Agenda Item 8.0A

Agenda Item 8.0a

PART I MEETING OF THE CASTLE POINT & ROCHFORD CLINICAL COMMISSIONING GROUP GOVERNING BODY ON 29th MAY 2014

SPECIALIST FERTILITY SERVICES

Submitted by: Kevin McKenny, Chief Operating Officer Prepared by: Emily Hughes, Head of Commissioning Status: For Approval

EXECUTIVE SUMMARY i. Recommendations

Members of the Governing Body are invited to approve the changes to the Specialist Fertility Services policy for south Essex. ii. Overview

Until March 2013 specialist fertility services, including In-vitro fertilisation (IVF), Intra- cytoplasmic sperm injection (ICSI), and Donor Insemination (DI) were commissioned by the East of England Specialised Commissioning Group (EoE SCG).

In April 2013, commissioning responsibility for specialist fertility services transferred to CCGs. East and North Hertfordshire CCG (ENCCG) are the lead CCG for contracting and commissioning specialist fertility services on behalf of all the CCGs in the East of England region (EoE). The EoE policies were adopted by the CCG and have remained in place across Essex until now, pending review.

NICE (National Institute for Health and Care Excellence) clinical guidance on Fertility was recently updated in February 2013, Fertility CG156 updates and replaces NICE clinical guideline 11 published in 2004. The publication of the NICE update, which differs from the currently used EoE fertility guidelines, has given rise to variation in interpretation and commissioning of the service.

The intention of this paper is to outline the key differences between the current EoE policy and the NICE update and to ask for approval to accept the updated policy across south Essex. This is particularly significant at this time as the region is about to begin a procurement exercise for the provision of specialist fertility services.

This proposal has been reviewed and supported by both the Castle Point and Rayleigh & Rochford Locality Commissioning Groups. iii. Key Issues

The significant changes that are proposed with regards to the EoE policy are as follows:

 Adopt the NICE approach of recommending fertility treatment for couples unable to achieve full sexual intercourse  Offer one cycle of IVF to women aged 40-42 years  Offer two full cycles of IVF for women aged 23-39 years

Bringing the CCG policy for specialist IVF services in line with the rest of Essex, and much of the region, will have minimal financial implication for the CCG.

It is important to note that the new policy will begin with the award of the new contract. The current eligibility criteria will apply to those who have been referred under it, and will continue to apply until they have used all the cycles they are entitled to or need. Patients referred after the new contract start date, will be subject to the new policy. iv. Risks

Continuing with the current provision and not extending the eligibility criteria will not comply with current Equality and Diversity requirements which are enshrined in law.

If the proposed amendments to the policy are not approved by all the south Essex CCGs there will be inconsistent provision in services leading to poor patient perception of ‘postcode lottery’, particularly as the changes have been approved across the other Essex CCGs.

Without a shared policy across south Essex, the planned procurement and commissioning of services will be much more complex and it will be difficult to ensure compliance by Providers and facilitate the Individual Funding Request process. v. Associated Papers

Appendix 1 – Proposed Specialist Fertility Services.

BOARD MONITORING INFORMATION Internal governance The Castle Point and Rayleigh & Rochford Locality Commissioning Groups support the proposed policy changes. Stakeholder and Community Engagement Stakeholder and Community Engagement will be undertaken as appropriate. Resource Implications Resource implications are outlined within the paper. Legal Implications Legal implications are outlined within the paper. NHS Constitution This report supports the following NHS Constitution principles: Principle 2: Access to NHS services is based on clinical need, not an individual’s ability to pay Principle 4: NHS Services must reflect the needs and preferences of patients, their families and their carers Principle 6: The NHS is committed to providing best value for taxpayers’ money and the most effective, fair and sustainable use of finite resources Equality and Diversity Implications An initial equality impact assessment has been completed by ENCCG. Further Information For further information about this report, contact Emily Hughes on 01268 594548.

Agenda Item 8.0a

PART I MEETING OF THE CASTLE POINT & ROCHFORD CLINICAL COMMISSIONING GROUP GOVERNING BODY ON 29th MAY 2014

SPECIALIST FERTILITY SERVICES

Submitted by: Kevin McKenny, Chief Operating Officer Prepared by: Emily Hughes, Head of Commissioning Status: For Approval

1.0 Background

It is estimated that infertility affects 1 in 7 heterosexual couples in the UK. Since the original NICE guideline on fertility published in 2004 there has been a small increase in the prevalence of fertility problems, and a greater proportion of people now seeking help for such problems.

The main causes of infertility in the UK are (percent figures indicate approximate prevalence):  unexplained infertility (no identified male or female cause) (25%)  ovulatory disorders (25%)  tubal damage (20%)  factors in the male causing infertility (30%)  uterine or peritoneal disorders (10%).

In April 2013, commissioning responsibility for specialist fertility services transferred to CCGs. East and North Hertfordshire CCG (ENCCG) are the lead CCG for contracting and commissioning specialist fertility services on behalf of all the CCGs in the East of England (EoE). The EoE policies were adopted by the CCG and have remained in place across Essex until now, pending review.

differs from the currently used EoE fertility guidelines, has given rise to variation in interpretation and commissioning of the service.

2.0 Provision of specialist fertility treatments in the East of England

The NICE guidance (2013) defines infertility as: “A woman of reproductive age who has not conceived after 1 year of unprotected vaginal sexual intercourse, in the absence of any known cause of infertility”.

The management of infertility falls into 3 main types:  Medical treatment to restore fertility (for example, the use of drugs for ovulation induction)  Surgical treatment to restore fertility (for example, laparoscopy for ablation of endometriosis)  Assisted reproduction techniques – any treatment that deals with means of conception other than vaginal coitus. It frequently involves the handling of gametes or embryos and mainly includes in vitro fertilisation (IVF), intra- cytoplasmic sperm injection (ICSI), and Donor Insemination (DI).

While the medical and surgical management is usually provided at a secondary care setting the assisted reproduction techniques, also called specialist fertility services, are provided only at selected centres across the country.

Specialist fertility services for the EoE population are currently provided by:  Barts and the London NHS Trust  Bourn Hall Clinic, Cambridge  Imperial College Healthcare NHS Trust  Oxford Fertility Unit  University Hospitals of Leicester NHS Trust

Historically, the majority of south Essex patients have accessed specialist fertility services at Bourn Hall clinic, Cambridge.

There is currently variation in the outcomes of the five providers and a procurement exercise is currently under way across all CCGs in the region to ensure high quality and efficient service provision.

3.0 Current activity and cost

The access criteria for fertility treatments are currently guided through the EoE fertility policy, adopted by the EoE CCGs in April 2013. Those patients who do not meet the access criteria can appeal to commissioning bodies for funding under Individual Funding Request schemes. These are mainly for intrauterine insemination, donor insemination, egg and sperm storage for patients undergoing cancer treatments, surgical sperm extraction, and pre-implantation genetic diagnosis (PGD).

It is estimated there are 1-2 individual funding requests for IVF per month for a population of about 500,000 of which 10-20% are approved for treatment. (Suffolk and Hertfordshire IFR team, 2013).

In the EoE approximately £11 million is spent annually on all specialist fertility related treatments, of this nearly £10 million is spent on IVF related procedures and treatments. (ENCCG 2013). The other £1 million is spent mainly on procedures not included within the EoE policy and funded predominantly through individual funding request or exceptional funding routes.

The average annual spend on all specialist fertility services across the EoE region is £192k per 100,000 population. Annually approximately 3000 IVF cycles are commissioned at a cost of £10 million (£170k per 100,000 population). The EoE average for number of IVF cycles is 52 per 100,000 and varies across the region. The spend and activity at a CCG level is shown in Table 1 below.

Table 1 presents costs and activities of all specialist and IVF treatments by CCGs estimated using PCT rates. This shows that the level of provision varies across the region, Luton CCG has highest spend per capita and Great Yarmouth and Waveney has the least spend, possibly due to demographic differences.

Table 1- Estimated activity and costs of fertility treatments by CCG

All Fertility IVF only treatment CCG Number Annual Annual spend of cycles spend £,000 per year £,000 NHS Cambridgeshire and 1,911 521 1,675 Peterborough NHS Great Yarmouth & Waveney 235 62 205 NHS Ipswich and East Suffolk 657 178 569 NHS North Norfolk 258 70 225 NHS Norwich 294 80 256 NHS South Norfolk 359 98 312 NHS West Norfolk 263 72 229 NHS West Suffolk 366 99 317 NHS Basildon and Brentwood 381 102 345 NHS Castle Point, Rayleigh and 257 67 232 Rochford NHS Mid Essex 699 189 638 NHS North East Essex 665 184 580 NHS Southend 262 68 236 NHS Thurrock 242 65 219 NHS West Essex 619 161 560 NHS Bedfordshire 886 244 799 NHS East and North Hertfordshire 1,158 311 1,021 NHS Herts Valleys 1,222 328 1,077 NHS Luton 595 155 541 East of England 11,328 3054 10,035

4.0 IVF Cycles

There is evidence to suggest that the chances of live birth decrease with increase in number of previous failed attempts of IVF. For the first cycle of IVF chances of live birth are one in four and decrease to one in five for two to four cycles of IVF.

In 2011, the All Party Parliamentary Group on Infertility produced a report into NHS IVF provision and found that the number of cycles of IVF provided by PCTs averaged at 1.8 nationally. They reported that 39% of PCTs only offered 1 cycle of treatment, 26% offered 2 and 27% offered 3 cycles. The remaining 8% of PCTs did not offer any cycle or status was unknown.

In summary, 73% of PCTs were offering less than the 3 cycles recommended by NICE guidelines Fertility: assessment and treatment for people with fertility problems’ (NICE CG11). PCTs in the EoE were one of the few PCTs in the country that offered 3 cycles.

5.0 Specialist Fertility Services for Same Sex and Disabled Couples

A new element of the updated NICE guidance is to recommend that fertility treatment be offered to patients who are unable to, or would find it very difficult to, have vaginal intercourse. For example recommendation 1.9.1.1 includes:  people who are unable to, or would find it very difficult to, have vaginal intercourse because of a clinically diagnosed physical disability or psychosexual problem who are using 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 [new in 2013].

Recommendation 1.9.1.2 states “For people in recommendation 1.9.1.1 who have not conceived after 6 cycles of donor or partner insemination, despite evidence of normal ovulation, tubal patency and semenalysis, offer a further 6 cycles of unstimulated intrauterine insemination before IVF is considered”

The intention of this proposal is to include this recommendation in the new policy.

6.0 Financial Implications of Implementing NICE Guidance

The updated NICE guideline recommends the provision of specialist fertility treatments to certain sections of the population for whom it was not previously available and reduces the suggested time for IVF treatment from 3 years to 2 years.

The three NICE criteria that are likely to have significant financial impact are:

1. Access to IVF after 2 years rather than 3, with earlier access for women aged 36 or over. The cost of implementing reduced time to access IVF is £201,000 per population of 100,000, spread over 3 years.

2. Inclusion of 40-42 year age group women for one cycle of IVF treatment. The additional cost of including 40-42 year age group women is expected be £26,000 per population of 100,000.

3. Use of single rather than double embryo transfers to reduce the multiple pregnancy rates and save costs. Use of single rather than 2 embryos is expected save £4000 per population of 100,000.

The additional cost of implementing the full NICE guidance in EoE is estimated at £4.5 million in year 1 (£76k per 100,000 population). There would be an additional £1 million in year 2 and £1.5 million in year 3 investments required for full implementation of NICE recommendations.

This paper proposes to include the age range extension (2) and use of single embryo transfer (3) but to not adopt guidance on reducing the suggested time for treatment from 3 years to 2 years (1).

Costs of Proposals

The cost of implementing the NICE guidance is shown below. The calculations have been completed used on the NICE costing tool and are based on annual spend averages across 2010-2013 PCT activity. Three primary options have been given as an illustration of the estimated costs:  Option A – No change to current specialist fertility services policy ie do not extend eligibility criteria, retain three cycles of IVF as standard, retain access to IVF at three years  Option B – Implement full NICE guidance including ie extend eligibility criteria, retain three cycles of IVF, reduce access to IVF to two years  Option C – Implement proposed changes ie extend eligibility criteria, reduce to two cycles of IVF, retain access to IVF at three years

Table 2 – Estimated Costs of Implementing the proposed changes

Population IVF Costs based Option A Option B Option C* numbers on current usage Basildon / Brentwood 248,812 £345,000 £381,000 £634,000 £371,000 CCG Castle Point & Rochford 171,297 £232,000 £257,000 £436,000 £254,000 CCG Southend CCG 174,274 £236,000 £262,000 £443,000 £259,000 Thurrock CCG 158,268 £219,000 £242,000 £403,000 £236,000 Total 752,651 £1,032,000 £1,142,000 £1,916,000 £1,120,000

*Note: The full year effect will not be realised until women currently in the system and receiving treatment under the old policy have completed their treatment.

7.0 Summary

There is a need to align the Specialist Fertility provision in south Essex with the other CCGs in the region to ensure equitable access and policy alignment to the most recent best evidence following the publication of updated NICE guidance in February 2013.

Those CCGs in the region that have already approved the policy changes will be implementing their new policy from June 2014 when the new specialist fertility service contracts will be awarded.

Below is a summary table to highlight the key differences between the current position, the NICE recommendations and the proposed recommendations:

Table 3 – Summary of policy changes

Option B – NICE Option A – recommendations Option C – Our Current position from Guidance proposed as per EoE policy CG156 (February recommendations (July 2011) 2013) Age at which IVF is available as Up to 39 years Up to 42 years Up to 42 years standard Access to IVF for unexplained fertility 3 years 2 years 3 years following investigation Cycles of IVF 3 cycles 3 cycles 2 cycles routinely offered Eligibility criteria Include couples Include couples who are unable or who are unable or No allowance for would find it difficult would find it difficult same sex couples to achieve full to achieve full vaginal intercourse vaginal intercourse

It is proposed that the south Essex CCGs adopt the position that has been agreed across the other Essex CCGs:  Allowing specialist fertility treatment for couples unable to achieve full sexual intercourse  Offer one cycle of IVF to women aged 40-42 years  Offer two full cycles of IVF for women aged 23-39 years in line with the majority of CCGs in England

 Retain access to IVF treatment after three years for unexplained infertility (this does not apply where there is a diagnosed cause of infertility)

Full policy details can be seen in the appended policy document (Appendix 1).

In summary, this proposal intends to extend access to IVF to women age 40-42 and those unable to achieve full vaginal sexual intercourse eg same sex and disabled couples; as a result more women will be eligible to receive and benefit from IVF services. Other existing eligibility criteria on BMI, smoking status and existing children will be retained.

The CCG must achieve the maximum benefit for the costs involved, whilst also ensuring that decisions are equitable and fair. There is evidence to suggest that the chances of live birth decrease with increase in number of previous failed attempts of IVF. For the first cycle of IVF chances of live birth are one in four and decrease to one in five for two to four cycles of IVF. Therefore this paper proposes to reduce the number of cycles of IVF provided from three to two cycles.

This proposal is not intending to implement the NICE recommendation to reduce the unexplained infertility waiting period from three to two years. However, where there is a diagnosed cause of infertility women will be still be eligible to access specialist fertility and IVF services immediately following secondary case assessment and investigation (after two years) rather than undergo additional waiting in line with the previous policy.

8.0 Recommendations

Members of the Governing Body are asked to approve the changes to the Specilaity Fertility Services policy, specifically noting the following:  Retain current eligibility criteria on BMI, smoking status and existing children  Extend access to IVF to women age 40-42  Reduce the number of cycles of IVF provided from three to two cycles in line with the majority of other CCGs nationally  Adopt the new NICE approach, which recommends access to specialist fertility services for same sex and disabled couples  Retain the access to IVF for unexplained infertility at three years. However, where there is a diagnosed cause of infertility women will be still be eligible to access specialist fertility and IVF services immediately following secondary care assessment and investigation (after two years) rather than undergo additional waiting  The new policy will begin with the award of the new contract. The current eligibility criteria will apply to those who have been referred under it, and

will continue to apply until they have used all the cycles they are entitled to or need. Patients referred after the new contract start date, will be subject to the revised specification and criteria

9.0 Appendices

Appendix 1 – Proposed Specialist Fertility Services.