poor quality it should be withdrawn from your website.

Both myself and Dr Sue de Lacy strongly refute your assertion that there is little evidence for the effectiveness of homeopathy; I think that the balance of evidence I have quoted above shows it can be an effective therapy. Our experience with Liverpool Clinical Commissioning Group patients shows that homeopathic treatment can help patients in situations where conventional treatment has failed or has unacceptable side effects; as such it is a valuable therapeutic option and should continue to be commissioned by Liverpool Clinical Commissioning Group.

Yours Sincerely

Dr Hugh Nielsen

Dr Sue de Lacy

Directors

The Liverpool Medical Homeopathy Service

Old Swan Health Centre

St Oswald’s street

Liverpool L13 2GA

References

1. House of Commons Science and Technology Committee, 2010. Evidence Check 2: Homeopathy: Fourth Report of Session 2009–10 2. On the evidence for decisions about the use of therapeutic interventions THE HARVEIAN ORATION The Royal College of Physicians of London Thursday 16 October 2008; by Professor Sir Michael David Rawlins MD FRCP 3. Kleijnen J, Knipschild P, ter Riet G. Clinical trials of homoeopathy British Medical Journal, 1991; 302: 316–323. 4. Cucherat M, Haugh MC, Gooch M, Boissel JP. Evidence of clinical efficacy of homeopathy – A meta-analysis of clinical trials. European Journal of Clinical Pharmacology, 2000; 56: 27–33. 5. Linde K, Clausius N, Ramirez G, et al. Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet, 1997; 350: 834–843. 6. Linde K, Scholz M, Ramirez G, et al. Impact of study quality on outcome in placebo controlled trials of homeopathy. Journal of Clinical Epidemiology, 1999; 52: 631–636.

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7. Shang A, Huwiler-Muntener K, Nartey L, et al. Are the clinical effects of homeopathy placebo effects? Comparative study of placebo-controlled trials of homeopathy and allopathy. Lancet 2005; 366: 726–732 8. Lüdtke R & Rutten ALB. The conclusions on the effectiveness of homeopathy highly depend on the set of analysed trials. J. Clin. Epidemiol. 2008; 61: 1197–1204 9. Kiene H, Kienle GS, von Schön-Angerer T. Failure to exclude false negative bias: a fundamental flaw in the trial of Shang et al. J Altern Complement Med 2005; 11: 783 10. Spence D, Thompson E and Barron S. Homeopathic treatment for chronic disease: a 6-year, university-hospital outpatient observational study. J Altern Complement Med 2005; 11: 793-8 11. Witt CM, et al. Homeopathic medical practice: long-term results of a cohort study with 3,981 patients. BMC Public Health, 2005; 5: 115 12. Sharples F, van Haselen R, Fisher P. NHS patients’ perspective on complementary medicine. Complementary Therapies in Medicine, 2003; 11: 243–8 13. http://facultyofhomeopathy.org/randomised-controlled-trials 14. Mathie RT, Lloyd SM, Legg LA, Clausen J, Moss S, Davidson JRT, Ford I (2014). Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis. Systematic Reviews; 3: 142. 15. Wardlaw JM, Murray V, Berge E, Del Zoppo GJ. Thrombolysis for acute ischaemic stroke.Cochrane Database Syst Rev 2009;4:CD000213. 16. Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, et al. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009; 373: 1849–60. 17. Flather MD, Yusuf S, Kober L, Pfeffer M, Hall A, Murray G, et al. Long-term ACE-inhibitor therapy in patients with heart failure or left-ventricular dysfunction: a systematic overview of data from individual patients. ACEInhibitor Myocardial Infarction Collaborative Group. Lancet 2000; 355: 1575–81. 18. Yang IA, Fong KM, Sim EH, Black PN, Lasserson TJ. Inhaled corticosteroids for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2007; 2: CD002991. 19. Barbui C, Furukawa TA, Cipriani A. Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic re-examination of published and unpublished data from randomized trials. CMAJ 2008; 178: 296–305.

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Appendix 7

Notes of Patient, Carer and Stakeholder Involvement Meetings

Patient and Carer Forum Event - Tuesday 26 April

Held at the CCG’s offices Old Market House, Hamilton Street, Birkenhead.

The event was attended by eight service users, one previous patient, one carer of a patient of the service and a patient’s support representative from the North West Friends of Homeopathy (NWFH). Most were aged 50-plus. Attendees’ voiced passionate support for homeopathy and felt strongly about the options under consideration. Their comments can be summarised as follows:

• Many people had benefitted from homeopathy, valued the service and felt it should be promoted • Conventional medicine had its side-effects and patients felt that choice was an important priority • It was unfair to target homeopathy when it was comparatively inexpensive compared to conventional treatments

Attendees were again asked to choose one of the three options. All voted unanimously for Option One, to extend the existing contract for a Homeopathy and Iscador service.

The CCG also asked attendees to complete the consultation survey.

Public Forum meeting – Tuesday 10 May 2016

Held at the CCG’s offices Old Market House, Hamilton Street, Birkenhead.

33 people attended the event from a wide age range consisting of:

• A homeopath from the Liverpool Medical Homeopathy Service (LMHS) • A Chairman from North West Friends of Homeopathy (NWFH)/Wirral Patient • Five representative of North West Friends of Homeopathy (NWFH) • Three interested parties (including The Good Thinking Society and Merseyside Skeptics Society) • Four patients of LMHS • Eight members of the public (both Wirral and general public) • One previous patient of LMHS • One Lay Member of Wirral Clinical Commissioning Group • A GP (area unknown) • 1 IFA • A carer • A Wirral Council Councillor • Five signed attendances with no status recorded.

The CCG was represented by its Medical Director, Director of Corporate Affairs, Head of Communication and Engagement, Head of Partnerships Team and Commissioning Support Manager, Partnerships Team.

Again, it was evident that many attendees held passionate views both for, and against, NHS funding for homeopathy and on homeopathy as a treatment option.

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Attendees were again asked to choose one of the three options. The results were:

Option 1 – Extend the existing contract for a Homeopathy and Iscador service: 12 respondents (5 members of the public, 4 patients and 3 previous patients).

Option 2 – Only fund the Homeopathy or Iscador service if the patient’s GP can prove that the patient is likely to derive greater benefit from the treatment than might normally be expected for patients with that condition (exceptional circumstance): 1 respondent (a member of the public).

Option 3 – Stop funding the service: 12 respondents (9 members of the public, 1 member of the public from Wirral and 2 interested parties.

A summary of themes that emerged from the discussions was:

• There were many reports and trials showing that homeopathy had been successful, comparatively inexpensive compared to other treatments, that patients felt choice and control over their care was important and they needed help to deal with side-effects And conversely: • That homeopathy did not work and CCGs should fund evidence-based treatments that both worked and gave value for money.

Attendees were also asked to complete the consultation survey.

Women’s Support Group - 30 June

Held at Maggie’s at Clatterbridge

Feedback from the six attendees is summarised as follows:

• Never used service before but not to say wouldn’t ever. It was an interesting service but couldn’t give an opinion as had not used it. Everyone was different. It could work for some. • Most cancer patients were probably not aware of the service. How was it promoted? Would prefer to ask their GP for a referral to see what they say before completing the consultation questionnaire. • A friend had used homeopathy and felt it had helped. • There were lots of allergic reactions to cancer treatment, some days were worse than others • NICE could present options for patients to consider

Colorectal Support Group – 7 July

Held at Maggie’s at Clatterbridge).

Feedback from the 11 attendees is summarised as follows:

• Lack of awareness of service which is not promoted. Oncologists relied on local GP/keyworker and agencies to provide information on services • The placebo effect was of benefit to some patients • Cancer treatment caused huge fatigue and GPs should provide more help. Side-effects could be difficult to manage and it was understandable why some would use the service • A relatively small amount was spent on the service but people understood the pressures on NHS budgets

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Just over 10 per cent of respondents were Wirral residents and the vast majority identified themselves as either British, Mixed English, White European or from a white background. Most were aged 25-64 years.

Just over 15% had an impairment and most identified their impairment is as relating to vision, hearing, mobility, mental health or being a “hidden impairment.”

Most respondents (94.81%) voted for Option 3, to stop funding the service.

The majority (over 93%) had never used the service

and over 85 % did not believe it would work.

Appendix 9

EQUALITY IMPACT & RISK ASSESSMENT STAGE 1 SCREENING TOOL

Organisation: Service:

Wirral Clinical Commissioning Group Homeopathy and Iscador Project Lead: Service Area: Lorraine Guy Partnerships Team

Person responsible for this Assessment: Date of Review:

Qurban Hussain , Equality and Inclusion Business Partner 22/08/2016

Brief explanation of what is happening / being assessed (MAX 1000 CHARACTERS) The proposed commissioning decision is regarding potential Service change proposals which could cease the current arrangement between Wirral Clinical Commissioning Group for Homeopathy and Iscador treatment provided by Liverpool Medical Homeopathy Service. Complementary/alternative services.

type QUESTION No. EQUALITY IMPACT Comments (provide example) y or n Example (click for examples) 1 Does this issue plan to withdraw a service, activity or presence? N

2 Does this issue plan to reduce a service, activity or presence? N

Does this issue plan to introduce or increase a charge for 3 N Service?

4 Does this issue plan to change to a commissioned service? N

Does this issue plan to introduce, review or change a policy, 5 N strategy or procedure?

6 Does this issue plan to introduce a new service or activity? N

Is this primarily about improving access to, or delivery of a 7 N service? Does this affect employees or levels of training for those who will 8 N be deliivering the service?

9 Does this issue affect Service users? N

Can you foresee a negative impact on any Protected 10 N Characteristic Group(s)? If YES please state what these could be.

EQUALITY RISK Comments (provide example)

Have you got any general intelligence (research, consultation, 11 Y etc.)? If YES please list any related documents.

Have you got any specific intelligence (research, consultation, 12 Y etc.)? If YES please list any related documents.

Have you taken specialist advice? (Legal, E&I Team, etc). If YES 13 Y please state. Have you considered your Public Sector Equality Duty? Please 14 Y provide a rationale.

Do you plan to publish your information? Include any "Decision 15 Y Reports"

16 Can you minimise any negative effect? Please state how. Y

Do you have any supporting evidence? If YES please list the 17 Y documents.

Have you/will you engage with affected staff and users on these 18 Y proposals?

IMPACT 0 There should be little or no impact. There is no requirement to carry out a Stage 2 assessment

RISK 0 There should be little risk involved

HUMAN RIGHTS IMPACT Comments (provide example)

Will the policy/decision or refusal to treat result in the death of a 19 N person?

20 Will the policy/decision lead to degrading or inhuman treatment? N

21 Will the policy/decision limit a person’s liberty? N

Will the policy/decision interfere with a person’s right to respect 22 N for private and family life?

23 Will the policy/decision result in unlawful discrimination? N

24 Will the policy/decision limit a person’s right to security? N

Will the policy/decision breach the positive obligation to protect 25 N human rights?

Will the policy/decision limit a person's right to a fair trial 26 N (assessment, interview or investigation)?

Will the policy/decision interfere with a persons right to 27 N participate in life?

RISK 0 There is little chance of Human Rights breach. There is no requirement to carry out a Stage 2 assessment

PRIVACY IMPACT Comments (provide example)

Will the project involve the collection of new information about 28 N individuals?

Will the project compel individuals to provide information about 29 N themselves? Will information about individuals be disclosed to organisations 30 or people who have not previously had routine access to the N information?

Are you using information about individuals for a new purpose or 31 N in a new way that is different from any existing use?

Does the project involve you using new technology which might 32 be perceived as being privacy intrusive? For example, the use of N biometrics or facial recognition.

Will the project result in you making decisions about individuals 33 in ways which may have a significant impact on them? e.g. N service planning, commissioning of new services.

Is the information to be used about individuals’ health and/or 34 N social wellbeing?

Will the project require you to contact individuals in ways which 35 N they may find intrusive?

RISK 0 There is little chance of a Privacy breach. There is no requirement to carry out a Stage 2 assessment

PLEASE SEND YOUR COMPLETED STAGE 1 SCREENING TOOL TO THE EQUALITY & INCLUSION TEAM EMAIL: [email protected] GENERAL GUIDANCE Please use the comments section to explain any 'RED' scores or to further elaborate what is being assessed is necessary

All 'RED' scores will require further action in future planning regardless of the requirement to carry out Stage 2 approaches.

Signature of person completing the screening tool: Qurban Hussain and Lorraine Guy.

Comments (MAX 250 CHARACTERS) Conference call, discussed and agreed all outcomes. 25 August 2016.

Signature of Equality & Inclusion Business Partner & Date Q.Hussain - 25 August 2016.

Comments (MAX 250 CHARACTERS) Commissioning decision to be made by Wirral Clinical Commissioning Group Governing Body on 06 September 2016.

GOVERNING BODY BOARD REPORT COVER SHEET

ASSURANCE FRAMEWORK Agenda Item: 3.1 Reference GB16-17/0014 Public / Private Public Meeting Date 4th October 2016 Lead Officer Paul Edwards, Director of Corporate Affairs Contributors Governing Body Members, Mersey Internal Audit Agency Link to CCG Strategic System 1 Patient and primary care centric and based on high quality primary care, secondary Plan and community services 2 Rigorously developed and agreed care pathways working together with patients to secure their help, understanding, ownership and support of the needed changes 3 Commissioned services which have a sound evidence base 4 Provides greater equality of access to all Link to current strategic objectives 1 Prevent people from dying prematurely 2 Enhance the quality of life for people with long term conditions 3 Helping people to recover from episodes of ill health or following injury 4 Ensuring people have a positive experience of care 5 Ensuring people are treated and cared for in a safe environment and protected from avoidable harm To approve Yes To note Summary The Assurance Framework was developed by the Governing Body in conjunction with Mersey Internal Audit Agency and identifies key risks to NHS Wirral CCG’s Strategic Objectives.

When presented at Governing Body in June 2013, key controls and assurances were identified against each risk, with any gaps identified as requiring an action plan to address them. The Assurance Framework has been reviewed a number of times since then (see Report History), with the whole structure of the Assurance Framework structure itself being reviewed at the Informal Governing Body session held on 1st March 2016 where risks were re-aligned to refreshed CCG Strategic Aims. This session also suggested the inclusion of ‘risk appetite’ and this was discussed at July 2016’s Governing Body and is now incorporated with this iteration of the Assurance Framework.

Additionally, the newly formed Finance Committee has suggested that a separate risk is added with regard to delivery of QIPP, with a further risk suggested regarding the capability and capacity to ensure the CCG meets its duties.

Comments No additional comments Next Steps Discuss and adopt updated Assurance Framework

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GOVERNING BODY BOARD REPORT COVER SHEET

What are the implications for the following (if not applicable please state why): Financial Does the report consider financial impact? YES

Part of Assurance Framework refers to the financial duties of the CCG and identifies risks related to QIPP delivery and the economy wide financial challenge

Value For Money Does the report consider value for money? NO

Not applicable

Risk Is there a documented risk assessment? YES

The Assurance Framework allows the Governing Body to consider the risks that may hamper the Clinical Commissioning Group from delivering its statutory duties and functions – these are the strategically significant risks facing the Clinical Commissioning Group. The Framework also outlines how the Governing Body is provided with assurance that these risks are being effectively managed and, as such, acts as a documented risk assessment. Legal Are there any legal implications and has legal advice been obtained? YES

All NHS organisations are required to develop and maintain an Assurance Framework in accordance with the governance regulations applied to the NHS. Legal advice was not deemed necessary for this paper. Patient and Public Does the report provide evidence whether there could be a positive or Involvement (PPI) negative impact on patients and public? YES

The Assurance Framework details risks related to patient and public engagement

Equality & Human Does the report provide evidence of whether there could be a positive or Rights negative impact on protected groups (statutory duty for new / changes to services) YES

The Assurance Framework highlights reducing inequalities as a key strategic objective

Workforce Does the report provide evidence of whether there could be a positive or negative impact on the CCG or other NHS staff? NO

Not applicable

Partnership Working Does the report evidence a partnership working in its development? YES

The review of the Assurance Framework has been undertaken with input from Local Authority staff and Lay representation. Some of the risks identified are associated with Partnership Working and what measures are in place to strengthen this

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GOVERNING BODY BOARD REPORT COVER SHEET

Performance Does the report indicate any relevant performance indicators for this item? Indicators The risk scores and mitigation actions will be regularly assessed by the Governing Body.

Sustainability Does the report address economic, social and environmental sustainability (should be addressed for new / change projects)? NO

Do you agree that this document can be published on the website?  (If not, please note that it may still be subject to disclosure under Freedom of Information - Freedom of Information Exemptions

Report History/Development Path

Report Name Reference Submitted to Date Brief Summary of Outcome Assurance GB16- Governing Body 5th July Review scores and add ‘risk appetite’ Framework 17/0006 2.2 2016 section Assurance N/A Informal Governing 1st March Updated to align to new refreshed Framework Body Session 2016 Strategic Aims, facilitated by Mersey Internal Audit Agency Assurance GB 15- Governing Body 3rd Approved Framework 16/0046 2.2 November 2015 Assurance N/A Informal Governing 6th October Updated subject to ratification at Framework Body Session 2015 November 2015 Governing Body Assurance GB 15- Governing Body 7th July Approved Framework 16/0024 2015 Assurance GB 14- Governing Body 3rd March Approved Framework 15/0068 2.1 2015 Assurance Informal Governing 3rd February Agreed amendments Framework Body Session 2015 Assurance GB 14- Governing Body 5th August Approved Framework 15/0026 2.3 2014 Assurance Informal Governing 23rd July Agreed amendments Framework Body Session 2014 Assurance GB 13- Governing Body 4th February Approved Framework 14/062 2.2 2014 Assurance Informal Governing 6th January Agreed amendments Framework Body Session 2014

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GOVERNING BODY BOARD REPORT COVER SHEET

Assurance GB 13- Governing Body 3rd Approved Framework 14//033 4.3 September 2013 Assurance GB 13- Governing Body 4th June Approved Framework 14/014 2013

Assurance Informal Board 25th April Governing Body Members agreed risk Framework Session 2013 ratings and scores. Actions to be added to address gaps in Assurance and present to Governing Body

Private Business

If a report is deemed to be for private business, please note that the tick in the box, indicating whether it can be published on the website, must be changed to an x.

If you require any additional information please contact the Lead Officer.

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Report Title Assurance Framework Lead Officer Paul Edwards, Director of Corporate Affairs

Contributors Recommendations Governing Body members are asked to approve the proposed changes, discuss new risks and assess whether any risk scores need to be modified.

Introduction

When presented at Governing Body in June 2013, key controls and assurances were identified against each risk, with any gaps identified as requiring an action plan to address them. The Assurance Framework has been reviewed a number of times since then, with the whole structure of the Assurance Framework structure itself being reviewed at the Informal Governing Body session held on 1st March 2016 where risks were re-aligned to refreshed CCG Strategic Aims. This session also suggested the inclusion of ‘risk appetite’ and this was discussed at July 2016’s Governing Body and is now incorporated with this iteration of the Assurance Framework, alongside the review of the risks.

Changes to the Assurance Framework agreed at July 2016 Governing Body

• New engagement strategy approved at July GB as additional control on risks: A1, A2, C5, D1, D3, D7 and E2 • Head of Communications and Engagement as additional control on risks: A1, A2, C5, D1, D2 and D7 • Implementation plan identified as a gap on risks: A1, A2, C5, D1, D2, and D7 • Development of local delivery plan added as a control into risks: B1, F1 and F2 • Financial recovery plan and confirm and challenge meetings and QIPP reports as additional controls on risks: B2, B3, C4 and E1 • Implementation of local delivery plan and identified gaps with a plan to have an implementation plan for LD & STDP by Q3 on identified by risks B1, F1 and F2 • Action plan to develop finance committee to be in place by July 2016 related to risk B3 • Risk Appetite section added to the Assurance Framework with each risk assessed and agreement on target impact and likelihood score. (See Assurance Framework for details of target scores and timescales

The following scores were amended

• Risk A1 & A2 – Likelihood reduced from 4 to 3 following approval of Engagement Strategy and appointment of Head of Communications and Engagement • Risk B1 – Likelihood reduced from 4 to 3 following approval of Local Delivery Plan and Sustainability and Transformation Plan. • Risk B2 Likelihood increased from 3 to 4 given financial situation • Risk C1 – Governing Body reassessed impact and lowered from 4 to 3 • Risk C5 – Impact and likelihood updated to 3 and 3 to reflect risk A1 as agreed by Governing Body • Risk D7 – impact and likelihood updated to 3 and 3 to reflect risk A1 as agreed by Governing Body

Implications

The newly formed Finance Committee has suggested that a separate risk is added with regard to delivery of QIPP, with a further risk suggested regarding the capability and capacity to ensure the CCG meets its duties. These will be reviewed and discussed at October 2016 Governing Body.

Conclusion

Governing Body members are asked to approve the proposed changes, discuss new risks and assess whether any risk scores need to be modified.

Wirral CCG

Controls Assurances Priority Gaps Responsible Committee Risk Appetite

Risk Impact Likelihood Risk Risk Target Risk Owner/ Lead Risk Description Key Controls Assurance on Controls Status Gaps in Control and Assurance Action plan Target Impact Target Likelihood Target Score Narrative No Rating Rating Score Rating Deadline

What are the principal risks that could prevent the CCG from achieving this Evidence that the controls are operating and the Detail of gaps where the controls / systems / assurances What actions are in place to close What controls / systems does the CCG have in place to aim/ objective e.g types of risk - CCG is reasonably managing its risks with aims/ have either not yet been put in place or are yet to be fully the gaps in the controls and manage the risk clinical, financial, reputational, objectives being delivered effective. What needs to be done assurance statutory,

1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Strategic Aim A To empower the people of Wirral to improve their physical, mental health and general well being

Public Health Communications Campaigns, Public Health workers. Diversity in delivery of health messages, i.e attendance at shopping/ community centres. . Links with VCAW. New Engagement Likelihood reduced from Develop Immplementation Strategy to be developed. Stakeholder database. QPF Minutes and reports, Governing Body 4 to 3 following approval Failure to engage general public Plan for Engagement Stategy. Healthy Wirral workstream promoting self care. minutes and reports, including Engagement of Engagement Strategy, A1 in change, difficultly in engaging 3 3 9 Implemtation Plan for Engagement Stategy Quarter 3 2016/17. Governing Body 3 2 6 Quarter 4 New Governing Body Reporting Format Report. Feedback captured from Healthy ↓ appointment of Head of with hard to reach groups. Lead: Director of Corporate incorporating Engagement reports. Expo Event Wirral events. . Communicatrionsand Affairs and other Healthy Wirral events set up to engage Engagement with wider public. New Engagement and Experience Strategy approved. Head of

Director of Quality and Patient Safety Patient and DirectorQuality of Communications and Engagement Recruited

PALS, Complaints management, website feedback mechanisms, Communications support systems provided by CSU, QPF Committee monitoring. Patient Engagement Reports to CCG Likelihood reduced from QPF Minutes and reports, BME worker Develop Immplementation Governing Body. CQC relationship, Quality 4 to 3 following approval CCG fails to understand people's quarterly report. GB minutes and papers Plan for Engagement Stategy. Surveillance Group, Complaints Monitoring. of Engagement Strategy, A2 health experiences due to lack of 3 including Engagement Report. Quality 3 9 Implemtation Plan for Engagement Stategy Quarter 3 2016/17. Governing Body 3 2 6 Quarter 1 Healthwatch. Quarterly aggregated reported to ↓ appointment of Head of engagement. Surveillance Group minutes. Healthwatch Lead: Director of Corporate QPF. New Governing Body Reporting Format Communicatrionsand member on GB. Quality & Safety Group. Affairs incorporating Engagement reports. New Engagement Engagement and Experience Strategy approved. ead of Communications and Engagement

Director of Quality and Patient Safety Patient and DirectorQuality of Recruited

Strategic Aim B To reduce health inequalities across the Wirral

CCG Strategy and Plan, Health & Wellbeing Implementation of Local Strategy, Contractual Quality and Performance Delviery Plan and requirements, patient engagement, public health Sustainability and JSNA and public health data and reports. QPF support and reports, QPF Committeee monitoring Transformation plan committee minutes. Governing Body minutes. Likelihood reduced from Failure to promote and and reporting. Assurance process from NHS Quarter 132016/17 Shared measures via the Better Care Fund 4 to 3 following approval commission safe services, England. In the future, will also incorporate Implementation of Local Delviery Plan and Lead: Chief Officer B1 4 External CCG Assurance Framework. 3 12 Governing Body 3 2 6 Quarter 4 of Local Delivery Plan therefore, outcomes for patients Outcomes Framework and Quality Premium. New ↓ Sustainability and Transformation plan Minutes of SI Review received at Quality, and Sustainability and don’t improve or deteriorate. Governing Body Reporting Format. Serious Review Terms of Reference of Performance and Finance Committee. Plan Trasformation Plan Incident Review process in place. Developemnt of Joint Commissioning Strategy delivery monitored through Governing Body

Local Delivery Service Plan, Sustainability and Group DirectorCommissioning of Transformation Plan. Approval of CCG Quarter 1 2016/17 Operational Plan Lead: Chief Officer Performance reports to Governing Body, QPF CCG Strategic Plan, NHS England performance Committee minutes. External CCG monitoring, Patient Feedback, Patient Practice Assurance Framework. External CCG Likelihood increased Fail to deliver agreed health B2 3 Groups, Quality and Performance Contract Assurance Framework. Monitoring of 4 12 No gaps indentified Governing Body 3 3 9 Quarter 1 from 4 to 3 given priorities and objectives. ↑

meetings, QPF Monitoring. Refreshed Strategic Financial Recovery Plan through 'Confirm and financial situation Director of

Commissioning Plan. Financial Recovery Plan. QIPP Reports. Challenge' Group and new Operational Group focus

Health and Wellbeing Board, QPF Committee QIPP Strategy and plans, DASS membership on minutes. Healthy Wirral SLG minutes. Joint CCG Governing Body, Health & Wellbeing Board, Strategic Commissioing minutes. Reports to Reducing financial resource QPF Committee monitoring. Integrated planning Finance Committee to be Health and Well Being Board. Pooling available across health and social processes. Joint Strategic Commissioning Group established July 2016 Quality, Performance and B3 4 arrangements for Better Care Fund. External 5 20 Establish dedicated Finance Committee 4 4 16 Quarter 3 care and failure to agree financial established. Healthy Wirral finance workstream. ↔ Finance Committee CCG Assurance Framework. Monitoring of arrangements. New Governing Body Reporting Format. Financial Recovery Plan through 'Confirm and Development and monitoring of Financial

Chief Financial Officer Financial Chief Challenge' Group and new Operational Group Recovery Plan. QIPP Plan focus

Strategic Aim C To adopt a health and well being approach in the way services are both commissioned and provided

Page 1 Wirral CCG

Controls Assurances Priority Gaps Responsible Committee Risk Appetite

Acute care does not have Friends and Family test, Quality Impact meetings. QPF Committee receives regular reports from sufficient focus on parity of Monitoring of CQUINS. Implementation of Datix providers which include an agreed set of HR esteem, therefore leading to risk management system. Hospital visits & walk metrics indicating adequate levels and Governing Body Re- failure to deliver high quality arounds. Quarterly aggregated reports to QPF. Quality, Performance and C1 3 competencies of staffing. Friends and Family 3 9 No gaps indentified 3 3 9 assessed impact and services for mental health Lay Member for Quality as part of new structure. ↓ Finance Committee test result. Monitoring of patient complaints. lowered from 4 to 3 patients. Contractual values could Head of Contacting and Delivery in post. Director Safe staffing levels now reported. External also impact on the quality of of Commissioning appointed. New Governing CCG Assurance Framework

services being provided. Body Reporting Format. Sustain Director of Quality and Patient Safety Patient and DirectorQuality of

CCG Strategic Plan, QIPP Plan with measurable outcome targets, QPF Committee monitoring and, Indicators of success/ failure in demand management and action plans as needed. QSG. QPF Committee monitoring of QIPP. CQUINS monitoring. QPF. Clinically led Systeme Resilience Group now in place to workstreams. 2 year plan in place & refocus of address economy wide pressures. Governing Inabiliy to manage rising demand commissioning intentions. New Governing Body Body minutes. External CCG Assurance and reducing capacity in a Quality, Performance and C4 4 Reporting Format. Financial Recovery plan Framework. Monitoring of Financial Recovery 4 16 No gaps indentified 4 3 12 Quarter 4 constrained financial ↔ Finance Committee developed. QIPP Reports. Confirm and Challenge Plan through 'Confirm and Challenge' Group environment. Meetings. Primary Care Quality Scheme and new Operational Group focus. Monitoring introduced

Chief Financial Officer Financial Chief impact of Primary Care Quality Scheme through QPF

Continuing work with community partners in voluntary, community and faith sectors plus QPF Committee reports on shifting local representatives of individuals with protected demographies and take up of services by Develop Immplementation characteristics to ensure their full representation in diverse populations. Friends and Family Test Impact and likelihood Organisations fail to put the Plan for Engagement Stategy. our commissioning plans . Friends and Family results. PPG forum agendas & minutes. updated to 3 and 3 to C5 patient at the heart of everything 3 3 9 Implemtation Plan for Engagement Stategy Quarter 3 2016/17. Governing Body 3 2 6 Quarter 4 Test. Public Health intelligence. Analysis of Quarterly aggregated complaints reports to ↑ reflect risk A1 as agreed Safety they do. Lead: Director of Corporate provider organisations complaints. PPGs. New QPF. Incidents reported and reviewed. by Governing Body Affairs Engagement and Experience Strategy approved. Engagement activities reported through Head of Communications and Engagement Governing Body

Director of Quality and Patient Patient and DirectorQuality of Recruited

Involvement in Clinical Senates; use of benchmarking analyses when undertakng needs Failure to adequately benchmark assessments. Joint work on reshaping the health Quality dashboard, Right Care data, minutes 3 2 6 No gaps indentified Governing Body 3 2 6 with peers. provider economy with neighbouring CCGs. CLRN of CWW Chairs and Chief Officers. ↔ meetings. AQUA/HIPP and other

C6 membership/subscription Director of Commissioning of Director

To commission and contract for services that: Demonstrate improved person centred outcomes ; Are high quality and seamless for the patient; Are safe and sustainable; Are evidenced based and Demonstrate value for money Stategic Aim D

CCG Strategic Plan, use of JSNA in plans, HWB membership and Plan, Patient Groups and Forums, Lay member for Patient Engagement, Develop Immplementation Public Health inclusion on CCG GB.Engagement Patient Group/Practice feedback, Public Socio demographic changes (e.g. Plan for Engagement Stategy. events and activities. Patient Engagement Reports Health Reports. Plans based on JSNA D1 ageing population, migrant 3 3 9 Implemtation Plan for Engagement Stategy Quarter 3 2016/17. Governing Body 3 2 6 Quarter 4 to CCG Governing Body. Healthwatch member at presented at GB. Engagement activities ↔ population) prevent inclusion. Lead: Director of Corporate GB. Healthy Wirral work re self care & prevention. reported through Governing Body Affairs New Engagement and Experience Strategy approved. Head of Communications and

Engagement Recruited Director of Quality and Patient Safety Patient and DirectorQuality of

Communications Support from CSU, Website development, Use of social media, Engagement Develop Immplementation events and activities, Public CCG GB meetings. Patient and public feedback, feedback/ Failure to engage widely means Plan for Engagement Stategy. Engagement Reports to CCG Governing Body. interaction with public at engagement events. D2 that decisions may be skewed by 3 3 9 Implemtation Plan for Engagement Stategy Quarter 3 2016/17. Governing Body 3 2 6 Quarter 4 Links to Healthwatch via GB attendance and GB minutes. Engagement activities reported ↔ Safety particular interest groups. Lead: Director of Corporate ongoing relationship.. New Engagement and through Governing Body Affairs Experience Strategy approved. Head of

Communications and Engagement Recruited Director of Quality and Patient Patient and DirectorQuality of

Page 2 Wirral CCG

Controls Assurances Priority Gaps Responsible Committee Risk Appetite

CCG Strategic Plan. Integration team work re Develop Immplementation Cultural and attitudinal issues patient care. Healthy Wirral workstream re self Plan for Engagement Stategy. Engagement activities reported through D3 skew expectations against self 3 care and prevention. New Engagement and 3 9 Implemtation Plan for Engagement Stategy Quarter 3 2016/17. Governing Body 3 2 6 Quarter 1 Governing Body ↔ Safety care. Experience Strategy approved. Head of Lead: Director of Corporate

Communications and Engagement Recruited Affairs Director of Quality and Patient Patient and DirectorQuality of

Communications Support from CSU, Website CCG fails to get information development, Choose Well/ Public Health Patient and public feedback, feedback/ across in a way that engages the campaigns, Some use of social media. Patient interaction with public at engagement events, Review of the use of language for minutes of D4 public and is understandable to 3 Engagement Reports to CCG Governing Body. PALS/ Complaints reporting through QPF 2 6 ↔ meetings on website to ensure are clear and Ongoing Governing Body 3 2 6

Affairs them (allowing for differing levels New Engagement and Experience Strategy Committee. Engagement activities reported understandable of understanding). approved. Head of Communications and through Governing Body

Director Corporate of Engagement Recruited New CCG structures enable clinical involvement through the Clinical Senate, Provider Forum and Membership Council as well as clinical membership of other committees and GB New Clinical Senate minutes. Key themes from Ineffective engagement from D5 4 Governing Body Reporting Format. Consultant practice visits. Membership Council Minutes. 3 12 ↔ Ongoing Governing Body 3 3 9 Quarter 4

Chair clinicians Further direct practice engagement by visits and Connect established, cycle of Practice Visits 360 results. events established, CCG to introduce locality approach. Review of Clinical Senate, Membership Council and Provider Forum taken place. JSNA and HWB Strategy and Board, Contract Contract management meetings and minutes, management arrangements, development of QPF Monitoring and reporting, QIPP Team service specifications which require collaborative minutes, Social Care updates to CCG GB. Providers/ Health and Social Care approach, Joint CQUIN development, Social Care Healhty Wirral SLG minutes. Joint Strategic D6 4 2 8 No gaps indentified Governing Body 4 2 8 fail to work together in partnership represenentation on CCG GB. Integrated planning Commissioing minutes. Reports to Health ↔ processes. Joint Strategic Commissioning Group and Well Being Board. Better Care Fund Plan established. Better Care Fund. Senior Leadership sign off by HWB and pooled budget

Group established arrangements Accountable Officer /Chair Accountable

Public consultation, Engagement through Wirral Voice/PPGs, CSU support, Use different comms Develop Immplementation mechansims e.g local press. Engagement Impact and likelihood Adverse public reaction to Patient group feedback, web site and social Plan for Engagement Stategy. Reports to CCG Governing Body. New updated to 3 and 3 to D7 decommissioning or reduction in 3 media feedback. Engagement activities 3 9 Implemtation Plan for Engagement Stategy Quarter 3 2016/17. Governing Body 3 2 6 Quarter 4 Engagement and Experience Strategy approved. ↓ reflect risk A1 as agreed access reported through Governing Body Lead: Director of Corporate Directoror Head of Communications and Engagement by Governing Body

Commissioning Affairs Recruited. Commissioning Decision Making process agreed

Strategic Aim E To be known as one of the leading Clinical Commissioning Groups in the country and locally across Wirral to patients / public

AQUA/HIPP and other membership/subscriptions. QIPP/Commissioning Plan/Urgent Care/Strategic Develop Organisaional Plan and Healthy Wirral programme all require Development plan innovation to change to system. Staff trained in Quarter 1 2015/16 Experience Lead Commissioning. Development of GB minutes. CCG plans. Clinical Senate Lead: Director of Corporate Clinical Senate to drive clinical innovation. CCG fails to be innovative and minutes. Organisational Development Affairs Examples of innovation include Think Pharmacy, E1 deliver sufficient appropriate 4 implementation plan. Confirm and Challenge 3 12 Governing Body 4 2 8 Quarter 4 OPAT, Single Front Door, Conultant Connect. ↔ Affairs change meetings and monitoring of QIPP Plan via Review Clinical Senate, Delivery against planning guidance and the Five QPF Membership Council and Year Forward View. Review of Clinical Senate, Provider Forum Membership Council and Provider Forum taken Quater 3 2015/16 place. New Organisational Development Strategy Lead: Medical Director

Medical Director/ Corporate Director of Medical approved. QIPP Plan and Confirm and Challenge CCGmeetings Comms and Engagement Plan, Regular communications with local politicians as Councillors, MPs plus regular, open, transparent communication with local media. Staff and community newsletters from CCG , Regular Develop Immplementation briefings of encouragement to the voluntary, Failure to be proactive with Plan for Engagement Stategy. community and faith sectors, Healthwatch and Engagement activities reported through opinion makers and the 3 2 6 Implemtation Plan for Engagement Stategy Quarter 3 2016/17. Governing Body 3 2 6 other local community representatives through Governing Body ↔ population of Wirral. Lead: Director of Corporate area fora etc. Patient Engagement Reports to Affairs CCG Governing Body. Triangulation as part of

Director of Corporate Affairs Corporate of Director Communications, Engagement and Experience Group. New Engagement and Experience Strategy approved. Head of Communications and E2 Engagement Recruited.

Page 3 Wirral CCG

Controls Assurances Priority Gaps Responsible Committee Risk Appetite

QPF Committee minutes. Finance Committee QPF Committee monitoring. Development and minutes External CCG Assurance Quality, Performance and Failure to deliver QIPP targets monitoring of Financial Recovery Plan. QIPP Plan, Framework. Monitoring of Financial Recovery Finance Committee/Finance Finance Committee Plan through 'Confirm and Challenge' Group Committte

and new Operational Group focus Director of Commissioning of Director

E3 Strategic Aim F Provide systems leadership in shaping the Wirral health and social care system so as to be fit for purpose both now and in five years time Implementation of Local Delivery Plan and Sustainability and Implementation of Local Delivery Plan and Transformation plan, including Failure to secure buy into Healthy Healthy Wirral Memorandum of Understanding in Sustainability and Transformation plan. Healthy Wirral Memorandum of clear governance F1 Wirral and the CCG's role as 3 place & Local Delviery Plan and Sustainability and 3 9 Governing Body 3 3 9 Quarter 4 New risk Understanding in place. SLG minutes. arrangements systems leader. Transformation plans approved. SLG established. Firm governance arrangements to be established Quarter 3 2016/17 following end of Vanguard resource

Lead: Chief Officer Accountable Officer Accountable

Implementation of Local Delivery Plan and Sustainability and Implementation of Local Delivery Plan and Failure to agree and operate Transformation plan, including Healthy Wirral Memorandum of Understanding in Sustainability and Transformation plan. appropriate and efficient Healthy Wirral Memorandum of clear governance F2 4 place & Local Delviery Plan and Sustainability and 3 12 Governing Body 4 2 8 Quarter 1 New risk governance processes and Understanding in place. SLG minutes. arrangements Transformation plans approved. SLG established. Firm governance arrangements to be established framework. Quarter 3 2016/17 following end of Vanguard resource

Lead: Chief Officer

of Corporate Affairs Corporate of Accountable Officer/ Director Accountable

Capability and capacity for CCG F3 staff to deliver key objectives and

Officer duties Accountable Accountable

Page 4

 Consensus for NHS providers to come together to form a ‘Wirral Accountable Care Partnership’  Consensus for NHS and Local Authority to move towards an integrated Wirral Health and Social Care Strategic Commissioner (comprising resources and staff from CCG, Public Health, and Social Care)  In order to create a more effective system, a single Wirral commissioning organisation and governance structure is required to ensure that Health and Care services are effectively joined up and sustainable through using resources to best effect and to deliver improved outcomes for people.

 The resources to be pooled and used to deliver the outcomes would include resources currently in separate NHS Contracts with key providers, and the majority of social care and public health commissioning resources, thus creating a single strategic commissioning fund for the Wirral footprint

 In order to facilitate this approach, a single NHS Accountable Care Partnership bringing together NHS providers and GP Federations needs to be created to deliver population level health outcomes

 In addition a comprehensive set of community based provision providing for the needs of people with Mental health needs, Older People and Disability along with specialist housing is required to enable people to remain independent for as long as possible

 Commissioners currently in the CCG Health system and in the Local Authority Care system will come together into a single integrated commissioning body

 Commissioners taking a strategic role, defining outcomes and measuring the performance of the system as a whole.

 Where appropriate, commissioners will work together across larger geographies than they do today.

 Developing effective strategic partnerships to deliver population level outcomes

 Health and social care commissioners pooling budgets, developing capitated approaches covering the whole of a population’s care.

 Commissioners setting clear outcomes expected for providers to deliver using the resources available.

 Commissioners doing less detailed contract negotiation and performance management of multiple providers.

The Integrated Strategic Commissioning Model Integrated Commissioning

Single Integrated Strategic Commissioning Body Care System Leadership, Strategic Planning and Partnering Pooled budgets, shared intelligence, Focus on outcomes and quality System wide performance Care market shaping and sustainability

Effective sustainable non-NHS Commissioned for outcomes market Independent sector Domiciliary care, Accountable Care Provider Partnership residential and nursing sector, specialist housing and support to independence Prime contractor model Market overseen by strategic commissioners, Key NHS Providers; Acute, Community GP setting rates and quality standards, quality Federations, social care delivery functions. assured Sub-contracting/procurement, Capitated Budget Services called off/ purchased by ACS Clinical Leadership Effective Care and Support Pathways System underpinned by, sustainable and effective voluntary and faith sector Commissioned at local neighbourhood level to maximise capacity Led through partnership across sectors Proactive in increasing opportunities to volunteer, Building community capacity Promoting well-being and active citizen participation

 ACP is a key enabler that is accountable for the quality, cost, and overall care of a defined population with the objective of decreasing the total cost of care for the population.

 NHS Providers including the Acute and Community providers together with aspects of social care delivery will come together with GP federated practices into a single ACP

 This will overcome the current fragmentation of provision across organisations but specifically in the NHS

 Bringing together a single comprehensive approach to joined up primary, secondary and community health care provision alongside social care.

 Meeting the needs of the whole population within a single capitated budget providing effective responses based on delivering outcomes not payment for activity.

 Organisations take a place based approach to collaborate and meet the needs of the population

 Provide effective clinical leadership to meet need through case management and population based health care models.  Healthy Wirral Partnership Board (HWPB) will be re-constituted to ensure appropriate organisational and lay representation, with an independent chair appointed  Two key tasks of the HWPB will be to oversee the development of, in parallel, the Wirral Accountable Care Partnership and the Wirral Integrated Commissioner  Therefore, reporting to the HWPB will be two implementation groups that will oversee these developments Independent Chair WUTH Chief Executive Non-Executive NHS Provider WFCT Chief Executive Non-Executive NHS Provider CWP Chief Executive Non-Executive NHS Provider Wirral CCG Chief Officer Lay Member Wirral CCG Wirral LA Chief Executive Wirral LA Councillor Director of Public Health Patient Representative GP Federation Representative GP Federation Representative Health and Wellbeing Board

Healthy Wirral Partnership Board

Accountable Care Integrated Partnership Commissioner Implementation Group Implementation Group  Revision of Healthy Wirral Partnership Board Terms of Reference  Agree process for recruitment of Independent Chair  Form implementation groups for Wirral Accountable Care Partnership and Wirral Integrated Commissioner  Explore appropriate organisational frameworks to enable these developments  Agree implementation timescales and milestones  Identify opportunities for both provision and commissioning across wider footprints NHS WIRRAL CCG

CORPORATE RISK REGISTER

To be reviewed at Quality Performance and Finance Committee - 27th September 2016

Consequence Likelihood 1 2 3 4 5 1 1 2 3 4 5 2 2 4 6 8 10 3 3 6 9 12 15 4 4 8 12 16 20 5 5 10 15 20 25

Page 1 of 4 Risk ID Date added Source Division Risk Description Organisational Conseque Likelihoo Matrix Score Key Control Established Key Gaps in Control Assurance on Controls Gaps in Assurance Consequ Likelihoo Previous Owner Date of next Date of last review Last review Objectives (reference nce d (reference to evidence)Master (reference14-15 to evidence) (reference to evidence) ence d Risk Rating review to detail) 14-15K August QPF CCG Gov Body Continuing Healthcare Quality / Patient Safety 3 5 15.00 Action plan in place and on- Reliance on shared CCG CSU monitored monthly 5 3 15.00 LQ September August 2016 QPF Reviewed at July 16 QPF - Due for next review at August 16 issues re the service going monitoring of service arrangements for against PUPoC target; 16 QPF QPF. provided, the CHC process performance via QPF. aspects of delivery and action plan to address followed, general CHC joint committee reliance on CSU for contract gaps in place Reviewed at QPF in August 16 and agreed no change at performance & quality. established to oversee delivery of PUPoC and minutes of joint present but to remain on the risk register and continue to be Gaps in contracts with service transition targets. Lack of contracts committee and QPF monitored. providers and delivery with provides against Previously 20/09/16 - Update provided from LQ (plan lead) to confirm Unassessed Periods of Care the next Joint CHC Committee is being held in 21/09/16 (PUPoC) trajectories and the risk register for this committee is included on the agenda for discussion. LQ to therefore provide a verbal update at QPF to be held on 27/09/16. Recommended for scores to remain the same. 14-15P January QPF CCG QPF Financial risk to CCG Financial 4 4 16.00 Regular financial reporting Ability to influence activity Minutes & monitoring of Timeliness of reporting / 4 4 16.00 MT September July 2016 QPF MT advised that a Lessons Learned report will be provided to through QPF & GB. Further trends. GB / QPF ability it implement action 2016 QPF May 16 QPF. detailed monitoring of plans directly. contractual prescribing & MT updated at April QPF with a view that a final year end other commissioning position will be presented at GB in May 16. expenditure areas as appropriate. Lessons Learned report presented at June QPF and received assurance that most of aciton plan has been implemented. Also agreed formaiton of Finance subcommittee. Score remains unchanged given scale of challenge.

Update provided at July 16 QPF to advise that the Finance Committee has not been set up and the first meeting has been held. Due for next review / update at August 16 QPF.

20/09/16 - Update provided from MT(plan lead) to update that the month 5 position has been agreed with NHS England and it has been forecast that a £9 million deficit will be the outturn position. However, still need to deliver the combination of circa £6 million reduction in 14-15Q February GB CCG GB Risk to delivery of services CCG organisational 3 3 9.00 Transition Board Transition plan, though Minutes from the Stability arrangements 3 3 9.00 PE September June 2016 QPF PE updated at June QPF that new structures still under bought from new CSU delivery established and two staff this is expected to be Transition Board and during transition and risk 2016 QPF consultaiton and will need to assess once in place agreed for provider following failure of appointed from CSU to developed once regular newsletters on of staff loss scores to remain the same on the register. former CSU to secure place oversee transition to new procurement begins progress on the Lead Provider providers or in-housing. 20/09/16 - Update provided from PE (plan lead) stating Framework. Agreed service that now that the staff consultation process is complete, specifications PE has requested formal CSU contract meetings on a monthly basis starting in October 2016. In addition, PE has requested a CSU performance dashboard to be produced and this will be added to future QPF agendas. Recommended for scores to remain the same. 14-15T Nov-15 CCG QPF Delivery of Continuing Quality / Patient Safety 3 4 12.00 Action plans are being 5 3 15.00 LQ September June 2016 QPF QPF agreed to reduce the consequence score to 3 as a Healthcare (CHC) risks in / Financial reviewed at the Joint 16 QPF result of new Head of Service being appointed, but to keep relation to: Committee. under close review whilst she conducts an in depth service review. Further update to be provided at April 16 QPF. - Packages of care - Complex patients Reviewed at June 2016. Agreed to share Joint CHC - Reputational and financial Committee risk register. risks to the organisation with regular reviews not being 20/09/16 - Update provided from LQ (plan lead) to confirm undertaken by CHC the next Joint CHC Committee is being held in 21/09/16 and the risk register for this committee is included on the agenda for discussion. LQ to therefore provide a verbal update at QPF to be held on 27/09/16. Recommended for scores to remain the same.

14-15V Feb-16 CCG QPF Wirral CCG is aiming to sign Corporate Affairs 3 3 9.00 Regular meetings with the No current alternative that Meetings with council are Lack of formal legal sub- 3 3 9.00 PE September July 2016 QPF New risk identified at Feb 16 QPF - Verbal update to be sub-lease arrangement with Council around would be instantly held weekly and evloving lease agreement which is 2016 QPF provided at March 2016 QPF. Wirral Local Authority on the accomodation. available with NHS plans documented. not possible until head assumption that they sign connectivity to the CCG. lease is agreed. Verbal update to be provided by PE at April 16 QPF. the head lease with the land Chief Officer in liaision with registry. This is because the NHS Property Services Reveiwed at April 16 QPF and agreed for next review at May current lease arrangements regarding contingency 16 QPF. have expired. plan. Updated at June 2016. Still awaiting head lease agreement. The risk is that if the head lease arrangement is not Update provided at July 2016 QPF - No further progress has signed by the Local been made and discussions remain ongoing. This remains a Authority, the CCG cannot concern - Agreed to leave risk on the register with the same rapidly redeploy to another scores. building because of ICT and telephony requirements.The 20/09/16 - Update provided from PE (plan lead) stating head lease was expected to that JD and he had met with the Deputy Chief Executive be agreed in January / of Wirral Council (who also leads on assets and estate) February 2016, but it has and agreed that the principles of co-location and just transpired that there are integration remained a firm commitment and were still still areas that the council exploring both OMH and other contingencies to secure a and land registry have not long term accomodation solution. The Deputy Chief agreed. Executive of Wirral Council provided assurance that, even though OMH is for sale, he could not forsee a scenario where the tenants would be required to move out immediately. In the interim PE continues to attend a weekly accomodation meeting to progress CCG / LA integrated Insert Rows Above This Line Only

Impact Values Negligible 1 Minor 2 Moderate 3 Major 4 Catastrophic 5

Probability Values

Rare 1 Unlikely 2 Possible 3 Likely 4 Almost Certain 5

Green/Yellow/Red Threshold Values Green - maximum score 4 Yellow - minimum score 5 Yellow - maximum score 12 Red - minimum score 15 Page 2 of 4 Process

Risk Register Process Before QPF Meeting E-mail to be sent to QPF members to request any new risks. Risk added to Register by Laura Wentworth.

At QPF Meeting: New Risks and corresponding action plan to be considered for inclusion - either keep or decision escalated to risk owner. Current risks to be reviewed in line with action plan progression.

After QPF Meeting Laura Wentworth to update Monitoring column with decisions made at group. Laura Wentworth to amend residual risk rating in line with actions.

At Governing Body Review new and escalated risks Agree to include or de-escalate risks

After Governing Body Laura Wentworth to update Monitoring column with decisions made at group. Laura Wentworth to amend residual risk rating in line with actions. Add removed risks to the Removed risks Tab. Save and copy for next reveiw.

Page 3 of 4 GB Governing Body QPF Quality, Performance and Finance Committee PCMH Primary Care Mental Health DNA Did not Attend KPI Key Performance Indicator SLA Service Level Agreement NWCSU North West Commissioning Support Unit MD Managing Director DMIC Data Managerment Information Centre OOH Out of Hours NHSD NHS Direct DOS Directory of Services CCG Clinical Commissioning Group AT Area Team