GOVERNING BOARD. Assisted Conception (IVF): Review of access criteria. Date of Meeting 21 January 2015 Agenda Item No 13. Title

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1 GOVERNING BOARD Date of Meeting 21 January 2015 Agenda Item No 13 Title Assisted Conception (IVF): Review of access criteria Purpose of Paper The SHIP (Southampton, Hampshire, Isle of Wight and Portsmouth) Priorities Committee was tasked with reviewing the most recent evidence of clinical and cost effectiveness for IVF treatments, and the implications of the latest NICE guideline, and to make recommendations to the CCGs regarding access criteria. This paper summarises the review of the clinical evidence, the Priorities Committee recommendations, and the results of public engagement work which was taken to inform the decision-making process. Recommendations/ Actions requested Approve the recommendations of the SHIP8 Priorities Committee, in the light of the results of public engagement Author Nick Brooks, Senior Communications and Engagement Manager Sponsoring member Innes Richens, Chief Operating Officer Date of Paper January 2015

2 Assisted Conception (IVF): Review of access criteria 1. Introduction When people living in the Southampton, Hampshire, Isle of Wight or Portsmouth (SHIP) areas seek treatment for infertility, their local Clinical Commissioning Group is responsible for decisions about the funding of fertility services (such as In-Vitro Fertilisation, or IVF) to help women become pregnant. Fertility services charges are significant, with some procedures costing over 4,000, so CCGs across SHIP must seek to balance the funding for this treatment alongside the many other demands on NHS funding. A shared CCG (and formerly PCT) infertility policy has been in place for over five years, ensuring consistent access criteria across Hampshire and the Isle of Wight. In February 2013, the National Institute for Health and Care Excellence (NICE) updated their clinical guideline: Fertility: Assessment and treatment for people with fertility problems. This included guidelines for CCGs regarding access to IVF treatments. Such guidelines set out a recommended (but not prescribed) course for CCGs, as opposed to Technology Appraisal Guidance (TAGs) issued by NICE, which stipulate a course of action which must be followed. This is how current SHIP access criteria compare to the latest version of the NICE guideline: Table 1: SHIP access criteria compared to NICE guideline SHIP CCG policy NICE guidelines Age at time of treatment Referral before woman s 35 th Up to 42 years old birthday Number of cycles One fresh cycle Three full cycles up to the age of 40. One full cycle between ages Previous infertility treatment One fresh cycle can be provided if there have been up to two self-funded cycles All previous cycles (NHS- and self-funded) count towards the maximum of three Transfer of frozen embryos BMI (Body Mass Index) Smoking NHS funding only covers the transfer of fresh embryos Woman must have a BMI of for six months Only non-smoking couples (for at least six months) are eligible for NHS funding A full cycle includes ovarian stimulation and the transfer of any (fresh or frozen) resultant embryos Women with BMI of more than 30 are offered advice and guidance Couples are advised of the adverse impact of smoking and offered cessation support 1

3 2. Priorities Committee Earlier this year, the SHIP-wide Priorities Committee was tasked by the eight CCGs in SHIP to review of the most recent evidence of clinical and cost effectiveness for IVF and Intra- Cytoplasmic Sperm Injection (ICSI), and the implications of the latest NICE guideline. (For the purposes of this document, the term IVF shall be considered to apply to both treatments). In August 2014 the Committee members reviewed a series of questions, relating to the criteria which are currently used to determine whether people seeking fertility treatment are eligible for NHS funding. The SHIP Priorities Committee is comprised of senior clinical and non-clinical members, who meet regularly to consider the implications of appropriate NICE publications, to review clinical variation and make recommendations for management, and to develop thresholds for access. The Committee s Terms of Reference are available on the CCG website, within the section covering the public engagement for IVF treatments. Those criteria are concerned specifically with the age of the person receiving IVF, the availability of fresh or frozen embryos, the number of cycles of treatment available, the Body Mass Index (BMI) of a potential recipient of IVF, and whether or not the potential recipient, or partner, is a smoker. The Priorities Committee considered a paper outlining the review of the clinical evidence (Appendix 1), and then met in September 2014 to agree their recommendations (Appendix 2) based upon that review. Those recommendations are to be considered by all eight CCGs in the SHIP area when making decisions regarding the future commissioning of IVF treatments. Age Members of the committee found high quality evidence that increasing age was a key predictor in determining the likely success or otherwise of fertility treatment (see Table 2 below). Although there have been improvements in the rates of live births achieved as a result of IVF treatments over time, the overall success rate still remains low even for the youngest age group, the 18-34s, slightly more than two out of every three treatment cycles result in a live birth. This success rate declines still further, and significantly, after the age of 34. Table 2: The influence of increasing maternal age on the outcomes of IVF: Source: HFEA 2012 Report Woman s age Live birth rate per treatment cycle started using patient s fresh eggs in 2011 (%) All ages Additional cycles 2

4 The committee members also sought to examine the case for funding additional cycles of fertility treatment. However, the committee found that there had been no new evidence presented regarding this measure since the publication of the new NICE guidelines in 2013, and so did not make any new recommendations regarding the relative chances of success of a first, second or third cycle of treatment, and therefore whether NHS funding for subsequent cycles was appropriate. Fresh/frozen The committee did find that there was good evidence to support the use of frozen embryos in advance of commencing a new fresh cycle of IVF. Live birth rates as a result of the use of frozen embryos have improved over time (see Table 3 below), and the clinical members of the committee attached great significance to the fact that the transfer of frozen embryos avoids the need for the woman to undergo the additional, difficult treatments associated with another attempt to conduct another fresh embryo transfer. Table 3: Live birth rate per cycle started after frozen embryo transfer using patients eggs 2012 Age 2011 (frozen) 2012 (frozen) 2011 (fresh cycle) years 21.4% 22.1% 32.2% % 20.7% 27.4% % 18.2% 19.9% % 15.0% 13.4% Source: Fertility treatment in 2012: trends and figures. HFEA Cost As well as an assessment of the most recent clinical evidence, the committee also reviewed modelling of the costs associated with nine different scenarios in terms of access criteria. Data shows that the eight SHIP CCGs currently spend approximately 1.25m a year on IVF treatments. By comparison, full implementation of NICE guidelines would cost approximately 4.7m a year, representing a recurring incremental cost pressure for the CCGs of 3.45m. CCGs would also be responsible for significant additional maternity and neonatal costs in addition to the extra funding required for the infertility treatments. The cost modelling considered by the Priorities Committee suggests that the criteria relating to the availability of fresh and frozen cycles could be adjusted to increase the number of live births each year as a result of NHS-funded IVF treatments, with a corresponding improvement in the cost-effectiveness of the treatment, but without a significant increase in the overall level of spending. The modelling suggests that funding one fresh and one subsequent frozen treatment (or two frozen treatments from the initial course of ovarian stimulation and egg retrieval) would lead to 54 additional live births across the SHIP area per year. There would be an additional overall cost ( 326,171 according to the model) but with a corresponding reduction in the cost per birth down from 9,699 to 8,547. Conclusions As a result of their considerations of both the clinical evidence and cost modelling data, the Priorities Committee has recommended a change to the current SHIP access criteria. Currently, 3

5 the local NHS only funds one fresh embryo transfer, whereas the recommendation of the Priorities Committee is that this be amended to cover up to two embryo transfers. The proposed access criteria is: 1.1 One cycle of IVF treatment is defined as one cycle of ovarian stimulation, egg retrieval and fertilisation and up to 2 separate embryo transfers (fresh/frozen or frozen/frozen as clinically indicated). It includes appropriate diagnostic tests, scans and pharmacological therapy. It is anticipated that, rarely, patients who are not eligible for treatment because they do not fulfil these criteria may, by virtue of their personal circumstances, be considered an exceptional case for NHS funding. If this is thought to be applicable, the patients GP or Hospital Consultant may contact the relevant CCG IFR panel which is responsible for considering funding for individual cases. This recommendation has already been considered and supported by the CCG s Clinical Cabinet, and forwarded on to the Governing Body for a final decision. 3. Public engagement Alongside the work of the Priorities Committee, a SHIP-wide engagement exercise was also carried out, using a survey. The survey format involved offering the respondent a proscribed set of possible answers, and the opportunity of adding to this answer in free text sections. The survey could be completed online, or hard copies could be downloaded and posted back. The engagement period ran from 22 September, 2014 until 7 November, The survey asked an overarching question regarding whether or not IVF was a priority for the NHS, and then posed further questions relating to specific aspects both of the service provision, and the health/lifestyle of the potential recipients of fertility treatment. Respondents were also given the chance to add free text comments alongside their answers. These questions to the public were designed to relate directly to the questions being addressed by the members of the Priorities Committee. The survey was accessible via the CCG s website, via social media, and was promoted to local media as well. As well using these channels to make the survey available to a general audience, the CCG also contacted local stakeholders directly to invite them to participate. In addition, organisations which were considered to have a particular interest in the issue (such as support networks for people experiencing infertility, and transgender groups) were also invited to participate, and encouraged to disseminate the survey to their members and contacts. In total, 95 people from the Portsmouth CCG area responded to the survey, out of 1,133 people from all of the eight CCGs in the SHIP area. Engagement Summary Responding to the overarching question Do you think funding for IVF is a priority for the NHS? more Portsmouth respondents (46.81%) said no, compared to 41.49% who said yes. Despite the high number of respondents stating that IVF was not a priority for the NHS, for all three of the subsequent questions relating to service provision regarding maximum age, the availability of fresh or frozen treatments, and the number of cycles the sample demonstrated a clear preference for a change to existing arrangements, either by the full adoption of NICE guidelines, or the partial extension of the access criteria. 4

6 For issues regarding the Body Mass Index (BMI) of the potential recipient of treatment, and the smoking status of the couple, there were clear majorities in favour of retaining the existing SHIP access criteria. An engagement report has been produced, which examines in detail the responses of people living in Portsmouth (Appendix 3), and the full results are available as Appendix Equalities Impact Assessment An Equalities Impact Assessment has been conducted. The review of the policy has a high equality impact on the protected characteristics defined in the Equality Act 2010 of age, disability, gender, pregnancy and maternity, and sexual orientation. The full report can be found at Appendix 5. The eligibility criteria for access to NHS-funded IVF have a positive equality impact for women under the age of 35 years (including single women and women in same sex couples), as well as for men of any age, who have confirmed infertility problems. People with disabilities and health conditions that do or may impact on their fertility can also access NHS treatment under the policy. The policy also has a positive impact for partners and close relatives of people who are unable to conceive. For women over the age of 35 years NHS funded fertility treatment is not available locally, and this may have a negative equality impact on them and their partner, especially if they are unable to afford to pay for infertility treatment privately. This is mitigated to some extent by the fact that people who do not meet the criteria set out in the local policy, can in exceptional circumstances make an Individual Funding Request via their clinician, to have their case looked at again. The local policy is more restrictive than the guidelines published by the National Institute for Health and Care Excellence (although the CCGs are not legally obliged to implement NICE guidelines in full). Again this may have a negative equality impact for people who fall outside the local criteria. Whether any negative impacts are discriminatory against groups protected by the Equality Act 2010 depends on whether the policy can be reasonably justified on the basis of evidence. The review of evidence of clinical and cost effectiveness suggests: although female age is a key predictor of the likely success of IVF treatment, the success rate for women aged years is only around five percentage points less than for those aged under 34 (27.4% and 32.2% respectively). CCGs should consider increasing the current upper age limit to reduce inequity there is good clinical evidence to support use of frozen embryos (the Priorities Committee have proposed that one cycle now include up to two separate embryo transfers (fresh or frozen, or frozen/ frozen as clinically indicated) In terms of an Equalities Impact Assessment it is recommended that: the CCGs consider increasing the upper age limit to 37 years decision making processes are demonstrably fair and transparent to reduce risk of Judicial Review 5

7 to support demonstration of due regard to Equality Act 2010, that collection and analysis of equalities information about people who receive NHS funded infertility treatment, and those who apply for Individual Funding Review is commenced by providers and the CSU. As a minimum this should include age, gender, disability status, sexual orientation and post code. Where this data highlights differential access for equality groups this can be considered as part of future reviews of this policy in order to demonstrate fairness. 5. Recommendations The Priorities Committee noted the strong evidence that maternal age was a key predictor in determining the likely success or otherwise of fertility treatment, and set out how the likelihood of success reduces as age increases. The committee noted that even for the younger age group, of years of age, the overall chance of a live birth as a result of IVF was slightly less than one in three, and so did not recommend any change to the current SHIP policy relating to upper age limit at which IVF is publicly funded. With regard to the issue of funding subsequent full cycles of treatment (including ovarian stimulation and egg retrieval), the committee found no new evidence presented since the publication of the new NICE guidelines in 2013 relating to the relative chances of success of a first, second or third cycle of treatment. As a result, the committee members did not recommend any change to the existing SHIP access criteria in terms of funding additional full cycles of treatment. The Committee did find that there was good evidence to support the use of frozen embryos in advance of commencing a new fresh cycle of IVF. This conclusion was as a result of the improving success rates relating to the use of frozen embryos, the real benefit to a woman of being able to attempt another treatment without having to undergo the difficulties associated with the commencement of a fresh cycle, and the greater cost-effectiveness of the transfer of a frozen embryo. As a result of these considerations, the Committee recommended that there should be a change to the existing access criteria with regard to the use of frozen embryos. The recommendation, as set out in Section 2 of this report, was that NHS funding should be made available for up to two separate embryo transfers (either fresh/frozen, or frozen/frozen, as clinically indicated). In terms of the public engagement which was undertaken alongside the clinical review, the survey responses show that many Portsmouth respondents (46.81%) consider that funding for IVF should not be a priority for the NHS. However, although the overall view of the sample did not support the idea that funding IVF is a priority for the NHS, the subsequent responses suggest that the views of the sample were not straightforward. Indeed, in terms of the upper age limit, the number of cycles available, and the availability of both fresh and frozen treatments, the sample exhibits a preference for NICE guidelines rather than the existing local policy. On the issue of the availability of fresh and frozen cycles of treatment the area where the work of the Priorities Committee suggests an extension of SHIP access criteria could be appropriate there is a very large absolute majority (80.85%) of Portsmouth residents who would support a move away from the existing criteria being employed across the SHIP area. 6

8 That figure consists of 57.45% of the sample who favoured the adoption of NICE guidelines, and a further 23.40% of respondents who supported the option of making a frozen cycle available in addition to a fresh cycle. Such strong support for the adoption of the full NICE guideline, however, needs to be viewed in the light of the very evident division of opinion regarding the overall issue of whether investing in assisted conception services at all should be a priority for the local NHS. Taken as a whole, the results of the public engagement do not present a consistent and compelling case for any particular course of action. However, the responses are broadly compatible with an amendment to the referral criteria, in line with that which has been proposed by the Priorities Committee. Governing Body Recommendation In the light of both the clinical review, and the results of the public engagement exercise, the Governing Body is asked to approve the following recommendations: That the recommendation of the SHIP Priorities Committee, that the current policy of funding one fresh embryo transfer be amended to fund up to two separate embryo transfers is adopted. This would require an anticipated additional recurrent annual investment of 36,000 for Portsmouth CCG which could be expected to result in between five or six additional live births for the local population. That the recommendations of the Equalities Impact Study are adopted and a report re-presented to the CCG in 12 months time. 7