Basildon and Brentwood CCG Board Part I Fit for Future 24 November 2016

Basildon and Brentwood CCG Board Part I Fit for future 24th November 2016

CONTENTS PAGE

Section No. Cover Paper Part I & Public Consultation Process 2 Intermediate Care Review & EQIA 3 E-cigarettes & EQIA 4 Gluten Free, EQIA & Appendices 5 Toric intraocular lens implants & EQIA 6 IVF and Assisted Conception (New referrals) & EQIA new and existing 7 IVF and Assisted Conception (Existing) 8 Simultaneous Joint Replacement & EQIA 9 Pain Treatments injections (back, hip & leg) & EQIA 10 Spinal Cord Stimulation & EQIA 11 Travel Vaccines & EQIA 12 Bariatric Surgery & EQIA 13 Cosmetic Procedures & EQIA 14 SRP Criteria Change and appendices 1-18, project timeline and plan 15 Glossary 16

1 Agenda Item 3.1 Fit for the Future Consultation Basildon and Brentwood CCG Board

24th November 2016

Document Status For decision

Purpose & Brief Description The purpose of this paper is to i) Set out why the CCG undertook the Fit for the Future consultation programme ii) The process that led to consulting on the range of propositions included in the Fit for the Future consultation iii) Inform the Board of the process undertaken to consult with the public and other stakeholders iv) Inform the Board of the feedback received from the public and other stakeholders during the Fit for the Future programme v) Taking into account the original proposal, feedback received and the CCG’s considerations on the feedback received, make recommendations to the Board on each proposal.

Preamble In order to share and develop the strategic vision for Basildon and Brentwood Clinical Commissioning Group and to consult on a number of potential service changes and restrictions as part of our Quality, Innovation, Productivity and Prevention (QIPP) programme for 16/17, the CCG undertook our “Fit for the Future” consultation exercise between 11th July and the 12th September 2016. The purpose of the Fit for the Future Engagement process was to engage with a wide variety of stakeholders to; - Outline the drivers for change that the CCG faces (e.g. increased demand due to an ageing population with increasingly complex needs and the need to address a deficit of £14m) - Clearly articulate o the CCG’s vision for future service provision o the CCG’s proposed reconfiguration of intermediate care o the CCG’s proposed changes to the service restriction policy - Seek feedback and more fully understand the impact of the proposed changes to assist the CCG Board when making decisions on the proposals.

2 Stakeholders consulted in the development of this paper This paper follows a comprehensive consultation exercise with the general public and other stakeholders. The full range of those consulted is included within the paper.

Recommendation For decision. NB. Each proposed change is subject to an individual decision.

Summary of Equality/Quality Impact Assessment (if relevant) EQIAs have been undertaken for all proposed changes. The detail of these is contained within this document

Presented By Prepared By Board members Karen Wesson Kathy Canham Paula Saunders Siobhan Redwood William Guy Kelly Burke

CCG Principles Confirm that this document supports the following CCG principles (tick those which apply)

Improved outcomes for patients (quality, safety, experience) Yes Equity of provision and outcome for all patients in the CCG Yes population Best value for money (proactive care, focussing on patient need) Yes

Contact Details for further information Karen Wesson Associate Director of Commissioning William Guy Director of Transformation

3 Fit for the Future

Purpose of this paper

In order to share and develop the strategic vision for Basildon and Brentwood Clinical Commissioning Group and to consult on a number of potential service changes and restrictions as part of our Quality, Innovation, Productivity and Prevention (QIPP) programme for 2016/17, the CCG undertook our “Fit for the Future” consultation exercise between 11th July and the 12th September 2016.

The purpose of this paper is to

i) Set out why the CCG undertook the Fit for the Future consultation programme ii) The process that led to consulting on the range of propositions included in the Fit for the Future consultation iii) Inform the Board of the process undertaken to consult with the public and other stakeholders iv) Inform the Board of the feedback received from the public and other stakeholders during the Fit for the Future programme v) Taking into account the original proposal, feedback received and the CCG’s considerations on the feedback received, make recommendations to the Board on each proposal. Background

In addition to fulfilling our statutory requirement to consult with the public, the Fit for the Future consultation aimed to help inform the CCG’s commissioning plans through engagement with a wide variety of stakeholders. The consultation was in three parts;

Part one - The Vision

Part one set out the local and national drivers for change and CCG’s vision for future service provision. This centred on the out-of-hospital model with primary care at its foundation, working collaboratively with community, mental health services and other statutory and non-statutory agencies to try and improve wellbeing and reduce dependence on acute hospital services.

The vision was the culmination of a 12-18 months of developments in CEGs, Senate meetings, Board Development Sessions and Board. The vision was informed by the previous Fit for the Future engagement exercise undertaken in summer 2015.

Part two - Intermediate Care

Part two described the CCG’s vision for Intermediate Care including the opportunities to deliver care in a different way that would lead to more patients being

4 managed at home and a reduced number of intermediate care beds being commissioned.

The proposed new model for Intermediate Care was the outcome of the Intermediate Care Review Group. This group has met regularly since July 2015 and involved representation from Thurrock CCG, Basildon and Thurrock Hospital, North East London Foundation Trust, South Essex Partnership Trust, Essex County Council and Thurrock Council.

During the period July 2015 to present, there have been various updates on this development in CEGs and Board meetings. This culminated in the “Intermediate Care Review” Board paper being presented to Board in May 2016. This outlined a number of options for the new model of Intermediate Care and recommended commencing a consultation on the preferred configuration of intermediate care beds. This approved recommendation was the basis of the consultation.

Part three - Service Restriction Policy Changes

Part three set out the requirement for the CCG to restrict a number of existing interventions as part of our overall QIPP programme.

In identifying the proposed Service Restriction Policy changes the overriding principle considered was securing the best outcomes for the population we serve within the financial resources we have at our disposal.

A Service Restriction Policy working group was established in June 2016. This group was led by GP Clinical Leads with support from Public Health and commissioning representatives. The role of this group was to review the clinical evidence, public health evidence and the Service Restriction Policies of other CCGs to make recommendations on further local restrictions.

The outcome of the working group’s considerations was presented to Board on 30th June 2016. Board endorsed proceeding to consultation on a range of proposals to cease commissioning a number of services/procedures and to amend the threshold or application process for a further range of services/procedures.

Consultation Process

Purpose

The purpose of the Fit for the Future Engagement process was to engage with a wide variety of stakeholders to;

- Outline the drivers for change that the CCG faces (e.g. increased demand due to an ageing population with increasingly complex needs and the need to address a deficit of £14m)

5 - Clearly articulate o the CCG’s vision for future service provision o the CCG’s proposed reconfiguration of intermediate care o the CCG’s proposed changes to the service restriction policy - Seek feedback and more fully understand the impact of the proposed changes to assist the CCG Board when making decisions on the proposals. Pre Consultation Engagement

As part of the preparation process, the CCG engaged with a number of stakeholders to inform them of the consultation and seek input into the key messages and approach to consultation. This included the Patient and Communities Reference Group.

Consultation

The consultation commenced on 11th July 2016 with a range of communications to stakeholders and press releases.

Throughout the consultation process, the following key messages were reiterated;

- That the Fit for the Future consultation process is a genuine engagement exercise and we are seeking feedback from the public and other stakeholders to assist our decision making process. - That doing nothing (i.e. not proceeding with any changes) is not an option and if we do not take forward all or any of the proposals set out in the Fit for the Future consultation, the CCG will need to consider alternative changes and other potential further service cuts. - That the CCG recognises that the proposed changes will have a direct impact on different patient groups served by the CCG. However, this has to balanced against the wider health outcomes of our whole population. - The proposed restrictions are only delivering part of the required savings. The CCG is undertaking a number of other initiatives to tackle our financial challenge in a bid to limit the need to cut or restrict service provision. How

General public

In order to engage with as broader spectrum of the local population and other interested stakeholders, the CCG adopted a multi-faceted approach to consulting.

How Audience Numbers Public Meetings (8) Public Up to 70 per meeting Questionnaire (web All stakeholders 711 based and paper based) Town centre stalls (3) Public Over 200 people visits the Basildon, Wickford and stalls Brentwood

6 Social media (Twitter and Public 752 impressions per day Facebook) (Twitter), 20,076 impression with a 1.81% click through rate (Facebook) Leaflet and poster Public Unknown distribution in hospitals, practices, libraries, supermarkets, council offices, cafes, charity shops and other locations Phlebotomy clinic Service users attending 30 attendance Basildon Hospital phlebotomy clinic Leaflet distribution at Commuters Approximately 200 per railway stations station Web based resource (on All stakeholders Unknown the CCG’s website) Newspaper adverts to All Unknown promote public events Patient Engagement Patient representatives 10-15 per group Group

Stakeholders

In addition to public engagement, the CCG engaged with the following range of stakeholders;

Stakeholder How Local MPs Meetings and letters Local councils Meetings and involvement in other (ECC/Basildon/Brentwood) forums (e.g. Basildon Renaissance Group) HOSC Attendance at HOSC meeting in July CCG Membership Through locality meetings, practice manager forums and general discussions Specialist interest groups (e.g. Fertility Through letters and consultation First, Coeliac UK) material Local clinicians Through face to face meetings on request Other stakeholders e.g. CVS Through attendance an annual meetings (including presentations)

Further detailed information can be found in the appendices.

7 Responding to feedback

To ensure that the consultation process was effective as practical, we adapted our approach on the basis of feedback received. This has included setting up addition public meetings (including evening meetings to try and get feedback from commuters), issuing flyers identifying proposed changes at railway stations across the area, amending the wording of elements of the consultation to try and ensure that the proposals were clear to both lay people and healthcare professionals alike.

Length

The CCG consulted during the period July 11th 2016 to September 12th 2016. Guidance requires us to ensure that our consultation approach is fair and proportionate. The timing of our consultation was impacted on two significant period of purdah earlier in 2016, firstly for local council elections and secondly for EU Referendum elections. The CCG has taken in to account the fact that this therefore took place over the summer. As outlined in this paper, we have undertaken a number of different approaches to seek feedback and adapted these to different audiences.

General feedback

In addition to the service specific feedback that is detailed in this paper, a number of general themes were fed back to the CCG. These included;

- The NHS should not be cutting services, it needs to be appropriately funded - Means testing access to some services would be a fairer approach to restrictions - Individual circumstances should determine access to services. Clinicians should always determine access. - Several other proposals for potential savings were suggested (e.g. improved purchasing, fining for missed appointments, charging overseas users for accessing NHS services, reduced medicines waste). - Restricting services could create greater long term costs not only to the NHS but the wider public sector and economy as a whole (e.g. unemployment or sickness absence) - Several respondents flagged the impact on quality of life of the proposed changes - Several respondents suggested that interventions resulting from lifestyle choices should not be funded - Several respondents noted a perceived bias against restricting services that are more likely to be accessed by women e.g. IVF, Breast Reconstruction, Vaginal prolapse These wider issues will be reviewed by the CCG and further considered as part of a future Board paper.

8 Media Coverage

The Fit for the Future consultation received a range of media coverage. The CCG proactively undertook a number of press releases at the outset and during the consultation period. In addition, the CCG responding to a number of enquiries from national and local news agencies. A full summary of coverage can be found in the appendices.

Learning

In line with good practice, the CCG will undertake a review of the consultation process to understand the strengths and opportunities for further development of our engagement processes. This will be fed back to a future Board meeting.

9 Fit for the Future 2016 Public consultation process Appendices Press releases:

Ensuring local health services are fit for the Future - tell us what you think (08-07- 2016) http://basildonandbrentwoodccg.nhs.uk/fit-for-the-future/news-release-ensuring- local-health-services-are-fit-for-the-future-tell-us-what-you-think Ensuring local health services are Fit for the Future – in a nutshell (25-07-16) http://basildonandbrentwoodccg.nhs.uk/fit-for-the-future/ensuring-local-health- services-are-fit-for-the-future-in-a-nutshell Extra public meeting on proposed changes to local NHS services (04-08-16) http://basildonandbrentwoodccg.nhs.uk/fit-for-the-future/news-release-extra- public-meeting-on-proposed-changes-to-local-nhs-services Commuters' views sought on proposed changes to NHS services (10-0816) http://basildonandbrentwoodccg.nhs.uk/fit-for-the-future/news-release- commuters-views-sought-on-proposed-changes-to-nhs-services Reminder to 'Have Your Say' in health service public consultation (25-08-16) http://basildonandbrentwoodccg.nhs.uk/fit-for-the-future/news-release-reminder- to-have-your-say-in-health-service-public-consultation Fit for the Future public consultation 2016: Special Board Meeting announced (14-09-16) http://basildonandbrentwoodccg.nhs.uk/fit-for-the-future/fit-for-the-future-public- consultation-2016-special-board-meeting-announced

(Distribution list: '[email protected]'; '[email protected]'; [email protected]>; '[email protected]'; '[email protected]'; '[email protected]'; '[email protected]'; '[email protected]'; '[email protected]'; '[email protected]'; '[email protected]'; '[email protected]'; [email protected]'; @btinternet.com; basildon@yellowad; @btuh.nhs.net; NHS ENGLAND communications;

Communications to stakeholders:

Press releases/posters with public meeting dates/updates etc. for public and staff noticeboard display/copy for staff newsletters and intranets sent by email to provider organisations etc.

10 (Distribution list: [email protected]; NHS THURROCK CCG;NHS CASTLE POINT AND ROCHFORD CCG;NHS MID ESSEX CCG) '[email protected]'; [email protected]; [email protected]; '[email protected]'; '[email protected]'; '[email protected]'; '[email protected]'; '[email protected]'; '[email protected]'; '[email protected]'; '[email protected]'; '[email protected]'; '[email protected]'

Stakeholder packs by post: Stakeholder packs contained Fit for the Future July 2016 Trifold, Intermediate Care discussion document and Service Restriction Policy Review discussion document (Distribution list: BW CVS; Basildon Council; Brentwood Council; ECC; LDC; LMC; LPC; John Baron MP; Mark Francoise MP; Eric Pickles MP; Stephen Metcalfe MP; BHRUT; NHS England; EEAMS; NELFT; SEPT; Healthwatch Essex; Essex HOSC; BMA; GMB; RCN; UNISON; UNITE; Billericay Town Council; Parish Councils - Basildon Borough and Brentwood Borough; Age UK Essex; Women4Women Essex; Gay Men’s Essex Social and Support Group’ Essex Cardiac and Stroke Network; Dancing Giraffe CIC; Disability Essex; Essex Coalition of Disabled People; Essex Carers Network; Brentwood Talking Newspaper; Wickford Talking Newspaper; Bridge Counselling Services; SEEDS; IC Care 24; Thurrock CCG; Castlepoint & Rochford CCG; Southend CCG; Mid Essex CCG; Mid Essex Hospital Trust; Southend University Hospital; Essex Cares Limited; Open Road; South Essex Rape and Incest Crisis Centre; Action for Family Carers; St Francis Hospice; St Luke’s Hospice; PCRG members; BBCCG Practice Managers)

Media broadcasts and articles:

Examples of media coverage relating to Fit for the Future: BBC Look East news - evening and late broadcast (12-07-16) BBC Essex news and subject of phone in (12-07-16) BBC Five Live - statement supplied on IVF proposals (08-08-16) The Times: Cataract patients offered surgery for only one eye (24-07-16) Phoenix radio broadcast Fit for the Future (23-07-16) Local media coverage included: Brentwood Weekly News – Have a say on plans to cut NHS services (30-08-16) Essex Enquirer - Health cuts to gluten-free prescriptions in Basildon and Brentwood are health danger warns charity (28-07-16) Yellow Advertiser - EXCLUSIVE: Eric Pickles blasts Basildon and Brentwood NHS bosses over plot to axe chronic pain treatments, holiday jabs, IVF, eye surgeries and more... (08-09-16) Basildon Recorder - Fertility cuts branded ‘appalling’ by charity (14-07-16)

11 Essex Live – Fertility campaigners attack cuts to NHS IVF treatment in Brentwood (13-07-16) see Comments and the response from the CCG The Enquirer - Care changes in the pipeline for Basildon and Brentwood CCG (14- 07-16) Basildon Echo - Couple who used IVF treatment while trying for a child label NHS funding cuts as ‘simply unfair’ (12-07-16) Basildon Echo - Beds could be lost at community hospital (13-07-16) BBC News online - Plans to cut IVF in Basildon and Brentwood an 'insult' to patients

Basildon Standard – NHS set to cut its hospital services

Other: Bio News - CCG plans to cut IVF for new and existing patients (18-07-16) Brentwood CVS Newsletter (update on Fit for the Future consultation supplied) (28- 07-16)

12 Advertising campaigns:

Brentwood Gazette, Billiercay Gazette,

Dates: 27th July 3rd August 17th August 31st August September 7th

Essex Enquirer

Dates: 21st July 4th August 18th August 1st September

Basildon Echo

Dates: July 22nd 5th August 19th August 2nd September

13 Phoenix Radio advert - broadcast 5x daily 23 August -11 September

Script: “We know how much YOU love the NHS. We want the NHS to be Fit for the Future, so that’s why we want to talk to you about our proposed changes to some local NHS services. Who are we?

We’re Basildon and Brentwood CCG – an NHS body led by GPs who choose and buy most of the health services for the people of Basildon and Brentwood.

Our public consultation runs until September 12th. Go to Basildon-and-Brentwood-C-C-G-dot-nhs-dot- uk to find out more and how you can have YOUR say.”

Social media:

BBCCG Twitter @BB_CCG (12-07-16 to 12-09-16) BBCCG Tweets earned 47.4k impressions over 63 day period (average 752 impressions per day)

Note: Impressions are the number of times that a tweet has been delivered to the Twitter stream of Twitter accounts

Facebook advertising campaigns

Local World (Gazette online) see below:

23-30 July

Total impressions 11,185 Click through rate 2.25%

2-7 August Total impressions 18,558 Click through rate 2.19%

Total impressions 20,076 Click through rate 1.81%

Note: Impressions are the number of times a post from a Facebook page is displayed, whether the post is clicked on or not. Click-through rate (CTR) is calculated by dividing the number of clicks on the Facebook ad by the number of impressions it gets.

15 Resource distribution:

Information packs/posters placed/circulated in hospitals, GP practices, Phlebotomy Clinics, pharmacies, Libraries, supermarkets, council offices, cafes, charity shops and other key locations. Resources were placed at request at councillor’s surgeries. All materials directed people to dedicated section on BBCCG website http://basildonandbrentwoodccg.nhs.uk/fit-for-the-future for more information and online surveys

Email signature on all BBCCG emails during public consultation phase:

20 Public meetings/drop in events/pop up stands:

The public engagement involved a range of public events across the BBCCG locality including public meetings, pop-up stands at a supermarket and community events such as Love Your Borough Basildon and Talking Diabetes Brentwood.

Pitsea: Tuesday 19 July Pitsea Leisure Centre

Basildon: Wednesday 27th July, 6pm - 8pm at Holiday Inn, Festival Leisure Park, Basildon SS14 3DG

Brentwood: Thursday 28th July, 6pm-8pm at Brentwood Community Hospital, Crescent Drive, Brentwood CM15 8DR

Wickford: Friday 12th August, 10am-12 noon at Wickford Health Centre, Market Road, Wickford SS12 0AG Wickford: Saturday, 20th August Wickford Co-op

Brentwood: Wednesday, 17th August, 7pm-9pm at Brentwood Baptist Church Hall, Kings Road, Brentwood CM14 4DR

Billericay: Friday 26th August, 1pm-3pm at Emmanuel Church Hall, Laindon Road, Billericay CM12 9LD

Basildon: Love Your Borough: Basildon: Saturday 3rd September, 10am-5pm - Love Your Borough event in marquee behind Costa, Basildon Town Square SS14 1BA

Billericay: Monday 5th September, 6pm-8pm Billericay Health Centre, Stock Road, Billericay CM12 0BJ

Basildon - CCG Annual General Meeting: Thursday 8th September, 4pm-8pm at St. George's Suite, The Basildon Centre, St. Martin’s Square, Basildon, Essex SS14 1DL

Brentwood: Saturday 10th September, 10am-4pm - pop-up stand at Baytree Centre - Chapel Ruins, Brentwood High Street CM14 4BX

Engagement at stations and flyer handouts: Handout of flyers to commuters at Ingatestone, Wickford, Billericay, Pitsea, Brentwood, Shenfield, Basildon and Laindon stations. (Circa 200 per station)

21 Briefings at external meetings, patient group meetings etc: Essex County Council:

Essex Health Overview and Scrutiny Committee – 27 July Basildon Council:

Basildon Infrastructure and Community Scrutiny Committee - 7 September Basildon Health Partnership –15 June and 14 September Brentwood Health and Wellbeing Board - 12 July Voluntary sector led partnership meetings:

 Heart of Pitsea – received briefings as attendees of Dipple Patient Group  Safer Brentwood – 29 July  Brentwood CVS Annual Networking Lunch - 12 July Practice Participation Group meetings – PCRG members cascaded to PEGs who cascaded to PPGs GP members and locality meetings:

 Partnership BIC – 3 August  Arterial - 13 July  Brentwood - 20 July  SEMC - 27 July (continued) Patient Engagement Group meetings:

 Arterial - 9 August  Brentwood - 15 July  SEMC – 5 August PCRG:

 Wednesday 20 July  workshop July 6

GP shutdown events – Time to Learn:

 21 June

Practice Manager meetings – received feedback

MPs - face-to-face meetings have taken place with local MPs and their aides including: Sir Eric Pickles MP (Basildon and Brentwood) Mark Francoise MP (Rayleigh and Wickford) John Baron MP (Basildon and Billericay) Stephen Metcalfe MP (South Basildon and East Thurrock – telephone conference)

Basildon and Brentwood CCG staff engagement:

Detailed briefing with workshop session on the Fit for the Future public consultation was included in the staff away day held at Wat Tyler Centre, Pitsea on 21 July. Briefings and updates have been communicated to staff at fortnightly staff briefings and in staff e-bulletins

Additional communications to GP practices:

Briefing and updates have been included in the weekly GP e-bulletin directed at GPs, practice managers, nurses and admin staff.

Meetings with Specialist Clinicians:

GP Board members and members of the CCG executive team met with BTUH clinicians for Pain and also Respiratory on 8 September

Research on Gluten-free flour

Two patients on gluten-free diets undertook some test baking with a range of gluten- free flours readily available in supermarkets, health food shops and online. One of the testers stepped forward after attending a public meeting in Wickford and visiting a Fir for the Future pop-up stand at Wickford Co-op. The other researcher was a CCG staff member whose sister also follows a gluten-free diet. Both completed feedback forms.

23 FREQUENTLY ASKED QUESTIONS A number of common themes emerged in the Q&A sessions at the public meetings. Our responses to these Frequently Asked Questions were posted in the Fit for the Future section of the BBCCG website as follows: Why is Basildon and Brentwood CCG undertaking this formal public consultation? We recognise that the way the health and social care system works at present is disjointed and does not work as well as it could to provide services to our population. Therefore, the CCG will be working with its providers and partners so that the people of Basildon, Brentwood, Billericay and Wickford can remain as well and as independent as possible throughout their lives. To achieve this all providers will need to work together more closely to ensure a seamless service/services experience for patients.

When does the CCG plan to implement any or all of the proposed changes outlined in the formal public consultation? This is a formal public consultation and the feedback received will be presented to the Basildon and Brentwood CCG Board for decision at an Extraordinary Board Meeting on 29 September 2016. Should any or all of the proposed changes be approved by the Board, they will come into effect from 1st October 2016.

How much money will this save? As a CCG we are accountable for making the most effective use of the resources that we have. We can only do this if our services are efficient, effective and of high quality. Last year the CCG spent £6.5m more than our allocation. We are statutorily bound to live within our means and we have agreed a plan with NHS England to do this by 31 March 2018.

Is there going to be a significant increase in local healthcare funding? Basildon and Brentwood CCG is not expecting any significant increase in funding in future years.

Does the CCG plan to close any hospitals? There are no plans to close any hospitals. Basildon and Brentwood CCG plans to spend more money on providing services in the community so that patients who might have been placed in community hospital beds for intermediate care, will instead receive safe and appropriate care in their own homes.

Will I have to travel further for care? Some patients may need to travel further for very specialist care - that is so we can ensure they receive the best care and that we as a CCG can deliver the care

24 in the most efficient way. However, most patients, will continue to receive care locally and we are committed to ensuring a wider range of services are available closer to, or in, the patient's home.

Whose views will be gathered by the CCG in its formal public consultation? As a CCG, we want to get the views of as wide a range of people as possible. We have a number of public events planned and will also be engaging with providers, system partners, MPs and local councillors, GPs and interest groups.

Intermediate Care Bed Review

Why are you undertaking the Intermediate Care Bed review? An audit conducted last year showed that as many as 40% of patients admitted to an intermediate care bed may have been better off with a package of care in their own home. There is much evidence that admission to hospital can make it much more difficult to regain previous levels of independence and should be avoided where possible. By investing in services based in the community we are able to offer care to more patients in a way that helps maintain their independence.

Are you closing Mayflower Community Hospital? We are not intending to close Mayflower Community Hospital but are proposing to reduce the number of Intermediate Care Beds within Basildon and Brentwood while boosting investment into a range of community health and care services.

What will happen to patients currently being looked after in an intermediate care bed? Patients who have been admitted to an intermediate care bed will be unaffected. Patients will continue to be assessed on their care needs, just as happens now, but the increased availability of community care services means patients who will be better off remaining in their own home will be able to access this care, resulting in a gradual reduction in patients requiring admission to a bed. Beds will still be there for patients who need them.

Why are you reducing the number of dementia beds when there is an increasing number of patients with dementia? It is widely recognised that people with dementia should be supported, where safe and possible, to stay in their own home. The services we have had in place to support people with dementia in the community have successfully managed to reduce the number of admissions by supporting dementia sufferers in their own home. We are increasing investment in these services to make them available to more people and therefore expect demand for dementia beds to reduce further.

25 Service Restriction Policy proposals - general

Will this mean people who live outside the Basildon, Brentwood, Billericay and Wickford areas will continue to receive the services you are proposing to restrict or stop? The CCG is responsible for commissioning services for our population and making the best use of the resources we have available. Other CCGs are responsible for services in their areas. While some other CCGs have made similar decisions on services to the ones we are proposing, not all will be making the same changes so there may be differences in the services offered.

Why are you proposing that some procedures and treatments should be restricted or stopped and not others? We reviewed all the services on the current service restriction policy.The procedures/treatments we are proposing to stop are those for which there is evidence of limited clinical effectiveness.For other procedures/treatment (e.g. gallstones) there is evidence that people are receiving surgery when this may not be the best treatment and we therefore we are proposing changes to some of the criteria.

What if I have already been referred for one of the treatments where changes are being proposed? You should only have been referred where your condition meets the criteria within the current Service Restriction Policy[http://basildonandbrentwoodccg.nhs.uk/about-us/policies-and- procedures/service-restriction-policy]. .After the CCG Board decision on 29 September 2016, the clinician who will undertake the proceedure will assess if you meet the new criteria which may have been adopted in the upated Service Restriction Policy. You will only be referred if you meet any new criteria. Should the CCG Board have decided not to fund a particular treatment, you will no receive that treatment.For those people referred for assisted conception and already in the system as at 29 September 2016, any new criteria for treatment will be applied. For those not yet referred for assisted conception, it is expected that, following the CCG Board meeting on 29 September, these people will not be referred for treatment should that be the decision of the CCG Board.

Cosmetic Surgery The information in your consultation suggests that reconstructive surgery for cosmetic reasons won't be funded. Does this include breast reconstruction after mastectomy following breast cancer?

26 One of the principles of equity is that people are treated based on their needs. We would not necessarily be making a distinction between the reason for people requiring treatment e.g. cancer or injury. The reason for undertaking this formal public consultation process is to listen to the views of our population. The CCG Board will then take a decision taking these views into account.

IVF and Assisted Conception (existing treatment) Hasn’t the CCG already consulted on the future of fertility services?

In Summer 2015 the CCG consulted on the provision of specialist fertility services for new patients. Through this current engagement process (Summer 2016) we are consulting on provision for existing patients. The outcome of both consultations will be presented at an Extraordinary Board Meeting on 29 September 2016 for agreement of future provision. At the moment,the CCG currently commissions a service in line with NICE Guidelines.

Will people who have already been told that they are eligible for funding for three full cycles of IVF have their treatment stopped?

Patients referred for specialist IVF services after April 2013 should have been made aware that the CCG commissions in line with NICE Guidance and the number of funded cycles depends on a number of criteria. Patients referred prior to this date would have been informed of the criteria and provision set by East of England Specialist Commissioning who were responsible for commissioning specialist fertility services at the time. For those people referred and already in the system as at 29 September 2016, any new criteria for treatment agreed by the CCG Board meeting on 29 September will be applied. It is proposed that this would be a phased process.

27 Fit for the Future: Intermediate Care

Original proposal

The CCG proposes to commission a new model of Intermediate Care which aims to manage patients with a combination of care in pa persons own home and through investment in community services and a reduced bed base specifically, the closure of beds at Mayflower Community Hospital (Billericay) and by combining the beds in Meadowview and Mayfield Ward (Thurrock Community Hospital) commissioned by all south Essex CCGs.

This will be undertaken by:

Phase 1 Creating Community Capacity

1) The CCG intend to invest circa £900k in additional provision/capacity focussed on a new Rehabilitation Service aligned to the Single Point of Response within existing community services. This will be primarily therapy led and work in partnership with a number of other community services e.g. the Dementia Crisis Team, Integrated Care Teams and Reablement Service.

Phase 2 Reduced bed base in line with delivery of option 2

2) Through the introduction of the proposed community rehabilitation model, the need for intermediate care beds will reduce as patients will be supported to become as independent as possible at home. This change allows a number of existing intermediate care beds to be closed. The CCG would cease commissioning beds at Mayflower Community Hospital (Billericay) and with the south Essex CCGs, consolidate the bed base on Meadowview and Mayfield Wards on the Thurrock Community Hospital site.

The CCG would therefore commission:

- The Community Rehabilitation Service - Thorndon Ward, Brentwood Community Hospital - Mountnessing Court in Billericay - In conjunction with south Essex CCGs, Meadowview Ward in Thurrock Community Hospital

Rationale

The drivers that acted as a catalyst for the CCG to review the provision of inpatient Intermediate Care it commissions are:

- The QIPP (Quality, Innovation, Prevention, Productivity) challenge faced by the CCG meant that all areas of spend required review to ensure that we commission best value care.

- The Fit for the Future programme intention is that we commission a service model that supports patients to regain their optimum level of independence (this should be delivered in the patients normal place of residence)

- Changes to the Essex County Council (ECC) reablement contract which BBCCG invest £900k per year via the Better Care Fund

- ECC commissioning of 10 reablement beds in the community

28 Current Service Model

An internal audit of patients in our current commissioned Intermediate Care beds was undertaken in September 2015 by the CCG which demonstrated:

- Patients were in beds when they could have been managed out of hospital if the right service had been offered/available

- That patients were admitted to the beds because this was seen as the right option and the beds were available

- A significant number of the patients could have their needs more appropriately in an out of hospital setting with a service provided by a domiciliary based health/social care package

- Not many of the patients were admitted to the intermediate care beds to have management of a health need that required a long admission to an intermediate care unit

Financial

- The current intermediate care bed base is expensive at an average cost to the CCG of up to £105k per bed/per annum

- Thurrock CCG have a vision for intermediate care bed provision which if BBCCG maintain the status quo, presents a significant cost pressure to the CCG

Operational reasons for change

- Delivery shows that our system adapts to use the capacity of all hospital beds available to the system (i.e. we fill all available beds regardless of need)

- The Dementia Crisis Support Team has been able to manage dementia patients out of hospital resulting in empty beds being available particularly within the dementia assessment and challenging behaviour wards (Meadowview and Mayfield)

- The current intermediate care bed model offers rigid capacity throughout the year regardless of need/demand and hasn’t changed to reflect the changing patient need

Meeting changing need

- Having a community based solution that is able to flex capacity to manage patients in their own home environment

- Having a model that can work with the new social care offer to provide a service enabling patients to be supported to achieve optimal independence and reduce dependence on health and care packages for as long as possible

Impact

The efficiencies made through this proposed change would allow the CCG to increase the number of patients it supports within its Intermediate Care services – whilst the bed numbers will reduce, the number of patients that can be managed by the total system (home based and bed based care) would increase. In addition, the resulting saving from this new model will go towards bringing the CCG back to its statutory financial balance position which is vital in order for it to be viable organisation and fund future services for the local population.

Comments received

The following themes were received;

If the right model of care can be commissioned for people managed in their own home, this could be an effective model.

Ensuring patients are assessed and managed into the correct pathway is pivotal to the success of intermediate care.

I would have been preferred to be managed at home.

Patients being managed at home should have the ability to step up to a bed if required.

Involvement of relatives/carers in the care planning process is important but also they cannot be relied on to fulfil the role of healthcare professionals.

There must be the right number of beds kept in the system for patients that need a bed.

Concern regarding ability to stay at home if they do not have support from relatives and carers.

There were first-hand accounts of

- Poor home care with a lack of joined up working between the various professionals managing the patient - Good home care with attentive staff - Poor care where it was perceived a patient was discharged too early and was readmitted with longer term implications. - Good experience of people using existing intermediate care beds and concern about losing them.

There was concern about the quantity and quality of personal carers (social care) and the impact that may have on this proposal.

Concern that the existing community capacity would be insufficient to deliver the additional pathway

Concerns regarding the state of peoples housing if they are to be managed at home (both in terms of quality and ability to function with limited movement i.e. toileting etc).

Concern that with the growing population, more patients will come through the system and therefore more capacity is required not less.

Concern regarding transport and access to the intermediate care beds.

Concern regarding availability of the beds currently and the impact on Basildon Hospital

There was concern that Mayflower Community Hospital would be mothballed.

Reflection on comments

CCG Comment - In terms of capacity, the CCG recognises that the existing community services have insufficient capacity to deliver the model and are therefore seeking to commission more

30 home based packages than the number of beds removed from the system. Therefore, it is our intention to increase the overall capacity within the system. This also takes into consideration the growing and ageing population. - The CCG will continue to commission intermediate care beds in Brentwood Community Hospital and Mountnessing Court in addition to dementia beds on the Thurrock Community Hospital site. - We will work closely with all stakeholders to ensure that the right cohorts of patients enter the right pathways – this includes aligning the services to SPOR so that GPs can refer through to SPOR and patients be navigated to the right pathway. Part of the assessment process will be determining whether the environment and support the patient has at home is suitable for a home based package. Those that do not have the right environment/support will instead access the bed based care. - Following further consideration with the community providers, the model will o Flexibility for people to move between the different elements of the pathway including, step up from a home based package to a bed if the patients situation deteriorates, reduced length of stay in intermediate care bed stepping down in to the home rehab service where appropriate. o Ensure that family/carers are involved in the care planning process and have a quick route to contacting the named lead for the patient in the event of needing advice or assistance. - Whilst the CCG accepts that public transport access is not ideal, the aim of this proposal is to manage more patients at home i.e. reduce the need for people to stay in a community hospital. - If supported this development will be undertaken in conjunction with all key stakeholders from the health and care system. We recognise that this requires significant collaborative working to be successful. - The CCG has invested additional monies in reablement services (jointly commissioned with Essex County Council) and will raise concerns regarding the provision of carers with Essex County Council. We believe that this issue is not directly connected to the Intermediate Care proposal. - North East London Foundation Trust would continue to deliver a range of services from Mayflower Community Hospital and have no intention to mothball/exit the site.

Finances

Further to the May Board paper, further refinement of the financial model has been undertaken. The CCG is currently in negotiations with both providers and fellow commissioners across South Essex. Key areas of negotiation include;

- Final refinement of the community solution - Agreement of stranded costs associated with overheads/unused ward space (Alistair Farquharson Centre) - Final ward models across all sites

Subject to the outcome of the negotiation, the CCG’s forecasting suggesting a likely cost saving from this initiative.

Risks

A number of risks associated with this development have been identified and are being appropriately mitigated. These include;

Risk Mitigation That the delivery of savings is subject The CCG is working in collaboration with the south Essex to negotiation with providers and CCGs to ensure a clear negotiation strategy with commissioners providers is in place. The CCG is having clear and effective dialogue with providers There is a risk that the community NELFT have a number of mitigating solutions including solution will take time to recruit to the use of locum staff from a preferred agency. and delay the delivery of the overarching model There is a risk that the wider system The development is a regular agenda item on the System does not support this change Resilience Group and will continue to be on the agenda throughout the implementation period There is a risk that the triage A number of workshops will be held during the process/pathway management is not implementation period to ensure that all staff are aware effective of the services and the most appropriate patients for each service. For GPs, referrals to both services will be managed through SPOR. SPOR staff will assess to ensure the patient enters the right pathway. There is a risk that Thurrock CCG The CCG has a shared implementation plan with implement their model ahead of the Thurrock CCG and a single Intermediate Care Review BB CCG model being implemented working group. There is a risk that the NHS Property Further work is being undertaken with NHS Property Service Vacant Space Policy does not Services to manage this risk. result in the anticipated savings associated with declaring Bayman Ward, Brentwood Community Hospital as vacant

Recommendation

It is recommended that subject to:

 Negotiations with providers and other commissioners resulting in the achievement of the required level of saving  The risks continue to be appropriately mitigated that the CCG proceed in commissioning a community rehabilitation service that will lead to the cessation of commissioning beds in Mayflower Community Hospital in Billericay and the consolidation of Mayfield Ward and Meadowview Ward on the Thurrock Community Hospital site.

The CCG would then commission;

32 - The Community Rehabilitation Service - Thorndon Ward, Brentwood Community Hospital (including the 8 Stroke beds) - Mountnessing Court in Billericay - In conjunction with south Essex CCGs, Meadowview Ward in Thurrock Community Hospital - In conjunction with Thurrock CCG, the CCG continues to commission 8 stroke beds within Thorndon Ward, Brentwood Community Hospital

33 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Quality/Equality Impact Assessment Tool 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 1 RARE 1 MINOR score 2 UNLIKELY 2 MODERATE / LOW 1 - 3 Low risk (green)

3 MODERATE 3 SERIOUS / POSSIBLE 4 - 6 Moderate risk (yellow) 4 LIKELY 4 MAJOR 8 - 12 High risk (orange)

5 ALMOST 5 FATAL / CATASTROPHIC 15 - 25 Extreme risk (red) CERTAIN

A fuller description of impact scores can be found at appendix 1.

IMPACT 1 2 3 4 5

1 1 2 3 4 5 Please take care with this assessment. A carefully completed assessment should safeguard against 2 2 4 6 8 10 challenge at a later date. 3 3 6 9 12 15

LIKELIHOOD 4 4 8 12 16 20 5 5 10 15 20 25

1 34 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Stage 1 The following assessment screening tool will require judgement against the 6 areas of risk in relation to Quality as well as equality and diversity. 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 Team.

Title and lead for scheme: Intermediate Care Review – William Guy, Director of Strategy and Transformation

Brief description of scheme: The Intermediate Care Review combines the requirement to deliver efficiencies and enable patients to receive care in the right place to optimise their independence and long term outcomes whilst addressing the changes required in the out of hospital community services. The Intermediate Care Bed review project was established to evaluate the existing intermediate care bed units function and utilisation to ensure keeping the units still met the needs of our population.

Following audit and detailed evaluation it became apparent that with enhanced community based (non bed based) provision in addition to Essex County Council re-ablement service, the majority of the existing intermediate care bed patients could have been managed at home. The CCG therefore recognised the need to implement new pathways of care to support a bed base reduction.

This EQIA has been undertaken to assess the impact of reducing the current IC bed base by 22 beds or one unit.

Answer positive/negative (P/N) in each area. If Negative score the impact, likelihood and total in the appropriate box. If score > 8 insert Y for full assessment

Area of Impact question P/N Impact Likeli- Score Full Quality hood Assessment required 1 Duty of Could the proposal impact positively or negatively on any of the P/N 5 5 25 Yes Quality following - compliance with the NHS Constitution (see appendix 3), partnerships, safeguarding children or adults ? 2 Equality and Could the proposal impact positively or negatively on any of the P/N 3 3 9 Yes Diversity protected characteristics under the Equality Act 2010 (see appendix 2) 3 Patient Could the proposal impact positively or negatively on any of the P Yes 2 35 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Experience following - positive survey results from patients, patient choice, personalised & compassionate care?

4 Carers Could the proposal impact positively or negatively on informal P/N Yes experience carers? (if negatively, is there an identified resource to meet the need, or does the need require flagging to the CCG carers lead)? 5 Patient Could the proposal impact positively or negatively on any of the P/N Safety following – safety, systems in place to safeguard patients to prevent harm, including infections? 6 Clinical Could the proposal impact positively or negatively on evidence P/N Effectiveness based practice, clinical leadership, clinical engagement and/or high quality standards? 7 Prevention Could the proposal impact positively or negatively on promotion P/N of self-care and health inequality? 8 Productivity Could the proposal impact positively or negatively on - the best P/N 4 3 12 Yes and setting to deliver best clinical and cost effective care; Innovation eliminating any resource inefficiencies; low carbon pathway; improved care pathway?

Please describe your rationale for any negative/positive impacts; key facts and figures about the local population including who has been consulted to complete this section.

Please see the descriptions in the relevant sections.

This document has been completed by Karen Wesson, Siobhan Redwood and William Guy.

3 36 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Signature: Designation: Date: S. Redwood/ K. Wesson/ W. Guy Commissioning/ Transformation 10/05/2016

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Stage 2

Risk (5 x5 risk

matrix)

Area of Mitigation strategy and

Description of impact (Positive or Indicators quality negative) monitoring arrangements

Score Impact Overall

Likelihood

AND

Does it impact on the organisation’s Currently the system is unable to achieve the The out of hospital IC model will commitment to the public to continuously 4 hour target for A&E with the existing IC bed be implemented with potential drive quality improvement as reflected in base. There is potential that any reduction ability to up scale to meet the the rights and pledges of the NHS will negatively impact this constitutional target increased demand- potentially EQUALITY Constitution? without investment in the alternative non bed reducing the negative impact. based model to mitigate the risk to the The out of hospital model needs system. to ensure that the 24hr period DUTY OF QUALITY can be managed in a non bed based setting.

5 38 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Does it impact on the organisation’s Through investment in the non based model commitment to high quality workplaces, with the chosen provider of this service will be Work with providers to commissioners and providers aiming to be able to evidence to staff that they are commence recruitment, employers of choice as reflected in the delivering and supporting a service with ensuring positive publicity to rights and pledges of the NHS Constitution? improved outcome measures for patients. support the new model to help This should increase staff satisfaction. entice staff to work within this service. There is however a potential negative impact in that staff who work in the current inpatient

units could be affected by TUPE, a concern 5 5 Ensuring that staff required to be 25 would be that the alternative non bed based redeployed through the option would require staff to travel to see proposed change are where patients, this was previously not a possible slotted in to vacancies requirement in their existing role. that meet their skills and competencies rather than loose Potential risk of staff satisfaction and the staff from the system. It may retention is impacted by the proposed need to be considered that they change. are notified of other local provider opportunities.

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What is the impact on strategic partnerships BTUH: Ensure all stakeholders are and shared risk?  Achievement of the constitutional standards aware of the IC bed review and  The impact ability to shape/ provide the alternative non bed based model potential impact on their service ECC: and have ability to adapt to the  The proposed change to the existing model potential reduction of an could pose a significant pressure on their inpatient unit. reablement service. This service is already at full capacity with no reduction to the bed base which is impacting on BTUH ability to deliver their constitutional standards. This is also potentially a cost pressure to ECC.  The proposed change will impact on interim care placements- increasing demand and occupancy.

NELFT:  Potential reduction in the services NELFT provide if unit to close is a NELFT unit.  The impact ability to shape/ provide the alternative non bed based model  Potential risk of staff satisfaction and retention is impacted by the proposed change. SEPT:  Potential reduction in the services SEPT provide if unit to close is a SEPT unit.

 The impact ability to shape/ provide the 4 5 alternative non bed based model 20  Potential risk of staff satisfaction and retention is impacted by the proposed change.

Thurrock Borough Council:  The proposed change to the existing model could pose a significant pressure on their reablement service. This service is already at full capacity with no reduction to the bed base which is impacting on BTUH ability to deliver their constitutional standards. This is also potentially a cost pressure to TBC.  The proposed change will impact on interim care placements- increasing demand and occupancy.

EEAST & Thames:  Potential increased patient journeys both for transfer from acute to IC unit and need for PTS for discharge and home visits to enable discharge.

Hospices:  Proposed change to IC unit function could impact on hospice services through increased demand on existing capacity. 7

40 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

What is the specific impact of the project on Age: Where reasonable adjustments people with protected characteristics, in • The units currently manage patients can be made to the new model terms of individual and community health, aged 18+. to address the identified impacts access to services and patient experience? Gender :(including gender identity) this happens. • Any reconfig of units would have to The providers are legal required ensure compliance with MSA to assess mental capacity of Marital status: patients and ensure use of • Any reconfiguration should ensure DOLs. the ability for married couples who required inpatient care to receive care in the same unit. Disability: • The units and out of hospital offer should be able to manage patients with disability and access relevant equipment, aids and appliances so there is no negative impact. Ethnicity / Race:

• N/A Religion or belief: • Any unit should have an area or room to allow patients to practice their religion or spiritual belief. • Cultural or religious requirements should be managed by the provider of the unit or non bed based unit.

Human Rights: Deprivation of liberties and mental capacity: • The default position is that everyone has capacity, however if they are assessed and deemed not to have capacity then the provider will utilise as part fo the Human Rights Act that they are assessed to ensure there is no impact on their DOLs Are core clinical quality indicators and Yes, any change will be contracted by the metrics in place to review impact on quality CCG with the use of the NHS standard contract. This has national quality indicators improvements? that the providers will be monitored against and local additional indicators can be added and managed through the contract. 8 41 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Will this impact on the organisation’s duty to The default position is that everyone has protect children, young people and adults? capacity, however if they are assessed and deemed not to have capacity then the

provider will utilise as part of the Human Rights Act that they are assessed to ensure there is no impact on their DOL Yes- Each provider is currently monitored and will continue to be monitored after the What impact is it likely to have on self change on FFT and local modification of FFT. reported experience of patients and service This will not change. The CCG will also users? (Response to national/local monitor incidents and complaints via the

surveys/complaints/PALS/incidents) relevant contractual quality groups. How will it impact on choice? No- Under the NHS framework for choice CCGs are not obligated to offer choice of provider. The framework supports CCGs to direct patients to the care of their commissioned community service. Where there is a need for a patient to access an acute service choice of provider will become

applicable.

PATIENT EXPERIENCE Does it support the compassionate and Yes- The change in both IC unit and non bed personalised care agenda? based unit will be underpinned by the CCG requiring the provider to manage the patient with and individualised and personalised care

plan that reflects their care and support n/a n/a n/a needs. n/a n/a n/a

9 42 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

What impact is it likely to have on self Yes- Each provider is currently monitored Transport links and support with reported experience of carer and service and will continue to be monitored after the transport costs should be made users? (Response to national/local change on FFT and local modification of FFT. public to minimise this risk.???? surveys/complaints/PALS/incidents) This will not change. The CCG will also Health costs don’t apply to monitor incidents and complaints via the carers. relevant contractual quality groups.

Potentially reduction of a unit may impact on carers ability to visit due to accessibility of public transport however there are bus routes via each unit.

Availability should be made within the

inpatient unit for carers to stay with the patient if required to have access to day rooms or quiet areas where they can spend time with the patient.

EXPERIENCE

The proposed model needs to ensure that the carers needs are reflected in the care

plan. 2 1 2

CARER How will it impact on choice? No- Under the NHS framework for choice CCGs are not obligated to offer choice of provider. The framework supports CCGs to direct patients to the care of their commissioned community service. Where there is a need for a patient to access an acute service choice of provider will become

applicable. n/a n/a n/a Does it support the compassionate and Yes- The change in both IC unit and non bed based unit will be underpinned by the CCG personalised care agenda? requiring the provider to manage the patient with and individualised and personalised care plan that reflects their care and support

needs. as above

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How will it impact on patient safety? Prior to admission to the IC unit or discharge to the out of hospital model, the patient should be assessed to ensure their needs can be safely managed in which ever setting is determined. Equipment, etc. should be assessed for the individuals use and the patient and/ or carer should be provided with training in the use of

it to remain safe. How will it impact on preventable harm? Through the reconfiguration the unit assessed for dementia patients will need to ensure compliance with requirements to reduce harm, maintain patient safety whilst not impacting on either the patients or other

patients.

Will it maximise reliability of safety Whichever unit remains will have been systems? chosen to ensure the relevant and required safety systems are in place.

n/a n/a n/a How will it impact on systems and Any commissioned service is required to PATIENT SAFETY processes for ensuring that the risk of ensure compliance with infection prevention healthcare acquired infections is reduced? control policies and report incidences in line with the NHS Standard Contract so that the route cause and avoidability can be assessed and future preventative measures implemented. Proposed changes will not

affect this process. Potentially there is :  Opportunity for development of skills in rehabilitation/ dementia  Opportunity to move within the services Need to ensure training and awareness in What is the impact on clinical workforce managing patients safety in an out of hospital capability care and skills? setting

11 44 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Any service change allows the CCG and How does it impact on implementation of provider to review the model ensuring it evidence based practice? meets current best practice.

The closure of a unit may potentially impact on the medical leadership and staffing model. This would need to be reviewed in line with

2 3 6

How will it impact on clinical leadership? the wider offer. Through the evaluation and audit undertaken by the IC bed review project group it was identified that patients were in IC units longer than required or admitted due to lack of Does it support the full adoption of Better alternative provision. The proposed care, Better Value metrics? commissioned change would address this. n/a n/a n/a

The potential change and model led by one Does it reduce/impact on variations in care? provider would reduce variation. n/a n/a n/a CLINICAL EFFECTIVENESS

Are systems for monitoring clinical quality supported by good information? Yes in line with the NHS Standard Contract n/a n/a n/a

Does it impact on clinical engagement? See stakeholders

as above

Yes, the premise of this model is to optimise and maintain patients/ people for as long as possible with the minimal level of care that they need to function, therefore not placing people in residential homes or providing them care packages before they have a true need PREVENTION Does it support people to stay well? for this. n/a n/a n/a

12 45 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Yes, the new model aims to ensure patients are maintained in their normal place of residence and supported to return to their optimal level of independence. There has been investment in services such as Does it promote self-care for people with dementia support and therapy to enable long term conditions? patients to be managed in this setting. n/a n/a n/a Yes- currently dependant on the persons initial presentation and assessment and where they are in the system, the impact could result in the wrong level of care however the proposed model should reduce Does it tackle health inequalities, focusing variation and inequality through equitable resources where they are needed most? standardised provision. n/a n/a n/a Yes, an audit of patients in community beds was undertaken in September 2015. This determined that a significant number of patients did not need bed based healthcare services but instead required either domiciliary based health/social care packages or bed based social care packages. The new model will ensure that patients have access to the most appropriate care package through either additional Does it ensure care is delivered in the most commissioned activity or new services in a clinically and cost effective way? community setting. n/a n/a n/a Yes, this model ensures that services users are managed in the most appropriate care pathway for their needs. In doing so, the CCG will be able to reduce the bed base it commissions and therefore generate Does it eliminate inefficiency and waste? efficiencies to the system. n/a n/a n/a PRODUCTIVITY AND INNOVATION Theoretically there will be more home visits undertaken by community staff. However, this will be part offset by a reduction in family

Does it support low carbon pathways? visits to intermediate care units 2 2 4

13 46 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Potentially: The out of hospital IC model will be • negative impact on the constitutional implemented with potential ability to up 4 hr standard scale to meet the increased demand- • positive impact for ECC performance potentially reducing the negative through increased reablement packages impact. reduced residential home placements The out of hospital model needs to

• positive impact on bed occupancy

Will the service innovation achieve large ensure that the 24hr period can be gains in performance? and ALOS for IC unit and acute 5 5 25 managed in a non bed based setting. Yes, through improved discharge from the acute to the community offer impacts on reduced LOS which in turn should positively impact on constitutional standards Reconfiguration of the IC model would streamline the pathway between IC beds and IC community offer and reablement. Potential positive impact on the CHC and IC interface pathway through potential reduction Does it lead to improvements in care in the need for CHC packages through the pathway(s)? optimisation of patients outcomes. n/a n/a n/a

Signature: Designation: Date: 10.05.2016

14 47 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 1.

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 15 48 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

16 49 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 2 Protected characteristics • Age • Gender (including gender identity) • Pregnancy • Sexual orientation • Marital status • Disability • Ethnicity / Race • Religion or belief • Human Rights (see below for summary of the main categories under the Human Rights Act 1998)

Human Rights The Human Rights Act 1998 sets universal standards to ensure that a person’s basic needs as a human being are recognised and met. Public authorities need to have arrangements in place to ensure they comply with the Act and it is unlawful for an NHS organisation to act in a way that is incompatible with the Act.

Below are some aspects of Human Rights principles and examples of their relevance to healthcare. Human rights principles should be taken into account when undertaken EIAs.

• The right to life e.g., Do Not Resuscitate orders, refusal or lifesaving medical treatment, Advance Directives

• The right not to be tortured or treated in an inhuman or degrading way e.g., leaving an incontinent patient without sufficient continence supplies or in soiled bed linen, staff not being protected from violent or abusive patients, leaving trays of food without helping patients to eat when they are too frail to feed themselves

• The right to liberty e.g., informal detention of patients who do not have the capacity to decide whether they would like to stay in or be admitted to hospital, e.g., dementia patients or people with learning disabilities

• The right to a fair trial

e.g., staff disciplinary proceedings, compensation claims, handling of special case panels 17 50 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 3

NHS Constitution (2013)

7 key principles 1. Comprehensive service available to all 2. Access to NHS services based on clinical need not ability to pay 3. Highest standards of excellence and professionalism 4. Patients at the heart of everything 5. Working across organisational boundaries in partnership 6. Best value for taxpayers’ money 7. Accountable to public

Values • Working together for patients • Respect and dignity • Quality of care • Compassion • Improving lives • Everyone counts

18 51 E-Cigarettes Original proposal

Basildon and Brentwood CCG are proposing that e-cigarettes and other novel nicotine containing products are not prescribed on the NHS until they have been fully evaluated, their place in therapy established, and formulary processes have been followed.

Smoking and stop smoking services fall under the remit of Public Health. NICE has issued guidance PH 45 https://www.nice.org.uk/Guidance/PH45 and associated quality standards. These recommend access to smoking cessation services, brief intervention and referral for smoking cessation. These services are available locally via Public Health.

The CCG feels there is existing sufficient support available to aid with the cessation of smoking. Rationale

Electronic cigarettes are novel devices that deliver nicotine by heating and vaporising a solution that typically contains nicotine, propylene glycol and/or glycerol and flavourings.

A Public Health England (PHE) report1 has estimated that about 2.6 million adults used electronic cigarettes in 2015. The report concluded that as of yet the long term health harms are not known.

The report also estimated that nationally there are currently 1.8m prescription items dispensed each year that relate to smoking cessation (of which about 50% are nicotine replacement therapies). The nicotine replacement therapies that can be prescribed include:

 skin patches  chewing gum  inhalators, which look like plastic cigarettes through which nicotine is inhaled  tablets, strips and lozenges, which you put under your tongue  nasal spray  mouth spray

These can all be prescribed by your GP or can be purchased within pharmacies.

Along with the prescribing of the above NRTs there is also the Public Health commissioned ‘NHS Stop Smoking Service’ that patients can access without having to contact their GP via telephone or the internet or via the online app. This service offers one-to-one sessions, group sessions or drop in services.

The CCG is not currently responsible for the commissioning of e-cigarettes. E-cigarettes are not currently prescribed as a nicotine replacement. Impact

The CCG believes that the proposed changes would have little impact on the local population as described above there are several NTRs available that support smoking cessation along with other therapies available from pharmacies. These methods are clinically proven to assist with the stopping of smoking altogether as opposed to moving to an alternative way of smoking.

52 It has been estimated that costs for e-cigarettes would be around £1.1m per 100,000 population per year and that with a population of over 260,000 the CCG would face a significant financial pressures to an already challenged health system.

EQIA

EQIA E-Cigarettes.docx

Public Survey Result

Reflection on comments

The comments are largely reflective of the vote and the common themes emerging from the feedback is that the NHS should not fund e-cigarettes as ‘smoking is a lifestyle choice’ and should be ‘self-funded’. However the counter arguments (although in the minority) from the responses received is that it is a ‘preventative measure’ and will ‘potentially save money in the long run’.

Recommendation

The recommendation to the Board is to support the following:

 for the CCG not to fund e-cigarettes  the CCG should review the position of prescribing of all nicotine replacements

53 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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 1 RARE 1 MINOR score 2 UNLIKELY 2 MODERATE / LOW 1 - 3 Low risk (green)

3 MODERATE 3 SERIOUS / POSSIBLE 4 - 6 Moderate risk (yellow) 4 LIKELY 4 MAJOR 8 - 12 High risk (orange)

5 ALMOST 5 FATAL / CATASTROPHIC 15 - 25 Extreme risk (red) CERTAIN

A fuller description of impact scores can be found at appendix 1.

IMPACT 1 2 3 4 5

1 1 2 3 4 5 Please take care with this assessment. A carefully completed assessment should safeguard against 2 2 4 6 8 10 challenge at a later date. 3 3 6 9 12 15

LIKELIHOOD 4 4 8 12 16 20 5 5 10 15 20 25

1 54 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Title and lead for scheme: Francoise Price/ Jonathan Andrews

Brief description of scheme: e-cigarettes not to be prescribable on FP10 until place in therapy and funding streams agreed

Answer positive/negative (P/N) in each area. If Negative score the impact, likelihood and total in the appropriate box. If score > 8 insert Y for full assessment

Area of Impact question P/N Impact Likeli- Score Full Quality hood Assessment required 1 Duty of Could the proposal impact positively or negatively on any of the No Quality following - compliance with the NHS Constitution (see appendix 3), partnerships, safeguarding children or adults ? 2 Equality and Could the proposal impact positively or negatively on any of the No Diversity protected characteristics under the Equality Act 2010 (see appendix 2) 3 Patient Could the proposal impact positively or negatively on any of the N 2 2 4 N Experience following - positive survey results from patients, patient choice, personalised & compassionate care?

4 Carers Could the proposal impact positively or negatively on informal No experience carers? (if negatively, is there an identified resource to meet the need, or does the need require flagging to the CCG carers lead)? 5 Patient Could the proposal impact positively or negatively on any of the P 3 2 6 N Safety following – safety, systems in place to safeguard patients to prevent harm, including infections? N 6 Clinical Could the proposal impact positively or negatively on evidence No 2 55 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Effectiveness based practice, clinical leadership, clinical engagement and/or high quality standards? 7 Prevention Could the proposal impact positively or negatively on promotion No of self-care and health inequality? 8 Productivity Could the proposal impact positively or negatively on - the best No and setting to deliver best clinical and cost effective care; Innovation eliminating any resource inefficiencies; low carbon pathway; improved care pathway?

Please describe your rationale for any negative/positive impacts; key facts and figures about the local population including who has been consulted to complete this section.

The proposal will not impact on 1,2,4,6,7 & 8 as it is seeking to provide evidence based cost effective prescribing.

There may be a negative impact on patient experience as a result of limiting patient choice initially. Once evidence based pathway agreed then those who fulfil the criteria will have access to e-cigarettes. People can currently purchase e-cigarettes from a range of outlest.

There may be a positive impact on patient safety as currently there is no information on long term harms from using e-cigarettes. There may be a negative impact on patient safety as patients continue to smoke however these patients still have access to stop smoking services which use a range of drugs and nicotine replacement.

See East of England Priority Advisory Committee Interim Guidance statement on Electronic cigarettes (e-cigarettes) and other novel nicotine containing products for tobacco dependence https://www.prescqipp.info/resources/send/282-e-cigarettes/2615-e- cigarettes

Signature: Designation: Date: Interim Head of Medicines Optimisation 13.6.16

3 56 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Stage 2

Risk (5 x5 risk

matrix)

Area of Mitigation strategy and

Description of impact (Positive or Indicators quality negative) monitoring arrangements

Score Impact Overall

Likelihood

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 AND EQUALITY

rights and pledges of the NHS Constitution? What is the impact on strategic partnerships and shared risk?

. What is the specific impact of the project on people with protected characteristics, in DUTY OF QUALITY

terms of individual and community health, access to services and patient experience?

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

4 57 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

What impact is it likely to have on self

reported experience of patients and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice?

Does it support the compassionate and personalised care agenda? PATIENT EXPERIENCE

What impact is it likely to have on self

reported experience of carer and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice? EXPERIENCE

Does it support the compassionate and

CARER personalised care agenda?

How will it impact on patient safety? SAFETY PATIENT

5 58 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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? CLINICAL EFFECTIVENESS

Does it reduce/impact on variations in care?

6 59 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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? PREVENTION

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

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

Does it eliminate inefficiency and waste?

PRODUCTIVITY AND INNOVATION Does it support low carbon pathways?

7 60 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Will the service innovation achieve large gains in performance?

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

Signature: Designation: Date:

8 61 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 1.

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

short-term reduction in public long-term reduction in public confidence confidence 9 62 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

10 63 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Below are some aspects of Human Rights principles and examples of their relevance to healthcare. Human rights principles should be taken into account when undertaken EIAs.

• The right to life e.g., Do Not Resuscitate orders, refusal or lifesaving medical treatment, Advance Directives

• The right to a fair trial

e.g., staff disciplinary proceedings, compensation claims, handling of special case panels 11 64 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 3

NHS Constitution (2013)

Values • Working together for patients • Respect and dignity • Quality of care • Compassion • Improving lives • Everyone counts

12 65 Gluten-free prescribed foods

Original proposal

As part of a wider review into service restrictions Basildon and Brentwood CCG is proposing to stop all gluten free products on prescription with exceptions of pregnant women (from the point of confirmed pregnancy) and under 18s.

Rationale

Initially gluten free products were added to the list of products available on NHS prescription when they were not easily available for patients to purchase.

However, there are now a wide range of gluten free products available from supermarkets, the internet, health food stores and pharmacies. There are alternative products that are sold at prices that are considerably lower than the NHS is charged for prescribed foods. In addition to these products there is a wide variety of naturally gluten free food including; fresh fruit and vegetables, meat, poultry, fish, cheese and eggs.

In October 2016 NICE published the first quality standard* for Coeliac disease (Appendix 4), this quality standard outlines that patients should be able to access support and guidance on how to follow a gluten free diet.

Rationale – Post Consultation

Gluten free products are now available to purchase, food products for other allergies are not funded on prescription and many not as accessible as Gluten Free foods for example soya, nut and dairy free.

The consultation was seeking to ensure a reduction in inequity for our patient population and as such should ensure that the same position is taken for all of the population.

Impact

With the variety of gluten free products widely available to buy at a reasonable cost, the CCG believes there will be minimal impact to patients.

EQIA

EQIA Gluten Free Prescibing v2 (3).docx

Public Survey Result

*Quality Standards are not mandatory

66 Reflection on comments

The comments received reflected either the person’s own opinion regarding their concern relating to:

 Cost of gluten free alternate products  Taste of gluten free alternate products  Accessibility of gluten free alternate products  Impact on cost if they have a pre-paid prescription card and then can’t use this as the CCG no longer prescribe these products

People who weren’t directly impacted by the proposal to cease prescribing of Gluten free feedback included:

 Why is the CCG prescribing gluten free if not prescribing/free foods for other allergies or food intolerances e.g. diary free/nut free/soya free  Other foods are high cost and not accessible therefore should be the same for all i.e. not prescribed

Work undertaken by the CCG to support the proposed change/consultation information:

 Provided unmarked gluten free flour products for a “blind trial” to a member of the public in order that they could test the baking and taste of three readily accessible products, and to subsequently let the CCG know how these compared to the prescription products  Scoped availability of gluten free products and accessibility/availability and cost  Reviewed the CCG website information for all allergy/intolerance support and navigation, and continue working on enhancing this information to support our population’s needs

Recommendation

The recommendation to Board is to:

 Support the proposal to stop all gluten free products on prescription with exceptions of pregnant women (from confirmation of pregnancy) and under 18s  Support further consideration or review by the CCG to stop prescribing gluten free products for pregnant women (from confirmation of pregnancy) and under 18s in line with the public feedback that this provides inequity across the population  If the above are approved, the Board is asked to support the below mitigating actions

Mitigating actions if recommendation approved:  Agree a process for those patients who have a pre-paid prescription (https://www.gov.uk/get- a-ppc) where it is only used for gluten free products  Ensure that the CCG website reflects that there are a range of dietary needs and can navigate patients to help and advice for accessing this regardless of diagnosis  Engage with organisations supporting those who require ‘free from’ allergens diet to ensure that the CCG is able to provide navigation on the website  Write requesting ‘free from’ allergens foods are more accessible locally in supermarkets and at other retailers including pharmacies

*Quality Standards are not mandatory

67 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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 1 RARE 1 MINOR score 2 UNLIKELY 2 MODERATE / LOW 1 - 3 Low risk (green)

3 MODERATE 3 SERIOUS / POSSIBLE 4 - 6 Moderate risk (yellow) 4 LIKELY 4 MAJOR 8 - 12 High risk (orange)

5 ALMOST 5 FATAL / CATASTROPHIC 15 - 25 Extreme risk (red) CERTAIN

A fuller description of impact scores can be found at appendix 1.

IMPACT 1 2 3 4 5

1 1 2 3 4 5 Please take care with this assessment. A carefully completed assessment should safeguard against 2 2 4 6 8 10 challenge at a later date. 3 3 6 9 12 15

LIKELIHOOD 4 4 8 12 16 20 5 5 10 15 20 25

1 68 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Title and lead for scheme: Siobhan Redwood/ Karen Wesson

Brief description of scheme: As part of a wider review into service restrictions Basildon and Brentwood CCG is proposing to stop all gluten free (GF) products on prescription (with exceptions of pregnant women and under 18s).

Answer positive/negative (P/N) in each area. If Negative score the impact, likelihood and total in the appropriate box. If score > 8 insert Y for full assessment

Area of Impact question P/N Impact Likeli- Score Full Quality hood Assessment required 1 Duty of Could the proposal impact positively or negatively on any of the P No Quality following - compliance with the NHS Constitution (see appendix 3), partnerships, safeguarding children or adults ? 2 Equality and Could the proposal impact positively or negatively on any of the N 2 3 6 No Diversity protected characteristics under the Equality Act 2010 (see appendix 2) 3 Patient Could the proposal impact positively or negatively on any of the N 2 3 6 No Experience following - positive survey results from patients, patient choice, personalised & compassionate care?

4 Carers Could the proposal impact positively or negatively on informal N 2 3 6 No experience carers? (if negatively, is there an identified resource to meet the need, or does the need require flagging to the CCG carers lead)? 5 Patient Could the proposal impact positively or negatively on any of the N/A Safety following – safety, systems in place to safeguard patients to prevent harm, including infections? 2 69 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

6 Clinical Could the proposal impact positively or negatively on evidence N/A Effectiveness based practice, clinical leadership, clinical engagement and/or high quality standards? 7 Prevention Could the proposal impact positively or negatively on promotion P No of self-care and health inequality? 8 Productivity Could the proposal impact positively or negatively on - the best P No and setting to deliver best clinical and cost effective care; Innovation eliminating any resource inefficiencies; low carbon pathway; improved care pathway?

Please describe your rationale for any negative/positive impacts; key facts and figures about the local population including who has been consulted to complete this section.

Initially gluten free products were added to the list of products available on NHS prescription when they were not easily available for patients to purchase.

Now there is a wide range of gluten free products available from supermarkets, the internet and health food stores along with local pharmacies that are sold at prices that are considerably lower than the NHS is charged when bought for use on prescription – in some cases less than half the price. In addition to these products there is also a wide variety of naturally gluten free food including; fresh fruit and vegetables, meat, poultry, fish, cheese and eggs.

However there could be a negative impact on elderly, the disabled or people who do not have access to the internet and do not have access to the large supermarkets where gluten free foods to purchase are stocked. Some more rural areas in the Brentwood villages may have pharmacies that don’t stock gluten free however there is the facility for the pharmacy to order goods or some GP practices which should reduce some of the impact.

There could be a potential negative impact on patients on restricted incomes however as the gluten free market is increasing this is making the market more competitive and therefore the prices are reducing in line with non- gluten free products.

In order to be transparent regarding the proposed changes the CCG is going out to public consultation for 12 weeks in which time it will ensure it liaises with service users, patient groups, stakeholders and interest groups.

3 70 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Neighbouring Essex CCGs have implemented these changes therefore in order to reduce variation across the county and promote self-care the CCG feels there would be negligible impact on patients.

The proposed changes would make approx. efficiencies of £100k over the course of a year which would be reinvested back into the system and go towards the viability of the local health economy and local services and would be the best value of tax payers’ money.

Signature: S. Redwood Designation: Senior Commissioning Support Officer Date: 08.06.2016

4 71 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Stage 2

Risk (5 x5 risk

matrix)

Area of Mitigation strategy and

Description of impact (Positive or Indicators quality negative) monitoring arrangements

Score Impact Overall

Likelihood

Does it impact on the organisation’s commitment to the public to continuously drive quality improvement as reflected in

rights and pledges of the NHS Constitution? What is the impact on strategic partnerships and shared risk?

. What is the specific impact of the project on people with protected characteristics, in DUTY OF QUALITY

terms of individual and community health, access to services and patient experience?

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

5 72 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

What impact is it likely to have on self

reported experience of patients and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice?

Does it support the compassionate and personalised care agenda? PATIENT EXPERIENCE

What impact is it likely to have on self

reported experience of carer and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice? EXPERIENCE

Does it support the compassionate and

CARER personalised care agenda?

How will it impact on patient safety? SAFETY PATIENT

6 73 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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? CLINICAL EFFECTIVENESS

Does it reduce/impact on variations in care?

7 74 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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? PREVENTION

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

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

Does it eliminate inefficiency and waste?

PRODUCTIVITY AND INNOVATION Does it support low carbon pathways?

8 75 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Will the service innovation achieve large gains in performance?

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

Signature: Designation: Date:

9 76 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 1.

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

short-term reduction in public long-term reduction in public confidence confidence 10 77 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

11 78 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Below are some aspects of Human Rights principles and examples of their relevance to healthcare. Human rights principles should be taken into account when undertaken EIAs.

• The right to life e.g., Do Not Resuscitate orders, refusal or lifesaving medical treatment, Advance Directives

• The right to a fair trial

e.g., staff disciplinary proceedings, compensation claims, handling of special case panels 12 79 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 3

NHS Constitution (2013)

Values • Working together for patients • Respect and dignity • Quality of care • Compassion • Improving lives • Everyone counts

13 80

Dr Arv Guniyangodage Basildon and Brentwood CCG Phoenix Place Christopher Martin Road Basildon Essex SS14 3HG

13 July 2016

Dear Dr Guniyangodage

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

It has come to our attention that Basildon and Brentwood 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].

We are concerned that the consultation document lacks direct reference to coeliac disease. We do not feel that this provides enough detail for people completing the survey who do not have coeliac disease themselves. Gluten-free foods on prescription are only approved by the Advisory Committee on Borderline Substances (ACBS) for patients with a medical diagnosis of coeliac disease. This misperception of the GFD is leading to an inequity in health care for patients with coeliac disease. Unlike other autoimmune diseases (such as Type 1 Diabetes or Autoimmune Thyroid Disease) where prescriptions are free, the selection of GFD prescriptions as an option for budgetary savings will have a significant impact on patients health and this in turn will generate long-term costs to the NHS which will be greater than the short term savings.

[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.

Dr Arv Guniyangodage Basildon and Brentwood CCG Phoenix Place Christopher Martin Road Basildon Essex SS14 3HG 13 July 2016 Dear Dr Guniyangodage

We have been made aware of the review of gluten-free prescribing by Basildon and Brentwood clinical commissioning group (CCG). As the 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 for adults, with the exception of pregnant women. Gluten-free food on prescription provides 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 the UK, bread remains a staple food and is an important source of energy (11% of total 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. Potatoes and rice, for example only provide a fraction of these important nutrients, so that removing important staples from the diet may therefore result in malnutrition particularly for those who will already struggle with such a major dietary change [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 We are concerned that the consultation document does not once reference coeliac disease and simply refers to gluten-free food. We do not feel that this provides reasonable context to those completing the

83 survey who many not be aware of the issues surrounding managing the gluten-free diet – indeed it could be said to be entirely misleading without this context. Gluten-free foods on prescription are only approved by the Advisory Committee on Borderline Substances (ACBS) for patients with a medical diagnosis of coeliac disease.

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. This is of particular importance since some areas of your CCG are in the most deprived 10 per cent of neighbourhoods nationally on the Index of Multiple Deprivation 2015 [9]. The consultation 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.

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. You state in the consultation document that the CCG feels there will be minimal impact to patients. Have you considered the draft National Institute of Health and Care Excellence (NICE) coeliac disease Quality Standard equality impact assessment in your 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

[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 [9] Department for Communities and Local Government (2015) The English Indices of Deprivation 2015.

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

01-07-2008 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

85 86 87 88 89 90 91 11/17/2016 NICE quality standard on coeliac disease published today

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NICE quality standard on coeliac disease View this email in your browser

NICE publishes the first quality standard on coeliac disease

On 19 October, the National Institute of Health and Care Excellence (NICE) published the first quality standard on coeliac disease.

The new standard sets out five key areas to drive measurable improvements in diagnosis, support and health for patients with coeliac disease.

One of the key themes of the standard is the need to address health inequalities.

NICE highlights the importance of equality and diversity considerations around access to gluten free food on prescriptions for vulnerable patients. NICE advises that support in maintaining a gluten free diet should include consideration of vulnerabilities, including where there is more than one person with coeliac disease in the household, where mobility issues exist and where patients are struggling on low incomes. The risk of widening health inequalities for people in deprived areas is also made with reference to attendance at annual patient review.

We share the concerns about growing inequality in the management of coeliac disease and are writing to commissioners and Health and Wellbeing Boards to highlight these issues and press for further action and improve monitoring. Please take some time to read through the new NICE quality standard and take action wherever you find the opportunity. Our priorities include ensuring patients who need support to adhere to the glutenfree diet are able to access help glutenfree food on prescription, that all patients with coeliac disease are offered an annual review and that the diagnosis rate of coeliac disease is lifted.

The five key areas within the standard are:

1. People at increased risk or with symptoms of coeliac disease are offered a serological test for coeliac disease.

2. People with a positive serological test for coeliac disease are referred to a specialist and advised to continue with a gluten‑containing diet until diagnosis is confirmed.

3. People referred to a specialist who need an endoscopic intestinal biopsy to diagnose coeliac disease have it within six weeks of referral.

4. People newly diagnosed with coeliac disease discuss how to follow a gluten‑free diet with a healthcare professional with specialist knowledge of coeliac disease and healthcare professionals should help people who may need support to find suitable glutenfree food products on prescription to enable them to maintain a glutenfree diet.

5. People with coeliac disease are offered an annual review and that healthcare professionals in socioeconomically deprived areas agree a local approach to encourage attendance.

92 http://us12.campaignarchive2.com/?u=a8ac5ed53d9251a292194fd1b&id=e6e261af7e&e=ea4f8407ca 1/2 11/17/2016 NICE quality standard on coeliac disease published today Read the full quality standard on the NICE website. Subscribe Share Past Issues Translate

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93 http://us12.campaignarchive2.com/?u=a8ac5ed53d9251a292194fd1b&id=e6e261af7e&e=ea4f8407ca 2/2 Toric Intraocular Lens Implants for Astigmatism

Original proposal

As part of a wider review of service restrictions Basildon & Brentwood CCG are proposing to cease the funding of Toric intraocular lens implant (IOLs) for astigmatism. Rationale

The standard IOLs design used for cataract surgery in the NHS is the monofocal IOLs. The Toric IOLs are the so called ‘premium lens’ however these come at a greater cost than the standard.

The proposal the CCG is making isn’t to stop funding all procedures of IOLs and correction of cataracts just the Toric IOLs. The Toric IOLs works towards patients not requiring glasses as it potentially improves astigmatism however with limited funds the CCG aim is to bring people back to a pre cataract position not correction of astigmatism

The CCG’s approach to the current financial challenges is to prioritise the limited funding it has so that the local population has access to the healthcare that is most needed. This assessment of need is made across the whole population of Basildon & Brentwood CCG and, wherever possible, on the basis of best evidence on what is clinically proven to work. Impact

The efficiencies made by not funding this procedure will go towards bringing the CCG back to its statuary financial balance position which is vital in order for it to be viable organisation and fund future services for the local population.

As there are alternative IOLs procedures available the CCG believes there would be limited impact to patients. EQIA

EQIA Toric IOLs v1.3.docx Public Survey Result

Reflection on comments

94 When reviewing the comments, the most common response was ‘if it is clinically effective it should be used’ however, another common response was ‘I don’t know what this is’. Overall the feedback is largely in favour for the CCG to fund this procedure although on balance based on the comments made, there may be an issue with understanding the specifics of this lens vs. what lenses are already available. Recommendation The recommendation to the Board is that Basildon and Brentwood CCG should not fund Toric Intraocular Lens Implants for Astigmatism. The basis for this recommendation is that the CCG already funds standard monofocal IOL and as the Toric lens is a premium lens it will be more expensive.

95 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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 1 RARE 1 MINOR score 2 UNLIKELY 2 MODERATE / LOW 1 - 3 Low risk (green)

3 MODERATE 3 SERIOUS / POSSIBLE 4 - 6 Moderate risk (yellow) 4 LIKELY 4 MAJOR 8 - 12 High risk (orange)

5 ALMOST 5 FATAL / CATASTROPHIC 15 - 25 Extreme risk (red) CERTAIN

A fuller description of impact scores can be found at appendix 1.

IMPACT 1 2 3 4 5

1 1 2 3 4 5 Please take care with this assessment. A carefully completed assessment should safeguard against 2 2 4 6 8 10 challenge at a later date. 3 3 6 9 12 15

LIKELIHOOD 4 4 8 12 16 20 5 5 10 15 20 25

1 96 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Title and lead for scheme: Toric intraocular lens implant for astigmatism

Brief description of scheme: As part of a wider review of service restrictions Basildon & Brentwood CCG are proposing to cease the funding of Toric intraocular lens implant for astigmatism.

Answer positive/negative (P/N) in each area. If Negative score the impact, likelihood and total in the appropriate box. If score > 8 insert Y for full assessment

Area of Impact question P/N Impact Likeli- Score Full Quality hood Assessment required 1 Duty of Could the proposal impact positively or negatively on any of the N/A Quality following - compliance with the NHS Constitution (see appendix 3), partnerships, safeguarding children or adults ? 2 Equality and Could the proposal impact positively or negatively on any of the N/A Diversity protected characteristics under the Equality Act 2010 (see appendix 2) 3 Patient Could the proposal impact positively or negatively on any of the N 2 3 6 No Experience following - positive survey results from patients, patient choice, personalised & compassionate care?

4 Carers Could the proposal impact positively or negatively on informal N/A experience carers? (if negatively, is there an identified resource to meet the need, or does the need require flagging to the CCG carers lead)? 5 Patient Could the proposal impact positively or negatively on any of the N/A Safety following – safety, systems in place to safeguard patients to prevent harm, including infections? 2 97 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

6 Clinical Could the proposal impact positively or negatively on evidence N/A Effectiveness based practice, clinical leadership, clinical engagement and/or high quality standards? 7 Prevention Could the proposal impact positively or negatively on promotion N/A of self-care and health inequality? 8 Productivity Could the proposal impact positively or negatively on - the best P 2 3 6 No and setting to deliver best clinical and cost effective care; Innovation eliminating any resource inefficiencies; low carbon pathway; improved care pathway?

Please describe your rationale for any negative/positive impacts; key facts and figures about the local population including who has been consulted to complete this section.

As there is insufficient clinical and cost effective evidence to support the use of Toric IOLs the CCG believes that use of the current IOLs is the best value for money. The Toric IOL has been described by the Royal College of Ophthalmologist as the so called ‘premium lens’ and is an additional cost. The CCG should providing care at the point of need rather than using more expensive methods with little or no evidence to support this.

Whilst this may impact on patient choice, there are still standard IOLs used that are funded therefore we believe that the impact to patients would be mimimal.

3 98 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Signature: Designation: Date: S. Redwood Senior Commissioning Support Officer 29/6/2016

4 99 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Stage 2

Risk (5 x5 risk

matrix)

Area of Mitigation strategy and

Description of impact (Positive or Indicators quality negative) monitoring arrangements

Score Impact Overall

Likelihood

Does it impact on the organisation’s commitment to the public to continuously drive quality improvement as reflected in

rights and pledges of the NHS Constitution? What is the impact on strategic partnerships and shared risk?

. What is the specific impact of the project on people with protected characteristics, in DUTY OF QUALITY

terms of individual and community health, access to services and patient experience?

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

5 100 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

What impact is it likely to have on self

reported experience of patients and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice?

Does it support the compassionate and personalised care agenda? PATIENT EXPERIENCE

What impact is it likely to have on self

reported experience of carer and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice? EXPERIENCE

Does it support the compassionate and

CARER personalised care agenda?

How will it impact on patient safety? SAFETY PATIENT

6 101 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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? CLINICAL EFFECTIVENESS

Does it reduce/impact on variations in care?

7 102 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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? PREVENTION

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

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

Does it eliminate inefficiency and waste?

PRODUCTIVITY AND INNOVATION Does it support low carbon pathways?

8 103 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Will the service innovation achieve large gains in performance?

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

Signature: Designation: Date:

9 104 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 1.

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

short-term reduction in public long-term reduction in public confidence confidence 10 105 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

11 106 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Below are some aspects of Human Rights principles and examples of their relevance to healthcare. Human rights principles should be taken into account when undertaken EIAs.

• The right to life e.g., Do Not Resuscitate orders, refusal or lifesaving medical treatment, Advance Directives

• The right to a fair trial

e.g., staff disciplinary proceedings, compensation claims, handling of special case panels 12 107 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 3

NHS Constitution (2013)

Values • Working together for patients • Respect and dignity • Quality of care • Compassion • Improving lives • Everyone counts

13 108 In-vitro Fertilisation (IVF) and Assisted Conception (new referrals)

Original proposal

Option 1 – No change to the existing policy

Maintenance of the status quo. Assisted conception, including offering three cycles of IVF, would continue to be available to those who meet the eligibility criteria. Outside the agreed eligibility criteria, clinically exceptional cases would be considered by application to the CCG’s exceptional cases panel.

Option 2 – Decommission Specialist Fertility Services

Under this option the CCG would cease commissioning specialist fertility services. Patients would only be able to access gynaecology services within local district general hospital. A summary of the fertility services that will be available under this option is defined in Appendix 1.

If implemented, this policy would apply to only those patients referred onto specialist fertility pathways from the date of implementation. Any patient on an existing pathway would be able to conclude their pathway in line with the current restriction policy1.

Clinically exceptional cases would be considered by application to the CCG’s Individual Funding Request Panel. The CCG would keep and monitor the impact of the change on both services and people with fertility problems. There would be a review of the policy annually and further changes could be applied, including a return to wider access to specialist fertility services, if this was considered to be affordable.

The only exception to this would be to continue to commission fertility preservation.

Proposed criteria Current criteria

Egg harvesting The CCG proposal is that they fund the When considering and using and storage for harvesting and storage of eggs that for cryopreservation for people before patients those undergoing treatment for cancer starting chemotherapy or undergoing and other medical conditions that affect radiotherapy that is likely to affect treatments their reproductive functions using the their fertility, follow likely to affect following criteria. recommendations in ‘The effects of cancer treatment on reproductive their fertility The CCG will fund the harvesting of eggs functions’ (2007). rd up to the day before the patient’s 43 birthday. When using cryopreservation to

1 Since this consultation we have carried out a public engagement to apply further restrictions to people already receiving assisted conception treatment.

109 preserve fertility in people diagnosed The CCG will fund the storage: with cancer, use sperm, embryos or oocyctes.  until the age of 25 if harvested before her 20th birthday Offer oocyte or embryo  for 5 years if harvested between cryopreservation as appropriate to her 20th and 38th birthday women of reproductive age (including  until her 43rd birthday if adolescent girls) who are preparing for harvested after the age of 38 medical treatment for cancer that is likely to make them infertile if: If the patient dies whilst their eggs are in  they are well enough to storage the CCG will no longer fund the undergo ovarian stimulation storage 3 months from the person dying. and egg collection and  this will not worsen their * Patients can choose to fund storage condition and themselves beyond the NHS funded  enough time is available period. before the start of their cancer treatment.

Cryopreserved material may be stored for an initial period of 10 years.

Following cancer treatment, couples seeking fertility treatment must meet the defined eligibility criteria. Sperm The CCG proposal is that they fund the Offer sperm cryopreservation to men collection and collecting and storage of sperm that for and adolescent boys who are storage for those undergoing treatment for cancer preparing for medical treatment for patients and other medical conditions that affect cancer that is likely to make them undergoing their reproductive functions using the infertile. treatments following criteria. Local protocols should exist to ensure likely to affect The CCG will fund the collecting of sperm that health professionals are aware of their fertility rd up to the day before the patient’s 43 the values of semen cryostorage in birthday. these circumstances, so that they deal with the situation sensitively and The CCG proposal is that they fund effectively. storage of sperm that have been frozen already for those undergoing treatment Cryopreserved material may be stored for cancer and other medical conditions for an initial period of 10 years. that affect their reproductive functions. Following cancer treatment, couples The CCG will fund the storage: seeking fertility treatment must meet the defined eligibility criteria.  until the age of 25 if harvested before his 20th birthday  for 5 years if harvested between his 20th and 38th birthday  until his 43rd birthday if harvested after the age of 38

110

If the patient dies whilst their sperm are in storage the CCG will no longer fund the storage 3 months from the person dying.

* Patients can choose to fund storage themselves beyond the NHS funded period.

There are other specialist services commissioned by NHS England, which are available separately, and not covered by BBCCG service restrictions policy. For example, BBCCG is not responsible for commissioning Pre-implantation Genetic Diagnosis and associated IVF/ICSI and specialist fertility services for members of the Armed Forces. These arrangements are not affected by this paper.

Rationale

In 2015 the CCG’s Turnaround Programme required the CCG to review all of its commissioning arrangements to identify whether services commissioned are a priority for the CCG. Those that are not priorities need to be reviewed to seek opportunities for delivering savings to protect priority provision. As part of this review, the CCG has reviewed the provision of Specialist Fertility Services.

Impact

The efficiencies made by not funding this procedure will go towards bringing the CCG back to its statutory financial balance position which is vital in order for it to be viable organisation and fund future services for the local population.

EQIA

Final IVF insert 2016-08-04 v1 0 FINAL.docx

Public Survey Result (2015)

Option 1: Status Quo 27 (42%)

Option 2: Decommission Specialist Fertility Services 10 (15%)

No Response 28 (43%)

Comments received

The following themes were received;

- In decommissioning Specialist Fertility Services will patients present elsewhere in the system (e.g. mental health needs)

111 - NICE has reviewed the efficacy of Fertility services, to restrict provision would be against NICE Guidance - That restricting provision would impact on health inequalities as those who could afford private treatment could access services. In addition, this change would create a postcode lottery - We need to ensure that the policy is easy to follow - Could savings be achieved through cheaper contracts or through a more restricted offer - Should services to support smokers or obese patients be prioritise ahead of couples seeking specialist fertility services.

In addition to the questionnaire responses summarised above, Basildon and Brentwood CCG also received a supplementary response from Fertility Fairness (a campaign group who aim to ensure people have access to comprehensive and equal access to a full range of appropriate NHS fertility services). This response outlined an evidence base on the impact on mental health of potential restrictions, impact of potential increase in multiple births for patients accessing specialist fertility services overseas and the risks of increase administrative costs associated with processing additional requests through IFR processes in the event of decommissioning access to Specialist Fertility Services as standard.

In addition, Fertility Fairness set out a number of elements of the patient pathway that NICE suggest are opportunities to identify pathway savings;

 Lifestyle Advice CCGs should ensure that written and verbal lifestyle advice is available, and forms part of consultation with healthcare professionals. There is no resource impact estimated by NICE for this recommendation, but it could reduce the need for onward referrals.

 ICSI Commissioning CCGs should ensure that they commission services from secondary and tertiary specialist fertility care providers who offer ICSI as an additional procedure only when there are recognised indications. According to NICE costings ICSI costs £500 in addition to the cost of IVF.

 Ineffective Investigations The All Party Group on Infertility (APGI) has previously highlighted that there is much unnecessary duplication of fertility investigations, particularly with tests being repeated by both GPs and hospital clinics.

Fertility Fairness do not recommend that Basildon and Brentwood CCG cut their IVF provision to anything lower than the three full cycles recommended by NICE but instead seek the CCG consider the ideas above to make Specialist Fertility Services more affordable.

112 Reflection on comments

CCG Comment - The CCG recognises the potential psychological impact that this change may have. The CCG is not able to quantify this. The CCG commissions psychological therapy services that could take referrals for patients affected by this change. - The CCG recognises that the standards for providing fertility services abroad differ from the UK and therefore there may be an increased risk of multiple pregnancies for patients who have access IVF abroad. - The CCG is not seeking to challenge the conclusions of the NICE Guideline. The consultation is focussed on whether the commissioning of specialist fertility services is a priority for the CCG - There is already variation in what is offered for specialist fertility services across Essex, therefore our proposals do not significantly exacerbate that position. - The clarity of eligibility was considered as part of the options development. Option 2 (Decommissioning of Specialist Fertility Services) did not seek to identify criteria for accessing service as the eligibility criteria was already strict and further restrictions would not have generated the financial saving. - All specialist fertility treatment requests already must pass through a prior approval process, therefore the CCG do not anticipate that there will be a significant additional administrative burden by the potential of extra individual funding requests. - The current prices paid for Specialist Fertility Service are the result of a competitive procurement exercise across the East of England (in 2014). It is highly unlikely that a better value like for like price could be secured by the CCG (when taking into account success rates and price paid). - The CCG accepts that due to only applying any policy change to new referrals, the full saving identify will only be achieved after a number of years application (estimated to be three years) see footnote 1. - The CCG accepts that any policy change could result in a backlog of cases that would make reintroduction of a service more expensive and therefore less likely. - Comprehensive lifestyle advice is currently given as part of the local fertility service that is currently commissioned and would continue to be commissioned under either option (see Appendix 1) - The CCG has received a paper for consideration from Fertility Fairness (Appendix 2). This has been considered as part of the consultation.

Recommendation

The recommendation to Board is to proceed with “Option 2” i.e. decommissioning specialist fertility services for all new referrals and where referral has taken place to a specialist provider where active treatment has not commenced from the date of implementation 28 November 2016. This is with exception of fertility preservation where the time periods for storage have been reduced for some patients but the criteria has been extended to cover other medical conditions that affect reproductive function and not just cancer. The CCG would continue to commission the range of gynaecology services from local district general hospitals set out in Appendix 1.

113 Appendix 1

Summary of Fertility Services that will continue to be commissioned under Option 2 Decommissioning of Specialist Fertility Services

 A thorough history will be taken from each couple including duration of sub-fertility; medical history including current medical problems and treatments; number and outcome of any conceptions with current or previous partner; social history including smoking and alcohol intake.  The female partner will also be asked about the following: any past or current gynaecology problems; whether she has been pregnant previously and the outcome of the pregnancies; her menstrual history and any menstrual problems; cervical smear history; folic acid intake.  Blood tests will be arranged for the woman for FSH, LH, Prolactin, Testosterone, Oestradiol and Thyroid function tests and for progesterone.  A pelvic examination is usually performed and screening tests for Chlamydia taken. Cervical smears are taken if relevant.  Semen analysis is organised for the male partner; two tests may be necessary one month apart.  A follow-up visit is arranged for 8-10 weeks to discuss results and management.  Results of the investigations are discussed with the couple.  A care pathway is discussed and appropriate management of the sub-fertility arranged.  Further care will depend on the underlying problem and could involve:  Ovulation induction with Clomiphene.  Management of Polycystic Ovary Syndrome.  Follicle scanning to determine the growth of the follicle and approximate time of ovulation.  Management of endometriosis.  Further exploration of tubal patency if unconfirmed by Hycosy eg: laparoscopy and dye under general anaesthetic.

The following procedures will also be commissioned;

Outpatient - Consultation Follicular tracking scan Fertility assessment ultrasound scan Ovulation induction treatment with drugs Hysterosalpingography

Day case - Laparoscopy + dye Laparoscopy + ovarian drilling Hysteroscopy Hysteroscopy + division of adhesions + resection of fibroid + tubal cannulation Laparoscopy + tubal surgery Laparoscopy + treatment of endometriosis

Inpatient - Myomectomy

114 Fertility Fairness paper appendix 2.pdf

115 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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 1 RARE 1 MINOR score 2 UNLIKELY 2 MODERATE / LOW 1 - 3 Low risk (green)

3 MODERATE 3 SERIOUS / POSSIBLE 4 - 6 Moderate risk (yellow) 4 LIKELY 4 MAJOR 8 - 12 High risk (orange)

5 ALMOST 5 FATAL / CATASTROPHIC 15 - 25 Extreme risk (red) CERTAIN

A fuller description of impact scores can be found at appendix 1.

IMPACT 1 2 3 4 5

1 1 2 3 4 5 Please take care with this assessment. A carefully completed assessment should safeguard against 2 2 4 6 8 10 challenge at a later date. 3 3 6 9 12 15

LIKELIHOOD 4 4 8 12 16 20 5 5 10 15 20 25

1 116 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Title and lead for scheme: Stop access to Specialist Fertility Services

Brief description of scheme: This EQIA covers the proposed impact of amending the CCG’s Service Restriction Policy for Specialist Fertility Services to;

“NHS Basildon and Brentwood CCG does not routinely fund Specialist Fertility Services including;  In-vitro fertilisation (IVF) and Intra-cytoplasmic sperm injection (ICSI)  Surgical sperm retrieval methods  Donor Insemination  Intra Uterine Insemination (IUI)  Sperm, embryo and male gonadal tissue cryostorage and replacement techniques and other micro-manipulation techniques including sperm washing.  Egg donation

Applications for funding for these procedures can be made through the Individual Funding Request process but should only be made where the patient demonstrates true clinical exceptionality.

This change in policy would apply only to new referrals. Patients within a specialist fertility pathway at the point of the policy being approved will receive treatment in line with the current NICE Guidelines.”

According to the recent NICE clinical guideline on Fertility, infertility affects one in seven heterosexual couples in the UK. NICE indicates that the following are the main causes of infertility in the UK (percentage figure indicates approximate prevalence)  Unexplained infertility – no identified male or female cause (20 percent)  Ovulatory disorders (20 percent)  Tubal damage (20 percent)  Factors in the male causing infertility (30 percent)  Uterine or peritoneal disorders (10 percent)

2 117 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

In about 40% of cases disorders are found in both the male and female.

A typical clinical commissioning group (CCG) is estimated to see 230 consultant referrals to the local district general hospital per 250,000 population per annum. An unknown percentage of these would then be referred for specialist fertility services.

The CCG will continue to commission fertility investigations and some interventions through local district general hospitals.

Answer positive/negative (P/N) in each area. If Negative score the impact, likelihood and total in the appropriate box. If score > 8 insert Y for full assessment

Area of Impact question P/N Impact Likeli- Score Full Quality hood Assessment required 1 Duty of Could the proposal impact positively or negatively on any of the N 3 5 15 Yes Quality following - compliance with the NHS Constitution (see appendix 3), partnerships, safeguarding children or adults ? 2 Equality and Could the proposal impact positively or negatively on any of the N 3 5 15 Yes Diversity protected characteristics under the Equality Act 2010 (see appendix 2) 3 Patient Could the proposal impact positively or negatively on any of the N 3 5 15 Yes Experience following - positive survey results from patients, patient choice, personalised & compassionate care?

4 Carers Could the proposal impact positively or negatively on informal None experience carers? (if negatively, is there an identified resource to meet the need, or does the need require flagging to the CCG carers lead)? 5 Patient Could the proposal impact positively or negatively on any of the None Safety following – safety, systems in place to safeguard patients to prevent harm, including infections? 6 Clinical Could the proposal impact positively or negatively on evidence N 3 5 15 Yes Effectiveness based practice, clinical leadership, clinical engagement and/or high quality standards? 7 Prevention Could the proposal impact positively or negatively on promotion N 3 3 9 Yes 3 118 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

of self-care and health inequality? 8 Productivity Could the proposal impact positively or negatively on - the best None and setting to deliver best clinical and cost effective care; Innovation eliminating any resource inefficiencies; low carbon pathway; improved care pathway?

Please describe your rationale for any negative/positive impacts; key facts and figures about the local population including who has been consulted to complete this section.

1. Duty of Quality It is viewed that the stopping of specialist fertility services will impact upon the following aspects of the NHS Constitution; - Comprehensive service available to all - Access to NHS services based on clinical need not ability to pay Whilst the stopping of specialist fertility services would move the CCG into alignment with two Essex CCGs (Mid Essex and North East Essex CCGs), other CCGs in Essex continue to commission specialist fertility services. On a like for like basis, the population served by NHS Basildon and Brentwood CCG would need to privately fund access to services that are routinely funded in NHS Thurrock CCG, NHS Castle Point and Rochford CCG and Southend CCG. Typical costs of a cycle of IVF are in the region of £2,700 (plus the costs of drugs). This rises to £7,500 if combined with ICSI.

2. Equality and Diversity The review of the this policy has a high equality impact on the protected characteristics defined in the Equality Act 2010 of age, disability and race

Fertility is affected by age and NICE criteria (2004) refer to IVF treatment for women between 23 and 39 years old. Suspension of NHS funding of fertility treatment for an extended period will be of greater impact to those women closest to the menopause.

Research carried out in America which suggest that black women have a higher prevalence compared to white women (Culley Hudson and Van Rooij 2009), although there is no UK evidence available.

For people with a disability or long-term health condition. Some physical disabilities may impede sexual intercourse. Also some medical treatments can cause long-term infertility.

The CCG currently commissions in line with NICE Guidance which applies equally to opposite and same sex couples. This is 4 119 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3 supported by Stonewall. Under the new service restriction policy, the application would apply equitable to same sex and opposite sex couples. Therefore, age and gender remain the only two protected characteristics affected by this policy change.

It is viewed that no other protected characteristics are affected by this change.

3. Patient Experience

Infertility often has a negative effect on the mental health of infertile patients. When prospective data has been sought from couples presenting for the treatment of infertility, 11% and 12% of male partners of infertile couples have reported moderate and severe depression respectively (Shindel et al, 2008). A study by Hammeril et al (2008) using self reporting questionnaires of infertile men and women found that more than 40% scored above the threshold of mild depression and 26% showed clinically relevant depressive symptoms. A population-based study in Finland (Klemetti et al, 2010) found that childless women with infertility experience increased adjusted risks for dysthymia (odds ratio 3.5) and anxiety (odds ratio 2.67) compared to women who had not experience infertility. Women with infertility experience but with a current child had an increased risk for panic disorder (odds ratio 2.58). Childless men with infertility experience had a significantly poorer quality of life compared to men without infertility.

The challenge for research is to address differential impacts of infertility itself, and additional sources of stress such as the high financial burden of treatment, the need to undergo surgical procedures, the invasion of sexual intimacy, and the response in a proportion of patients to therapeutic failure. For example, Palcios & Jadresic (2000) review literature and conclude that following therapeutic failure, which the most common outcome (70% of couples), 50% of couples show some significant psychological distress. Cognitive behaviour therapy (CBT) for depressed infertile women effectively reduces the mean of all four mental distress subscales (anxiety, social function, depression and psychosomatic signs) of the General Health Questionnaire and successful treatment by CBT compared to comparison groups is 79% for CBT, 50% for fluoxetine and 10% for control group (Faramarzi et al, 2008).

During suspension of funding for specialist fertility services, couples will still have access to support and advice to reduce risk factors for infertility and improve general health (e.g. alcohol, smoking and body weight). In addition, patients would be able to access IAPT and other psychological support services.

6. Clinical Effectiveness

Implementation of this would result in the CCG no longer commissioning in line with NICE Guidelines. On this basis, the CCG is not advocating an amended version of the existing NICE Guidelines as there is no clinical evidence justification for doing so. Instead, the CCG’s decision to stop access to Specialist Fertility Services is an acceptance that the NICE Guidelines are the right clinical guidelines for service provision but are not affordable or a priority for the CCG in the current commissioning climate.

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7. Prevention

There is a potential that the service cessation would result in an increase in health inequalities as access to specialist fertility services would be based on ability to pay privately.

Signature: Designation: Date: William Guy Head of Commissioning 18/01/16

6 121 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Stage 2

Risk (5 x5 risk

matrix)

Mitigation strategy and

Description of impact (Positive or Indicators negative) monitoring arrangements

Score Impact Overall

Likelihood Does it impact on the organisation’s It is anticipated that this cessationswill have The CCG is currently commitment to the public to continuously an impact on the NHS Constitution participating in the Essex drive quality improvement as reflected in commitments of “Comprehensive service Success Regime of Service the rights and pledges of the NHS available to all” and “Access to NHS services Restrictions. The CCG would Constitution? based on clinical need not ability to pay” review its service restriction (including access to Specialist Fertility Services) as a result of the Essex Success Regime Area of review. quality Applications for funding for these procedures can be made through the Individual Funding Request process but should only be made

where the patient demonstrates 3 5 15 true clinical exceptionality. Does it impact on the organisation’s There is no expected impact on this. Not applicable 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? 0 0 0 What is the impact on strategic partnerships There is no expected impact on strategic Not applicable and shared risk? partnerships/shared risk

0 0 0

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What is the specific impact of the project on As outlined above, this service cessation The CCG would continue to people with protected characteristics, in would have a greater impact on patient aged commission the services terms of individual and community health, between 23 and 42 years, in particular those outlined in attachment 1. In access to services and patient experience? approaching menopause. It is view that this addition, patients would still be does not have any specific impact on gender able to access services to as infertility causes could be male or female. improve lifestyle factors that In addition, this does not impact upon may impact upon fertility. sexuality as the same policy would apply The CCG is currently equally to same sex couples as opposite sex participating in the Essex couples. Success Regime of Service Restrictions. The CCG would This cessation could have a greater impact review its service restriction on some ethnic groups as highlighted by (including access to Specialist research carried out in America suggesting Fertility Services) as a result of that black women have a higher prevalence the Essex Success Regime compared to white women (Culley Hudson review. and Van Rooij 2009), although there is no UK evidence available, and some research highlights that the fertility issues within those ethnic groups are likely to be linked to social factors rather than race factors.

Some physical disabilities may impede sexual intercourse. Also some medical treatments can cause long-term infertility. Therefore this group of people may be more

disadvantaged 3 5 15 Are core clinical quality indicators and There is no expected impact on this Not applicable metrics in place to review impact on quality improvements?

0 0 0 Will this impact on the organisation’s duty to There is no expected impact on our duty to Not applicable protect children, young people and adults? protect.

0 0 0

8 123 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Following feedback from consultation, it is The CCG is currently participating in the likely that this service cessation will increase Essex Success Regime of Service What impact is it likely to have on self the number of complaints/negative feedback Restrictions. The CCG would review its reported experience of patients and service received by the CCG. This will primarily be service restriction (including access to

users? (Response to national/local due to the variation in access between CCGs Specialist Fertility Services) as a result surveys/complaints/PALS/incidents) in Essex. 3 5 15 of the Essex Success Regime review. How will it impact on choice? The choice of NHS funded Specialist Fertility The CCG would continue to Services for patients under the care of commission the services outlined in Basildon and Brentwood CCG would end. attachment 1. In addition, patients would still be able to access services to improve lifestyle factors that may

impact upon fertility. 3 5 15

PATIENT EXPERIENCE Does it support the compassionate and personalised care agenda?

3 5 15

What impact is it likely to have on self

reported experience of carer and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice? EXPERIENCE

Does it support the compassionate and

CARER personalised care agenda?

How will it impact on patient safety? SAFETY PATIENT

9 124 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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? This cessation would result in the CCG The CCG has deliberately taken the ceasing to commission in line with NICE decision not to commission a locally Clinical Guidelines for those services amended version of NICE Guidelines

consulted upon. For those services outside of as there is no consistent clinical the consultation, we will still commission in evidence for doing so and the NICE line with NICE Guidelines (where the CCG is Guideline is recognised as good the lead commissioner). practice. Therefore, the proposed

How does it impact on implementation of cessation is based on affordability and evidence based practice? 3 5 15 priority. There is no expected impact on clinical Not applicable leadership

How will it impact on clinical leadership? 0 0 0 There is no expected impact on Better Care Not applicable CLINICAL EFFECTIVENESS Better Value metrics

Does it support the full adoption of Better care, Better Value metrics? 0 0 0

10 125 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Following feedback from consultation, it is The CCG is currently participating in the likely that this service cessation will increase Essex Success Regime of Service the number of complaints/negative feedback Restrictions. The CCG would review its received by the CCG. This will primarily be service restriction (including access to

due to the variation in access between CCGs Specialist Fertility Services) as a result Does it reduce/impact on variations in care? in Essex. 3 5 15 of the Essex Success Regime review. There is no expected impact on monitoring Not applicable

Are systems for monitoring clinical quality supported by good information? 0 0 0 There is no expected impact on clinical Not applicable engagement

Does it impact on clinical engagement? 0 0 0 As outlined above, infertility has an evidence Patients would still be able to access based impact on the mental health of infertile local fertility services (please see patients. appendix 1 for the full description of these services). Patients would be able to access IAPT and other psychological support services commissioned by the Clinical Commissioning Group.

Does it support people to stay well? 3 3 9 There is no expected impact on overall Patients would still be able to access wellbeing/lifestyle factors that affect fertility. services that support the reduction in lifestyle factors that affect fertility (e.g.

Does it promote self-care for people with smoking cessation, weight PREVENTION long term conditions? 0 0 0 management) This change has a potential negative impact The CCG needs to consider delivering on health inequality as patients seeking the best and most equitable outcomes access to specialist fertility services would within our overall resource allocation. need to self fund (circa £2,700 plus drugs Specialist Fertility Services has been rising to £7,500 for ICSI). deemed to be low priority in comparison

Does it tackle health inequalities, focusing to other services commissioned by the resources where they are needed most? 3 3 9 CCG.

N Does it ensure care is delivered in the most

VITY VITY AND PRODUCTI INNOVATIO clinically and cost effective way? 11 126 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Does it eliminate inefficiency and waste?

Does it support low carbon pathways?

Will the service innovation achieve large gains in performance?

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

Signature: Designation: Date:

12 127 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 1.

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

short-term reduction in public long-term reduction in public confidence confidence 13 128 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

14 129 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Below are some aspects of Human Rights principles and examples of their relevance to healthcare. Human rights principles should be taken into account when undertaken EIAs.

• The right to life e.g., Do Not Resuscitate orders, refusal or lifesaving medical treatment, Advance Directives

• The right to a fair trial

e.g., staff disciplinary proceedings, compensation claims, handling of special case panels 15 130 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 3

NHS Constitution (2013)

Values • Working together for patients • Respect and dignity • Quality of care • Compassion • Improving lives • Everyone counts

16 131 APPENDIX 3

51 Holland Street London W8 4JB T: 0207 368 1611 E: [email protected]

REDUCING LOCAL IVF PROVISION: A BUSINESS CASE

THE COSTS TO THE HEALTH ECONOMY

Fertility Fairness would strongly encourage Basildon and Brentwood CCG to put the costs discussed below into the context of the price currently paid for assisted conception services.

The CCG estimate their annual spend on this service to be £400 000, with a price of roughly £3000 per cycle of IVF. According to NICE the CCG will commission on average 2.2 cycles of IVF per patient. When taken in comparison with the potentially high costs to the overall health economy discussed below, this represents a very cost effective service, which also offers patients a strong chance of a successful pregnancy.

Mental ill health and the associated long-term costs

There are clear and strong links between infertility and mental health problems. Multiple studies have found that the prevalence rate of major depression is significantly higher in childless couples, with estimates ranging from between 15-54% (Domar 1992; Demyttenaere 1998; Lukse 1999; Parikh 2000; Chen 2004).

Anxiety has also been shown to be significantly higher in infertile couples with 8%-28% reporting clinically significant anxiety (Anderson 2003; Chen 2004; Parikh 2000). In addition to this there are social costs, with studies suggesting that one in three involuntarily childless couples break down. 1 Relationship breakdown itself can bring attendant mental health problems.

These mental health issues will have major financial repercussions for the NHS. In the short term, the Basildon and Brentwood CCG will bear the cost of treating the depression, anxiety and other associated conditions. In 2007 the Kings Fund estimated that the average annual service cost of treating moderate-severe depression was £2085 per patient (today this represents a cost of £2695 taking into account inflation). 2 If both partners are in need of treatment, or if the depression lasts longer than 1 year, these costs will quickly outweigh the cost of providing just 1 cycle of IVF.

In the long term the costs to the Basildon and Brentwood CCG will likely be even greater. There is a clear relationship between mental ill health and physical illness. According to the Kings Fund mental health “problems account for a quarter of the overall burden of disease in the UK…and have a similar effect on life expectancy to smoking”. 3 They further estimate that between 12-18% “of all money spent by the NHS on long-term physical health conditions is linked to poor mental health”.4 These costs are hard to model for Basildon and Brentwood, but they will have an inevitable and substantial impact on the future health economy.

Fertility Treatment Abroad and Multiple Births

In recent years fertility treatment abroad has become an increasingly affordable option for UK patients unable to access IVF on the NHS, and evidence suggests that the demand is increasing exponentially. WhatClinic, a private healthcare search engine, has reported a 191% increase in enquiries from UK patients to clinics abroad for IVF treatment in the last year alone.5

1 http://www.theguardian.com/theobserver/2001/feb/04/focus.news 2 http://www.kingsfund.org.uk/sites/files/kf/Paying-the-Price-the-cost-of-mental-health-care-England-2026-McCrone-Dhanasiri-Patel-Knapp-Lawton-Smith-Kings-Fund- May-2008_0.pdf 3 http://www.kingsfund.org.uk/blog/2012/06/what-every-ccg-leader-should-know-about-mental-health 4 http://www.kingsfund.org.uk/blog/2012/06/what-every-ccg-leader-should-know-about-mental-health 5 As of September 2015 (see http://www.whatclinic.com/) Fertility Fairness (FF) campaigns for equal access for those with an established clinical need to a full range of services for the investigation and treatment of infertility on the NHS - It is funded through equal grants from Ferring Pharmaceuticals Ltd and Merck Serono Pharmaceuticals Ltd - Its activities are directed by the FF Committee, on which non-commercial interests enjoy a significant majority - For further information, please visit: www.fertilityfairness.co.uk

Or write to Fertility Fairness (Decideum Ltd), NIddry Lodge, 51 Holland St, London W8 7JB - For patient information please call Infertility Network UK 0800 008 7464 - Email: [email protected]

132 APPENDIX 3

However, whilst this treatment might represent an affordable option for patients it carries hidden costs to the NHS. The Human Fertilistation & Embryology Authority (HFEA) has always strictly regulated the number of embryo that can be transferred during IVF treatment to reduce the chance of multiple pregnancies. Since 2009 the HFEA, strongly supported by the professional bodies and patient organisations, requires UK fertility clinics to aim for a target of a maximum 10% multiple birth rate. The main way to achieve this is through elective single embryo transfer.6 UK guidelines indicate that women under the age of 37 should, in most cases, receive only a single embryo transfer during their first cycle of IVF. 7

By contrast, research from the European Society of Human Reproduction and Embryology (ESHRE) shows that in some other European countries, and outside of the EU, there is often no statutory limit to the number of embryos transferred. One ESHRE study examining 225 507 IVF cycles across Europe found that the majority of clinics questioned were not only conducting two embryo transfers, but that 22% were using three embryo transfers, and a further 3% were using four embryo transfers. 8

The UK has pursued strict strategies to restrict multiple embryo transfers because of the complications for mothers and babies and high costs that arise out of multiple pregnancies. At least half of twins are born before 37 weeks (making them pre-term) with low birth weights, which puts them at a high risk of serious health problems. Over 90% of triplets are born before 37 weeks, and many are born so early that they are at high risk of long-lasting serious health problems and death. 9

The HFEA has highlighted a study showing that the cost of looking after the mother of twins was twice as expensive as the care for a mother with a singleton pregnancy. 10 The cost of looking after a mother of triplets was four times as expensive. The cost of looking after the babies themselves was even more striking. Neonatal twin costs were 16 times higher than singleton costs, and triplet costs were 109 times higher. According to this study, in 2006 a singleton pregnancy cost the NHS £3313 compared to £9122 for twins and £32 354 for triplets.11

Any pre-term babies born as a result of multiple pregnancies will also likely have associated long-term health conditions that will represent a considerable cost to the NHS over the course of their lifetime. For instance, evidence indicate that triplets are associated with a 300% increase in the relative risks of handicapping conditions compared with singletons, and a 650% increase in the rate of cerebral palsy per 1000 live births compared with singletons.12

If IVF cycles are funded by the NHS patients are less likely to seek treatment abroad. Clinicians have reported that where NHS funding is not available patients are far more reluctant to accept their advice to transfer only one embryo with freezing of surplus embryos.

The cost of IFRs

Evidence taken from Fertility Fairness’ 2015 audit of CCGs indicates that CCGs with low IVF provision can face high rates of individual funding requests (IFRs), with 1 cycle providers receiving as many as 102 IFRs per year.

If Basildon and Brentwood CCG drops their provision of IVF they should consider that potential savings might well be offset by the administrative burden (and associated cost) of processing a significant increase in IFR appeals. Even if the CCG does not assent to the IFR, the application adds considerably to the bureaucratic workload of the CCG.

SAVINGS AVAILABLE WITHIN BASILDON AND BRENTWOOD’S CURRENT COMMISSIONING POLCY

Rather than simply cut their IVF provision entirely, Fertility Fairness would encourage the Basildon and Brentwood CCG to seek efficiencies within their existing commissioning system.

6 http://www.hfea.gov.uk/docs/Multiple_Births_Report_2015.pdf 7 https://www.fertility.org.uk/news/pressrelease/08_09-SingleEmbyoGuidelines.html 8 McKelvey et Al (BJOG 2009) 9 http://www.hfea.gov.uk/docs/Multiple_Births_Report_2015.pdf 10 http://www.hfea.gov.uk/docs/MBSET_report.pdf 11 https://ueaeprints.uea.ac.uk/14156/ 12 http://www.ncbi.nlm.nih.gov/pubmed/10929683

Fertility Fairness (FF) campaigns for equal access for those with an established clinical need to a full range of services for the investigation and treatment of infertility on the NHS - It is funded through equal grants from Ferring Pharmaceuticals Ltd and Merck Serono Pharmaceuticals Ltd - Its activities are directed by the FF Committee, on which non-commercial interests enjoy a significant majority - For further information, please visit: www.fertilityfairness.co.uk

Or write to Fertility Fairness (Decideum Ltd), NIddry Lodge, 51 Holland St, London W8 7JB - For patient information please call Infertility Network UK 0800 008 7464 - Email: [email protected]

133 APPENDIX 3

The below recommendations have been taken from a variety of sources, including NICE commissioning guidance, Quality Statements and recommendation of the All Party Group on Infertility.

Providing 3 Full Cycles of IVF

Evidence taken from Fertility Fairness’ 2014 and 2015 audit of NHS assisted conception services indicates that the Basildon and Brentwood CCG has only been commissioning ‘a full cycle of IVF’ as defined by NICE since December 2014.

NICE have explicitly noted that commissioning less than a full cycle of IVF will reduce the cost effectiveness of the treatment, however NICE have also been clear that the cost-savings of introducing a full cycle of IVF will take time to materialise. The NICE costing template suggests that after 3 years of operating at three full cycles of IVF there will be real term reductions in the cost of the service. 13 If the Basildon and Brentwood CCG gives this policy change a chance to take effect, they will likely find their service becoming more cost effective over the next two years.

Improving the patient pathway

There are several elements of the patient pathway that NICE have suggested present common opportunities for savings. Fertility Fairness would urge the Basildon and Brentwood CCG to investigate these issues to discover if these recommendations have been taken forward.14 These include:

• Lifestyle Advice

CCGS should ensure that written and verbal lifestyle advice is available, and forms part of consultation with healthcare professionals. There is no resource impact estimated by NICE for this recommendation, but it could reduce the need for onward referrals. Onward referral for an outpatient appointment in gynaecology would cost £131 and in urology it would cost £127.

• ICSI Commissioning

CCGs should ensure that they commission services from secondary and tertiary specialist fertility care providers who offer ICSI as an additional procedure only when there are recognised indications. According to NICE costings ICSI costs £500 in addition to the cost of IVF.

• Ineffective Investigations

The All Party Group on Infertility (APGI) has previously highlighted that there is much unnecessary duplication of fertility investigations, particularly with tests being repeated by both GPs and hospital clinics. 15 NICE and the APGI have raised particular concerns with regards to semen testing, and in 2014 NICE issued a Quality Standard which urged CCGs to “ensure that the laboratory services they use comply with most recent World Health Organization laboratory manual”. NICE noted that “variations in laboratory techniques significantly influence the reliability of the results of semen analysis”. 1617

ALTERNATE COMMISSIONING OPTIONS

Fertility Fairness cannot recommend that Basildon and Brentwood CCG cut their IVF provision to anything lower than the three full cycles recommended by NICE, and we would urge the CCG to consider how much more difficult it will be for the CCG to return to any level of IVF funding if they decommission the service entirely.

13 https://www.nice.org.uk/guidance/cg156/resources/cg156-fertility-costing-report2 p7-8 14 https://www.nice.org.uk/guidance/sfcqs73/chapter/specifying-services-using-the-nice-quality-standard-for-fertility-problems 15 ‘Taking NICE Forward’ The All Party Group on Infertility (2004) 16 ‘Taking NICE Forward’ The All Party Group on Infertility (2004) 17 https://www.nice.org.uk/guidance/qs73/chapter/quality-statement-4-semen-analysis Fertility Fairness (FF) campaigns for equal access for those with an established clinical need to a full range of services for the investigation and treatment of infertility on the NHS - It is funded through equal grants from Ferring Pharmaceuticals Ltd and Merck Serono Pharmaceuticals Ltd - Its activities are directed by the FF Committee, on which non-commercial interests enjoy a significant majority - For further information, please visit: www.fertilityfairness.co.uk

Or write to Fertility Fairness (Decideum Ltd), NIddry Lodge, 51 Holland St, London W8 7JB - For patient information please call Infertility Network UK 0800 008 7464 - Email: [email protected]

134 APPENDIX 3

Attempting to fund IVF from a position of no provision will represent a much greater financial barrier, than increasing provision from even one cycle of IVF. In addition to the loss of infrastructure and contracts, there will be a substantial backlog of patients generated from any period of decommissioning.

Basildon and Brentwood CCG should consider what third option to decommissioning exists, that may allow them to make financial savings, but also we urge the CCG to ask itself why this distressing and often treatable condition is any less deserving of funding than any other.

Should the CCG wish to take advice on how the most efficient and cost effective way to organise their service, Fertility Fairness would be happy to put them into contact with appropriate advisors.

Or write to Fertility Fairness (Decideum Ltd), NIddry Lodge, 51 Holland St, London W8 7JB - For patient information please call Infertility Network UK 0800 008 7464 - Email: [email protected]

135 In-vitro Fertilisation (IVF) and Assisted

Conception (existing treatment)

Original proposal

In 2015 NHS Basildon and Brentwood CCG undertook a Public Consultation to cease specialist fertility service provision. No decision has yet been made following the consultation. However, if the proposal (as per consultation in 2015) were to be approved by the CCG Board, then services would be decommissioned for those requiring referral for tests or procedures that were deemed specialist (specialist assisted conception services e.g. IVF). The CCG would continue to fund those tests or procedures that would diagnose fertility problems and those that can be undertaken in a local hospital to aid fertility. We are now consulting on proposals for people who have already been referred for specialist fertility treatment, for whom the decision of what the CCG will fund for them was not addressed in the original consultation. The proposals for people who have already been referred or are receiving treatment for specialist assisted conception services cover the following: • In Vitro Fertilisation (IVF) with or without Intracytoplasmic Sperm Injection (ICSI) • Frozen Embryo Transfer • Embryo/Blastocyst Freezing and Storage • Surgical Sperm Recovery (Testicular Epididymal Sperm Aspiration (TESA)/Percutaneous Sperm Aspiration (PESA) including storage where required) • Intrauterine Insemination (IUI) - unstimulated • Donor Oocyte Cycle • Donor Sperm Insemination • Egg Storage for Patients Undergoing Treatments likely to affect their fertility • Sperm Storage for Patients Undergoing Treatments likely to affect their fertility For those patients who have already been referred for specialist fertility treatment and are in the process of receiving the above specialist services, the CCG is proposing to introduce the following restrictions:

136 Procedure Proposal What it currently is

In Vitro Fertilisation For anyone who has progressed to IVF the CCG is proposing A full cycle of IVF treatment, with or without intracytoplasmic sperm (IVF) with or without that they will fund the current cycle with a cycle being defined injection (ICSI), should comprise 1 episode of ovarian stimulation Intracytoplasmic as: and the transfer of any resultant fresh and frozen embryo(s). This Sperm Injection (ICSI)  One fresh and up to one frozen transfer (the number will include the storage of any frozen embryos for 1 year following of embryos per transfer is not defined) egg collection. Patients should be advised at the start of treatment that this is the level of service available on the NHS and following * Where more embryos are frozen than can be used for this period continued storage will need to be funded by themselves the proposed cycle/s patients can choose to fund storage or allowed to perish. themselves. An embryo transfer is from egg retrieval to transfer to the uterus. This will include the storage of any frozen embryos for 1 year The fresh embryo transfer would constitute one such transfer and following egg collection. Patients should be advised at the each subsequent transfer to the uterus of frozen embryos would start of treatment that this is the level of service available on constitute another transfer. the NHS and following this period continued storage will need to be funded by themselves or allowed to perish. Before a new fresh cycle of IVF can be initiated any previously frozen embryo(s) must be utilised. For anyone who has already had one fresh and one frozen transfer of their current cycle and has already started the Where couples have previously self-funded a cycle then the couples process for the next round of frozen e.g. started taking the must utilise the previously frozen embryos, rather than undergo drugs the that the round would be funded. ovarian stimulation, egg retrieval and fertilisation again.

Active treatment must have been commenced on or before the 28 November 2016.

For anyone who has frozen embryos stored which under previous arrangements would have been eligible for NHS funded services then any frozen embryos will be stored for 1 year from 28 November 2016.

Patients can choose to fund embryo storage themselves beyond the NHS funded period.

Frozen Embryo For those who have previously had CCG funding and have For women less than 37 years of age only one embryo or blastocyst Transfer embryos in storage the CCG is proposing: to be transferred in the first cycle of IVF and for subsequent cycles  Funding only where considered as part of the current only one embryo/blastocyst to be transferred unless no top quality cycle (as above) embryo/blastocyst available then no more than 2 embryos to be transferred 137 * Where more embryos are frozen than can be used for the proposed cycle/s patients can choose to fund storage For women age 37-39 years only one embryo/blastocyst to be themselves. transferred unless no top quality embryo/blastocyst available then no more than 2 embryos to be transferred. For definition and timeframe please refer to section on IVF cycle For women 40-42 years consider double embryo transfer.

A fresh cycle would be considered completed with the attempt to collect eggs and transfer of a fresh embryo.

Embryo/Blastocyst Where embryos have previously been stored the CCG is Freezing and Storage proposing:

 Freezing and storage for up to one year from the date of egg collection (as previous arrangements)*

* Patients can choose to fund embryo / blastocyst storage themselves beyond the NHS funded period.

Surgical Sperm Where this is part of a current cycle the proposal is that: Recovery Testicular  The CCG will fund this for the current cycle only. Epididymal Sperm  The CCG will not fund storage beyond the current Aspiration (TESA) / funded cycle requirement. Percutaneous Sperm

Aspiration (PESA) including storage * Patients can choose to fund sperm storage themselves where required) beyond the NHS funded period. For definition and timeframe please refer to section on IVF and IUI cycle

Intrauterine The CCG proposal is that: NICE guidelines state that unstimulated intrauterine insemination as Insemination (IUI) - a treatment option in the following groups as an alternative to  the patient is able to complete the current cycle of unstimulated vaginal sexual intercourse: IUI.  people who are unable to, or would find it very difficult to, have vaginal intercourse because of a clinically diagnosed Where they have started active treatment on or before the 28 physical disability or psychosexual problem who are using 138 November 2016 e.g. had scanning ahead of the IUI. partner or donor sperm  people with conditions that require specific consideration in relation to methods of conception (for example, after sperm washing where the man is HIV positive)  people in same-sex relationships

Due to poor clinical evidence, a maximum of 6 cycles of IUI (as a replacement for IVF/ICSI and without donor sperm).

Donor Oocyte Cycle The CCG proposal is that: The patient may be able to provide an egg donor; alternatively the patient can be placed on the waiting list, until an altruistic donor  the patient is able to complete the current donor becomes available. If either of the couple exceeds the age criteria oocyte cycle prior to a donor egg becoming available, they will no longer be  Up to 2 transfers eligible for treatment.

This will be available to women who have undergone premature * Patients can choose to fund oocyte / embryo / ovarian failure (amenorrhoea >6 months and a raised FSH >25) due blastocyst storage themselves. to an identifiable pathological or iatrogenic cause before the age of 40 years or to avoid transmission of inherited disorders to a child where the couple meet the other eligibility criteria.

Donor Sperm The CCG proposal is that: The use of donor insemination is considered effective in managing Insemination fertility problems associated with the following conditions:  the patient is able to use donated sperm for the  obstructive azoospermia current cycle of:  non-obstructive azoospermia o IUI  severe deficits in semen quality in couples who do not wish o IVF to undergo ICSI.

 Infectious disease of the male partner (such as HIV) * Patients can choose to fund sperm storage themselves  Severe rhesus isoimmunisation beyond the NHS funded period.  Where there is a high risk of transmitting a genetic disorder to the offspring For definition and timeframe please refer to section above on

IVF and IUI Donor insemination is funded up to a maximum of 6 cycles of Intrauterine Insemination (IUI).

Egg storage for The CCG proposal is that they fund storage of eggs that have When considering and using cryopreservation for people before patients undergoing been frozen already for those undergoing treatment for starting chemotherapy or radiotherapy that is likely to affect their treatments likely to cancer and other medical conditions that affect their fertility, follow recommendations in ‘The effects of cancer treatment

139 affect their fertility reproductive functions. on reproductive functions’ (2007).

The CCG will fund the storage: When using cryopreservation to preserve fertility in people diagnosed with cancer, use sperm, embryos or oocyctes.  until the age of 25 if harvested before her 20th birthday Offer oocyte or embryo cryopreservation as appropriate to women  for 5 years if harvested between her 20th and 38th of reproductive age (including adolescent girls) who are preparing birthday for medical treatment for cancer that is likely to make them infertile  until her 43rd birthday if harvested after the age of 38 if:  they are well enough to undergo ovarian stimulation and If the patient dies whilst their eggs are in storage the CCG will egg collection and no longer fund the storage 3 months from the person dying.  this will not worsen their condition and  enough time is available before the start of their cancer * Patients can choose to fund storage themselves beyond the treatment. NHS funded period.

If the person is already deceased the 3 months commences on Cryopreserved material may be stored for an initial period of 10 28 November 2016. years.

Following cancer treatment, couples seeking fertility treatment must meet the defined eligibility criteria.

Sperm storage for The CCG proposal is that they fund storage of sperm that have Offer sperm cryopreservation to men and adolescent boys who are patients undergoing been frozen already for those undergoing treatment for preparing for medical treatment for cancer that is likely to make treatments likely to cancer and other medical conditions that affect their them infertile. affect their fertility reproductive functions. Local protocols should exist to ensure that health professionals are The CCG will fund the storage: aware of the values of semen cryostorage in these circumstances, so that they deal with the situation sensitively and effectively.  until the age of 25 if harvested before his 20th birthday Cryopreserved material may be stored for an initial period of 10  for 5 years if harvested between his 20th and 38th years. birthday  until his 43rd birthday if harvested after the age of 38 Following cancer treatment, couples seeking fertility treatment must meet the defined eligibility criteria. If the patient dies whilst their sperm are in storage the CCG will no longer fund the storage 3 months from the person dying.

140 * Patients can choose to fund storage themselves beyond the NHS funded period.

If the person is already deceased the 3 months is from the 28 November 2016.

141 Rationale

The CCG believe that this decision supports transparency and equity of approach to the population and reduces the perception that for some people we are funding fully in line with NICE guidance whilst for others not supporting funding at all.

Impact

The CCG also considers that withdrawing support for funding for those in the system is unfair without notification of this change in decision or approach.

EQIA

Final IVF insert 2016-08-04 v1.0 FINAL.docx Public Survey Result

Reflection on comments

The majority of the comments received related to new referrals for assisted conception and IVF, these have been reflected within the Assisted conception and IVF (new referrals) paper

The comments received that were directly related to existing patients were to:

 seek clarification regarding the implementation  support that the proposals seemed to be clear  seek advice/guidance regarding freezing and storage of eggs or sperm as referred to in the proposal  that the CCG raised peoples hopes and expectations through initial funding of assisted conception

Recommendation

The recommendation to the Board members is to:

 approve the recommended proposal for each component of Assisted conception and IVF as outlined in the paper above  if approved by the Board – members are asked to also support the following actions: o CCG writes a letter for Providers to send to existing patients outlining the outcome of the proposal

142 o CCG ensures that following Board decision all providers are notified as soon as possible of the decision

143 Simultaneous joint replacement (bilateral knee, bilateral hip & shoulder)

Original proposal

As part of a wider review of service restrictions Basildon & Brentwood CCG are proposing to cease the funding of the following joint replacement procedures

• simultaneous hip replacement i.e. replacing both hips at the same time

• simultaneous knee replacement i.e. replacing both knees at the same time

• simultaneous shoulder joint replacement

Rationale

Simultaneous joint replacement, both joints would be replaced at the same time. Whilst there may be an advantage that the surgery is undertaken in one go, it does pose greater risks. By having both joints replaced at the same time the surgery is therefore longer which alone can increase the risk of complications.

Recovery and rehabilitation time may be increased when having simultaneous joint replacements and therefore this can place a greater demand on the body which in turn could lead to a complex and more expensive package of care being required.

The proposed change would mean that simultaneous joint replacement inserts would no longer be funded under the CCG however staged joint replacement would still be.

Impact

It is suggested that staged joint replacement poses less risk to older patients and patients with heart conditions whilst also reducing the length of time patients are in hospital. The majority of patients having total joint replacements are over the age of 65 and whilst having staged joint replacements will mean having two episodes of surgery the main advantage is that it reduces risks of complications.

The efficiencies made by no longer funding these procedures will go towards bringing the CCG back to its statutory financial balance position which is vital in order for it to be viable organisation and fund future services for the local population.

EQIA

EQIA Bi-lateral Joint Replacement FINAL.docx

144

Public Survey Result

Reflection on comments

Although the survey reflects the CCG should fund this, there were very few comments on the simultaneous joint replacement specifically. However for the comments we did receive, the emerging themes are stated below:

“Don't know - Simultaneous Joint Replacement comments: If it would be beneficial for the health of these patients to have both joints replaced at the same time, then it would make sense to do the operation then rather than make the patient wait until later and have to go through another recovery period?”

“I am not certain of - I know patients who have undergone this procedure with the benefit of just the one anaesthetic and recovered well. I have known others who have suffered horrendous joint infection. “

Recommendation

The recommendation to the Board is that the CCG should not fund Simultaneous Joint Replacements.

145 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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 1 RARE 1 MINOR score 2 UNLIKELY 2 MODERATE / LOW 1 - 3 Low risk (green)

3 MODERATE 3 SERIOUS / POSSIBLE 4 - 6 Moderate risk (yellow) 4 LIKELY 4 MAJOR 8 - 12 High risk (orange)

5 ALMOST 5 FATAL / CATASTROPHIC 15 - 25 Extreme risk (red) CERTAIN

A fuller description of impact scores can be found at appendix 1.

IMPACT 1 2 3 4 5

1 1 2 3 4 5 Please take care with this assessment. A carefully completed assessment should safeguard against 2 2 4 6 8 10 challenge at a later date. 3 3 6 9 12 15

LIKELIHOOD 4 4 8 12 16 20 5 5 10 15 20 25

1 146 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Title and lead for scheme: Cease the funding of:  Simultaneous bilateral hip and knee replacements  Shoulder joint replacement

Brief description of scheme: As part of a wider review of service restrictions Basildon & Brentwood CCG are proposing to cease the funding of:  Simultaneous bilateral hip and knee replacements  Simultaneous bilateral shoulder joint replacement

Answer positive/negative (P/N) in each area. If Negative score the impact, likelihood and total in the appropriate box. If score > 8 insert Y for full assessment

Area of Impact question P/N Impact Likeli- Score Full Quality hood Assessment required 1 Duty of Could the proposal impact positively or negatively on any of the N 2 3 6 n Quality following - compliance with the NHS Constitution (see appendix 3), partnerships, safeguarding children or adults ? 2 Equality and Could the proposal impact positively or negatively on any of the P n Diversity protected characteristics under the Equality Act 2010 (see appendix 2) 3 Patient Could the proposal impact positively or negatively on any of the P n Experience following - positive survey results from patients, patient choice, personalised & compassionate care?

4 Carers Could the proposal impact positively or negatively on informal p n experience carers? (if negatively, is there an identified resource to meet the need, or does the need require flagging to the CCG carers lead)? 5 Patient Could the proposal impact positively or negatively on any of the P n 2 147 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Safety following – safety, systems in place to safeguard patients to prevent harm, including infections? 6 Clinical Could the proposal impact positively or negatively on evidence N/A Effectiveness based practice, clinical leadership, clinical engagement and/or high quality standards? 7 Prevention Could the proposal impact positively or negatively on promotion P of self-care and health inequality? 8 Productivity Could the proposal impact positively or negatively on - the best N 2 3 6 n and setting to deliver best clinical and cost effective care; Innovation eliminating any resource inefficiencies; low carbon pathway; improved care pathway?

Please describe your rationale for any negative/positive impacts; key facts and figures about the local population including who has been consulted to complete this section. The CCG is not proposing to cease provision of unilateral joint replacement, but the replacement of both hips or knees during the same operation.

The rationale for this proposal is that this is deemed by Public Health to be a procedure of limited clinical effectiveness. While there may be reasons to want to replace both sides at the same time, the CCG feels that the impact on the length and potential for rehabilitation, for the patient, is not outweighed by the benefit of having the procedure done at the same time. There could be increased risks associated with the length of the anaesthetic and operation and any complication with one replaced joint would hinder the rehabilitation of the other.

Whilst the CCG acknowledges there are benefits of knee and hip replacements in improving patients quality of life and there is evidence to support this (http://bmjopen.bmj.com/content/2/1/e000332.full). The CCG does not feel that there is significant supporting evidence to consider the funding of bilateral hip or knee replacements as a routine procedure.

3 148 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

In the year 2015/16 the CCG was only asked to fund:  One bi-lateral hip joint replacement  One bi-lateral knee replacement  One bi-lateral shoulder replacement.

There may be a positive impact on the elderly who, if less healthy may be more at risk risks from a bilateral procedure due to longer anaesthetic and recovery times. Carrying out the procedures unilaterally is likely to produce a more positive experience for most patients and carers due to that reduced recovery period, although it is acknowledged that for some patients, a further procedure may be required at a later date. Although an evidence search did not reveal any further robust evidence base for unilateral versus bilateral replacements, these procedures are listed by PHE as procedures of limited clinical effectiveness.

Therefore the CCG feel that this is an exception to the norm, and therefore will restrict the funding of this procedure to exceptional clinical circumstances only.

Signature: Designation: Date:

Stage 2

Risk (5 x5 risk

matrix)

Area of Mitigation strategy and Description of impact (Positive or Indicators quality negative) monitoring arrangements

Score Impact Overall

Likelihood

AND DUTY OF QUALITY EQUALITY

4 149 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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 specific impact of the project on people with protected characteristics, in

terms of individual and community health, access to services and patient experience?

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?

What impact is it likely to have on self reported experience of patients and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice?

PATIENT EXPERIENCE

5 150 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Does it support the compassionate and personalised care agenda?

What impact is it likely to have on self

reported experience of carer and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice? EXPERIENCE

Does it support the compassionate and

CARER personalised care agenda?

How will it impact on patient safety?

How will it impact on preventable harm?

Will it maximise reliability of safety systems? PATIENT SAFETY

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

6 151 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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? CLINICAL EFFECTIVENESS

Are systems for monitoring clinical quality supported by good information?

Does it impact on clinical engagement?

PREVENTI Does it support people to stay well?

7 152 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

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

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

PRODUCTIVITY AND INNOVATION gains in performance?

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

Signature: Designation: Date:

8 153 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 1.

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

short-term reduction in public long-term reduction in public confidence confidence 9 154 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

10 155 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Below are some aspects of Human Rights principles and examples of their relevance to healthcare. Human rights principles should be taken into account when undertaken EIAs.

• The right to life e.g., Do Not Resuscitate orders, refusal or lifesaving medical treatment, Advance Directives

• The right to a fair trial

e.g., staff disciplinary proceedings, compensation claims, handling of special case panels 11 156 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 3

NHS Constitution (2013)

Values • Working together for patients • Respect and dignity • Quality of care • Compassion • Improving lives • Everyone counts

12 157 Pain treatments/injections (back, hip and leg)

Original proposal

As part of a wider review of service restrictions Basildon & Brentwood CCG are proposing to cease the funding of pain insert procedures (facet joint injections, hip & spinal injections).

For note:

These procedures are not those available at General Practice but those that are required referral to be undertaken at an acute hospital.

Rationale

As a result of this, the CCG has identified procedures that are of either limited clinical value or that does not cater for the wider needs of the population. Therefore it has been proposed to implement these changes in order for the local health economy and services to be sustainable.

The CCG in consultation with the Dr Simon Thompson (Pain Specialist Consultant, Basildon Hospital) have developed a criteria (see below proposed criteria) for injections for diagnostic purposes that supports both current and proposed NICE Guidance and reflects the position of the British Pain Society.

Impact

The proposed changes would mean that secondary care (acute) pain injections (facet joint injection, hip and spinal injection) would no longer be funded by the CCG except as a diagnostic intervention. There will still be a range of pain relief interventions available that will be funded and/or can be prescribed. These may include (list not exhaustive):

 Community Pain Management Programme  Palliative Medications to manage pain  Injections administered by General Practice  Conservative Pain Management through Physiotherapy

EQIA

EQIA Pain Inserts (Recovered)v 4 0 revised FINAL.docx

Public Survey Result

158 Reflection on comments for facet joint injection, hip and spinal injection

The comments received were in the main:

 From those who had received or were within the care of the pain service and as such their comments reflected the treatment and benefit they had felt as a result of their intervention  From people who linked this to support and pain management of people with life limiting conditions and as such should or should not receive pain relief – these interventions are not palliative medicine and the CCG was not consulting on changes to palliative medicine – the CCG already has a formulary for prescribing for palliative medicine

Following the feedback from the Public consultations, the opportunity was taken to redefine our proposals in collaboration with Dr Simon Thomson of Basildon Hospital.

Proposed Criteria developed with Dr Simon Thomson and proposed to the Board

Facet Joint Pain (posterior spinal element/facetogenic back and leg pain)

 Medial Branch Block Injection (hip and leg) – The CCG will only commission: o One Medial Branch Block Injection (hip and leg) as a diagnostic o Progression to Medial Branch Block Radiofrequency Denervation will only be commissioned (funded) where there is evidence of pain relief of ≥80% at time of the medial branch block injection (hip and leg), and that the pain returned within 72hours  Prior to the person receiving Medial Branch Block Injection (hip and leg) they must have had: o the pain for more than 3 months and other conventional options have failed to resolve the pain (oral analgesics and physiotherapy)  The CCG no longer funds intra-facet or facet joint (steroid) injections in any other indication

Sacro-iliac joint mediated back and leg pain

 Sacro-iliac joint (targeted) lateral branch block with intra-articular steroid (these are undertaken as one procedure only) – The CCG will only commission: o One Sacro-iliac joint (targeted) lateral branch block with intra-articular steroid injection (one procedure) as a diagnostic o Progression to Medial and lateral branch block radiofrequency denervation will be commissioned where pain relief of ≥80% at time of injection, and pain returned within 72hours (this will need to be evidenced)  Prior to the person receiving Sacro-iliac joint (targeted) lateral branch block Injection (hip and leg) they must have had: o the pain for more than 3 months and other conventional options have failed to resolve the pain (oral analgesics and physiotherapy)  The CCG no longer funds sacro-iliac joint mediated back and leg pain injections in any other indication

Discogenic and radicular back pain

The CCG will commission targeted (interlaminar/transforaminal/combined) spinal steroid injections for those meeting the following criteria:

159  where there is evidence of neuropathy (documented) then one injection will be funded  where there is no evidence of neuropathy: o but documented evidence of discogenic and/or radicular back pain and the pain has been present for more than 3 months and other conventional options have failed to resolve the pain (oral analgesics and physiotherapy) o then the initial injection would be funded o if there was clear evidence (documented) that the pain had resolved by 100% for 6 weeks then a further 2 injections (totalling 3 injections) would be funded – this is to provide long term cure or palliation o if there is clear evidence (documented) that the pain had reduced by 50% or more for at least 3 months then a further 2 injections (totalling 3 injections) would be funded – this is to provide long term cure or palliation  Where there is no clear documented evidence of improvement from the initial or total of 3 injections then the patient should be referred for consideration of decompression surgery  The CCG no longer funds Discogenic and radicular back pain injections in any other indication

Recommendation

The Board is asked to approve the following recommendations:

 The CCG only commission Back, Hip and Spine Injections (indications as outlined in proposal above) as a diagnostic procedure for Facet Joint Pain (posterior spinal element/facetogenic back and leg pain)  The CCG only commission Back, Hip and Spine Injections (indications as outlined in proposal above) as a diagnostic procedure for Sacro-iliac joint mediated back and leg pain  The CCG only commission Back, Hip and Spine Injections (indications as outlined in proposal above) as a diagnostic procedure for Discogenic and radicular back pain

160 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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 1 RARE 1 MINOR score 2 UNLIKELY 2 MODERATE / LOW 1 - 3 Low risk (green)

3 MODERATE 3 SERIOUS / POSSIBLE 4 - 6 Moderate risk (yellow) 4 LIKELY 4 MAJOR 8 - 12 High risk (orange)

5 ALMOST 5 FATAL / CATASTROPHIC 15 - 25 Extreme risk (red) CERTAIN

A fuller description of impact scores can be found at appendix 1.

IMPACT 1 2 3 4 5

1 1 2 3 4 5 Please take care with this assessment. A carefully completed assessment should safeguard against 2 2 4 6 8 10 challenge at a later date. 3 3 6 9 12 15

LIKELIHOOD 4 4 8 12 16 20 5 5 10 15 20 25

1 161 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Title and lead for scheme: Pain Inserts (Facet joint injections, hip and spinal injections and spinal cord stimulation) and Medial Branch Blocks

Brief description of scheme: As part of a wider review of service restrictions Basildon & Brentwood CCG are proposing to cease the funding of pain procedures including:  facet joint injections  hip injections  medial branch block  spinal injections  spinal cord stimulation

Answer positive/negative (P/N) in each area. If Negative score the impact, likelihood and total in the appropriate box. If score > 8 insert Y for full assessment

Area of Impact question P/N Impact Likeli- Score Full Quality hood Assessment required 1 Duty of Could the proposal impact positively or negatively on any of the N/A Quality following - compliance with the NHS Constitution (see appendix 3), partnerships, safeguarding children or adults ? 2 Equality and Could the proposal impact positively or negatively on any of the N 2 2 4 n Diversity protected characteristics under the Equality Act 2010 (see appendix 2) 3 Patient Could the proposal impact positively or negatively on any of the N 2 4 8 n Experience following - positive survey results from patients, patient choice, personalised & compassionate care?

2 162 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

4 Carers Could the proposal impact positively or negatively on informal N 2 3 6 n experience carers? (if negatively, is there an identified resource to meet the need, or does the need require flagging to the CCG carers lead)? 5 Patient Could the proposal impact positively or negatively on any of the N/A Safety following – safety, systems in place to safeguard patients to prevent harm, including infections? 6 Clinical Could the proposal impact positively or negatively on evidence N 2 4 8 n Effectiveness based practice, clinical leadership, clinical engagement and/or high quality standards? 7 Prevention Could the proposal impact positively or negatively on promotion N 2 4 8 n of self-care and health inequality? 8 Productivity Could the proposal impact positively or negatively on - the best N 2 3 6 n and setting to deliver best clinical and cost effective care; Innovation eliminating any resource inefficiencies; low carbon pathway; improved care pathway?

Please describe your rationale for any negative/positive impacts; key facts and figures about the local population including who has been consulted to complete this section.

This policy change has been proposed in line with those other CCGs in the Essex Success Regime Footprint commissioning position. The CCG intention is to reduce the clinical variation and equity of provision across the ESR geography.

The current position is varied: North East Essex CCG position is that: The CCG does not fund Hip Injections based on the current evidence on safety and efficacy does not appear adequate to recommend hip injections. On this basis we would not routinely support hip injections. Funding is approved for the following:

 Diagnostic aid  To introduce contrast medium to the joint as part of hip arthrogram  Babies for hip arthrography  Children and adults with inflammatory arthropathy  Investigation of infection in biological and replaced hips.

3 163 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

MidEssex CCG does not routinely fund Therapeutic facet joint injections and medial branch blocks

Facet joint injections are only commissioned for diagnostic assessment and only in patients being assessed for surgical management of chronic spinal pain.

The other south Essex CCGs currently commission in line with BBCCG however, are reviewing their position.

Facet, joint and fusion and medial branch block injections are identified by Public Health as being procedures of low clinical value and with limited clinical evidence.

Evidence supporting this as a procedure of clinical value: Ref: Procedures of Limited Clinical Effectiveness Phase 1, Consolidation and repository of the existing evidence-base Meeyin Lam, Public Health Trainee, Jennie Mussard, Assistant Director (PCT Intelligence) Updated to include procedure codes and information on outliers, October 2010

Gibson JNA, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database of Systematic Reviews 2007, Issue 2. Ibrahim T; Tleyjeh IM; Gabbar O. Surgical versus non-surgical treatment of chronic low back pain: a meta-analysis of randomised trials. International Orthopaedics, February 2008, vol./is. 32/1(107-13), 0341-2695 Mirza SK; Deyo RA Systematic review of randomized trials comparing lumbar fusion surgery to non-operative care for treatment of chronic back pain. Spine, April 2007, vol./is. 32/7(816-23), 1528-1159 Rivero-Arias O, Campbell H, Gray A et al. Surgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trial. BMJ. 2005 May 28;330(7502):1239 Van Tulder M, Koes B, Seitsalo S, Malmivaara A. Outcome of invasive treatment modalities on back pain and sciatica: an evidence-based review. Volume 15, Supplement 1 / January, 2006 Can be purchased from http://www.springerlink.com/content/718525118748783t/fulltext.pdf For discectomy: Butterman GR. Treatment of lumbar disc herniation: epidural steroid injection compared to discectomy. J Bone and Joint Surgery 2004; 86-a: 670-9 Greenfield K, Nelson RJ et al. Microdiscectomy and conservative treatment for lumbar disc herniation with back pain and sciatica: a randomized clinical trial. Proceedings of the International Society for the Study of the Lumbar Spine, 2003: 245 4 164 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Hoffman RM, Wheeler KJ, Deyo RA. Surgery for herniated lumbar discs: a literature synthesis. J Gen Int Med 1993; 8: 487-96 Malter AD, Larson EB et al. Cost effectiveness of lumbar discectomy for the treatment of herniated invertebral disc. Spine 1996; 21: 1048-55 Weber H. Lumbar disc herniation. A controlled, prospective study with ten years of observation. Spine 1983 8(2): 131-40 Weinstein JN, Torteson TD, Lurie JD et al. Surgical vs Nonoperative Treatment for Lumbar Disk Herniation. JAMA 2006 296

Also see listing for Lumbar disc prolapse (A09) Note: HRG4 HC01Z, HC02B, HC02C, HC03A, HC03B, HC03C, HC04A, HC04B, HC04C, HC05B, HC05C, HC07Z, HC08Z, HC09Z OPCS V221, V231, V241, V251, V253 ,V261, V333, V335, V336, V371, V372, V373, V374, V378, V379, V381, V382, V383, V384, V388, V389, V391, V392, V393, V394, V395, V398, V399,

Spinal Cord Stimulation The CCG currently commissions spinal cord stimulation in accordance with NICE TA 159.

Spinal cord stimulation is recommended as a possible treatment for adults with chronic pain of neuropathic origin if they:

• continue to experience chronic pain (measuring at least 50 mm on a 0-100 mm visual analogue scale) for at least 6 months despite standard treatments, and • have had a successful trial of spinal cord stimulation as part of an assessment by a specialist team.

Treatment with spinal cord stimulation should only be given after the person has been assessed by a specialist team experienced in assessing and managing people receiving treatment with spinal cord stimulation.

Ceasing provision of Spinal Cord Stimulation for those newly identified as requiring Stimulation and those currently with a stimulator that would require refill and “top up” would negatively impact on the NHS responsibility regarding NICE TA’s

The centre is commissioned based on the defined population requiring the specific pain management treatments, therefore they 5 165 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3 should have the appropriate level of resource to achieve the constitutional RTT requirements.

Technology appraisals and the NHS Constitution

The NHS is legally obliged to fund and resource medicines and treatments recommended by NICE's technology appraisals.

This is reflected in the NHS Constitution, which states that patients have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if their doctor believes they are clinically appropriate. When NICE recommends a treatment 'as an option', the NHS must make sure it is available within 3 months (unless otherwise specified) of its date of publication. This means that, if a patient has a disease or condition and the doctor responsible for their care thinks that the technology is the right treatment, it should be available for use, in line with NICE's recommendations.

Protected Characteristics:

With regards to disabled patients, there may be a negative impact in terms of additional travel and commuting to a tertiary centre.

There is however assistance available for patients that meet the criteria for health costs and patient transport to contribute towards or cover any additional costs incurred by traveling to specialist centres.

Signature: Designation: Date:

Stage 2

Risk (5 x5 risk

matrix)

Area of Mitigation strategy and Description of impact (Positive or Indicators quality negative) monitoring arrangements

Score Impact Overall

Likelihood

6 166 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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 EQUALITY

and shared risk?

What is the specific impact of the project on people with protected characteristics, in

terms of individual and community health, access to services and patient experience?

DUTY OF QUALITY 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?

What impact is it likely to have on self reported experience of patients and service CE users? (Response to national/local PATIENT

EXPERIEN surveys/complaints/PALS/incidents)

7 167 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

How will it impact on choice?

Does it support the compassionate and personalised care agenda?

What impact is it likely to have on self

reported experience of carer and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice? EXPERIENCE

Does it support the compassionate and

CARER personalised care agenda?

How will it impact on patient safety?

How will it impact on preventable harm?

Will it maximise reliability of safety PATIENT SAFETY systems?

8 168 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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? CLINICAL EFFECTIVENESS

Are systems for monitoring clinical quality supported by good information?

Does it impact on clinical engagement?

9 169 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Does it support people to stay well?

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

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

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

PRODUCTIVITY AND INNOVATION gains in performance?

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

10 170 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Signature: Designation: Date:

11 171 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 1.

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

short-term reduction in public long-term reduction in public confidence confidence 12 172 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

13 173 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Below are some aspects of Human Rights principles and examples of their relevance to healthcare. Human rights principles should be taken into account when undertaken EIAs.

• The right to life e.g., Do Not Resuscitate orders, refusal or lifesaving medical treatment, Advance Directives

• The right to a fair trial

e.g., staff disciplinary proceedings, compensation claims, handling of special case panels 14 174 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 3

NHS Constitution (2013)

Values • Working together for patients • Respect and dignity • Quality of care • Compassion • Improving lives • Everyone counts

15 175 Spinal Cord Stimulation (SCS)

Original proposal

As part of a wider review of service restrictions Basildon & Brentwood CCG are proposing to cease the funding of pain insert procedure (spinal cord stimulation).

Definition

Spinal cord stimulation involves placing a series of electrical contacts in the spine near the region that supplies nerves to the painful area. The procedure is a minimally invasive surgical technique.

Rationale

As a result of this, the CCG has identified procedures that are either limited clinical value or that does not cater for the wider needs of the population or therefore it has been proposed to implement these changes in order for the local health economy and services to be sustainable.

Impact

The proposed changes would mean that pain procedure (spinal injection) would no longer be funded by the CCG however there will still be a range of alternate pain relief methods available that will be funded and/or can be prescribed.

For patients who already have a Spinal Cord Stimulator device in situ – they would continue to receive the on-going support they require. However, this proposal would determine where they would receive this support in the future.

EQIA

EQIA Pain Inserts (Recovered)v 4 0 revised FINAL.docx

Public Survey Result

176 Reflection on comments for Spinal Cord Stimulation

The comments received were in the main (as for back, hip and spinal injections):

 From those who had received or were within the care of the pain service and as such their comments reflected the treatment and benefit they had felt as a result of receiving their care at Basildon Hospital  From people who linked this to support and pain management of people with life limiting conditions and as such should or should not receive pain relief – these interventions are not palliative medicine and the CCG was not consulting on changes to palliative medicine – the CCG already has a formulary for prescribing for palliative medicine

Proposed commissioning of Spinal Cord Stimulation

The CCG acknowledges that NICE Technical Appraisals (NICETA) require NHS Organisations to provide the procedure/intervention recommended. As outlined in the consultation Spinal Cord Stimulation (NICE TA) approved is commissioned from NHS England approved specialised centres.

Basildon and Thurrock University Hospital NHS Foundation Trust (BTUH) is seeking accredited status to become a specialised (approved) centre for the provision of Specialised Pain Services (Spinal Cord Stimulation included) within the next 12-18months. If this is achieved then the CCG would not wish to disrupt continuity for patients by repatriating their care to London only to have to bring it back if this approval occurs.

As such the CCG would propose the following:

 The CCG work with the Trust to support their accreditation  The CCG work with the Trust to agree a funding and risk (cost) managed service model for Spinal Cord Stimulation  If either of the above aren’t achieved then the CCG support the move to repatriate the activity and service to NHS England

Recommendation

The Board is asked to approve the following:

 That if the CCG can’t agree a: o Risk (cost) managed local service model by 5 December 2016 o The Trust (BTUH) can’t evidence with a project plan detailing the milestones to delivery (agreed with NHS England) the progression of the BTUH Pain service becoming accredited  Then the Spinal Cord Stimulation Service will be transferred to NHS England Specialised Commissioning.

177 Travel Vaccinations

Original proposal

In line with national recommendations from PrescQIPP, Basildon and Brentwood CCG is proposing to put in place a policy which clarifies the position of certain vaccines when requested in relation to travel abroad. This is to ensure that certain vaccines which are not allowed on the NHS for travel purposes, are not prescribed on FP10 prescription.

Rationale

NHS patients are entitled to receive free advice on travel vaccinations, however, only some vaccinations required for travel are available on the NHS. This includes Hepatitis A vaccine, Typhoid vaccine, combined hepatitis A and typhoid vaccine, combined Tetanus, diphtheria and polio vaccine and Cholera vaccine.

Other vaccines such as Hepatitis B, Meningitis ACWY, Yellow fever, Japanese B encephalitis, Tick bourne encephalitis and Rabies vaccine are not remunerated by the NHS as part of additional services in relation to travel abroad, and these vaccines should not be prescribed on FP10 prescription. It is proposed that a GP practices may charge a registered patient for the immunisation if requested for travel, or the patient may be given a private prescription to obtain the vaccines.

In addition, the combined hepatitis A/hepatitis B vaccine is prescribable on the NHS because it contains hepatitis A. However, because hepatitis B is not commissioned by the NHS as a travel vaccine, Basildon and Brentwood CCG does not support the prescribing of this item. Patients requiring both vaccines for travel purposes should receive hepatitis B privately.

Impact

There is currently very little prescribing of Meningitis ACWY, Yellow fever, Japanese B encephalitis, Tick bourne encephalitis and Rabies vaccines on FP10 prescription in BBCCG, and therefore this policy would help to ensure no new prescribing. There is however a BBCCG spend of almost £75k per year associated with Hepatitis B vaccine, as well as the combined hepatitis A/hepatitis B vaccine. It is envisaged that implementation of local policy would reduce any inappropriate prescribing for travel abroad, and could produce annual savings to the CCG of approximately £75k across the course of a year.

EQIA

EQIA travel vaccines updated by NL GP V2.docx

178 Public Survey Result

Reflection on comments Although the majority vote states that ‘CCG should not fund’ the comments are fairly split. The comments that are in support of the CCG not funding are mainly along the lines of ‘if you can pay to go abroad you can pay for vaccines’ and ‘travelling is a lifestyle choice’. However the other comments suggest ‘prevention is better than cure’ and ‘vaccines work to protect the wider public’. Recommendation The recommendation to the Board is that Basildon and Brentwood CCG should not fund the following travel vaccinations as these are not standard NHS vaccines:

 Hepatitis B  Meningitis ACWY  Yellow fever  Japanese B encephalitis  Tick bourne encephalitis  Rabies vaccine

179 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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 1 RARE 1 MINOR score 2 UNLIKELY 2 MODERATE / LOW 1 - 3 Low risk (green)

3 MODERATE 3 SERIOUS / POSSIBLE 4 - 6 Moderate risk (yellow) 4 LIKELY 4 MAJOR 8 - 12 High risk (orange)

5 ALMOST 5 FATAL / CATASTROPHIC 15 - 25 Extreme risk (red) CERTAIN

A fuller description of impact scores can be found at appendix 1.

IMPACT 1 2 3 4 5

1 1 2 3 4 5 Please take care with this assessment. A carefully completed assessment should safeguard against 2 2 4 6 8 10 challenge at a later date. 3 3 6 9 12 15

LIKELIHOOD 4 4 8 12 16 20 5 5 10 15 20 25

1 180 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Title and lead for scheme: Francoise Price/ Jonathan Andrews

Brief description of scheme: Implementation of a policy around Travel vaccines in line with NHS guidance

Answer positive/negative (P/N) in each area. If Negative score the impact, likelihood and total in the appropriate box. If score > 8 insert Y for full assessment

Area of Impact question P/N Impact Likeli- Score Full Quality hood Assessment required 1 Duty of Could the proposal impact positively or negatively on any of the P Quality following - compliance with the NHS Constitution (see appendix 3), partnerships, safeguarding children or adults ? 2 Equality and Could the proposal impact positively or negatively on any of the N 2 4 8 No Diversity protected characteristics under the Equality Act 2010 (see appendix 2) 3 Patient Could the proposal impact positively or negatively on any of the N 4 1 4 No Experience following - positive survey results from patients, patient choice, personalised & compassionate care?

4 Carers Could the proposal impact positively or negatively on informal N 2 2 4 No experience carers? (if negatively, is there an identified resource to meet the need, or does the need require flagging to the CCG carers lead)? 5 Patient Could the proposal impact positively or negatively on any of the N 4 2 8 No Safety following – safety, systems in place to safeguard patients to prevent harm, including infections?

2 181 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

6 Clinical Could the proposal impact positively or negatively on evidence N 2 3 6 No Effectiveness based practice, clinical leadership, clinical engagement and/or high quality standards? 7 Prevention Could the proposal impact positively or negatively on promotion N 4 2 8 No of self-care and health inequality? 8 Productivity Could the proposal impact positively or negatively on - the best P 2 2 4 No and setting to deliver best clinical and cost effective care; Innovation eliminating any resource inefficiencies; low carbon pathway; improved care pathway?

Please describe your rationale for any negative/positive impacts; key facts and figures about the local population including who has been consulted to complete this section.

In line with national recommendations from PrescQIPP1, Basildon and Brentwood CCG is proposing to put in place a policy which clarifies the position of certain vaccines when requested in relation to travel abroad. This is to ensure that certain vaccines which are not allowed on the NHS for travel purposes, are not prescribed on FP10.

The policy will particularly affect provision of Hepatitis B vaccine, as well as the combined hepatitis A/hepatitis B vaccine in relation to travel abroad. It does not affect occupational Hepatitis B vaccination.

There is a possibility that people will continue to travel abroad without having the vaccinations, however, the hepatitis B risk ipredominantly relates to higher risk travellers and precautions such as avoid unprotected sexual intercourse, tattooing, piercing or acupuncture etc are the most important preventative measure. However.

Hepatitis B can be transmitted by anyone engaging in risky sexual behaviour, such as having casual, unprotected, anonymous sex with other men. Therefore, the inability to get the vaccine on the NHS could negatively discriminate against some sexuality.

Re ethnicity, Also, re ethnicity, a government study (2012) on London prevalence showed Hepatitis B positivity was higher in certain minority ethnic groups ; those identified as black were over four times and Asians twice as likely to test positive as those identified as white or white British. Nineteen out of every 20 antenatal women testing positive for hepatitis B were born abroad, nearly half were born in Africa and an

3 182 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3 increasing number of women from Eastern Europe have tested positive for hepatitis B, although numbers appear to be plateauing.

The impact of patients not getting fully protected with Hep B vaccination may impact upon the overall clinical effectiveness of the vaccination campaign

Patients may possibly continue to expect to receive these vaccines prior to travelling abroad, as this may have been common practice in the past (there has traditionally been a lack of clarity about the provision and charging of vaccinations for patients in at-risk groups, prior to travel abroad).

Clear communication from the CCG, and from practice staff (especially Practice Nurses) will therefore be necessary to implement this policy, and to minimise the risk of patients opting to travelling abroad without the necessary vaccinations (as these may now need to be paid for privately). There is also a small potential for conflict as a result of implementing this policy – again clear CCG communication will help to minimise this risk.

1. PrescQIPP Bulletin 74: Travel Vaccines (DROP-LIST) September 2014.

Vaccination is a valuable preventative measure. However, it is estimated that only 10% of travel related illness is preventable by vaccination

Travellers contracting tropical diseases abroad and importing them back to the United Kingdom pose a significant problem. Many diseases, such as typhoid fever, are occasionally notified in the United Kingdom but are usually contracted abroad.

Signature: J Andrews Designation: Deputy Head of Medicines Management Date: 13.06.2016

4 183 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Stage 2

Risk (5 x5 risk

matrix)

Area of Mitigation strategy and

Description of impact (Positive or Indicators quality negative) monitoring arrangements

Score Impact Overall

Likelihood

Does it impact on the organisation’s commitment to the public to continuously drive quality improvement as reflected in

rights and pledges of the NHS Constitution? What is the impact on strategic partnerships and shared risk?

. What is the specific impact of the project on people with protected characteristics, in DUTY OF QUALITY

terms of individual and community health, access to services and patient experience?

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

5 184 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

What impact is it likely to have on self

reported experience of patients and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice?

Does it support the compassionate and personalised care agenda? PATIENT EXPERIENCE

What impact is it likely to have on self

reported experience of carer and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice?

Does it support the compassionate and

CARER EXPERIENCE personalised care agenda?

How will it impact on patient safety? SAFETY PATIENT

6 185 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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? CLINICAL EFFECTIVENESS

Does it reduce/impact on variations in care?

7 186 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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? PREVENTION

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

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

Does it eliminate inefficiency and waste?

PRODUCTIVITY AND INNOVATION Does it support low carbon pathways?

8 187 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Will the service innovation achieve large gains in performance?

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

Signature: Designation: Date:

9 188 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 1.

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

short-term reduction in public long-term reduction in public confidence confidence 10 189 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

11 190 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Below are some aspects of Human Rights principles and examples of their relevance to healthcare. Human rights principles should be taken into account when undertaken EIAs.

• The right to life e.g., Do Not Resuscitate orders, refusal or lifesaving medical treatment, Advance Directives

• The right to a fair trial

e.g., staff disciplinary proceedings, compensation claims, handling of special case panels 12 191 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 3

NHS Constitution (2013)

Values • Working together for patients • Respect and dignity • Quality of care • Compassion • Improving lives • Everyone counts

13 192 Bariatric Surgery

Original proposal

As part of a review into service restrictions Basildon and Brentwood CCG was proposing not to fund bariatric surgery.

NHS England transferred responsibility for commissioning Bariatric surgery to the CCG from 1 April 2016. This service is provided from specialised centres so patients must travel to London for this surgery.

Whilst the funding will return with the service, the CCG feel that it should consult on not providing this service to the population and instead work with Public Health to promote healthier lifestyles and tackle obesity rather than managing the problem once it occurs. However, as stipulated in the latest NICE guidance (CG189; 2014), there will be a group of patients, especially people of different ethnicity, who may benefit from bariatric surgery as they are likely to develop more complex health conditions (especially Diabetes) if they are already significantly overweight.

Obesity & Weight Management Obesity rates have doubled in 20 years (men 24%, women 26%) but Basildon (30.2%) has a greater percentage of adults that are classified as obese or excess weight compared to the regional and national average, in sharp contrast with Brentwood (18.6%). In regards to children, the rate of obesity is higher in Basildon than Brentwood with both tracking the general upward trend in the past few years but levelling off now. There is over 10% decrease in children with ‘healthy weight’ between Reception year and Year 6 cohorts.

Definition - Bariatric surgery

This type of surgery is only available on the NHS to treat people with potentially life- threatening obesity when other treatments, such as lifestyle changes, haven't worked.

Potentially life-threatening obesity is defined as:

 having a body mass index (BMI) of 40 or above  having a BMI of 35 or above and having another serious health condition that could be improved if you lose weight, such as type 2 diabetes or high blood pressure

Adults who have recently been diagnosed with type 2 diabetes may also be considered for an assessment for weight loss surgery if they have a BMI of 30-34.9.

Rationale

The CCG wish to support people to self-manage their condition, empowering them to have greater control over their lives’. Where there is a pressing clinical need, cases will be considered on an exceptional basis. The CCG feel that through working with Public Health and our providers to support people to better manage their conditions and engage and participate in improving their wellbeing the need for bariatric surgery should decrease whilst outcomes for patients should improve.

Both Basildon and Brentwood Health and Well Being Boards (HWB) support the need to prevent obesity and manage it so as to reduce the need to progress onto surgical intervention.

193 Impact

It is suggested that the proposal should not greatly impact patients with obesity and weight issues as there are already various weight management services available that teach nutrition and lifestyle changes rather than opting for surgery. With any surgery there are risks and if patients can lose weight themselves naturally with the support of local services they are not going to be exposed to the risks of bariatric surgery and any possible complications.

EQIA: Assessing the impact of ceasing provision as per Public Consultation – see recommendation for Board below.

Bariatric EQIA- revised 2016-09-20 v1.0.docx Public Survey Result

Reflection on comments

Where the CCG received comments in support of the proposal to stop or not fund bariatric surgery the feedback centred on:

 that it was a lifestyle choice and as such should not be funded  that should only be funded in exceptions i.e. due to an illness or disability

Where the CCG received comments for funding of bariatric surgery not to stop the feedback centred on:

 that there potentially was a greater benefit to the system if this was in place as would reduce long term health impact of bariatric patients

Recommendation

The recommendation to the Board is that they:

 Support the proposal to fund bariatric surgery (via Individual Prior Approval), using the NHS England criteria (see below) that was in place prior to the transfer of the service from NHS England to CCGs.  Support and approve the mitigation to this decision listed below o ensure that through closer working with Public Health the CCG promote and refer patients for support for Tier 2 (Lifestyle interventions weight management services) that Public Health commission

194 o ensure access for Tier 3 (specialist weight management services) for those that are outside of the Tier 2 criteria and that the CCG monitor the impact and outcomes of the Tier 3 weight management service o ensure that information is available on the CCG website to navigate people to weight management programmes and support

NHS England criteria for Bariatric Surgery that the CCG are proposing to adopt:

Surgery should only be considered as a treatment option for people with morbid obesity providing all of the following criteria are fulfilled:

• The individual is considered morbidly obese.

For the purpose of this guidance and in accordance with previous and current NICE Guidance, obesity surgery will be offered to adults with a BMI of 40kg/m2 or more, or between 35 kg/m2 and 40kg/m2 or greater in the presence of other significant diseases. However, NICE have recently updated their guidance on obesity surgery (NICE CG189). This expands the above criteria - to the consideration of newly diagnosed diabetics ( 30 to < 35, for assessment of obesity surgery. Moreover, patients with newly diagnosed diabetes within the former group (≥35) should be expedited for consideration of obesity surgery. All groups will have been treated in a Tier 3 specialist weight management service. NICE guidance also includes consideration of assessment of newly diagnosed Asian diabetes patients at BMI levels2.5 kg/m2 less.

• There must be formalised MDT led processes for the screening of comorbidities and the detection of other significant diseases.

These should include:

• Disease / condition / Risk factor identification, diagnosis, severity / complexity assessment, risk stratification/scoring and appropriate specialist referral for specialist medical management. Such medical evaluation and optimization is mandatory prior to entering a surgical pathway.

• The individual has recently received and complied with a local specialist weight management programme (non-surgical Tier 3 mostly and Tier 4 in some urgent or complex cases) described as follows:

 This will have been for a duration considered appropriate by the MDT (previous requirement was for 12-24 months). For patients with BMI > 50 attending a specialist obesity service, this period should include the stabilisation and assessment period prior to obesity surgery (previous requirement was a minimum of 6 months). Patients with new onset type 2 diabetes may have their surgical assessment concurrently with the medical tier 3 service.

195 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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 1 RARE 1 MINOR score 2 UNLIKELY 2 MODERATE / LOW 1 - 3 Low risk (green)

3 MODERATE 3 SERIOUS / POSSIBLE 4 - 6 Moderate risk (yellow) 4 LIKELY 4 MAJOR 8 - 12 High risk (orange)

5 ALMOST 5 FATAL / CATASTROPHIC 15 - 25 Extreme risk (red) CERTAIN

A fuller description of impact scores can be found at appendix 1.

IMPACT 1 2 3 4 5

1 1 2 3 4 5 Please take care with this assessment. A carefully completed assessment should safeguard against 2 2 4 6 8 10 challenge at a later date. 3 3 6 9 12 15

LIKELIHOOD 4 4 8 12 16 20 5 5 10 15 20 25

1 196 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Title and lead for scheme: Ceasing funding of bariatric surgery / procedures

Brief description of scheme: This EQIA covers the proposed impact of ceasing funding of the bariatric procedures.

Answer positive/negative (P/N) in each area. If Negative score the impact, likelihood and total in the appropriate box. If score > 8 insert Y for full assessment

Area of Impact question P/N Impact Likeli- Score Full Quality hood Assessment required 1 Duty of Could the proposal impact positively or negatively on any of the N 3 5 15 Yes Quality following - compliance with the NHS Constitution (see appendix 3), partnerships, safeguarding children or adults ? 2 Equality and Could the proposal impact positively or negatively on any of the N 2 3 6 No Diversity protected characteristics under the Equality Act 2010 (see appendix 2) 3 Patient Could the proposal impact positively or negatively on any of the N 2 4 8 No Experience following - positive survey results from patients, patient choice, personalised & compassionate care?

4 Carers Could the proposal impact positively or negatively on informal N 2 3 6 No experience carers? (if negatively, is there an identified resource to meet the need, or does the need require flagging to the CCG carers lead)? 5 Patient Could the proposal impact positively or negatively on any of the N 2 3 6 No Safety following – safety, systems in place to safeguard patients to prevent harm, including infections? 2 197 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

6 Clinical Could the proposal impact positively or negatively on evidence N 2 3 6 No Effectiveness based practice, clinical leadership, clinical engagement and/or high quality standards? 7 Prevention Could the proposal impact positively or negatively on promotion N 2 3 6 No of self-care and health inequality? 8 Productivity Could the proposal impact positively or negatively on - the best P 2 2 4 No and setting to deliver best clinical and cost effective care; Innovation eliminating any resource inefficiencies; low carbon pathway; improved care pathway?

Please describe your rationale for any negative/positive impacts; key facts and figures about the local population including who has been consulted to complete this section.

Duty of Quality It is viewed that the restriction of bariatric surgery will impact upon the following aspects of the NHS Constitution; - Comprehensive service available to all - Access to NHS services based on clinical need not ability to pay

Whilst the restriction of bariatric surgery would increase the inequality of access to surgery for our population as opposed to other CCGs in Essex who continue to commission this service, it would enable an increased access to prevention and targeted management and supported self-management thorough access to Public Health and Health commissioned services. This cessation should only affect a small number of the population as there was only 20 obesity procedures in 2015/16.

Evidence - • National Obesity Observatory publication in 2011, compared to the general population the prevalence of obesity is lower among men from Bangladeshi and Chinese communities in particular. Among women, obesity prevalence is higher for those from Black African, Black Caribbean and Pakistani communities • Chang (2014) Bariatric surgery provides substantial and sustained effects on weight loss and ameliorates obesity- attributable comorbidities in the majority of bariatric patients, although risks of complication, reoperation, and death exist. Death rates were lower than those reported in previous meta-analyse Equality and Diversity – cultural prevalence; The prevalence of obesity is also linked to socioeconomic status; people with learning disabilities are also at higher risk of being obese Duty of Quality - impact on access to NHS service based on clinical need not the ability to pay. 3 198 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Patient Safety – patients may continue to be morbidly obese Patient experience - Impact on choice for less affluent people Clinical Effectiveness – Doesn’t comply with NICE QS

Signature: Designation: Date:

Stage 2

Risk (5 x5 risk

matrix)

Area of Mitigation strategy and

Description of impact (Positive or Indicators quality negative) monitoring arrangements

Score Impact Overall

Likelihood

4 199 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Does it impact on the organisation’s It is anticipated that this restriction will have 3 5 15 The CCG is currently commitment to the public to continuously an impact on the NHS Constitution participating in the Essex drive quality improvement as reflected in commitments of “Comprehensive service Success Regime of Service the rights and pledges of the NHS available to all” and “Access to NHS services Restrictions. The CCG is Constitution? based on clinical need not ability to pay” reviewing its service restriction as a result of the Essex Success Regime review.

Applications for funding for these procedures can be made through the Individual Funding Request process but should only be made where the patient demonstrates true clinical exceptionality.

Does it impact on the organisation’s There is no expected impact on this. Not applicable 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? 0 0 0 What is the impact on strategic partnerships There is no expected impact on strategic Close working with partner and shared risk? partnerships/shared risk – potential impact on organisations other services due to continuing morbid

obesity 3 3 0 0 What is the specific impact of the project on people with protected characteristics, in terms of individual and community health, access to services and patient experience?

0 0 0 Are core clinical quality indicators and There is no expected impact on this Not applicable metrics in place to review impact on quality improvements?

0 0 0 Will this impact on the organisation’s duty to There is no expected impact on our duty to Not applicable protect children, young people and adults? protect.

0 0 0

5 200 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

What impact is it likely to have on self

reported experience of patients and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice?

Does it support the compassionate and personalised care agenda? PATIENT EXPERIENCE

What impact is it likely to have on self

reported experience of carer and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice? EXPERIENCE

Does it support the compassionate and

CARER personalised care agenda?

How will it impact on patient safety?

How will it impact on preventable harm? PATIENT SAFETY

6 201 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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?

CLINICAL EFFECTIVENESS

Does it reduce/impact on variations in care?

Are systems for monitoring clinical quality supported by good information?

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Does it impact on clinical engagement?

Does it support people to stay well?

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

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

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? PRODUCTIVITY AND INNOVATION

Will the service innovation achieve large gains in performance?

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

Signature: Designation: Date:

9 204 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 1.

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

short-term reduction in public long-term reduction in public confidence confidence 10 205 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

11 206 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Below are some aspects of Human Rights principles and examples of their relevance to healthcare. Human rights principles should be taken into account when undertaken EIAs.

• The right to life e.g., Do Not Resuscitate orders, refusal or lifesaving medical treatment, Advance Directives

• The right to a fair trial

e.g., staff disciplinary proceedings, compensation claims, handling of special case panels 12 207 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 3

NHS Constitution (2013)

Values • Working together for patients • Respect and dignity • Quality of care • Compassion • Improving lives • Everyone counts

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Cosmetic Surgery

Original proposal

That the CCG no longer commission Cosmetic Surgery procedures: • Breast Procedures – asymmetry / reduction / mastoplexy including revision / replacement • Gynaecomastia • Liposuction / skin contouring / body contouring • Cosmetic Surgery

Funding for reconstructive surgery will continue, where this is not for cosmetic purposes. Rationale

The CCG has a current financial deficit and is having to make decisions about ceasing funding of services and therefore has to review funding of all procedures of low/limited clinical value.

Impact

There should be limited impact on patients as these procedures are thought to be of low clinical value. Cosmetic surgery is a choice rather than a clinical need and should therefore be self-funded. Efficiencies made will go towards the CCGs financial deficit position and work towards bringing the CCG back to its statutory requirement to achieve financial balance.

EQIA

Cosmetic EQIA v1.1 Revised 2016-07-28.docx

Public Survey Result

Comments received

The comments received centred around the following themes:

 The decision to fund cosmetic procedures depended on the individual circumstances  Cosmetic procedures should only be carried out only after trauma, surgery or if someone is born with a problem  Cosmetic surgery after cancer is acceptable  Funding should be available to people with burn injuries

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 People with disfigurements should able to have procedures eg. acid facial injuries, cleft palate.  Only corrections for medical problems should be funded not for vanity reasons.  There were comments from people who had had mastectomy with reconstruction who stated their strong support for continuing to fund reconstruction  There were comments from people who thought post mastectomy breast reconstruction was low priority and one affected person who’d opted not to have reconstruction believed it should be self funded.  There were a number of comments supporting correction of facial disfigurement.  A number of comments supported cosmetic procedures for psychological reasons and number other supported not funding for emotional reasons.  There were general comments supporting only funding treatments that are lifesaving or have significant healthcare benefit that cannot be derived by other ways.  There were a few comments supporting corrective procedures for protruding ears Proposed Cosmetic Surgery – General Principles (which would replace existing general principles)

The proposed general principles are that procedures for cosmetic reasons will not be funded.

Referrals for plastic surgery from both primary, secondary and tertiary sources will be assessed in line with the relevant section of the Service Restriction Policy and the clinical evidence provided.

The Mental Health Transformational Delivery Board decided that it does not support commissioning cosmetic surgery to treat mental health symptoms. It concluded that this would be considered a low priority mental health intervention and that there was insufficient evidence to support the effectiveness of the intervention in terms of treating mental health conditions.

The following is from the existing service restriction policy:

Cosmetic Surgery - General Principles

Referrals for plastic surgery from both primary and tertiary sources will be assessed in line with the relevant section of the Service Restriction Policy and the clinical evidence provided.

For an authorised first appointment, the Plastic Surgery Specialist to whom the referral is subsequently passed should decide whether the patient would benefit from plastic surgical intervention, and if so, establish that the patient fully understands the risks and benefits of surgery.

All referrals should be assessed for both first Outpatients Department appointments and subsequent procedure appointments, in line with this policy and clinical evidence.

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The Mental Health Transformational Delivery Board has recently decided that it does not support commissioning cosmetic surgery to treat mental health symptoms. It concluded that this would be considered a low priority mental health intervention and that there was insufficient evidence to support the effectiveness of the intervention in terms of treating mental health conditions.

Assessment of patients being considered for referral who have an underlying conditions e.g. genetic or endocrine should have had this fully investigated by a relevant specialist prior to the referral to plastic surgery being made.

Surgery should be supported where a patient has been accepted onto an NHS waiting list prior to taking up residence in south Essex, providing the existing clinical evidence has remained the same. Referrals within the NHS for the revision of treatments originally performed outside the NHS will not usually be permitted unless the patient meets the local criteria for the original treatment. Referrers should be encouraged to re- refer to the practitioner who carried out the original treatment for resolution first where not endangering the health of the individual.

Where a patient has previously had NHS funded treatment, procedures necessary for dealing with complications or an outcome that, because of complications or technical difficulties, has resulted in cosmetic or physical problems that, from a professional point of view, are severe enough to oblige the NHS to fund corrective treatment, should be supported.

The National Service Framework for Children (National Service Framework for Children, Young People and Maternity Services (DH October 2004)), defines childhood as ending at 19 years. Funding for this age group should only be considered if there is a problem likely to impair normal emotional development. Children under the age of five rarely experience teasing and referrals may reflect concerns expressed by the parents rather than the child, which should be taken into consideration prior to referral. Some patients are only able to seek correction surgery once they are in control of their own healthcare decisions and again this should be taken into consideration prior to referral.

Cosmetic surgery – mental health grounds

Referrals will only be reviewed by the Individual Funding Request panel on an exceptional case basis.

Specific Conditions / Treatments

The current SRP states that cosmetic surgery is not funded. There are a number of specific conditions / procedures which have cosmetic components which could be viewed as anomalies which sit outside of this statement, they are:

Acne – resurfacing for severe post-acne facial scarring

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Aesthetic facial surgery Rhinoplasty Body contouring Breast procedures Breast augmentation / breast reconstruction Breast lift / mastoplexy Breast reduction Gynaecomastia Hair depilation Hymenorrhaphy Laser treatment for tattoo removal Liposuction / liposculpture / body contouring Pinnaplasty / otoplasty Plagiocephaly Repair of ear lobes – post trauma Rhinophyma Scar revision – keloid Scar revision – other Septoplasty / septorhinoplasty Vaginal labia refashioning

The following table sets out the proposed funding status and criteria for each condition / treatment / procedure.

The highlighted text is new wording and wording that is proposed to be deleted has been struck through.

4 212 Condition / Proposed Proposed detail Current Current detail Treatment status status Acne vulgaris Not Procedures to treat facial acne scarring will not be Funded The treatment of mild to moderate acne vulgaris should - resurfacing funded funded routinely commissioned by the NHS. be provided in primary care. Severe acne, that is acne for severe The treatment of mild to moderate acne vulgaris unresponsive to prolonged courses of oral antibacterials, post-acne should be provided in primary care. Severe acne, that or with scarring, or acne associated with psychological facial scarring is acne unresponsive to prolonged courses of oral problems should be referred to a consultant antibacterials, or with scarring, or acne associated dermatologist. with psychological problems should be referred to a consultant dermatologist. Resurfacing procedures can be undertaken under the NHS for severe facial post-acne by the plastic surgery Resurfacing procedures can be undertaken under the service once the active disease is controlled. All NHS for severe facial post-acne by the plastic surgery resurfacing techniques, including laser, dermabrasion service once the active disease is controlled. All and chemical peels may be considered for post-traumatic resurfacing techniques, including laser, dermabrasion scarring, including post-surgical and severe acne and chemical peels may be considered for post- scarring once the active disease is controlled. traumatic scarring, including post-surgical and severe acne scarring once the active disease is controlled. Aesthetic Funded Aesthetic facial surgery will be funded in the Funded NHS funding will only be available in the following facial surgery following circumstances: NHS funding will only be circumstances: (amalgamated available in the following circumstances: • Pathological abnormalities. with facial • Pathological abnormalities causing severe • Anatomical abnormalities in children <19 years, likely to surgery deformity / disfigurement. cause impairment of normal emotional development. section) • Anatomical abnormalities in children <19 years, likely • Correction of post traumatic bony and soft tissue to cause impairment of normal emotional deformity of the face. development. • Correction of post traumatic bony and soft tissue causing severe deformity / disfigurement of the face. • Congenital face abnormalities causing severe deformity / disfigurement • Facial palsy (congenital or acquired paralysis) causing severe disfigurement • As part of the treatment of specific conditions affecting the facial skin e.g. cutis laxa, pseudoxanthoma elasticum, neurofibromatosis causing severe deformity / disfigurement. • To correct the consequences of trauma • To correct severe deformity / disfigurement following surgery

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Abdominoplas Funded South Essex CCGs do not routinely commission Funded South Essex CCGs do not routinely commission ty / Abdominoplasty or apronectomy is funded for abdominoplasty or apronectomy. Funding may be apronectomy patients who meet the following criteria: Funding considered on a restricted basis for patients who meet may be considered on a restricted basis for patients the following criteria: who meet the following criteria: A Where it is required as part of abdominal hernia A Where the procedure it is required as part of correction or other abdominal wall surgery abdominal hernia correction or other abdominal wall OR surgery B Those patients from the following groups who have OR significant abdominal aprons as a result of weight loss and have severe functional problems*: B Patients with significant abdominal aprons as a • Patients with excessive abdominal folds who had an result of weight loss. and have severe functional initial BMI >40 and have achieved a reduction in BMI < impairment. Weight loss must result in a BMI <25 or a 25 and have maintained the BMI < 25 for at least 2 reduction in BMI points of at least 25 points that has years. been maintained for at least two years. Those patients OR from the following groups who have significant • Patient with excessive abdominal folds who have an abdominal aprons as a result of weight loss and have initial BMI > 50 and have achieved a minimum drop of 20 severe functional problems*: BMI points and have maintained this BMI (reduction of a • Patients with excessive abdominal folds who had an minimum of 20 points) for at least 2 years. initial BMI >40 and have achieved a reduction in BMI < 25 and have maintained the BMI < 25 for at least 2 *Severe functional problems include, but are not limited years. to,: OR • Recurrent intertrigo beneath the skin fold that re-occurs • Patient with excessive abdominal folds who have an or fails to respond despite appropriate medical therapy initial BMI > 50 and have achieved a minimum drop of for at least 6 months. 20 BMI points and have maintained this BMI • Abdominal wall prolapse with proven urinary symptoms. (reduction of a minimum of 20 points) for at least 2 • Problems associated with poorly fitting stoma bag. years. • Patient is experiencing severe difficulties with daily AND living i.e. ambulatory restrictions.

• Severe functional problems e.g.: o recurrent / persistant intertrigo resistant to professionally prescribed appropriate treatment beneath the skin folds for 12 months o abdominal wall prolapse with proven urinary symptoms o problems associated with poorly fitting stoma 6 214

bags o patient is experiencing severe difficulties with daily living i.e. ambulatory restrictions.

These patients will need full assessment by appropriate professional prior to referral.

This procedure will not be funded for cosmetic purposes. Buttock lifts, thigh lifts and arm lifts (brachioplasty), procedures will not normally be funded.

Severe functional problems impairment includes, but are is not limited to,: • Recurrent intertrigo beneath the skin fold that re- occurs or fails to respond despite appropriate medical therapy for at least 6 months. • Abdominal wall prolapse with proven urinary symptoms. • Problems associated with poorly fitting stoma bag. • Patient is experiencing severe Difficulties with daily living i.e. ambulatory restrictions. Rhinoplasty Funded Rhinoplasty will be funded for functional impairment. is Funded Rhinoplasty is funded on a restricted basis only. Before funded on a restricted basis only. Before proceeding proceeding except in instances of trauma or where except in instances of trauma or where patients are patients are being treated as an emergency, referring being treated as an emergency, referring and treating and treating clinicians must ensure thresholds are met. clinicians must ensure thresholds are met. Requests for Rhinoplasty may be considered for the Requests for rhinoplasty may be considered for the following indications: following indications: • Significant post-traumatic nasal injury causing • Significant post-traumatic nasal injury causing functional impairment. functional impairment. OR OR • Correction of complex congenital conditions e.g. cleft lip • Correction of complex congenital conditions e.g. cleft and palate. lip and palate. OR OR • Part of reconstructive head and neck surgery. • Part of reconstructive head and neck surgery to correct functional impairment. 7 215

Alopecia Not Not funded funded Belt lipectomy Not Not funded funded Breast Not Procedures to correct breast asymmetry will not Funded Funding will only be considered if there is gross disparity asymmetry funded be funded. of breast cup sizes i.e. asymmetry where there is at least 2 cup size difference in breast size on initial consultation Funding will only be considered if there is gross with the patient’s GP. disparity of breast cup sizes i.e. asymmetry where there is at least 2 cup size difference in breast size on The goal of surgery is to correct a significant deformity. initial consultation with the patient’s GP. Contour irregularities and moderate asymmetry (including dog-ears, nipple direction or position, breast The goal of surgery is to correct a significant size and shape disparity) are predictable following deformity. Contour irregularities and moderate surgery. Any post-surgical cosmetic irregularities will not asymmetry (including dog-ears, nipple direction or be funded by the CCGs in revision surgery. position, breast size and shape disparity) are predictable following surgery. Any post-surgical Patients are eligible for surgery to correct breast cosmetic irregularities will not be funded by the CCGs asymmetry if all the following criteria are met and in revision surgery. confirmed by a consultant plastic surgeon:

Patients are eligible for surgery to correct breast • There is a natural absence of breast tissue unilaterally asymmetry if all the following criteria are met and where there is no ability to maintain a normal breast confirmed by a consultant plastic surgeon: shape using non-surgical methods (e.g. padded bra). and • There is a natural absence of breast tissue • There is a difference of at least 2 cup sizes (e.g. C and unilaterally where there is no ability to maintain a DD cup size differential). normal breast shape using non-surgical methods (e.g. and padded bra). • Patient Aged ≥ 18 years old and has reached end of and puberty (referral should be delayed if end of puberty has • There is a difference of at least 2 cup sizes (e.g. C not been reached). and DD cup size differential). and and • Where relevant, treatment of the underlying cause of • Patient Aged ≥ 18 years old and has reached end of the problem has been undertaken. puberty (referral should be delayed if end of puberty and has not been reached). • The patient has a BMI<25 and evidence that the and patient’s weight has been stable for 2 years. • Where relevant, treatment of the underlying cause of the problem has been undertaken. The choice of surgical intervention (i.e. unilateral breast

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and reduction or unilateral breast augmentation) should be • The patient has a BMI<25 and evidence that the made jointly by the person and the clinician and taking patient’s weight has been stable for 2 years. into account: • The experience of the surgeon who will perform the The choice of surgical intervention (i.e. unilateral operation, and breast reduction or unilateral breast augmentation) • the best available evidence on effectiveness and long should be made jointly by the person and the clinician term effects, and and taking into account: • the facilities and equipment available, and • The experience of the surgeon who will perform the • Significant musculo-skeletal pain/functional problems. operation, and • the best available evidence on effectiveness and Patient must be aged at least 18 years. Surgery for long term effects, and patients aged 16 or 17 years will only be funded if breast • the facilities and equipment available, and size has been stable for at least one year, and the • Significant musculo-skeletal pain/functional referring clinician can satisfy the Individual Funding problems. Request panel that it is unreasonable to wait until the patient is 18 years old. Patient must be aged at least 18 years. Surgery for patients aged 16 or 17 years will only be funded if breast size has been stable for at least one year, and the referring clinician can satisfy the Individual Funding Request panel that it is unreasonable to wait until the patient is 18 years old. Breast Not Breast augmentation will not be funded. is routinely Funded Breast augmentation is routinely funded for the following augmentation funded funded for the following indications: indications: excluding • Reconstructive following or as part of surgery for • Reconstructive following or as part of surgery for breast reconstruction breast malignancy or its prevention – Funding malignancy or its prevention – Funding Approval not post surgery / Approval not required. required. trauma • Congenital amastia (complete absence of breast • Congenital amastia (complete absence of breast tissue). tissue).

Breast implants for cosmetic purposes are not funded. Breast implants for cosmetic purposes are not funded. In In particular funding is not available for breast particular funding is not available for breast augmentation augmentation in the case of: in the case of: • Small but normal breasts, • Small but normal breasts, • Breast changes following pregnancy or with age. • Breast changes following pregnancy or with age.

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Breast Funded Breast reconstruction will be funded (Individual Funded Breast augmentation is routinely funded for the following reconstruction Prior Approval) for the following indications: indications: post surgery / • Reconstructive following or as part of surgery for • Reconstructive following or as part of surgery for breast trauma mastectomy or lumpectomy causing significant malignancy or its prevention – Funding Approval not deformity when undertaken as part of treatment or required. prophylaxis of cancer OR • Congenital amastia (complete absence of breast tissue)OR • Post-trauma reconstruction surgery

Breast surgery to rebuild the normal contour of the affected and the contralateral unaffected breast to produce a more normal appearance, is considered reconstructive, following a mastectomy, lumpectomy, or other breast surgery to treat breast cancer.

In all cases the CCG only funds a mximum of two elective operations for an individual patient as part of the episode of care for the purpose of breast reconstruction- the first during or soon after the initial surgery e.g. mastectomy (although this may be delayed for medical reasons) followed by one further operation which is usually carried out as a day case.

The second operation may include contra-lateral reduction, nipple reconstruction, lipofilling and removal of dog-ears.

All patients must be advised that further requests for surgery to address concerns about appearance, size, position, angle or balance- breast asymmetry- will be considered to be cosmetic and as such will not be routinely funded.

Breast implants for cosmetic purposes are not funded. In particular funding is not available for breast augmentation in the case of: 10 218

• Small but normal breasts, • Breast changes following pregnancy or with age.

Breast lift / Not Mastoplexy will not be funded. This is included as Funded This is included as part of the treatment of breast Mastoplexy funded part of the treatment of breast asymmetry and asymmetry and reduction but not for purely reduction but not for purely cosmetic/aesthetic cosmetic/aesthetic purposes such as post-lactational purposes such as post-lactational ptosis. ptosis.

Breast Funded Breast reduction surgery will be funded for Funded Breast reduction surgery is regarded as a procedure of a Reduction functional impairment only. is regarded as a low clinical priority. Cosmetic breast surgery (surgery procedure of a low clinical priority. Cosmetic breast undertaken exclusively to improve appearance) is not surgery (surgery undertaken exclusively to improve provided to correct natural changes such as those appearance) is not provided to correct natural associated with pregnancy or ageing. This procedure is changes such as those associated with pregnancy or therefore not routinely funded by the CCGs. Breast ageing. This procedure is therefore not routinely reduction surgery is an effective intervention that should funded by the CCGs. Breast reduction surgery is an be funded if one of the following sets of criteria is met: effective intervention that should will be funded if one of the following sets of criteria is met: CRITERIA SET 1: • The patient is suffering from neck ache or backache. CRITERIA SET 1: Clinical evidence will need to be produced to rule out any • The patient is suffering from neck ache or backache. other medical/physical problems to cause these Clinical evidence will need to be produced to rule out symptoms; and the wearing of a professionally fitted any other medical/physical problems to cause these brassiere has not relieved the symptoms, symptoms; and the wearing of a professionally fitted and brassiere has not relieved the symptoms, • Full evidence is provided of all conservative and management options that have been attempted, • Full evidence is provided of all conservative and management options that have been attempted, • The patient has a BMI < 25 and evidence that the and weight has been stable for 2 years, • The patient has a BMI < 25 and evidence that the and weight has been stable for 2 years, • The patient has persistent intertrigo for at least one year and and confirmed by GP OR another serious functional • The patient has persistent intertrigo which is impairment for at least one year resistant to an appropriate professionally 11 219 prescribed treatment regime for at least one year CRITERIA SET 2: and confirmed by GP OR another serious functional The patient is male with hormonal or drug related breast impairment for at least one year growth (Please see Gynaecomastia)

CRITERIA SET 2: CRITERIA SET 3: The patient is male with hormonal or drug related Pubertal hyperplasia breast growth (Please see Gynaecomastia) • A reduction can be performed if it is expected that at least 500g will be removed from each breast. CRITERIA SET 3: Pubertal hyperplasia - Patients who have predictable breast changes due to • A reduction can be performed if it is expected that at pregnancy are excluded. least 500g will be removed from each breast. Patients should have an initial assessment by the referrer Patients who have predictable breast changes due to prior to an appointment with a consultant plastic surgeon pregnancy are excluded. to ensure that these criteria are met. Assessment of the thorax should be performed, including relevant Patients should have an initial assessment by the diagnostics. referrer prior to a referral to an appointment with a consultant plastic surgeon to ensure that these criteria are met. Assessment of the thorax should be performed, including relevant diagnostics.

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Removal and Funded South Essex CCGs only commission The removal and Funded South Essex CCGs only commission the removal and replacement replacement of breast implants will be only funded in replacement of breast implants in the following of breast the following circumstances: circumstances: implants • Breast implants that were provided by the NHS (e.g. • Breast implants were provided by the NHS (e.g. as part as part of treatment for breast cancer). OR of treatment for breast cancer). OR • The implant needs to be removed for clinical reasons • The implant needs to be removed for clinical reasons such as implant rupture or for treatment of breast such as implant rupture disease (whether the implantation was funded (whether the implantation was funded privately or privately or under the NHS). under the NHS).

Replacement implants will not be funded. If privately funded breast implants are required to be removed for clinical reasons, patients will be offered the If privately single NHS funded breast implants are choice of removing both prostheses in the event that only required to be removed for clinical reasons, patients one has ruptured with the intention of preserving will be offered the choice of removing both prostheses symmetry. in the event that only one has ruptured with the intention of preserving symmetry. The replacement of privately funded breast implants where removal is clinically required is not routinely The replacement of privately funded breast implants commissioned. where removal is clinically required is not routinely commissioned.

Facial Surgery See These procedures will be considered for the treatment Funded These procedures will be considered for the treatment of: see aesthetic aesthetic of: • Congenital face abnormalities facial surgery facial • Congenital face abnormalities • Facial palsy (congenital or acquired paralysis) surgery • Facial palsy (congenital or acquired paralysis) • As part of the treatment of specific conditions affecting • As part of the treatment of specific conditions the facial skin e.g. cutis laxa, pseudoxanthoma affecting the facial skin e.g. cutis laxa, elasticum, neurofibromatosis pseudoxanthoma elasticum, neurofibromatosis • To correct the consequences of trauma • To correct the consequences of trauma • To correct deformity following surgery • To correct deformity following surgery They will not be available to treat the natural processes They will not be available to treat the natural of ageing. processes of ageing.

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Gynaecomastia Not Procedures to treat gynaecomastia will not be Funded All men have breast tissue and a breast bud. This policy funded funded. intends to provide treatment for extreme/severe breast contour resulting from true breast development. This All men have breast tissue and a breast bud. This policy excludes treatment for excess skin folds in the policy intends to provide treatment for extreme/severe breast following weight loss. breast contour resulting from true breast development. This policy excludes treatment for excess skin folds in True gynaecomastia is benign enlargement of male the breast following weight loss. breast tissue. It can be defined as the presence of >2cm palpable, firm, subareolar gland and ductal tissue (not True gynaecomastia is benign enlargement of male fat) which should be confirmed by ultrasound. breast tissue. It can be defined as the presence of >2cm palpable, firm, subareolar gland and ductal True gynaecomastia will be funded (i.e. true breast tissue tissue (not fat) which should be confirmed by is present not just adipose tissue – ultrasound. pseudogynaecomastia). The clinician should ensure that the following are confirmed: True gynaecomastia will be funded (i.e. true breast • Breast cancer has been ruled out. tissue is present not just adipose tissue – • Testicular cancer has been ruled out. pseudogynaecomastia). The clinician should ensure • Underlying endocrine or liver abnormality has been that the following are confirmed: ruled out. • Breast cancer has been ruled out. • The condition is not due to the abuse of drugs with • Testicular cancer has been ruled out. bodybuilding. • Underlying endocrine or liver abnormality has been • The condition is not a side effect of medication or drugs ruled out. e.g. spironolactone, cimedtidine, digoxin or cannabis. • The condition is not due to the abuse of drugs with bodybuilding. Surgery to correct unilateral or bilateral gynaecomastia • The condition is not a side effect of medication or should be funded if the patient: drugs e.g. spironolactone, cimedtidine, digoxin or • Is post pubertal (stable height for past 6 months). cannabis. and • Has BMI < 25 kg/m2 with evidence that the patient’s Surgery to correct unilateral or bilateral weight has been stable for 2 years. gynaecomastia should be funded if the patient: and • Is post pubertal (stable height for past 6 months). • Has breast enlargement on at least one side which is and Grade III or above using Cordova’s classification system • Has BMI < 25 kg/m2 with evidence that the patient’s OR has unilateral breast enlargement with a difference of weight has been stable for 2 years. at least 2 grades (e.g. normal and Grade II differential). and • Has breast enlargement on at least one side which is Scarring, contour irregularities and moderate asymmetry Grade III or above using Cordova’s classification (including dog-ears, nipple direction or position, breast system OR has unilateral breast enlargement with a size and shape disparity) are predictable following 14 222

difference of at least 2 grades (e.g. normal and Grade surgery. Any post-surgical revision for cosmetic II differential). irregularities will not be funded by the CCG.

Scarring, contour irregularities and moderate Applications must include at least 2 colour photographs asymmetry (including dog-ears, nipple direction or of the chest. Photographs should go from the top of the position, breast size and shape disparity) are chest down to the umbilicus. One should be taken from predictable following surgery. Any post-surgical directly in front of the patient and another at an angle of revision for cosmetic irregularities will not be funded 45 degrees(e.g. Grades II – IV). by the CCG.

Applications must include at least 2 colour photographs of the chest. Photographs should go from the top of the chest down to the umbilicus. One should be taken from directly in front of the patient and another at an angle of 45 degrees(e.g. Grades II – IV).

Hair Depilation Not Hirsutism/hair depilation is not routinely funded Not Hirsutism/hair depilation is not routinely funded including funded including hair depilation procedures or medication. funded hair depilation procedures or medication. Hair depilation Hair depilation will only be considered via IFR route. will only be considered via IFR route. Hair Not Hair transplantation will not be funded. will only be Not Hair transplantation will only be considered for transplantation funded considered for reconstruction via IFR route in funded reconstruction via IFR route in exceptional cases, such exceptional cases, such as reconstruction of the as reconstruction of the eyebrow following cancer or eyebrow following cancer or trauma. trauma. Hymenorrhaphy Not Hymenorrhaphy, or hymen reconstruction surgery will Not Hymenorrhaphy, or hymen reconstruction surgery, is a funded not be funded. is a cosmetic procedure and is not funded cosmetic procedure and is not routinely funded. This routinely funded. This policy does not apply to genital policy does not apply to genital reconstruction for gender reconstruction for gender dysphoria which is covered dysphoria which is covered by the East of England by the East of England Gender Dysphoria Policy. Gender Dysphoria Policy.

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Laser Funded Rosacea is a syndrome of the facial skin consisting of Rosacea is a syndrome of the facial skin consisting of a treatment for a combination of cutaneous signs including flushing, combination of cutaneous signs including flushing, Rosacea erythema, papules (small solid elevation of the skin), erythema, papules (small solid elevation of the skin), pustules (a small collection of pus), telangiectasia’s, pustules (a small collection of pus), telangiectasia’s, oedema (abnormal accumulation of fluid beneath the oedema (abnormal accumulation of fluid beneath the skin), ocular lesions and rhinophyma. These signs skin), ocular lesions and rhinophyma. These signs typically involve the convexities of the central face typically involve the convexities of the central face (cheeks, chin, nose and central forehead). (cheeks, chin, nose and central forehead).

Eligibility Criteria: Eligibility Criteria:

Laser treatment for moderate to severe rosacea on Laser treatment for moderate to severe rosacea on the the face and neck area which is erythemato- face and neck area which is erythemato-telangiectatic in telangiectatic in nature will be considered for patients nature will be considered for patients with the following: with the following: • Frequent severe and troublesome flushing, moderate to • Frequent severe and troublesome flushing, moderate pronounced persistent erythema, many prominent to pronounced persistent erythema, many prominent telangiectasia’s, possible burning, stinging or scaling of telangiectasia’s, possible burning, stinging or scaling the skin. of the skin. and and • All other treatments have been attempted and have • All other treatments have been attempted and have failed. These include trigger identification, lifestyle failed. These include trigger identification, lifestyle management, and drug therapies such as topical management, and drug therapies such as topical metronidazole or oral tetracycline for papules and metronidazole or oral tetracycline for papules and pustules. pustules. Surgery is a more effective treatment for rhinophyma, Surgery is a more effective treatment for rhinophyma, therefore, laser therapy should not be offered. See therefore, laser therapy should not be offered. See policy for Rhinophyma for more information. policy for Rhinophyma for more information.

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Laser Not Tattoo removal will not be funded. The funding for Funded The funding for removal of tattoos will be considered in treatment for Funded removal of tattoos will be considered in the following the following circumstances: Tattoo circumstances: • Funding may be considered for tattoos inflicted under Removal • Funding may be considered for tattoos inflicted duress during adolescence. In such instances, tattoo under duress during adolescence. In such instances, removal will only be considered where the tattoo is on the tattoo removal will only be considered where the tattoo face or visible parts of the body. is on the face or visible parts of the body. OR OR • In unusual circumstances where the tattoo causes • In unusual circumstances where the tattoo causes marked limitations of psychosocial function marked limitations of psychosocial function Psychiatric/psychological reports will need to be provided Psychiatric/psychological reports will need to be with the initial referral. provided with the initial referral.

Liposuction / Funded Liposuction will only be funded for functional Funded Liposuction will not be funded simply to correct the Liposculpture / impairment. will not be funded simply to correct the distribution of fat. Liposuction is sometimes an adjunct to Body distribution of fat. Liposuction is sometimes an other surgical procedures and may be useful for Contouring adjunct to other surgical procedures and may be contouring of localised fat atrophy or pathological useful for contouring of localised fat atrophy or hypertrophy e.g. multiple lipomatosis, lipodystrophies. pathological hypertrophy e.g. multiple lipomatosis, lipodystrophies. Those considered an exception will have to provide evidence to (at a minimum) demonstrate the following: Patients with significant abdominal aprons as a result • Patients with excessive folds who have an initial BMI of weight loss and have severe functional impairment. greater than 40 and have achieved a reduction in BMI to Weight loss must result in a BMI <25 or a reduction in 25 or less and have maintained this BMI of 25 and under BMI points of at least 25 points that has been for at least 2 years OR maintained for at least two years. Those considered • Patients with excessive folds who have an initial BMI of an exception will have to provide evidence to (at a greater than 50 and have achieved a minimum drop of 20 minimum) demonstrate the following: BMI points and have maintained this for at least 2 years. • Patients with excessive folds who have an initial BMI • Severe functional problems: greater than 40 and have achieved a reduction in BMI o recurrent intertrigo beneath the skin folds to 25 or less and have maintained this BMI of 25 and o abdominal wall prolapse with proven urinary symptoms under for at least 2 years OR o problems associated with poorly fitting stoma bags • Patients with excessive folds who have an initial BMI o patient is experiencing severe difficulties with daily of greater than 50 and have achieved a minimum drop living i.e. ambulatory restrictions.

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of 20 BMI points and have maintained this for at least 2 years. These patients will need full assessment by appropriate professional prior to referral. AND This procedure will not be funded for cosmetic purposes. • Severe functional problems e.g.: Buttock lifts, thigh lifts and arm lifts (brachioplasty), o recurrent / persistant intertrigo resistant to procedures will not normally be funded. professionally prescribed appropriate treatment beneath the skin folds for 12 months o abdominal wall prolapse with proven urinary symptoms o problems associated with poorly fitting stoma bags o patient is experiencing severe difficulties with daily living i.e. ambulatory restrictions.

These patients will need full assessment by appropriate professional prior to referral.

This procedure will not be funded for cosmetic purposes. Buttock lifts, thigh lifts and arm lifts (brachioplasty), procedures will not normally be funded. Penile Funded Penile implants will only be funded for Funded This procedure will not be funded other than post cancer Implants reconstructive procedures to correct functional reconstruction. impairment.

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Pinnaplasty/Ot Funded Pinnoplasty / otoplasty will not be funded other than Pinnoplasty/Otoplasty will not be considered unless there oplasty for functional impairment. considered unless there is evidence of significant impact upon ability to lead a is evidence of significant impact upon ability to lead a normal life, and the child expresses concern, rather than normal life, and the child expresses concern, rather the parents alone, than the parents alone, Surgery will only be funded if BOTH of the criteria below Surgery will only be funded if BOTH of the criteria are met: below are met: • Patient is aged between 10 and 16 years old and has • Patient is aged between 10 and 16 years old and expressed concern about their appearance AND has expressed concern about their appearance AND • the prominence is of a severity that it presents as • the prominence is of a severity that it presents as disfigurement which is having a significant detrimental disfigurement which is having a significant detrimental impact upon the child’s ability to lead a normal life. impact upon the child’s ability to lead a normal life.

Plagiocephaly Not Procedures to correct nonsynostotic (positional) Not South Essex CCGs commission treatment for / Funded plagiocephaly / brachycephaly has not been funded Plagiocephaly on a restricted basis, requests will be brachycephal shown to be associated with any long term considered on a case by case basis by the CCGs y developmental problems and its treatment has Individual Funding Request panel. been described as entirely cosmetic and will not be funded. Plagiocephaly may be divided into craniosynostosis, which results from premature closure of one or more of Craniosynostosis is excluded as this carries a the cranial sutures, and nonsynostotic or positional significant risk of raised intracranial pressure, plagiocephaly (also referred to as deformational therefore requiring interventional surgery. plagiocephaly, non-synostotic plagiocephaly, positional Interventions for craniosynostosis are covered by plagiocephaly, flat-head syndrome and occipital NHS England specialised commissioning plagiocephaly). arrangements. This distinction is highly important as craniosynostosis South Essex CCGs commission treatment for carries a significant risk of raised intracranial pressure, Plagiocephaly on a restricted basis, requests will be therefore requiring interventional surgery. Interventions considered on a case by case basis by the CCGs for craniosynostosis are covered by NHS England Individual Funding Request panel. specialist commissioning arrangements.

Plagiocephaly may be divided into craniosynostosis, Positional plagiocephaly, however, has not been shown which results from premature closure of one or more to be associated with any long term developmental of the cranial sutures, and nonsynostotic or positional problems and its treatment has been described as plagiocephaly (also referred to as deformational entirely cosmetic and is therefore not funded. plagiocephaly, non-synostotic plagiocephaly, 19 227

positional plagiocephaly, flat-head syndrome and occipital plagiocephaly).

This distinction is highly important as craniosynostosis carries a significant risk of raised intracranial pressure, therefore requiring interventional surgery. Interventions for craniosynostosis are covered by NHS England specialist commissioning arrangements.

Positional plagiocephaly, however, has not been shown to be associated with any long term developmental problems and its treatment has been described as entirely cosmetic and is therefore not funded. Repair of Ear Not Post trauma repair will not be funded Not Funded for primary suture post trauma at the time of Lobes – Post funded Funded for primary suture post trauma at the time of funded trauma e.g. the patient is automatically eligible for Trauma trauma e.g. the patient is automatically eligible for emergency treatment when he/she presents for repair at emergency treatment when he/she presents for repair Emergency Department at the time of trauma. at Emergency Department at the time of trauma. Post trauma applications will only be considered where Post trauma applications will only be considered there are clinically exceptional circumstances. where there are clinically exceptional circumstances. Rhinophyma Not Cosmetic correction of rhinophyma is not funded. Not South Essex CCGs will not fund cosmetic correction of funded South Essex CCGs will not fund cosmetic correction funded rhinophyma. of rhinophyma. The first-line treatment of the nasal skin condition is The first-line treatment of the nasal skin condition is medical. Severe cases or those that do not respond to medical. Severe cases or those that do not respond to medical treatment may be considered for surgery or laser medical treatment may be considered for surgery or treatment on a case by case basis via the individual laser treatment on a case by case basis via the funding request route. individual funding request route.

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Scar Revision Funded The South Essex CCGs will only fund keloid Keloid Funded The South Essex CCGs will only fund keloid scar – Keloid scar revision will be only be funded where they revision in the following circumstances. In all cases Scar cause a functional impairment or where they are Revision will only be funded after 2 years to allow the on the face (excluding ears) and cause severe natural healing process to complete. disfigurement (see aesthetic facial surgery) in the • Scars on the face (excluding ears) secondary to following circumstances. In all cases scar revision will trauma/accident that are ragged, or can otherwise be only be funded after two years to allow the natural regarded as particularly disfiguring. healing process to complete. • Scars (excluding those on the ears) as a result of self- • Scars on the face (excluding ears) secondary to harm trauma/accident that are ragged, or can otherwise be These are very difficult to treat and usually the only regarded as particularly disfiguring. achievable outcome is to make the scars resemble • Scars (excluding those on the ears) as a result of trauma or burns rather than be obviously due to self- self-harm harm. Treatment will only be funded when there has These are very difficult to treat and usually the only been a minimum period of three years where there has achievable outcome is to make the scars resemble been no self-harm and where there is a supporting report trauma or burns rather than be obviously due to self- from a psychiatrist indicating that the behaviour would be harm. Treatment will only be funded when there has unlikely to recur. been a minimum period of three years where there • Scars (excluding those on the ears) that are resulting in has been no self-harm and where there is a physical disability due to contraction, tethering or supporting report from a psychiatrist indicating that the recurrent breakdown behaviour would be unlikely to recur. • Scars (excluding those on the ears) that are resulting Funding may be available via Individual Funding Request in physical disability due to contraction, tethering or for the following criteria: recurrent breakdown [In all cases, medical photography will be required as Funding may be available via Individual Funding part of the Individual Funding Request} Request for the following criteria: • Significant Keloid scarring on the face (excluding those on the ears) [In all cases, medical photography will be required as • Keloid scars (excluding those on the ears) that result in part of the Individual Funding Request} physical distress due to significant pain or pruritis. • Significant Keloid scarring on the face (excluding • Scars secondary to trauma/accident (other than those those on the ears) on the face) for cosmetic purposes will not be funded • Keloid scars (excluding those on the ears) that result unless the disfigurement can be regarded as particularly in physical distress due to significant pain or pruritis. grave. • Scars secondary to trauma/accident (other than those on the face) for cosmetic purposes will not be In all cases Scar Revision will only be funded after 2 funded unless the disfigurement can be regarded as years to allow the natural healing process to complete. particularly grave. Funding will not be available for: 21 229

In all cases Scar Revision will only be funded after 2 • Keloid scars (with exception of criteria above and years to allow the natural healing process to complete. excluding those on the ears) • Keloid scars secondary to body piercing procedures Funding will not be available for: (including those on the ears) or other cosmetic • Keloid scars (with exception of criteria above and procedures. excluding those on the ears) • Keloid scars secondary to body piercing procedures (including those on the ears) or other cosmetic procedures.

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Scar Revision Funded Scar revision will be funded for functional Funded Funding may be available via Individual Funding Request – Other impairment only. Funding may be available via panel for the following criteria: Individual Funding Request panel for the following criteria: [In all cases, medical photography will be required for the individual funding request] [In all cases, medical photography will be required for the individual funding request] • Scars as a result of self-harm

• Scars as a result of self-harm These are very difficult to treat and usually the only achievable outcome is to make the scars resemble These are very difficult to treat and usually the only trauma or burns rather than be obviously due to self- achievable outcome is to make the scars resemble harm. Treatment will only be funded when there has trauma or burns rather than be obviously due to self- been a minimum period of three years where there has harm. Treatment will only be funded when there has been no self-harm and where there is a supporting report been a minimum period of three years where there from a psychiatrist indicating that the behaviour would be has been no self-harm and where there is a unlikely to recur. supporting report from a psychiatrist indicating that the behaviour would be unlikely to recur. • Scars secondary to trauma/accidents • Scars on the face that are ragged, or can otherwise be • Scars secondary to trauma/accidents regarded as particularly disfiguring will be funded. • Scars on the face that are ragged, or can otherwise • Scars on the rest of the body. Scar revision for cosmetic be regarded as particularly disfiguring will be funded. purposes will not be funded unless the disfigurement can • Scars on the rest of the body. Scar revision for be regarded as particularly grave. Cases will be judged cosmetic purposes will not be funded unless the on an individual basis. disfigurement can be regarded as particularly grave. • Other Cases will be judged on an individual basis. • Keloid scars (refer to section on keloid scarring above). • Other • Scars that are resulting in physical disability due to • Keloid scars (refer to section on keloid scarring contraction, tethering or recurrent breakdown will be above). funded. • Scars that are resulting in physical disability due to contraction, tethering or recurrent breakdown will be Scar revision will only be offered after 2 years to allow funded. the natural healing process to complete.

Scar revision will only be offered after 2 years to allow the natural healing process to complete.

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Septoplasty / Funded South Essex CCGs will not fund Septorhinoplasty Function South Essex CCGs will not fund Septorhinoplasty Septorhinopla procedures for cosmetic reasons will not be funded. al procedures for cosmetic reasons. sty reasons Criteria for Septoplasty include: only Criteria for Septoplasty include:

• Problems caused by obstruction of the nasal airway • Problems caused by obstruction of the nasal airway amenable to the procedure amenable to the procedure • Deviated nasal septum causing significant and • Deviated nasal septum persistent nasal blockage Criteria for Septorhinoplasty for functional reasons Criteria for Septorhinoplasty for functional reasons include: include: • Patient has a deviated septum causing significant and • Patient has a deviated septum causing significant persistent nasal blockage and persistent nasal blockage • A septoplasty alone will not improve functional • A septoplasty alone will not improve functional impairment impairment • Septorhinoplasty is not being performed for cosmetic • Septorhinoplasty is not being performed for cosmetic reasons reasons

Vaginal Labia Funded Labiaplasty is not funded. Funded South Essex CCGs do not routinely commission elective Refashioning vaginal labia reduction/refashioning or vaginoplasty as Vaginoplasty is only only funded for functional this is considered to be a cosmetic procedure, except in impairment. the circumstances outlined below.

Requests for reconstructive vaginoplasty will be Any referrals will be reviewed on an exceptional considered for the following indications: treatment case basis by the Individual Funding Request • Congenital absence or significant panel. developmental/endocrine abnormalities of the vaginal canal. In all cases, medical photography will be required as part • Where repair of the vaginal canal is required after of the IFR submission. trauma • Female genital mutilation. Labiaplasty Labiaplasty is generally a cosmetic procedure to improve appearance alone and is not routinely funded. South Essex CCGs do not routinely commission elective vaginal labia reduction/refashioning or Requests for labiaplasty will be considered for the vaginoplasty as this is considered to be a cosmetic following indication: procedure, except in the circumstances outlined • Where repair of the labia is required after trauma. 24 232 below. • Where the labia are directly contributing to recurrent Any referrals will be reviewed on an exceptional disease or infection treatment case basis by the Individual Funding Request panel. Vaginoplasty In all cases, medical photography will be required as Non-reconstructive vaginoplasty or "vaginal rejuvenation" part of the IFR submission. is used to restore vaginal tone and appearance and is not routinely funded. Labiaplasty Labiaplasty is generally a cosmetic procedure to Requests for vaginoplasty will be considered for the improve appearance alone and is not routinely funded. following indications: Requests for labiaplasty will be considered for the • Congenital absence or significant following indication: developmental/endocrine abnormalities of the vaginal • Where repair of the labia is required after trauma. canal. • Where the labia are directly contributing to recurrent • Where repair of the vaginal canal is required after disease or infection trauma • Female genital mutilation. Vaginoplasty Non-reconstructive vaginoplasty or "vaginal rejuvenation" is used to restore vaginal tone and Hymenorrhaphy – refer to policy for Hymenorrhaphy. appearance and is not routinely funded. Or hymen reconstruction surgery, is a cosmetic procedure and is not routinely funded Requests for vaginoplasty will be considered for the following indications: • Congenital absence or significant developmental/endocrine abnormalities of the vaginal canal. • Where repair of the vaginal canal is required after trauma • Female genital mutilation.

Hymenorrhaphy – refer to policy for Hymenorrhaphy. Or hymen reconstruction surgery, is a cosmetic procedure and is not routinely funded

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Recommendation

The recommendation is:

 The Board approves the general principles proposed for Cosmetic Surgery that procedures for Cosmetic reasons will not be funded.

 The Board approve the proposed criteria change for each condition:

o Acne – resurfacing for severe post-acne facial scarring o Aesthetic facial surgery o Rhinoplasty o Body contouring o Breast procedures o Breast augmentation / breast reconstruction o Breast lift / mastoplexy o Breast reduction o Gynaecomastia o Hair depilation o Hymenorrhaphy o Laser treatment for tattoo removal o Liposuction / liposculpture / body contouring o Pinnaplasty / otoplasty o Plagiocephaly o Repair of ear lobes – post trauma o Rhinophyma o Scar revision – keloid o Scar revision – other o Septoplasty / septorhinoplasty o Vaginal labia refashioning

234 26

Glossary

Acne is a common skin condition that affects most people at some point. It causes Acne spots, oily skin and sometimes skin that's hot or painful to touch.

Alopecia is the general medical term for hair loss. There are many types of hair loss Alopecia with different symptoms and causes.

Belt lipectomy see liposuction

Most skin lesions are benign; however, some concern has caused the patient to make an inquiry, and a correct diagnosis is important. The plethora of dermatologic conditions makes a correct diagnosis challenging. To combat this, the clinician must Benign skin lesions approach the evaluation of the lesion in a systematic way. In addition to the physical characteristics of the lesion, the patient’s demographics, presence of associated symptoms, related systemic disorders, and location and growth patterns of the lesion all give clues to adequately diagnose and treat.

Blephoraplasty Eyelid surgery (blepharoplasty) is cosmetic surgery to remove excess skin or fat from the eyelids

Body contouring see liposuction

Having a breast enlargement is a major decision. It can be expensive, the results Breast augmentation / aren't guaranteed, and there are risks to weigh up. breast reconstruction It involves inserting breast implants to increase the size of the breasts, change their shape, or make them more even.

Breast lift / mastoplexy Mastopexy (up-lifting of droopy breasts)

Breast reduction surgery can help women who are unhappy with the shape, weight Breast reduction or droop of their breasts by making them smaller and more lifted Gynaecomastia (sometimes referred to as "man boobs") is a common condition that Gynaecomastia causes boys’ and men’s breasts to swell and become larger than normal. It is most common in teenage boys and older men

Hair depilation Hair removal

Hymenorrhaphy or hymenoplasty has emerged as a procedure which attempts to Hymenorrhaphy restore the ability of the hymen to bleed at intercourse.

Laser treatment for Unwanted tattoos can be removed gradually over a series of sessions using a laser. tattoo removal

Liposuction / liposculpture / body Liposuction is a cosmetic procedure used to remove unwanted body fat. contouring

Pinnaplasty / otoplasty Surgery and cartilage moulding techniques for the treatment of prominent ears

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Babies sometimes develop a flattened head when they're a few months old, usually as a result of them spending a lot of time lying on their back. This is known as "flat head syndrome", and there are two main types: plagiocephaly – the head is flattened on one side, causing it to look asymmetrical; Plagiocephaly the ears may be misaligned and the head looks like a parallelogram when seen from above, and sometimes the forehead and face may bulge a little on the flat side brachycephaly – the back of the head becomes flattened, causing the head to widen, and occasionally the forehead bulges out Rhinophyma is a swelling of the nose. If the condition progresses, the nose becomes redder, swollen at the end and gains a bumpy surface which changes its shape. This Rhinophyma swelling is because there is formation of scar-like tissue and the sebaceous glands (which produce oil on the skin) get bigger. Much more rarely, swellings can arise on other parts of their face such as the ears and chin. Keloid scars – these are caused by an excess of scar tissue produced at the site of Scar revision – keloid the wound, where the scar grows beyond the boundaries of the original wound,

even after it has healed. The septum is a thin piece of cartilage and bone inside the nose between the left Septoplasty and right sides. It is about 7cm long in adults. In some people this septum is bent septorhinoplasty into one or both sides of the nose which can lead to blockage. This is the surgery to repair or correct the defect. A labiaplasty is surgery to reduce the size of the labia minora – the flaps of skin either side of the vaginal opening. Vaginal labia refashioning Vaginoplasty is a blanket term for surgery to either construct or reconstruct a vagina.

28 236 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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 1 RARE 1 MINOR score 2 UNLIKELY 2 MODERATE / LOW 1 - 3 Low risk (green)

3 MODERATE 3 SERIOUS / POSSIBLE 4 - 6 Moderate risk (yellow) 4 LIKELY 4 MAJOR 8 - 12 High risk (orange)

5 ALMOST 5 FATAL / CATASTROPHIC 15 - 25 Extreme risk (red) CERTAIN

A fuller description of impact scores can be found at appendix 1.

IMPACT 1 2 3 4 5

1 1 2 3 4 5 Please take care with this assessment. A carefully completed assessment should safeguard against 2 2 4 6 8 10 challenge at a later date. 3 3 6 9 12 15

LIKELIHOOD 4 4 8 12 16 20 5 5 10 15 20 25

1 237 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Title and lead for scheme: Ceasing funding of cosmetic surgery and associated procedures

Brief description of scheme: This EQIA covers the proposed impact of ceasing funding of the following:

 Breast Procedures - Asymetry/reduction/mastoplexy including revision/replacement  Gynaecomastia  Liposucton /Skin contouring/Body contouring  Cosmetic Surgery

Answer positive/negative (P/N) in each area. If Negative score the impact, likelihood and total in the appropriate box. If score > 8 insert Y for full assessment

Area of Impact question P/N Impact Likeli- Score Full Quality hood Assessment required 1 Duty of Could the proposal impact positively or negatively on any of the N 3 5 15 Yes Quality following - compliance with the NHS Constitution (see appendix 3), partnerships, safeguarding children or adults ? 2 Equality and Could the proposal impact positively or negatively on any of the N 2 4 8 No Diversity protected characteristics under the Equality Act 2010 (see appendix 2) 3 Patient Could the proposal impact positively or negatively on any of the N 3 5 15 Yes Experience following - positive survey results from patients, patient choice, personalised & compassionate care?

2 238 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

4 Carers Could the proposal impact positively or negatively on informal None experience carers? (if negatively, is there an identified resource to meet the need, or does the need require flagging to the CCG carers lead)? 5 Patient Could the proposal impact positively or negatively on any of the None Safety following – safety, systems in place to safeguard patients to prevent harm, including infections? 6 Clinical Could the proposal impact positively or negatively on evidence N 3 3 9 Yes Effectiveness based practice, clinical leadership, clinical engagement and/or high quality standards? 7 Prevention Could the proposal impact positively or negatively on promotion N 2 2 4 No of self-care and health inequality? 8 Productivity Could the proposal impact positively or negatively on - the best None and setting to deliver best clinical and cost effective care; Innovation eliminating any resource inefficiencies; low carbon pathway; improved care pathway?

Please describe your rationale for any negative/positive impacts; key facts and figures about the local population including who has been consulted to complete this section. Duty of Quality It is viewed that the restriction of cosmetic surgery will impact upon the following aspects of the NHS Constitution; - Comprehensive service available to all - Access to NHS services based on clinical need not ability to pay

Whilst the restriction of cosmetic surgery would increase the inequality of access to surgery for our population as opposed to other CCGs in Essex who continue to commission these service.

Patient Experience This could impact negatively on the patients view of the CCG. This should be mitigated through our patient engagement and stakeholder activities.

Clinical Effectiveness There is likely to be NICE guidance promoting some of the ‘cosmetic/reconstructive’ procedures which we are consulting on and 3 239 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3 therefore may contradict our proposal. Signature: Designation: Date: William Guy Head of Commissioning 18/01/16 Stage 2

Risk (5 x5 risk

matrix)

Mitigation strategy and

Description of impact (Positive or Indicators negative) monitoring arrangements

Score Impact Overall

Likelihood Does it impact on the organisation’s It is anticipated that this restriction will have 3 5 15 The CCG is currently commitment to the public to continuously an impact on the NHS Constitution participating in the Essex drive quality improvement as reflected in commitments of “Comprehensive service Success Regime of Service the rights and pledges of the NHS available to all” and “Access to NHS services Restrictions. The CCG would Constitution? based on clinical need not ability to pay” review its service restriction (including access to Specialist Fertility Services) as a result of the Essex Success Regime review. Area of quality Applications for funding for these procedures can be made through the Individual Funding Request process but should only be made where the patient demonstrates true clinical exceptionality.

Does it impact on the organisation’s There is no expected impact on this. Not applicable commitment to high quality workplaces, with commissioners and providers aiming to be

0 0 0

4 240 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

What is the specific impact of the project on people with protected characteristics, in terms of individual and community health, access to services and patient experience?

0 0 0 Are core clinical quality indicators and There is no expected impact on this Not applicable metrics in place to review impact on quality improvements?

0 0 0 Will this impact on the organisation’s duty to There is no expected impact on our duty to Not applicable protect children, young people and adults? protect.

0 0 0 It is possible that this service restriction will 3 5 15 The CCG is currently participating in the increase the number of complaints/negative Essex Success Regime of Service What impact is it likely to have on self feedback received by the CCG. This will Restrictions. The CCG is reviewing its

reported experience of patients and service primarily be due to the variation in access service restriction as a result of the users? (Response to national/local between CCGs in Essex. Essex Success Regime review. surveys/complaints/PALS/incidents) How will it impact on choice?

Does it support the compassionate and

PATIENT EXPERIENCE personalised care agenda?

What impact is it likely to have on self reported experience of carer and service users? (Response to national/local surveys/complaints/PALS/incidents) How will it impact on choice? EXPERIENCE

CARER 5 241 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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?

PATIENT SAFETY

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?

6 242 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

NICE evidence suggests that discussions We are engaging with the public within regarding breast reconstruction are had with the consultation for their feedback and patients who have had a mastectomy. views on whether to proceed with the proposal. All patients should be treated equally regardless of how a mastectomy could arise. We understand that this may conflict with NICE guidance however the CCG is under no obligation to comply with NICE guidance, this is merely recommendations. With the CCG financial deficit we have to make difficult decisions in order to use the

How does it impact on implementation of funds we have for the whole population. evidence based practice? 3 3 9 GPs and consultants may have to have There is a full consultation process in difficult conversations but ultimately the which we are gathering the views of the decision rests with the Board to make the public. This proposals has been

final agreement suggested by clinicians and a clinical How will it impact on clinical leadership? 3 3 9 lead appointed for each SRP proposal. It can be seen as negative and positive in the By stopping the proposed procedures sense that it may not be viewed as ‘better we are standing by our view of care’ as patient disagrees as they are healthcare for everyone and focusing

Does it support the full adoption of Better potentially not going to have the procedure on the needs to the population as a 3 3 9 CLINICAL EFFECTIVENESS care, Better Value metrics? they feel they require. whole and at an individual basis. In our CCG it would reduce the variation in Ensuring that any proposal that is care as it would not matter how (for instance) passed is used across all surgeries and a mastectomy was required- the same providers for our patients to ensure no

outcome would be for everyone variation. Does it reduce/impact on variations in care? 2 3 6 The information for this proposal has come Ultimately our clinicians will reach a from clinical guidance and Public Health and decision based on the information that therefore we feel that there is enough has been considered and the feedback evidence and understanding to support the from the public. requirement for change It has been through the appropriate governance routes aswell as making

Are systems for monitoring clinical quality our providers aware from a clinical supported by good information? 3 2 6 perspective.

7 243 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

There may be a negative impact from some We have engaged at all stages with our of our clinicians as some of the procedures GPs to ensure that they are fully on within the proposal may prove controversial. board with the proposals. We have provided them opportunities to express

their opinions and ensure they (the Does it impact on clinical engagement? 3 3 9 Board) make the final decision.

Does it support people to stay well?

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

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

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? PRODUCTIVITY AND INNOVATION

Will the service innovation achieve large gains in performance?

8 244 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

Signature: Designation: Date:

9 245 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 1.

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

short-term reduction in public long-term reduction in public confidence confidence 10 246 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

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

11 247 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Below are some aspects of Human Rights principles and examples of their relevance to healthcare. Human rights principles should be taken into account when undertaken EIAs.

• The right to life e.g., Do Not Resuscitate orders, refusal or lifesaving medical treatment, Advance Directives

• The right to a fair trial

e.g., staff disciplinary proceedings, compensation claims, handling of special case panels 12 248 NL Final Version agreed at BBCCG Governance Committee 23rd April 2015 Amended 3.9.15 NL V3

Appendix 3

NHS Constitution (2013)

Values • Working together for patients • Respect and dignity • Quality of care • Compassion • Improving lives • Everyone counts

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Service Restriction Policy Criteria Changes (SRP)

Board 24th November 2016

Document Status For Decision

Purpose & Brief Description As part of the Fit For Future engagement, the CCG consulted on changes to current SRP criteria in addition two new areas for adding to the current policy.

Overview The following chart shows those areas where changes have been made to the proposed criteria following public feedback and those where no change is required as a result of public engagement therefore the CCG intends to adopt the revised criteria.

Procedure Changes made to proposed criteria Appendix following consultation feedback?

Benign skin lesion Yes, in line with cosmetic surgery 1 proposal Carpal Tunnel 2 Cataract 3 Cholecystectomy (gall stones) 4 Diagnostic Colonoscopy for 5 IBS Dupuytren’s Contracture 6 Female Genital Prolapse 7 Gastroscopy for dyspepsia 8 Hernia 9 Hip Arthroscopy Yes, 10  Removed specialist physiotherapy replaced with MSK physiotherapy Hysterectomy for 11 Menorrhagia Knee Arthroscopy 12

250 Knee Replacement 13 Microsuction 14 Shoulder Arthroscopy Yes, 15 For the avoidance of doubt the CCG does not commission shoulder arthroscopy in the following: • As a diagnostic tool • For frozen shoulder or adhesive capsulitis – except in the circumstances outlined above

The CCG will commission Shoulder arthroscopy as part of a procedural treatment i.e. as a less invasive surgical treatment but if used to treat adhesive capsulitis will only be funded if the above are criteria are met. Sleep Studies Yes, 16  Epworth score changed to 10 from 15  Criteria to specify obstructive sleep apnoea and snoring Trigger Finger 17 Varicose 18

Recommendation/Action Required of the Committee/Board The Board is asked to approve the change in criteria and additions to the SRP following the public engagement.

251 Appendix 1

Proposed Change to SRP Current SRP

Policy statement: Benign Skin Lesions/Conditions Benign Skin Lesions/Conditions

Individual Prior Approval Individual Prior Approval Status:

BBCCG does not commission surgical removal, laser treatment or South Essex CCGs do not commission removal or treatment of cryotherapy of clinically benign skin lesions/conditions for purely clinically benign skin lesions/conditions for purely cosmetic reasons. cosmetic reasons. N.B. A patient with a skin or subcutaneous lesion that has features Surgery or treatments to improve appearance alone is not provided for suspicious of malignancy must be referred to appropriate setting for normal changes such as those due to ageing. The fact that a patient assessment – this may be a 2 week wait clinic (for suspected wants to have a lesion removed does not constitute a sound reason for melanoma/Squamous Cell Carcinoma). doing so at NHS expense. Surgery or treatments to improve appearance alone is not provided for BBCCG commissions the removal of benign skin lesions on a restricted normal changes such as those due to ageing. basis only. This restriction applies to referrals to secondary care dermatology/plastic surgery services commissioned by the CCG. GPs Lesions included in this policy include: should not refer patients who do not meet the criteria detailed below.  Benign pigmented naevi (moles)  Seborrhoeic keratoses (benign  Comedones skin growths, basal cell Referrals to CCG commissioned community based dermatology or  Corn/callous papillomas) minor surgery clinics must meet the criteria laid down in the service  Dermatofibromas (skin growths)  Skin tags including anal tags specification. Providers will not be funded where patients are treated  Lipomas  Spider naevus (telangiectasia) outside the commissioned service.   Thread veins Milia  Warts and plantar warts This policy does not apply to minor surgery undertaken in primary care  Molluscum contagiosum  which is outside the remit of this policy as it falls under the  Sebaceous cysts (epidermoid and Xanthelasma (cholesterol commissioning responsibility of NHS England. GPs providing Minor pilar cysts) deposits underneath the skin), Surgery as an Additional Service (curettage and cautery and, in relation  Neurofibromata to warts, verrucae and other skin lesions e.g. seborrhoeic keratosis, cryocautery) or Minor Surgery as a Directed Enhanced Service (DES) South Essex CCGs commission the removal of benign skin lesions on a under GMS/PMS contracts must adhere to the restrictions as detailed restricted basis only. This applies to GPs providing Directed Enhanced within those service specifications. GPs should note that removal of Services for Minor Surgery under GMS/APMS/PMS contracts as well benign skin lesions for purely cosmetic reasons will not be funded by as secondary care consultants. Practices should not submit, and the NHS England under this DES. CCG reserves the right not to fund, claims for procedures that would be classified as exclusions under this service restriction policy.

252 All suspected malignant lesions are excluded from this policy – Individual prior approval must be obtained before referral to secondary these should be managed via the 2 week wait with the exception of care in all circumstances other than where a patient meets criteria A Basal Cell Carcinoma (BCC), where low risk BCC may be removed in below. the community in line with NICE recommendations and high risk BCC should be referred through the usual pathway. A. Threshold Approval If a benign skin lesion of the eye obscures vision or is causing a separate Once it is established that a skin lesion is not malignant its removal ocular problem then the patient can be referred to an appropriate service will not normally be funded by the NHS though a clinician may for removal. request exceptional funding. Clinicians referring on this basis should make the patient explicitly aware that removal of the lesion may not B. Individual Prior Approval occur. Requests for the removal of benign skin lesions will be considered for:  Sebaceous cysts where there has been more than one episode of The list below gives examples of lesions included in this policy. This list infection. is not exhaustive. OR  Benign pigmented naevi  Seborrhoeic keratoses  Lesions which cause functional impairment which prevents the (moles) (benign skin growths, basal individual from fulfilling work/study/carer or domestic  Comedones cell papillomas) responsibilities.  Dermatofibromas (skin growths)  Skin tags including anal tags OR  Lipomas  Spider naevus  Lesions on the face where the extent, location and size of the  Milia (telangiectasia) lesion can be regarded as considerable disfigurement, and which  Molluscum contagiosum  Thread veins sets them apart from the cohort of people with lesions.  Sebaceous cysts (epidermoid  Warts and plantar warts and pilar cysts)  Xanthelasma (cholesterol Evidence that previous treatment has been pursued before referral has been made will be required.  Port wine stains deposits underneath the For those requiring prior approval this  Post acne scarring skin), evidence must be provided with the request for funding.  Neurofibromata

Requests for the removal of benign skin lesions will be considered where one or more of the following apply:

 There is confirmed, evidenced, history of recurrent (3 or more for the same lesion) infection requiring courses of antibiotics.  There is significant pain as a direct result of the lesion requiring regular prescribed strong analgesics.  Lesions are rapidly growing or abnormally located (e.g. sub- fascial, sub-muscular).  Lesions cause demonstrable severe functional impairment which prevents the individual from fulfilling work/study/carer or

253 domestic responsibilities  Lesions are on the face where the extent, location and size of the lesion can be regarded as considerable severe disfigurement, and which sets them apart from the cohort of people with lesions.  There is clinical evidence that a commonly benign or non- aggressive lesion may be changing to a malignancy, or there is sufficient doubt over the diagnosis to warrant removal.

Evidence that previous treatment has been pursued before requesting approval to refer will be required. For those requiring prior approval this evidence must be provided with the request for funding.

254 Appendix 2

Proposed Change to SRP Current SRP

Policy statement: Carpal Tunnel Carpal Tunnel

Individual Prior Approval Individual Prior Approval Status: Patients with wasting of the hand muscles should be urgently referred Current wording of SRP. to the acute (outside the scope of this policy). Patients with wasting of the hand muscles should be urgently referred to the acute (outside the scope of this policy). The CCG commissions surgery for carpal tunnel syndrome on a restricted basis. South Essex CCGs commissions surgery for carpal tunnel syndrome on a restricted basis. Nerve conduction studies are NOT generally needed to confirm the diagnosis. In elderly patients the condition may develop insidiously and Nerve conduction studies (EMG) are NOT generally needed to confirm nerve conduction studies may be useful to assess severity. the diagnosis and are not routinely funded by the south Essex CCGs.

Patients with Carpal Tunnel Syndrome should be referred if any of the following apply: Community based conservative treatment should be initiated for ALL  Severe symptoms (fewer than 5% of patients) uncontrolled by patients with suspected Carpal Tunnel Syndrome for a period of 6 conservative measures, has a demonstrable significant months, excluding those noted below. detrimental impact on daily activities with a functional limitiation. Conservative treatment will include the following:  Neurological deficit i.e. constant sensory blunting or weakness of thenar abduction (wasting or weakness of abductor pollicis  Analgesia brevis).  Splinting with Futuro-type cock up splint (night time only or  Unclear diagnosis or dual pathology constant)  Rheumatoid  Steroid injection – should be administered once prior to referral  Recent hand trauma for consideration of surgery  Previous hand surgery All GPs should seek access to carpal tunnel injections prior to Community based conservative treatment should be initiated for all referral to surgery. patients with suspected Carpal Tunnel Syndrome for a period of 6 months, excluding those who meet the criteria outlined above. Patients with Carpal Tunnel Syndrome should be referred if any of the following criteria apply: Conservative treatment will include the following:  Analgesia  Severe symptoms (fewer than 5% of patients) uncontrolled by

255  Splinting with Futuro-type cock up splint (night time only or conservative measures, significantly interfering with daily constant) activities.  Steroid injection – should be administered twice prior to  Neurological deficit i.e. constant sensory blunting or weakness referral for consideration of surgery. of thenar abduction (wasting or weakness of abductor pollicis  All GPs should seek access to carpal tunnel injections brevis). in the community.  Unclear diagnosis or dual pathology  Rheumatoid Prior approval and referral letter must detail conservative methods tried  Recent trauma and the length of time that each of these was carried out to enable a  Previous surgery funding decision to be made. Where applicable, referral letter must detail conservative methods tried Uncomplicated cases who have NOT responded to conservative and the length of time that each of these was carried out. management for 6 months should be referred to community based MSK service. Uncomplicated cases who have NOT responded to conservative management for 6 months should be referred. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. Rationale: Conservative treatment offers short-term benefit (1-3 months) similar to Rationale: surgery and many patients’ symptoms may resolve for at least a year Conservative treatment offers short-term benefit (1-3 months) similar to after conservative treatment. After corticosteroid injection, up to 50% of surgery and many patients’ symptoms may resolve for at least a year patients may report minor or no symptoms at one year. after conservative treatment. After corticosteroid injection, up to 50% of The benefits of conservative therapy are seen early after treatment and patients may report minor or no symptoms at one year. then decrease while the benefits of surgery take longer to be fully The benefits of conservative therapy are seen early after treatment and realised. then decrease while the benefits of surgery take longer to be fully realised. Corticosteroid injections and nocturnal splinting are effective conservative therapies. Therefore patients would not normally be Corticosteroid injections and nocturnal splinting are effective referred for carpal tunnel syndrome unless they have had a local conservative therapies. Therefore patients would not normally be steroid injection into the carpal tunnel together with the provision of referred for carpal tunnel syndrome unless they have had a local night splints. steroid injection into the carpal tunnel together with the provision of night splints. Electro-diagnostic tests are not indicated in the diagnosis of classical carpal tunnel syndrome. These may be done where there is doubt Electro-diagnostic tests are not indicated in the diagnosis of classical about the diagnosis, which is uncommon. carpal tunnel syndrome. These may be done where there is doubt about the diagnosis, which is uncommon. In the longer term (3-18 months), surgery is better than conservative therapy with up to 90% of patients reporting complete or much In the longer term (3-18 months), surgery is better than conservative improvement at 18 months. therapy with up to 90% of patients reporting complete or much 256 improvement at 18 months. A trial of conservative therapy offers the opportunity to avoid surgery for A trial of conservative therapy offers the opportunity to avoid surgery for some patients. some patients.

257 Appendix 3

Proposed Change to SRP Current SRP

Policy statement: Cataract Cataract

Individual Prior Approval Individual Prior Approval Status: Referrals should not be based simply on the presence of a cataract. Referrals should not be based simply on the presence of a cataract. Referral of patients with cataracts to ophthalmologists should be Referral of patients with cataracts to ophthalmologists should be based upon the two following indications: based upon the following indications:

A: Impairment of lifestyle (not exhaustive list) such as; A: The patient accepts that there are risks and benefits and wishes to  the patient is at significant risk of falls, or undergo cataract surgery.  the patient’s vision is affecting their ability to drive, or The referring optometrist or GP should discuss the above with the patient  the patient’s vision is substantially affecting their ability to work, before referring. or  the patient’s vision is substantially affecting their ability to Patients who are not willing to have Cataract surgery should not be referred. undertake leisure activities such as reading, watching television or recognising faces or And B: Corrected visual acuity documented of 6/12 or worse in the affected  management of other co-existing eye conditions worse eye, assessed by the clinician as being due to a rectifiable lenticular opacity and

Or C: B: The patient understands the risks and benefits and is willing to Impairment of lifestyle (not exhaustive list) such as; have cataract surgery.

 the patient is at significant risk of falls, or The referring optometrist or GP should discuss the risks and benefits  the patient’s vision is affecting their ability to drive, or using an approved information leaflet (national or locally agreed)  the patient’s vision is substantially affecting their ability to work, or before referring.  the patient’s vision is substantially affecting their ability to undertake leisure activities such as reading, watching television or recognising South west Essex - Second eye faces or As the benefits of second eye surgery have been demonstrated  management of other co-existing eye conditions patients will be offered second eye surgery provided they fulfil the referral criteria (see above). Second eye surgery should be deemed The reasons why the patient’s vision and lifestyle are adversely affected by urgent when there is resultant anisometropia (a large refractive cataract and the likely benefit from surgery must be documented in the difference between the two eyes of 2 ½ dioptas) which would result in poor binocular vision or diplopia (this should be clearly recorded in the 258 clinical records. patient’s notes).

Second eye The reasons why the patient’s vision and lifestyle are adversely affected by cataract and the likely benefit from surgery must be There are sound clinical grounds for cataract surgery in the second eye. documented in the clinical records. Providers will be audited on the indications for cataract surgery. Patients will be offered second eye surgery provided they fulfil the referral criteria (see above).

Second eye surgery should be deemed urgent when there is resultant symptomatic anisometropia ie a large refractive difference between the two eyes resulting in poor binocular vision (this should be clearly recorded in the patient’s notes).

259 Appendix 4

Proposed changes to SRP Current criteria

Policy statement: Cholecystectomy (Gall Stones) Cholecystectomy (Gall Stones)

Individual Prior Approval Threshold Status: Cholecystectomy is routinely approved for symptomatic gallstones. The CCG does not fund cholecystectomy for Gall Stones if they are:

Treatment is not routinely approved for asymptomatic gallstones  Asymptomatic because the risks of prophylactic cholecystectomy outweigh the benefits. because the risks of prophylactic cholecystectomy outweigh the benefits.

This is in patients who have a normal gallbladder and normal biliary tree. Asymptomatic gallstones are defined as the presence of gallstones - The patient will have had stones diagnosed incidentally and had no detected incidentally in patients who do not have any abdominal symptoms from the stones within the previous 12 months prior to being symptoms, or have symptoms that are not thought to be due to gallstones. diagnosed (NICE 2014).

If symptoms develop, the patient will be treated by the correct clinical The following tables indicate appropriateness of indication versus risk due pathway. to patient co-morbidity.

Cholecystectomy not funded for the following: Indications for cholecystectomy:

Indication Investigative Findings Comorbidity Indication Investigative Findings Comorbidity Asymptomatic Single stone in GB All Vague Symptoms Stone in CBD No+low Multiple stones in GB, Med/high Single attack of Stone(s) in GB or CBD No+low chronic acalulous biliary colic or non-functioning GB cholecystitis, or stone in Multiple attacks of Stone(s) in GB or CBD No+low CBD biliary colic or non-functioning GB Vague Stone in GB or chronic Med+high Confirmed acute Stone(s) in GB or CBD No+low Symptoms cholecystitis cholecystitis or non-functioning GB Any High Suspected acute Stone(s) in GB or CBD No+low Single attack of Stone(s) in GB or non- High cholecystitis biliary colic functioning GB Porcelain gall Stone(s) in GB or CBD No Suspected No Stones High bladder acute Stones but no High cholecystitis complications Silent onset of Stone in CBD or dilated No+low jaundice CBD

260 Porcelain gall High Acute pancreatitis Stone(s) in GB or CBD No+low bladder with and without Silent onset of No Stones All appreciable alcohol jaundice Stones in GB only Low+med intake Stones in CBD only High Acute recurrent Stone(s) in GB or CBD No, low +med Acute No Stones All pancreatitis – no pancreatitis Stones in GB only High significant alcohol with and intake without Acute recurrent Stone in CBD No + low appreciable pancreatitis – alcohol intake appreciable alcohol Acute recurrent No Stones Med+high intake pancreatitis – Incidental No no significant cholecystectomy + alcohol intake compatable symptoms Acute recurrent No Stones All pancreatitis – Stones in GB only High Inappropriate Indications for cholecystectomy : appreciable alcohol intake Indication Investigative Findings Comorbidity Incidental Med + high Asymptomatic Single stone in GB All cholecystectom Multiple stones in GB, Med/high y + chronic acalulous Asymptomatic cholecystitis, or stone in Long term TPN Symptoms only Med + high CBD Stones only Med + high Vague Symptoms Stone in GB or chronic Med+high Symptoms + stones High cholecystitis Incidental findings Med + high Any High Asymptomatic Med+high Single attack of Stone(s) in GB or non- High cholecyternteric biliary colic functioning GB fistula Suspected acute No Stones High

cholecystitis Stones but no High Exceptions to the treatment threshold include the following groups where complications treatment will be considered (Behari and Kapoor, 2012); Porcelain gall High  People with diagnosed chronic haemolytic syndromes bladder  People with an increased risk of developing gallbladder cancer Silent onset of No Stones All  Immunosuppressed patients who would be at a greater risk of jaundice Stones in GB only Low+med infective complications Stone in CBD only High

261  Others deemed at an increased risk of complication (as Acute pancreatitis No Stones All confirmed by a secondary care clinician) with and without Stones in GB only High  Stones found within the common bile duct should be treated. This appreciable alcohol includes both symptomatic and asymptomatic patients (see NICE intake guideline CG188). Acute recurrent No Stones Med+high pancreatitis – no significant alcohol The following tables indicate appropriateness of indication versus risk intake due to patient co-morbidity. Acute recurrent No Stones All Indications for cholecystectomy: pancreatitis – Stones in GB only High appreciable alcohol Indication Investigative Comorbidity intake Findings Incidental Med + high Vague Symptoms Stone in CBD No+low cholecystectomy + Single attack of biliary Stone(s) in GB or No+low Asymptomatic colic CBD or non- Long term TPN Symptoms only Med + high functioning GB Stones only Med + high Multiple attacks of Stone(s) in GB or No+low Symptoms + stones High biliary colic CBD or non- Incidental findings Med + high functioning GB Asymptomatic Med+high Confirmed acute Stone(s) in GB or No+low cholecyternteric cholecystitis CBD or non- fistula functioning GB Suspected acute Stone(s) in GB or No+low Exceptions to this policy could include patients with asymptomatic cholecystitis CBD gallstones Porcelain gall bladder Stone(s) in GB or No and CBD  Sickle cell disease. Silent onset of Stone in CBD or No+low jaundice dilated CBD  Calcified 'porcelain' gallbladder or a family history of gallbladder Acute pancreatitis Stone(s) in GB or No+low carcinoma immunosuppression, as they would be at higher risk if with and without CBD they develop an infective complication i.e. cholecystitis or appreciable alcohol cholangitis. intake Acute recurrent Stone(s) in GB or No, low +med pancreatitis – no CBD significant alcohol intake

262 Acute recurrent Stone in CBD No + low pancreatitis – appreciable alcohol intake Incidental No cholecystectomy + compatable symptoms

Condition: Gallstones are hard deposits that form within the gallbladder. - The gallbladder is a small structure that sits behind the liver on the left side of the body. It holds bile. Bile is made in the liver. The bile moves from the liver to the gallbladder via small tube like structures called ducts. It is estimated that up to 15% of people have gallstones in the UK (NICE 2014).

Most people will experience no symptoms from them. Often they will be diagnosed during tests including ultrasounds or scans for other health problems.

Treatment:  Commonly include drug therapy  Ultrasound treatment or surgery that removes the gallbladder. This surgery is called a cholecystectomy.

Rationale: NICE guidelines (CG188) published in October 2014 recommend that people with asymptomatic gallstones should not receive treatment.

This is in people who have a normal gallbladder and normal biliary tree. They should receive reassurance about their condition rather than have treatment. They may receive treatment if they develop symptoms. 80% of people with gallbladder stones will not develop symptoms (NICE 2014).

These groups should be considered for treatment due to the comorbidities that exist and the complications that could develop if they do

263 not receive treatment (Behari and Kapoor, 2012).

Common bile duct stones should be treated regardless of symptoms. This is due to the complications that can develop if they are left (NICE, 2014).

Evidence (NICE 2014 CG188) - The evidence reviewed for the NICE guidelines was insufficient. The recommendations are largely based on the panel’s experience and judgement. From the review that was carried out on the question ‘what strategies should be used to treat asymptomatic gallbladder stones?’ no evidence could be found.

Cholecystectomy (the surgical removal of the gallbladder) is a common treatment. Although successful because it removes the gallbladder and stone content, the risks of surgery including general anaesthetic were thought to outweigh benefits of surgery. Overall, treatments were not thought to benefit the patient nor be an effective use of NHS resources.

Additional searches for evidence did not find further information to dispute NICE guidelines. Equality Impact Assessment has been completed and submitted for review.

References:  NICE (2014)  NICE guidelines (CG188) Gallstone Disease (Full guidance). www.nice.org.uk  Kapoor A and Behari V.K. (2012) Asymptomatic gallstones (AsGs); to treat or not to treat? Indian Journal of Surgery 2012 Feb; 74 (1): 4-12 Accessed April 2015 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3259178/ NICE (2014)  NICE guidance costing statement (CG188) www.nice.org.uk

Glossary: Gallbladder; this is a pouch that sits on the left side of the body near the liver. Common bile duct; this is a channel like structure that is the main duct between the liver and gallbladder. Gallstones; these are small stones that form within the gallbladder. Most of these stones are made

264 up of cholesterol or pigment. Common bile duct stones; these are stones that have moved from the gallbladder into the common bile duct. Cholecystectomy; surgical removal of the gallbladder.

265 Appendix 5

Proposed New Addition to SRP No Current Policy

Diagnostic Colonoscopy/Flexible Diagnostic Colonoscopy/Flexible Sigmoidoscopy for Irritable Bowel Policy statement: Sigmoidoscopy for Irritable Bowel Syndrome Syndrome

Individual Prior Approval No current policy Status:

Calprotectin is a protein biomarker which is used in the differentiation of inflammatory bowel disease (IBD) from irritable bowel syndrome (IBS).

As such in a primary care setting it assists in ruling out IBS patients, who can be managed in primary care, and facilitates appropriate referral to secondary care of patients with IBD.

Patients presenting with the following symptoms should be offered a calprotectin test:

 Abdominal pain relieved by defecation  Altered bowel frequency or consistency  Symptoms for at least 6months.  No red flag symptoms  Normal examination and blood tests Patients with calprotectin levels <30ug/g should be managed as IBS patients in primary care.

Patients with calprotectin levels between 30-75ug/g should have a repeat test in 4 weeks. If the repeat test shows a calprotectin level of <30ug/g, the patient should be managed, as an IBS patient, in the primary care setting.

If the first test shows calprotectin level >75ug/g, or if the repeat test shows levels >30ug/g the patient should be referred to secondary care for inflammatory bowel disease.

This policy does not cover those patients with the following red flag

266 symptoms, who should be referred via a 2 week wait referral.

 Unintentional weight loss  Family history of bowel or ovarian cancer  Age >60 and a change in bowel habits lasting >6weeks  Symptoms suggestive of ovarian pathology Requests of endoscopy to diagnose irritable bowel syndrome will not be approved for funding unless the above process has been followed and evidenced in the funding request and referral. NICE DG 11, NICE QS 81

267 Appendix 6

Proposed Changes to SRP Current SRP

Policy statement: Dupuytren’s Contracture Dupuytren’s Contracture

Individual Prior Approval Threshold Status: The CCG will only fund surgery if patients meet the criteria below: Dupuytren’s Contracture Nodular or cord-like thickening of the palmar fascia causing a tethering  Metacarpophalangeal joint (MCPJ) and/or Proximal IP (flexion) joint of the digits and a loss of range of extension. contracture of 30° and/or more (inability to place hand flat on table) AND Surgery for Dupuytrens’s contracture will only be funded for patients  Where such condition (either MCPJ or PIPJ) is severely impacting who have a flexion contracture exceeding 30 degrees at the on activity of daily living with a demonstrable significant detrimental metacarpophalanageal joint and/or a contracture exceeding 10 degrees impact on daily activities with functional limitation. at the proximal interphalangeal joint. Needle apronectomy will not be OR funded (this may be reviewed in light of any published NICE guidance  Young patients with early onset disease (25-40) +/- family history, for the treatment) whose clinical assessment demonstrates that they will benefit from Simple nodules in the palm are not an indication for referral. surgery. Rationale: The following are not funded: Many hand conditions occur commonly, cause few serious symptoms  The use of Collagenase clostridium histolyticum (Xiapex®) is not and will generally resolve spontaneously. Given the potential funded. complications of surgical procedures and the duty of the CCGs to use  Radiation therapy for early Dupuytren’s contracture is not funded. its limited resources to provide the greatest benefit to the population of  Needle apronectomy south Essex, the below criteria for referral have been developed. These  Simple nodules in the palm criteria are aimed at offering treatment to those who need it most and who are most likely to benefit from surgical treatment.

For audit purposes the Individual Prior Approval and Referral Letter should  Most patients with Dupuytren's disease do not need treatment, detail loss of extension and functional impairment. but regular follow-up is needed to detect early joint contracture. Intervention is almost exclusively surgical and should be Funding for patients not meeting the above criteria will only be granted in considered when the patient is having functional difficulties. clinically exceptional circumstances. Recurrence is very common after surgery (up to 50%) but some patients References: with a ‘Dupuytren’s diathesis’ are particularly at risk. A recent review  www.nice.org.uk/guidance/IPG43 regarding this found that with a family history, bilateral disease, Garrod’s  www.nice.org.uk/guidance/IPG368 pads, male sex and onset less than 50 years the risk of recurrent

268  www.nice.org.uk/guidance/indevelopment/gid-tag364 disease was 71%. With none of these risk factors the rate was 23%.

269 Appendix 7

Proposed change to SRP Current Criteria

Female Genital Prolapse (Surgical and Non- Policy statement: Female Genital Prolapse (Surgical and Non-Surgical) Surgical)

Individual Prior Approval Threshold Status: Definition: South Essex CCGs will only fund surgical interventions for Uterovaginal Pelvic organ prolapse is bulging of one or more of the pelvic organs into Prolapse in the following circumstances: the vagina. These organs are the uterus, vagina, bowel and bladder.1  In cases of mild to moderate symptomatic cystoceles where trial of a pessary has failed. Non- Surgical Interventions:  In cases of mild to moderate symptomatic rectoceles. The CCG will only fund (Vaginal Prolapse/ Asymptomatic pelvic organ  In severe cases of prolapse or procedentia prolapse/Mild pelvic organ prolapse) the following non-surgical interventions and will not fund surgical intervention unless these options Initially, patients should be assessed and managed conservatively in have been tried and there is evidence that they have been unsuccessful in primary care. Also refer to sections below on vaginal pessaries and managing the Female Genital Prolapse. surgery.

Patients should be assessed and managed conservatively in primary care 1. Watchful waiting, with observation for the development of new with the following interventions: symptoms or complications is appropriate if the prolapse is minimal (Stage I), or asymptomatic Watchful waiting, with observation for the development of new symptoms or complications is appropriate if the prolapse is asymptomatic 2. Conservative treatment options

Conservative treatment options 2.1 Lifestyle modification Lifestyle modification  Treatment of conditions that increase intra-abdominal  Treatment of conditions that increase intra-abdominal pressure: constipation, chronic cough, pressure: constipation, chronic cough, overweight/obesity; overweight/obesity; reduction of heavy lifting (while POP reduction of heavy lifting (while Pelvic Organ Prolapse has been associated with these factors, the role of (POP)) has been associated with these factors, the role of lifestyle modification in prevention/treatment has not lifestyle modification in prevention/treatment has not been been investigated) investigated) 2.2. Pelvic floor muscle exercises

1 http://www.nhs.uk/conditions/Prolapse-of-the-uterus/Pages/Introduction.aspx

270 Pelvic floor muscle exercises  Role in managing prolapse unclear; probably not useful if  Role in managing prolapse unclear; probably not useful if the prolapse ex ends to or beyond the vaginal introitus. the prolapse ex ends to or beyond the vaginal introitus.  Cochrane review 2006: concluded evidence was  Cochrane review 2006: concluded evidence was insufficient insufficient (from 3 randomised trials) to judge the value (from 3 randomised trials) to judge the value of conservative of conservative management of POP, & that further trials management of POP, & that further trials were needed were needed  The pilot study for the Pelvic Organ Prolapse Physiotherapy  The pilot study for the Pelvic Organ Prolapse (POPPY) multi-centre trial suggested that pelvic floor Physiotherapy (POPPY) multi-centre trial suggested that muscle training delivered by a physiotherapist to pelvic floor muscle training delivered by a physiotherapist symptomatic Stage I or II POP women in an outpatient to symptomatic Stage I or II POP women in an outpatient setting may reduce the severity of prolapse setting may reduce the severity of prolapse

Local (vaginal) oestrogen creams and oral treatments (see CCG formulary) 2.3. Local (vaginal) oestrogen creams and oral treatments see  Brentwood and Basildon CCG: CCG formulary http://www.basildonandbrentwoodccg.nhs.uk/ See Medicines Management and further information on criteria for funding, please see the Medicines Management section of Vaginal pessary insertion: each CCG website at:  Although not supported by definitive evidence, current opinion is that pessaries are effective & should be  Brentwood and Basildon CCG: considered before surgery in women who have symptomatic http://www.basildonandbrentwoodccg.nhs.uk/ prolapse; they can be attempted in all POP cases  irrespective of stage Castle Point and Rochford CCG : https://www.castlepointandrochfordccg.nhs.uk/  Those participating in active vaginal intercourse should be  offered use of pessaries for those women who have Southend CCG: http://www.southendccg.nhs.uk/ symptomatic prolapse. Or to unmask occult urodynamic  Thurrock CCG: http://www.thurrockccg.nhs.uk/ stress incontinence before surgery  To predict surgical outcomes or unmask occult urodynamic 3. Vaginal pessary insertion – those participating in active vaginal stress incontinence before surgery, as part of the intercourse should be offered surgery once occult urodynamic stress investigation of continent women with POP (so that the incontinence has been explored. decision to perform a concomitant continence procedure along with pelvic reconstruction can then be individually  Cochrane review 2004: no RCTs of pessary use in tailored) women with prolapse; there is no consensus on the use  Risk factors for unsuccessful fitting include: short vaginal of different types of device, the indications, nor the length <6 cm and wide introitus fingerbreadths; local patterns of replacement & follow-up care; evidence or oestrogens may play a role in successful fitting pessary selection and management is incomplete so trial  Failure to retain the pessary has been associated with and error, expert opinion, and experience remain the best increasing parity and previous hysterectomy; and guides for use and management of the pessary discontinuation with history of hysterectomy or prolapse  Although not supported by definitive evidence, current

271 surgery, and stress incontinence; opinion is that pessaries are effective1 & should be  Follow-up: no clear consensus on how often to follow up; considered before surgery in women who have after 3 months & then every 6 months, if there are no symptomatic prolapse; they can be attempted in all POP complications. cases irrespective of stage  Complications tend to occur in women who are not regularly o For short-term relief before surgery, or in the long- followed up; self- care of pessary is also important to term if surgery is not wanted or recommended minimise adverse events; however, many patients find o To predict surgical outcomes or unmask occult insertion & removal of most pessary types challenging urodynamic stress incontinence before surgery, as part of the investigation of continent women Evidence: with POP (so that the decision to perform a Cochrane review 2004: Pessary use in women with prolapse; there is no concomitant continence procedure along with consensus on the use of different types of device, the indications, nor the pelvic reconstruction can then be individually patterns of replacement & follow-up care; evidence or pessary selection tailored) and management is incomplete so trial and error, expert opinion, and experience remain the best guides for use and management of the  Risk factors for unsuccessful fitting include: short vaginal pessary length <6 cm and wide introitus fingerbreadths; local oestrogens may play a role in successful fitting Surgical Intervention:  Failure to retain the pessary has been associated with The CCG will only fund surgery for Female Genital Prolapse (Vaginal increasing parity and previous hysterectomy; and Prolapse/ Asymptomatic pelvic organ prolapse/Mild pelvic organ prolapse) discontinuation with history of hysterectomy or prolapse where there is evidence of the failure of the non-surgical interventions surgery, and stress incontinence; shown above.  Follow-up: no clear consensus on how often to follow up1 ; after 3 months & then every 6 months, if there are no The CCG will fund surgery for Female Genital Prolapse for those who complications, has been suggested; meet the following criteria:  Complications tend to occur in women who are not  Women with symptomatic prolapse (including those combined with regularly followed up1; self- care of pessary is also urethral sphincter incompetence or faecal incontinence) important to minimise adverse events16; however, many  Prolapse combined with urethral sphincter incompetence/ urinary patients find insertion & removal of most pessary types incontinence or faecal incontinence challenging

Use of slings for management of vaginal genital prolapse – is not 4. Surgery - those participating in active vaginal intercourse should be funded by the CCG: offered use of pessaries prior to surgical intervention for those women who have symptomatic prolapse. Or to unmask occult urodynamic Evidence: stress incontinence before surgery Refer to section on use of vaginal NICE Interventional Procedure Guidance (IPG282) pessaries above Current evidence on the safety and efficacy of insertion of mesh uterine suspension sling (including sacrohysteropexy) for uterine prolapse repair is  Assessed as effective, but with a close risk/benefit in mild inadequate. cases; a combination of procedures may be required and

272 reoperation is required in 29% of cases Obliterative Surgery  Types of repair surgery vary depending on type of POP &  Corrects POP by moving the pelvic viscera back into the pelvis & associated symptoms, whether the woman is sexually closing of the vaginal canal; vaginal intercourse is no longer active & her fitness for surgery possible Reconstructive surgery (abdominal or vaginal approach)

 2010 Cochrane review of surgical management of POP: found 40 RCTs with a variety of types of POP5 o There was not enough evidence on most types of common prolapse surgery nor about the use of mesh or grafts in vaginal prolapse surgery o Impact of POP surgery on bowel, bladder and sexual function can be unpredictable and may make symptoms worse or result in new symptoms such as leakage of urine (unmask occult SI) or problems with intercourse o Uterine/vaginal vault prolapse: abdominal sacral colpopexy may be better than vaginal sacrospinous colpopexy – it was associated with a lower rate or recurrent vault prolapse and dyspareunia; these benefits must be balanced against a longer operating time, longer time to return to activities of daily living and increased cost of the abdominal approach o Posterior vaginal wall prolapse/rectocele: posterior vaginal wall repair may be better than transanal repair in terms of recurrence of prolapse (limited evidence) o Value of the addition of a continence procedure to a prolapse repair operation in women who are dry before operation remains to be assessed

Use of mesh/graft inlays (biological or synthetic): o 2010 Cochrane review: use of mesh or grafts at the time of anterior vaginal wall repair reduces the risk of recurrent anterior wall prolapse on examination; however, evidence of benefit to the woman, including symptoms and quality of life

273 improvement, is lacking for the use of grafts over native tissue repairs o 2008 NICE guidance: surgical repair of vaginal wall prolapse using mesh

See Synthetic Mesh and Biological Mesh (see SRP)

Obliterative Surgery

o Corrects POP by moving the pelvic viscera back into the pelvis & closing of the vaginal canal; vaginal intercourse is no longer possible

Clinical scenarios where Clinical scenarios where surgery referral for will not be routinely funded specialist assessment is necessary to determine suitability for surgery Asymptomatic pelvic organ Failure of pessary prolapse Mild pelvic organ prolapse Women with symptomatic (unless prolapse (including those combined with urinary/faecal combined with urethral sphincter incontinence) incompetence or faecal incontinence) Prolapse combined with urethral sphincter incompetence/ urinary incontinence or faecal incontinence Women with moderate to severe prolapse who want definitive treatment

Recommendations

274  Initially, patients should be assessed and managed conservatively in primary care  All patients should have a trial of ring pessary, including suitable candidates for surgery, as part of the investigation of continent women with prolapse; the decision to perform a concomitant continence procedure along with pelvic reconstruction can then be individually tailored

Patient information: http://www.nhs.uk/conditions/Prolapse-of-the- uterus/Pages/Introduction.aspx

275 Appendix 8

Proposed New Addition to SRP No Current Policy

Policy statement: Gastroscopy for Dyspepsia Gastroscopy for Dyspepsia

Individual Prior Approval No current policy Status: Gastroscopy for dyspepsia is only funded when in line with NICE guidance (CG 17 Dyspesia in adults).

Urgent endoscopy is indicated for patients of any age with dyspepsia when presenting with any of the following:

 gastrointestinal bleeding  progressive unintentional weight loss  progressive difficulty swallowing  persistent vomiting  iron deficiency  anaemia epigastric mass  suspicious barium meal Urgent endoscopy is also indicated in patients aged 55 years and older with unexplained and persistent recent onset dyspepsia alone.

Routine endoscopic investigation of patients of any age, presenting with dyspepsia and without alarm signs, is not usually necessary and will not be funded unless the patient fits the following criteria:

 dyspepsia that is responding poorly to medical treatment  atypical symptoms e.g. satiety, nausea, bloating  investigation of upper abdominal pain/ noncardiac chest pain  being considered for anti-reflux surgery

No restrictions are applied to gastroscopy for indications other than dyspepsia

276 Appendix 9

Proposed changes to SRP Current Criteria

Policy statement: Hernia Hernia

Individual Prior Approval Threshold Status: If emergency treatment is required e.g. strangulation is suspected If emergency treatment is required e.g. strangulation is suspected then the referring clinician should refer the patient. then the referring clinician should refer the patient.

Femoral: South Essex CCGs commissions surgical treatment of hernias on a All suspected femoral hernias should be referred to secondary care due restrictive basis for patients meeting the defined criteria below. This to the increased risk of incarceration/strangulation Service Restriction Policy covers the management of;  Inguinal The CCG commissions surgical treatment of hernias on a restrictive  Femoral basis for patients meeting the defined criteria below. This Service  Umbilical Restriction Policy covers the management of the following types of  Ventral hernia:  Incisional hernias  Inguinal  Umbilical Criteria for referrals/treatment as below:  Incisional/Ventral Inguinal: For asymptomatic or minimally symptomatic hernias, a watchful waiting Inguinal: approach is advocated with informed consent. For asymptomatic or minimally symptomatic hernias, a watchful waiting Surgical treatment should only be offered when one of the following approach is advocated with informed consent. criteria is met:

Surgical treatment will only be funded when one of the following criteria  Symptomatic i.e. symptoms are such that they interfere with work is met: or activities of daily living  Symptomatic i.e. symptoms are such that they interfere with work or or activities of daily living with a demonstrable significant  The hernia is difficult or impossible to reduce detrimental impact on daily activities with functional limitation. or OR  Inguino-scrotal hernia  The hernia is difficult or impossible to reduce, or OR  The hernia increases in size month on month  Inguino-scrotal hernia, or OR  The patient is currently asymptomatic but works in a heavy  The hernia increases in size month on month manual occupation (for e.g. in removal firms lifting heavy weights)

277 OR and there is an increased risk of strangulation and future  The patient is currently asymptomatic but works in a heavy complications. manual occupation (for e.g. in removal firms lifting heavy weights) and there is an increased risk of strangulation and future Femoral: complications. All suspected femoral hernias should be referred to secondary care due to the increased risk of incarceration/strangulation Umbilical: Surgical treatment should only be offered when one of the following Umbilical: criteria is met: Surgical treatment should only be offered when one of the following  Symptomatic i.e. symptoms are such that they interfere with work criteria is met: or activities of daily living with a demonstrable significant  detrimental impact on daily activities with functional limitation. pain/discomfort interfering with activities of daily living or Or  increase in size month on month  increase in size month on month or Or   to avoid incarceration or strangulation of bowel to avoid incarceration or strangulation of bowel or Or  The patient is currently asymptomatic but works in a heavy  The patient is currently asymptomatic but works in a heavy manual occupation (for e.g. in removal firms lifting heavy weights) manual occupation (for e.g. in removal firms lifting heavy weights) and there is an increased risk of strangulation and future and there is an increased risk of strangulation and future complications complications

Incisional: Incisional/Ventral: Surgical treatment should only be offered when BOTH of the following Surgical treatment should only be offered when BOTH of the following criteria are met: criteria are met:

  Pain/discomfort interfering with activities of daily living Symptomatic i.e. symptoms are such that they interfere with work And or activities of daily living with a demonstrable significant  Appropriate conservative management has been tried first e.g. detrimental impact on daily activities with functional limitation. weight reduction where appropriate And or  Appropriate conservative management has been tried first e.g.  The patient is currently asymptomatic but works in a heavy weight reduction where appropriate manual occupation (for e.g. in removal firms lifting heavy weights) or and there is a risk of strangulation and future complications.  The patient is currently asymptomatic but works in a heavy manual occupation (for e.g. in removal firms lifting heavy weights) Patient Information: and there is a risk of strangulation and future complications. http://www.nhs.uk/conditions/hernia/pages/introduction.aspx

278 Divarication of Recti: References: Diastases/Divarication of recti is a separation between the left and right 1. Simons MP, Aufenacker T. European Hernia Society guidelines side of the rectus abdominis muscle, and causes a protrusion in the on the treatment on inguinal hernia in adult patients. Hernia 2009; midline, but is not a 'true' hernia and does not carry the risk of bowel 13:343-403. becoming trapped within it and thus does not require repair. 2. Fitzgibbons RJ, Giobbe-Hurder A. Watchful waiting vs. Repar of Evidence suggests that divarication does not carry the same risks as that Inguinal Hernia in Minimally Symptomatic Men. JAMA 2006; of actual herniation. 295:285292 3. O’Dwyer PJ, Norrie J. Observation or Operation for Patients with The CCG considers repair of divarication of recti as a cosmetic an Asymptomatic Inguinal hernia. Ann Surg 2006; 244:167-173> procedure and a low priority and as such does not fund this procedure.

Patient Information: http://www.nhs.uk/conditions/hernia/pages/introduction.aspx

References: 1. Simons MP, Aufenacker T. European Hernia Society guidelines on the treatment on inguinal hernia in adult patients. Hernia 2009; 13:343-403. 2. Fitzgibbons RJ, Giobbe-Hurder A. Watchful waiting vs. Repar of Inguinal Hernia in Minimally Symptomatic Men. JAMA 2006; 295:285292 3. O’Dwyer PJ, Norrie J. Observation or Operation for Patients with an Asymptomatic Inguinal hernia. Ann Surg 2006; 244:167-173>

279 Appendix 10

Proposed Change to SRP Current SRP

Policy statement: Hip Arthroscopy Hip Arthroscopy

Threshold Approval Individual Prior Approval Status: Hip Arthroscopy: Current wording of SRP.

Will only be funded for:  Hip Arthroscopy (HA) was found to be more sensitive and specific than MRI and MRI arthrography. It is useful in patients with  Sepsis of the hip joint (septic arthritis) chronic (>6m) hip pain who have negative radiological  Washout of an infected native hip joint in patients with clear investigations. evidence of resistance to medical management; patients with Therapeutic Hip Arthroscopy is indicated in the following: underlying disease; patients who are immunosuppressed  Radiological proven loose bodies that are within the hip joint  Loose bodies  Excision of radiological proven labral tears in the absence of  Labrum lesions osteoarthritis  Tears, flaps  Excision of radiological proven labral tears associated with an Septic arthritis – for debridment and lavage NICE Interventional acute traumatic episode in the absence of osteoarthritis or FAI Procedure Guidance 213 suggests that arthroscopic femoro-acetabular syndrome surgery for hip impingement syndrome should only be used with “special The CCG will fund open or arthroscopic hip surgery for the treatment of arrangements for consent and research” femoro-acetabular impingement (FAI) ONLY when patients fulfil ALL of the following criteria:

 Diagnosis of definite femoro-acetabular impingement defined by X-rays, MRI and CT scans.  Evidence that an orthopaedic surgeon has discussed each case with a specialist musculoskeletal radiologist.  Severe symptoms typical of FAI with duration of at least six months where diagnosis of FAI has been made with the diagnostic tests listed above.  Evidence of failure to respond to all available conservative treatment options including activity modification, pharmacological

280 intervention and MSK physiotherapy.  Compromised function, which requires urgent treatment within a 6-8 month timeframe, or where failure to treat early is likely to significantly compromise surgical options at a future date.  Treatment with more established surgical procedures is not clinically viable.

The CCG will NOT fund hip arthroscopy in patients with femoro- acetabular impingement (FAI) where any of the following criteria apply:

 Patients with advanced Osteo-Arthritic change on preoperative X- ray (Tonnis grade 2 or more) or severe cartilage injury (Outerbridge grade lll or lV).  Patients with a joint space on plain radiograph of the pelvis that is less than 2mm wide anywhere along the sourcil.  Patients who are a candidate for hip replacement.  Any patient with severe hip dysplasia or with a Crowe grading classification of 4.  Patients with generalised joint laxity expecially in diseases connected with hypermobility of the joints, such as Marfan syndrome and Ehlers-Danlos syndrome.  Patients with osteogenesis imperfecta.

Treatment of FAI should be restricted to centres experienced in treating this condition and staffed by surgeons adequately trained in techniques addressing FAI and all governance and audit undertaken in accordance with NICE IPG 403 and 408.

REFERENCES:

NICE IPG213 Arthroscopic femoro-acetabular surgery for hip impingement syndrome.

281 Appendix 11

Proposed Change to SRP Current Criteria

Hysterectomy for Menorrhagia (non-cancer) Policy statement: or heavy menstrual bleeding (including Hysterectomy for Menorrhagia (non-cancer) fibroids up to 3cm)

Individual Prior Approval Individual Prior Approval Status: Definition Hysterectomy for non-cancerous heavy menstrual bleeding will only be Heavy menstrual bleeding is defined as excessive menstrual blood loss funded by south east Essex CCGs within NICE guidance and when; which interferes with a woman's physical, social, emotional and/or material quality of life.  There has been an unsuccessful trial and appropriate clinical assessment, with a levonorgestrel-releasing intrauterine system NOTE: LNG-IUS, e.g. Mirena®, unless contraindicated, for at least 12 Removal of healthy ovaries at the time of hysterectomy should not be months which has not successfully relieved symptoms or has undertaken, as per the NICE guidelines, however prophylactic removal of produced unacceptable side effects. fallopian tubes may be considered to reduce the risk of ovarian cancer. and  At least one alternative treatment has failed, is not appropriate or Rationale: is contra-indicated in line with NICE guidelines. This policy has been developed using NICE (2008) guidance (CG44) and Alternative hormonal treatment NICE Quality standard (QS47). It supports the premise that less invasive Other hormone methods (e.g. combined oral contraceptives, injected treatments should be attempted, if appropriate, before hysterectomy is progesterons, Gn-RH analogue). performed. NICE recommends that in some women with heavy  In line with NICE guidance. menstrual bleeding, hormonal or non-hormonal drug treatments can  NSAIDs and Tranexamic Acid. reduce the bleeding or stop it completely. If no structural or histological and abnormality is suspected these treatments should be attempted before  The following are not clinically appropriate: referral into secondary care for specialist treatment. 1. Endometrial ablation if normal uterus or if LNG-IUS contraindicated or if ablation is contraindicated e. g. previous This may reduce the number of inappropriate referrals into secondary multiple caesarean section care. 2. Uterine Artery Embolisation (for fibroids under 3cm) 3. Myomectomy (for fibroids over 3cms) (NICE QS) NICE recommend that UAE (Uterine artery embolization) be considered for the management of heavy menstrual bleeding associated Contraindications to the levonorgestrel intrauterine system are: with fibroids >3cm, this is an alternative to surgical hysterectomy and  Distorted or small uterine cavity (with proven ultrasound may potentially allow women to retain fertility. A scientific paper measurements; Uterocervical canal length < 5cm). published by the RCOG in November 2014 discussed the rapidly  Genital malignancy.

282 increasing body of evidence supporting the fallopian tube as the site of  Active trophoblastic disease. origin of HGSOC (high grade serous ovarian cancer). The RCOG  Active pelvic inflammatory disease. recommend that women who are not at high risk for BRCA mutation and  Large cavity over 10cm length. have completed their families should be carefully considered for prophylactic removal of the fallopian tubes with conservation of ovaries References: at the time of gynaecological or other intraperitoneal surgery. 1. Brown JS, Sawaya G, Thom DH, Grady D. Hysterectomy and urinary incontinence: a systematic review. Lancet. 2000; 356: Primary Care Management 535-9. NICE guidance recommends that if hormonal or non-hormonal 2. Clarke J. Treatment of heavy menstrual bleeding. BMJ 2010; treatments should be considered in the following order: 341: 353. 1. levonorgestrel-releasing intrauterine system (LNG-IUS) 3. Lethaby A, Shepperd S, Farquhar C, Cooke I. Endometrial 2. tranexamic acid or non-steroidal anti-inflammatory drugs (NSAIDs) or resection and ablation versus hysterectomy for heavy menstrual combined oral contraceptives (COCs) bleeding. Cochrane Database of Systematic Reviews 1999, Issue 3. norethisterone (15 mg) daily from days 5 to 26 of the menstrual cycle, 2. Art. No.: CD000329. DOI:10.1002/14651858.CD000329 or injected long-acting progestogens. 4. National Institute for Health & Care Excellence (NICE) Heavy menstrual bleeding, Jan 2013 Where hormonal treatments are not acceptable to the woman then either http://publications.nice.org.uk/heavy-menstrual-bleeding-qs47. tranexamic acid or NSAIDS should be used. 5. National Institute for Health and Care Excellence (NICE) Heavy Menstrual Bleeding January 2007. Hysterectomy for heavy menstrual bleeding will only be funded by the CCG when:

 There has been a trial, after appropriate clinical assessment, with a levonorgestrel-releasing intrauterine system LNG-IUS, e.g. Mirena®, unless contraindicated, for at least 6 cycles and this has not successfully relieved symptoms or has produced unacceptable side effects. AND  At least one other treatment (see below) has failed. This should be documented in the referral and request for funding approval  Or there is evidence that interventions are not clinically appropriate (see below) this should be documented in the referral and request for funding approval  Or there is evidence that alternatives are contra-indicated in line with NICE guidelines (see below) this should be documented in the referral and request for funding approval

Other treatments:

283 • Alternative hormonal treatment in keeping with NICE guidance • NSAIDs and Tranexamic Acid

 Not clinically appropriate • Endometrial ablation if normal uterus • If LNG-IUS contraindicated • If ablation is contraindicated e. g. previous multiple caesarean section • Endometrial resection

Evidence: Endometrial ablation is a less invasive surgical procedure than hysterectomy; is associated with fewer complications and can be performed as day surgery. NICE therefore recommend that in women with heavy menstrual bleeding alone, with a uterus no bigger than a 10- week pregnancy, endometrial ablation should be considered preferable to hysterectomy. Evidence suggests that women who live in poorer areas are more likely to undergo hysterectomy rather than endometrial ablation compared with women who live in more affluent areas.

 Contraindications to the levonorgestrel intrauterine system are: • Distorted or small uterine cavity (with proven ultrasound measurements; Uterocervical canal length < 5cm) • Genital malignancy • Active trophoblastic disease • Active pelvic inflammatory disease • Large cavity over 10cm length

Full hysterectomy for Menorrhagia for those patients who, for ethical reasons, cannot accept the use of Mirena®, will only have funding approval for a full hysterectomy if:

 They have tried at least two of the “other treatments” listed above AND  If either of the following treatments are not clinically appropriate:

• Endometrial ablation if normal uterus or if LNG-IUS

284 contraindicated or if ablation is contraindicated e.g. previous multiple caesarean section • Endometrial resection

References: • The Distal Fallopian Tube as the Origin of Non-Uterine Pelvic High-Grade Serous Carcinomas [online] Available from: https://www.rcog.org.uk/globalassets/documents/guidelines/scien tific-impactpapers/sip44hgscs.pdf • Royal College of Obstetricians and Gynaecologists (2014) Advice for Heavy Menstrual Bleeding (HMB) Services and Commissioners [online] Available from: https://www.rcog.org.uk/globalassets/documents/guidelines/resea rch--audit/advice-forhmb-services-booklet.pdf • National Institute for Health and Care Excellence (2013) Heavy Menstrual Bleeding. • NICE quality standard 47 [online] Available from: https://www.nice.org.uk/guidance/qs47 National Institute for Health and Care Excellence (2013) Heavy Menstrual Bleeding. • NICE Clinical Guideline No.44 [online] Available from: https://www.nice.org.uk/guidance/cg44

285

Appendix 12

Proposed Change to SRP Current Criteria

Knee Arthroscopy/Arthroscopic Lavage Policy statement: Knee Arthroscopy/Arthroscopic Lavage (washout) (washout)

Individual Prior Approval Threshold Approval Status: Knee Arthroscopy: Current wording of SRP.

Will only be funded for: Cases for knee arthroscopy will only be funded if they meet the criteria below:  Removal of loose body when there is clear history of locking and reported history of other treatment failing  Arthroscopy of the knee can be undertaken where a competent  Meniscal Surgery clinical examination (or MRI scan if there is a diagnostic reason)  Repair of cruciate ligament Synovectomy/Symptomatic Plica has demonstrated clear evidence of an internal joint derangement  Knee “washout” (arthroscopic lavage) for osteoarthritis will not be (meniscal tear, ligament rupture or loose body) and where funded unless there is clear documented history of mechanical conservative treatment has failed and there is clear evidence that locking (not gelling, giving way or x-ray evidence of loose conservative treatment will not be effective. bodies) Knee Arthroscopy can be carried out for:  Continued diagnostic use following MRI in the following  Removal of loose body circumstances:  Meniscal repair or resection/repair chrondral defects o When the MRI report shows significant degree of  movement deficit Ligament reconstruction/repair (including lateral release)  o If the patient has an Anterior Cruciate Ligament Synovectomy/symptomatic plica reconstruction and the metal screws are affecting the MRI  To assist slection of patients suitable for unicompartmental knee image quality replacement o Patient has a Pacemaker Knee arthroscopy should NOT be carried out (and will not be funded) for  If there are Red Flag symptoms or signs including: recent any of the following: trauma, constant progressive non-mechanical pain (particularly at  Investigation of knee pain (MRI is less invasive alternative for night), previous history of cancer, long term steroid use, history of investigation of knee pain) drug abuse, history of HIV, fever, being systematically unwell,

286 recent unexplained weight loss, persistent severe restriction of Treatment of osteoarthritis including arthroscopic “washout” . In line with joint movement, widespread neurological changes, and structural NICE Guidance CG59; this should not be offered as part of a treatment deformity. for osteoarthritis unless the person has a clear documented history of  If there are Red Flag conditions: infection, carcinoma, nerve root mechanical locking (not gelling, giving way or x-ray evidence of loose impingement, bony fracture and avascular necrosis. bodies) Will not be funded and should not be undertaken in any of the following circumstances:

 Diagnostic purposes only (note the above exceptions)  Treatment of osteoarthritis (arthroscopic lavage) “washout” and debridement. In line with NICE Guidance CG59/177; this should not be offered as part of a treatment for osteoarthritis unless the person has a clear documented history of mechanical locking (not gelling, giving way or x-ray evidence of loose bodies)  Arthroscopic lavage (“washout” – HRG: HB25B, HB25C) will only be funded as a clinical exceptional case and funding request should be via IFR.

287 Appendix 13

Proposed Change to SRP Current criteria

Policy statement: Knee Replacement Knee Replacement

Individual Prior Approval Threshold Status: Referral should be when other pre-existing medical conditions have been optimised AND conservative measures have been exhausted and The CCG will only fund Knee Replacement/Revision/Resurfacing where failed. This will include weight reduction, NSAIDs and analgesics, there is evidence that the patient has meet the following criteria: changing activity, and introducing a walking aid. • Been referred to and managed by the MSK Community Service South Essex CCGs will only fund knee replacements (total knee Provider replacement: patello-femoral (PFJ) and unicompartmental) if: • Been supported in making an informed decision using a shared decision making tool/process with the referring clinician  The patient complains of intense or severe symptomatology AND Referral for knee replacements (total knee replacement: patello-femoral has radiological features of severe disease AND has (PFJ) and unicompartmental) will only be funded following MSK demonstrated disease within all three compartments of the knee Community Service Management or Assessment and when there is clear (tri-compartmental) or localised to one compartment plus patello- femoral disease (bi-compartmental). OR evidence that:  The patient complains of intense or severe symptomatology AND • Pre-existing medical conditions have been optimised has radiological features of moderate disease AND is troubled by • Conservative measures have been exhausted and failed and are limited mobility or stability of the knee joint. correctly done (see table below), these include:  The patient has completed a self-assessment score, e.g. the o Weight reduction that is maintained over a one year period Oxford Hip Score as part of their pre-assessment provided by o NSAIDs and analgesics have been tried secondary care prior to surgery. o Moderating activity levels without significantly impacting on daily function http://www.orthopaedicscore.com/scorepages/oxford_hip_score.html

o Use of appropriate walking aid  Has supporting clinical diagnostics and other assessments to AND if the patient meets criteria 1 (see below) or criteria 2 (see below): support the decision to operate Criteria 1 Knee replacement: classification of pain levels and functional limitations  (as per table below) The patient complains of intense pain Variable Definition AND

288  Has radiological features of severe disease Pain Level AND Pain interferes minimally on an intermittent basis with  Has demonstrated disease within all three compartments of the usual daily activities. knee (tri-compartmental) or localised to one Mild Not related to rest or sleep. compartment plus patello-femoral disease (bi-compartmental) Pain controlled by one or more of the following: NSAIDs with no or tolerable side effects, Criteria 2 aspirin/paracetamol at regular doses

Pain occurs daily with movement and interferes with  (as per table below) The patient complains of severe pain usual daily activities. AND Vigorous activities cannot be performed. Moderate  Has radiological features of moderate disease Not related to rest or sleep. AND Pain controlled by one or more of the following:  Has functional limitations that are moderate or severe (as per NSAIDs with no or tolerable side effects, table below) aspirin/paracetamol at regular doses Pain is constant and interferes with most activities of Severe daily living. Prior to referral to secondary care: Pain at rest or interferes with sleep. The patient has completed a self-assessment score, e.g. the Oxford Hip Pain not controlled, even by narcotic analgesics. Score as part of their pre-assessment provided by secondary care prior to Previous non-surgical treatments surgery. NSAIDs, paracetamol, aspirin or narcotic analgesics Correctly at regular doses during 6 months with no pain relief; http://www.orthopaedicscore.com/scorepages/oxford_hip_score.html Done weight control treatment if overweight, physical Has supporting clinical diagnostics and other assessments to support the therapies done. NSAIDs, paracetamol, aspirin or narcotic analgesics decision to operate Incorrectly at inadequate doses or less than 6 months with no Done Knee replacement: classification of pain levels and functional limitations pain relief; or no weight control treatment if overweight or no physical therapies done. Variable Definition Functional Limitations Pain Level Functional capacity adequate to conduct normal Minor activities and self-care. Pain interferes minimally on an intermittent basis with Walking capacity of more than one hour. usual daily activities. No aids needed. Not related to rest or sleep. Mild Functional capacity adequate to perform only a few or Pain controlled by one or more of the following: Moderate none of the normal activities and self-care. NSAIDs with no or tolerable side effects, Walking capacity of about one half hour. aspirin/paracetamol at regular doses Aids such as a cane are needed.

289 Pain occurs daily with movement and interferes with Largely or wholly incapacitated. usual daily activities. Walking capacity of less than half hour or unable to Severe Vigorous activities cannot be performed. walk or bedridden. Moderate Not related to rest or sleep. Aids such as a cane, a walker or a wheelchair are

Pain controlled by one or more of the following: required. NSAIDs with no or tolerable side effects, aspirin/paracetamol at regular doses Pain is constant and interferes with most activities of Severe daily living. Pain at rest or interferes with sleep. Pain not controlled, even by narcotic analgesics. Previous non-surgical treatments NSAIDs, paracetamol, aspirin or narcotic analgesics at Correctly regular doses during 6 months with no pain relief; Done weight control treatment if overweight, physical therapies done. NSAIDs, paracetamol, aspirin or narcotic analgesics at Incorrectly inadequate doses or less than 6 months with no pain Done relief; or no weight control treatment if overweight or no physical therapies done. Functional Limitations Functional capacity adequate to conduct normal Minor activities and self-care. Walking capacity of more than one hour. No aids needed. Functional capacity adequate to perform only a few or Moderate none of the normal activities and self-care. Walking capacity of about one half hour. Aids such as a cane are needed. Largely or wholly incapacitated. Walking capacity of less than half hour or unable to Severe walk or bedridden. Aids such as a cane, a walker or a wheelchair are required.

290 Appendix 14

Proposed Change to SRP Current criteria

Microsuction/Removal of ear wax in secondary Policy statement: Microsuction/Removal of ear wax in secondary care care

Individual Prior Approval Threshold Approval Status: The CCG does not routinely fund removal of ear wax via microsuction (a Removal of ear wax in secondary care will not be funded unless a patient quick and painless procedure where a small device is used to suck the has one of the following contraindications to ear irrigation: earwax out of your ear) in secondary care unless there are exceptional clinical circumstances to indicate that the wax cannot be removed through  The patient has previously experienced complications following an alternate method. this procedure in the past.  There is a history of a middle ear infection in the last six weeks.  The patient has undergone ANY form of ear surgery (apart from  eardrops – drops used several times a day for a few days to grommets that have soften the earwax so that it falls out by itself extruded at least 18 months previously and the patient has been  ear irrigation – a quick and painless procedure where an electric discharged from the ENT Department).  pump is used to push water into your ear and wash the earwax The patient has a perforation or there is a history of a mucous 2 discharge in the last year. out  The patient has a cleft palate (repaired or not).  In the presence of acute otitis externa with pain and tenderness of the pinna. NHS Choices outlines the following:

What to do if you think your ear is blocked Don't try to remove a build-up of earwax yourself with your fingers, a cotton bud or any other object. This can damage your ear and push the wax further down.

If the earwax is only causing minor problems, you can try buying some eardrops from a pharmacy. These can help soften the earwax so that it falls out naturally.

There are several different types of eardrops you can use, including drops containing sodium bicarbonate, olive oil or almond oil.

2 http://www.nhs.uk/conditions/earwax/Pages/Introduction.aspx

291

However, eardrops aren't suitable for everyone and some can irritate the skin. For example, eardrops shouldn't be used if you have a perforated eardrum (a hole or tear in your eardrum).

292 Appendix 15

Proposed Change to SRP Current criteria

Policy statement: Shoulder Arthroscopy Shoulder Arthroscopy

Individual Prior Approval Threshold Approval Status:

Shoulder Arthroscopy Current wording of SRP.

The CCG will only fund in exceptional circumstances for patients with Shoulder Arthroscopy will only be funded for patients with adhesive adhesive capsulitis (“frozen shoulder”) where there is evidence that all of capsulitis (“frozen shoulder”) if the following treatments have been the following treatments have been trialled and failed: trialled and failed:

 Activity modification  Activity modification  Physiotherapy and exercise programme  Physiotherapy and exercise programme  Oral analgesia including NSAIDs unless contraindicated  Oral analgesia including NSAIDs unless contraindicated  Intra-articular steroid injections  Intra-articular steroid injections  Manipulation under anaesthetic  Manipulation under anaesthetic Frozen shoulder or adhesive capsulitis following a fracture WILL be funded as undertaking the risk of re-manipulation under anaesthetic The CCG will fund shoulder arthroscopy only in the following increases the risk of re-fracture circumstance: In the majority of circumstances a clinical examination (history and  Frozen shoulder or adhesive capsulitis following a fracture as the physical examination) by a competent clinician will give a diagnosis and risk of re-manipulation under anaesthetic increases the risk of re- demonstrate if internal joint degeneration is present. If there is a fracture diagnostic uncertainty despite competent examination or if there are red flag symptoms/signs/conditions then an MRI scan might be indicated.

In the majority of circumstances a clinical examination (history and Red Flag symptoms or signs including: recent trauma, constant physical examination) by a competent clinician will give a diagnosis and progressive non-mechanical pain (particularly at night), previous history demonstrate if internal joint degeneration is present. If there is a of cancer, long term steroid use, history of drug abuse, history of HIV, diagnostic uncertainty despite competent examination or if there are red fever, being systematically unwell, recent unexplained weight loss, flag symptoms/signs/conditions then an MRI scan (not shoulder persistent severe restriction of joint movement, widespread neurological arthroscopy) might be indicated. changes, and structural deformity.

293 Red Flag conditions: infection, carcinoma, nerve root impingement, bony fracture and avascular necrosis. For the avoidance of doubt the CCG does not commission shoulder arthroscopy in the following:

 As a diagnostic tool  For frozen shoulder or adhesive capsulitis – except in the circumstances outlined above

Red Flag symptoms or signs including: recent trauma, constant progressive non-mechanical pain (particularly at night), previous history of cancer, long term steroid use, history of drug abuse, history of HIV, fever, being systematically unwell, recent unexplained weight loss, persistent severe restriction of joint movement, widespread neurological changes, and structural deformity.

Red Flag conditions: infection, carcinoma, nerve root impingement, bony fracture and avascular necrosis.

294 Appendix 16

Proposed Change to SRP Current criteria

Sleep Studies for snoring and obstructive Policy statement: Sleep Studies sleep apnoea

Individual Prior Approval Threshold Approval Status: Basildon & Brentwood CCG considers treatment for snoring to be a LOW South Essex CCGs commission sleep studies for patients with suspected PRIORITY and will not normally fund treatment where this is the sole sleep apnoea, complex sleep disorders or where necessary to confirm a problem. Patients with snoring and other symptoms such as nasal diagnosis of narcolepsy. obstruction should be assessed by nasendoscopy Snoring (defined as) If sleep apnoea is suspected, the following criteria must be present - loud and chronic (ongoing) - Pauses may occur in the snoring. prior to referral to the sleep unit: - Choking or gasping may follow the pauses.

Sleep apnoea (defined as) 1) Daytime sleepiness (rather than tiredness) assessed by Epworth score - fighting sleepiness during the day, at work, or while driving (>10) - witnessed breathing pauses whilst asleep

AND one or more of the following If sleep apnoea is suspected patients should be referred if they have red

flag symptoms or relevant comorbid conditions (see below). Those 2) Witnessed regular or frequent nocturnal apnoeic episodes of stopping without red flag symptoms or relevant comorbid condition must meet the breathing following criteria prior to referral to the sleep unit. 3) Waking with sensations of choking/obstruction o Daytime sleepiness (rather than tiredness) assessed by 4) Neck circumference 17ins or over Epworth score of 10 or above AND 5) Significant retrognathia o symptoms and / or signs indicating significant sleep apnoea. 6) Small oedematous pharynx on visual inspection Red flag symptoms: o Patients referred for sleep studies should also have a nasendoscopic cor pulmonale o assessment of their upper airways to exclude any structural cause for respiratory failure/severe pulmonary disease o obstruction vigilance critical occupations (pilots, professional drivers, operators of heavy machinery) All patients who are smokers should be referred to smoking o extreme sleepiness leading to risk of danger to self or cessation services before referring for an initial assessment others o planned general anaesthetic appointment.

Note: Patients who are not eligible for treatment under this policy may be

295 considered on an individual basis where their GP or consultant believes Relevant comorbid conditions: exceptional circumstances exist that warrant deviation from the rule of this o respiratory failure/severe pulmonary disease policy. o significant neurological or neuromuscular disease o uncontrolled hypertension Individual cases will be reviewed as per the CCG Individual Funding o unstable angina/ischaemic heart disease Request (IFR) policy. o pregnancy o recent cerebrovascular disease o congestive heart failure

Where nasal obstruction is an issue, patients should be referred for nasoendoscopic assessment of their upper airways prior to referral for sleep studies to exclude any structural cause for obstruction.

South Essex CCGs do not commission sleep studies for parasomnia, periodic limb movement disorder, chronic insomnia or snoring.

296 Appendix 17

Proposed Change to SRP Current criteria

Policy statement: Trigger Finger Trigger Finger

Individual Prior Approval Threshold Status: Trigger Finger Referral for trigger finger in secondary care will only be funded if A tender nodule in the flexor tendon at base of a finger or thumb they meet one of the three the criteria below: causing a snapping of the finger/thumb as it is extended from a flexed position.  Patients who fail to respond to all appropriate conservative treatments for a minimum of 6 months. OR Referrals for surgery for trigger finger will only be funded for patients who have fulfilled one or more of the criteria as follows:- Conservative treatments include: Reassurance – up to 83% have been found to resolve  Failure to respond to conservative measures [e.g. up to 2 spontaneously after a few months. hydrocortisone injections]  When the patient has a fixed deformity that cannot be Steroid injection – 50-80% will resolve after a single injection and a corrected second injection should be carried out after 6 weeks if no response  Patients for whom corticosteroid treatment is not suitable to first injection. such as multiple digits affected.

 Patients who have a fixed flexion deformity that cannot be Rationale: corrected and that is severely impacting on activity of daily Many hand conditions occur commonly, cause few serious living with a demonstrable significant detrimental impact on symptoms and will generally resolve spontaneously. Given the daily activities with functional limitation. OR potential complications of surgical procedures and the duty of the

 Patients for whom corticosteroid treatment is not suitable CCGs to use its limited resources to provide the greatest benefit to such as multiple digits affected – 50-80% will resolve after a the population of south Essex, the below criteria for referral have single injection and a second injection should be carried out been developed. These criteria are aimed at offering treatment to after 6 weeks if no response to first injection. those who need it most and who are most likely to benefit from surgical treatment. For audit purposes, the referral letter, and Individual Prior Approval form must include evidence that the patient meets the criteria, Trigger finger and thumb in adults is caused by thickening of the A1 including the dates of the corticosteroid injections and any other conservative management. pulley. It is most common in middle aged women, is more frequent in diabetics but is usually idiopathic. Patients complain of the finger

297 Funding for patients not meeting the above criteria will only be becoming stuck bent. When the digit is straightened there is a granted in clinically exceptional circumstances. palpable clunk which is painful. Examination reveals a tender thickening over the A1 pulley which is at the level of the distal palmar crease in the fingers and at the base of the thumb.

Conservative treatment includes rest and avoiding precipitating activities. Non-steroidal anti-inflammatory drugs will often settle early cases. Injection of hydrocortisone is safe and can provide lasting relief in up to 70% of cases.

Trigger thumb is also very common and often more painful. It also occurs in infants due to a lump in the tendon rather than pulley thickening. In adults trigger thumb seems to respond less well to injections than fingers but it is still worthwhile. In infants surgery is often required if the deformity persists after 1 year.

298 Appendix 18

Proposed Change to SRP Current criteria

Policy statement: Varicose Veins Varicose Veins

Individual Prior Approval Individual Prior Approval Status: Treatments for varicose veins are considered as procedures of low clinical Current wording of SRP. priority and therefore not routinely funded by the Commissioner. South Essex CCGs will not normally fund surgical treatment for those Conservative management is the first line of treatment and applications veins that present a largely cosmetic problem or that cause simple will not normally be accepted without evidence that conservative aching that could be adequately controlled by properly measured surgical management of asymptomatic and symptomatic varicose veins has been hosiery. tried, and failed, for a period of at least six months. Surgery for patients with varicose veins with the complications outlined Prior to consideration for intervention patients should be given information below will continue to be funded on the NHS: regarding  venous ulceration  Weight loss if they have a raised BMI  venous eczema refractory to short term steroid cream  Light to moderate physical activity  recurrent superficial thrombophlebitis (at least two minor  Avoiding factors which are known to make their symptoms worse, episodes) if possible  bleeding associated with varicose veins (at least two minor or one  Use of compression stockings for a 6 month duration, where this is major bleed) considered appropriate  post phlebitic syndrome (PTS).  When and where to seek further medial help BBCCG commissions treatment or surgery for varicose veins on a restrictive basis. Funding for treatment or surgery will only be made available for Grade III and above Varicose Veins. Grade III: Varicose veins with complications, including bleeding, recurrent phlebitis or eczema.

 Patients who have had bleeding associated with varicose veins should be referred urgently.  Patients with recurrent thrombophlebitis and persistent varicose veins may be referred, especially if phlebitis has affected veins above the knee.

299  Patients with eczema near the ankle or associated with varicose veins below the knee should be referred for specialist advice.

Interventional treatment should be in line with NICE guidance which identifies endothermal ablation as the first line intervention where suitable. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances.

In drafting this policy it was noted that NICE CG 168 recommends that all symptomatic varicose veins should be referred for investigation and, where appropriate, treatment. Current resources cannot meet the demand that this would generate either in commissioning costs or in the capacity to undertake Doppler examinations etc.

This policy is intended as a holding position until resources are available and the required pathway and contracting changes have been made to enable full adoption of NICE CG 168. http://www.nice.org.uk/guidance/CG168/chapter/introduction

300 ID Task Name Duration Start Finish % Complete

1 Fit for the Future Consultation 149 daysTue 07/06/16 Fri 30/12/16 95% 2 Pre Consultation Planning 25 days Tue 07/06/16 Mon 11/07/16 100% 3 Meeting to discuss comms strategy for FFTF inc. SRP and IC 1 day Tue 07/06/16 Tue 07/06/16 100% Beds 4 Organise meeting to discuss timescales for consultation 1 day Tue 07/06/16 Tue 07/06/16 100% 5 Meet to agree timescales and key dates/ stakeholders for 1 day Wed 08/06/16 Wed 08/06/16 100% consultation and engagement 6 Develop template to be populated with procedures for 1 day Wed 08/06/16 Wed 08/06/16 100% consultation 7 Draft FFTF template finalised (wrap around) (less inserts on 1 day Fri 10/06/16 Fri 10/06/16 100% SRP) 8 Populate templates with information for each procedure 3 days Thu 09/06/16 Mon 13/06/16 100%

9 Complete EQIAs with sign off from Quality 4 days Thu 09/06/16 Tue 14/06/16 100%

10 Send propsal re intermediate care review to NELFT & SEPT 6 days Fri 10/06/16 Fri 17/06/16 100% for comment 11 Send populated SRP & Intermediate Care Review templates 1 day Tue 14/06/16 Tue 14/06/16 100% to Romina for review and fro draft discussion document 12 Practice manager meeting 1 dayWed 15/06/16 Wed 15/06/16 100% 13 Meet with Basildon Health Partnership 1 dayWed 15/06/16 Wed 15/06/16 100% 14 Identify stakeholders for each area for consultation 1 day Thu 16/06/16 Thu 16/06/16 100% 15 Share timescale with Thurrock CCG for comment and for 1 day Thu 16/06/16 Thu 16/06/16 100% them to add their timescales 16 Take draft (pre engagement) consultation doc to Board 1 day Thu 23/06/16 Thu 23/06/16 100% development for discussion 17 Stakeholder engagement plan developed 1 day Fri 24/06/16 Fri 24/06/16 100% 18 Pre-engagement 11 daysMon 27/06/16 Mon 11/07/16 100% 19 Letter written on behalf of John L to MPs 3 days Wed 22/06/16 Fri 24/06/16 100% 20 MP & Healthwatch Letters to be distrubuted 2 daysMon 27/06/16 Tue 28/06/16 100% 21 Distrubution list to be shared with Exec for final additions 1 dayMon 27/06/16 Mon 27/06/16 100% 22 BBCCG Website updated to include proposal 1 day Mon 27/06/16 Mon 27/06/16 100% 23 Press releases to be drafted and confirmed with John/ Arv5 daysTue 28/06/16 Mon 04/07/16 100% 24 Posters to be drafted 5 daysTue 28/06/16 Mon 04/07/16 100% 25 Engagement presentation pack to be drafted 7 daysTue 28/06/16 Wed 06/07/16 100% 26 Q&A document to be drafted 7 daysTue 28/06/16 Wed 06/07/16 100% 27 All meetings and public events finalised and log 8 days Tue Thu 07/07/16 100% sent to Execs, Clinicians and Officers 28/06/16 28 Response form to be drafted and sent to Rob/ 4 days Tue Fri 01/07/16 100% Kathy for upload on Survey Monkey 28/06/16 29 Finalise by all stakeholder distrubution 1 day Fri 01/07/16 Fri 01/07/16 100% 30 Meet with local providers (WG/ KW NELFT&SEPT), (KWr 1 day Wed 06/07/16 Wed 06/07/16 100% BTUH) 31 PCRG workshop 1 dayWed 06/07/16 Wed 06/07/16 100% 32 Feeback from PCRG workshop fed back to comms 1 day Thu 07/07/16 Thu 07/07/16 100% 33 All pre-engagment comments collated and final 1 day Thu Thu 07/07/16 100% document ready 07/07/16 34 Upload historic FFTF documentation and paragraph 1 dayThu 07/07/16 Thu 07/07/16 100% 35 Updated final documents (inc any pre-engagement 1 day Fri 08/07/16 Fri 08/07/16 100% comments) presented to Board Session 36 Pre consultation press release 1 day Fri 08/07/16 Fri 08/07/16 100% 37 Documents to print 1 day? Mon 11/07/16 Mon 11/07/16 100% 38 Public Consultation 46 daysMon 11/07/16 Mon 12/09/16 100% 39 Consultation Begins 0 daysMon 11/07/16 Mon 11/07/16 100% 40 Send propsal to interest groups & stakeholders 1 day Mon 11/07/16 Mon 11/07/16 100% 41 Arrange meetings with John Leslie and MPs 1 day Fri 15/07/16 Fri 15/07/16 100% 42 Locality, Practice Manager Meetings & TTL 40 daysWed 13/07/16 Tue 06/09/16 100% 43 Arterial 1 day Wed 13/07/16 Wed 13/07/16 100% 44 Brentwood 1 day Wed 20/07/16 Wed 20/07/16 100% 45 SEMC 1 day Wed 27/07/16 Wed 27/07/16 100% 46 Partnership & Bic 1 day Wed 03/08/16 Wed 03/08/16 100% 47 GP Time to Learn 1 dayTue 06/09/16 Tue 06/09/16 100% 48 Public Engagement Events 39 daysTue 19/07/16 Sat 10/09/16 100% 49 Public engagement event Pitsea 1 dayTue 19/07/16 Tue 19/07/16 100% 50 Public enegagement event Basildon 1 dayWed 27/07/16 Wed 27/07/16 100% 51 Public engagement event Brentwood 1 dayThu 28/07/16 Thu 28/07/16 100% 52 Public engagement event Wickford 1 day Fri 12/08/16 Fri 12/08/16 100% 53 Second public engagement event Brentwood 1 dayWed 17/08/16 Wed 17/08/16 100% 54 Public engagement second event Wickford 1 day Sat 20/08/16 Sat 20/08/16 100% 55 Public engagement event Billericay 1 day Fri 26/08/16 Fri 26/08/16 100% 56 Public engagement event Basildon- 'Love Your Borough' 1 day Sat 03/09/16 Sat 03/09/16 100% 57 Second public engagement event Billericay 1 dayMon 05/09/16 Mon 05/09/16 100% 58 Public engagement event Brentwood- pop up stand 1 day Sat 10/09/16 Sat 10/09/16 100% 59 Diabetes UK event Brentwood 1 day Sat 10/09/16 Sat 10/09/16 100% 60 CCG AGM Basildon 1 dayThu 08/09/16 Thu 08/09/16 100% 61 Patient baking gluten free test 1 dayWed 17/08/16 Wed 17/08/16 100% 62 Communications 48 daysMon 11/07/16 Wed 14/09/16 100%

Page301 1 ID Task Name Duration Start Finish % Complete

63 Press releases 24 daysMon 25/07/16 Thu 25/08/16 100% 64 'Fit for the Future in a nutshell' 1 dayMon 25/07/16 Mon 25/07/16 100% 65 'Fit for the Future- extra meetings on proposed 1 day Thu Thu 04/08/16 100% changes' 04/08/16 66 'Fit for the Future- commuters views sought' 1 dayWed 10/08/16 Wed 10/08/16 100% 67 'Fit for the Future- have your say reminder' 1 dayThu 25/08/16 Thu 25/08/16 100% 68 Staff Comms 46 daysMon 11/07/16 Mon 12/09/16 100% 69 Staff bulletin 46 daysMon 11/07/16 Mon 12/09/16 100% 70 GP bulletin 46 daysMon 11/07/16 Mon 12/09/16 100% 71 Staff Away Day 1 dayThu 21/07/16 Thu 21/07/16 100% 72 Media Broadcasts and articles 44 daysMon 11/07/16 Thu 08/09/16 100% 73 BBC News online-IVF article 1 dayMon 11/07/16 Mon 11/07/16 100% 74 BBC Look East Broadcase 1 dayTue 12/07/16 Tue 12/07/16 100% 75 BBC Essex news and phone in 1 dayTue 12/07/16 Tue 12/07/16 100% 76 BBC Five Live- IVF Proposal 1 dayTue 12/07/16 Tue 12/07/16 100% 77 Basildon Echo- IVF article 1 dayTue 12/07/16 Tue 12/07/16 100% 78 Essex Live- IVF article (with CCG response) 1 dayWed 13/07/16 Wed 13/07/16 100% 79 Basildon Echo-Intermediate bed review article 1 dayWed 13/07/16 Wed 13/07/16 100% 80 Basildon Recorder- IVF article 1 dayThu 14/07/16 Thu 14/07/16 100% 81 The Enquirer- CCG changes article 1 dayThu 14/07/16 Thu 14/07/16 100% 82 Bio News- IVF article 1 dayMon 18/07/16 Mon 18/07/16 100% 83 Phoenix FM boardcast 1 day Sat 23/07/16 Sat 23/07/16 100% 84 Brentwood CVS Newsletter- update on consultation 1 dayThu 28/07/16 Thu 28/07/16 100% 85 Essex Enquirer- Gluten free article 1 dayThu 28/07/16 Thu 28/07/16 100% 86 The Times- Cataract article 1 dayMon 08/08/16 Mon 08/08/16 100% 87 Brentwood Weekly News- article 1 dayTue 30/08/16 Tue 30/08/16 100% 88 Yellow Advertiser- Eric Pickles article 1 dayThu 08/09/16 Thu 08/09/16 100% 89 Advertising Campaigns 37 daysThu 21/07/16 Sun 11/09/16 100% 90 Brentwood Gazette, Billiercay Gazette 31 daysWed 27/07/16 Wed 07/09/16 100% 91 Ad 1 dayWed 27/07/16 Wed 27/07/16 100% 92 Ad 1 dayWed 03/08/16 Wed 03/08/16 100% 93 Ad 1 dayWed 17/08/16 Wed 17/08/16 100% 94 Ad 1 dayWed 31/08/16 Wed 31/08/16 100% 95 Ad 1 dayWed 07/09/16 Wed 07/09/16 100% 96 Essex Enquirer 31 daysThu 21/07/16 Thu 01/09/16 100% 97 Ad 1 dayThu 21/07/16 Thu 21/07/16 100% 98 Ad 1 dayThu 04/08/16 Thu 04/08/16 100% 99 Ad 1 dayThu 18/08/16 Thu 18/08/16 100% 100 Ad 1 dayThu 01/09/16 Thu 01/09/16 100% 101 Basildon Echo 31 days Fri 22/07/16 Fri 02/09/16 100% 102 Ad 1 day Fri 22/07/16 Fri 22/07/16 100% 103 Ad 1 day Fri 05/08/16 Fri 05/08/16 100% 104 Ad 1 day Fri 19/08/16 Fri 19/08/16 100% 105 Ad 1 day Fri 02/09/16 Fri 02/09/16 100% 106 Phoenix radio advert 19 daysWed 17/08/16 Sun 11/09/16 100% 107 Ad 19 daysWed 17/08/16 Sun 11/09/16 100% 108 Social Media 45 daysTue 12/07/16 Mon 12/09/16 100% 109 BBCCG Twitter 45 daysTue 12/07/16 Mon 12/09/16 100% 110 Facebook ad- Local World (Gazette online) 7 days Sat 23/07/16 Sat 30/07/16 100% 111 Leaflet and Poster Distribution 16 daysWed 10/08/16 Wed 31/08/16 100% 112 Leaflet distribution Wickford train station 1 dayThu 11/08/16 Thu 11/08/16 100% 113 Leaflet distribution Shenfield train station 1 dayMon 15/08/16 Mon 15/08/16 100% 114 Leaflet distribution Brentwood train station 1 dayMon 15/08/16 Mon 15/08/16 100% 115 Leaflet distribution Pitsea train station 1 dayTue 23/08/16 Tue 23/08/16 100% 116 Leaflet distribution Basildon train station 1 dayWed 31/08/16 Wed 31/08/16 100% 117 Leaflet distribution Laindon train station 1 dayThu 25/08/16 Thu 25/08/16 100% 118 Leaflet distribution Ingastone train station 1 dayWed 10/08/16 Wed 10/08/16 100% 119 Leaflet and survey promotion at BTUH Phlebotomy 1 dayWed 31/08/16 Wed 31/08/16 100% 120 External Stakeholder Meetings 47 daysTue 12/07/16 Wed 14/09/16 100% 121 Brentwood Health and Wellbeing Board 1 dayTue 12/07/16 Tue 12/07/16 100% 122 John L telecon with John Baron MP 1 dayThu 14/07/16 Thu 14/07/16 100% 123 Meet with ECC 1 dayTue 19/07/16 Tue 19/07/16 100% 124 John to meet with MP Eric Pickles rep 1 day Fri 22/07/16 Fri 22/07/16 100% 125 Meet with HOSC 1 dayWed 27/07/16 Wed 27/07/16 100% 126 Meet with Brentwood Council 1 dayMon 05/09/16 Mon 05/09/16 100% 127 Meet with Basildon Council (Basildon 1 day Wed Wed 07/09/16 100% Infrastructure and Community Scrutiny 07/09/16 128 JohnCommittee) to meet with MP Mark Francois 1 day Fri 09/09/16 Fri 09/09/16 100% 129 Meet with Basildon Health Partnership 1 dayWed 14/09/16 Wed 14/09/16 100% 130 Meet with BTUH pain and respiratory consultants 1 dayThu 08/09/16 Thu 08/09/16 100% 131 PEGs 20 daysWed 20/07/16 Tue 16/08/16 100% 132 PCRG meeting 1 dayWed 20/07/16 Wed 20/07/16 100% 133 Arterial 1 dayTue 16/08/16 Tue 16/08/16 100%

Page302 2 ID Task Name Duration Start Finish % Complete

134 Brentwood 1 dayMon 01/08/16 Mon 01/08/16 100% 135 Voluntary sector led partnership meetings: 27 daysTue 12/07/16 Wed 17/08/16 100% 136 Safer Brentwood 1 day Fri 29/07/16 Fri 29/07/16 100% 137 Heart of Pitsea 1 dayWed 17/08/16 Wed 17/08/16 100% 138 CVS Brentwood Meeting 0 daysTue 12/07/16 Tue 12/07/16 100% 139 Mid point report 1 dayThu 11/08/16 Thu 11/08/16 100% 140 Report presented at Senate 1 dayThu 11/08/16 Thu 11/08/16 100% 141 Consultation Closes 1 dayMon 12/09/16 Mon 12/09/16 100% 142 Post Consultation 58 daysTue 13/09/16 Thu 01/12/16 23%

Page303 3 304 Glossary: Acne is a common skin condition that affects most people at some point. It causes spots, oily skin and sometimes skin that's hot or painful Acne to touch.

Alopecia Alopecia is the general medical term for hair loss. There are many types of hair loss with different symptoms and causes.

Analgesics Pain killers

Astigmatism Astigmatism is a common and usually minor eye condition that causes blurred or distorted vision.

Bariatric surgery Weight loss surgery, also called bariatric surgery, is used to treat people who are dangerously obese.

Belt lipectomy see liposuction

Most skin lesions are benign; however, some concern has caused the patient to make an inquiry, and a correct diagnosis is important. The plethora of dermatologic conditions makes a correct diagnosis challenging. To combat this, the clinician must approach the evaluation of the lesion in a systematic Benign skin lesions way. In addition to the physical characteristics of the lesion, the patient’s demographics, presence of associated symptoms, related systemic disorders, and location and growth patterns of the lesion all give clues to adequately diagnose and treat.

Blephoraplasty Eyelid surgery (blepharoplasty) is cosmetic surgery to remove excess skin or fat from the eyelids

Body contouring see liposuction

Breast augmentation / Having a breast enlargement is a major decision. It can be expensive, the results aren't guaranteed, and there are risks to weigh up. breast reconstruction It involves inserting breast implants to increase the size of the breasts, change their shape, or make them more even.

Breast lift / mastoplexy Mastopexy (up-lifting of droopy breasts)

Breast reduction surgery can help women who are unhappy with the shape, weight or droop of their breasts by making them smaller and Breast reduction more lifted

305 Glossary:

Cutis Laxa Cutis laxa is a disorder of the connective tissue, causing normally tight elastic tissue to be loose.

Discogenic and Radicular Discogenic- is pain originating from a damaged vertebral disc, particularly due to degenerative disc disease. back pain Radicular- is a type of pain that radiates into the lower extremity directly along the course of a spinal nerve root.

Gynaecomastia (sometimes referred to as "man boobs") is a common condition that causes boys’ and men’s breasts to swell and become Gynaecomastia larger than normal. It is most common in teenage boys and older men

Hair depilation Hair removal

Intermediate care describes short term NHS and/or social care support that aims to help you return to live as independently as possible Intermediate Care following a period of ill health, for example following a fall or a period of severe respiratory problems. It is typically in place for a period of three to eight weeks In vitro fertilisation (IVF) is one of several techniques available to help people with fertility problems have a baby. During IVF, an egg is removed from the woman's ovaries and fertilised with sperm in a laboratory. The fertilised egg, called an embryo, is IVF then returned to the woman's womb to grow and develop. It can be carried out using your eggs and your partner's sperm, or eggs and/or sperm from donors.

Artificial insemination is a treatment that can help some couples have a baby. It involves directly inserting sperm into a woman’s womb. IUI It's also known as intrauterine insemination (IUI).

Hymenorrhaphy Hymenorrhaphy or hymenoplasty has emerged as a procedure which attempts to restore the ability of the hymen to bleed at intercourse.

Laser treatment for tattoo Unwanted tattoos can be removed gradually over a series of sessions using a laser. removal

Liposuction / liposculpture / body Liposuction is a cosmetic procedure used to remove unwanted body fat. contouring

Neurofibromatosis This is the general name for a number of genetic conditions that cause tumours to grow along your nerves.

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Pinnaplasty / otoplasty Surgery and cartilage moulding techniques for the treatment of prominent ears

Pseudoxanthoma This is a progressive disorder that is characterized by the accumulation of deposits of calcium and other minerals (mineralization) in elastic elasticum fibers

Radiofrequency This is a procedure to help treat back or neck pain that comes from your facet joints. denervation

Rhinophyma is a swelling of the nose. If the condition progresses, the nose becomes redder, swollen at the end and gains a bumpy surface which changes its shape. This swelling is because there is formation of scar-like tissue and the sebaceous glands (which produce oil on the Rhinophyma skin) get bigger. Much more rarely, swellings can arise on other parts of their face such as the ears and chin.

Keloid scars – these are caused by an excess of scar tissue produced at the site of the wound, where the scar grows beyond the Scar revision – keloid

boundaries of the original wound, even after it has healed.

Septoplasty The septum is a thin piece of cartilage and bone inside the nose between the left and right sides. It is about 7cm long in adults. In some septorhinoplasty people this septum is bent into one or both sides of the nose which can lead to blockage. This is the surgery to repair or correct the defect.

Soft, thin wires with electrical leads on their tips are placed through a needle in the back near to the spinal column. The leads are placed Spinal Cord Stimulation through a needle inserted in the back. A small incision is then made and a tiny, programmable generator is placed in the upper buttock or abdomen (under the skin) which emits electrical currents to the spinal column. 307 Glossary:

Intraocular lenses (IOLs) are medical devices that are implanted inside the eye to replace the eye's natural lens when it is removed during Toric Intraocular Lens cataract surgery. A Toric lens is a particular type of lens that corrects astigmatism (see astigmatism above).

Vaginal labia refashioning A labiaplasty is surgery to reduce the size of the labia minora – the flaps of skin either side of the vaginal opening.

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