NWL CSU IFR Team CLINICAL COMMISSIONING GROUP BRIEFING UPDATE OF THE PPwT POLICY ON IN-VITRO FERTILISATION (IVF) NWL CSU- PPwT Version 3 update- IVF Page 1 of 9
1. INTRODUCTION The NHS NWL policy on access to in-vitro fertilisation (IVF) has been in place since April 2011. National Institute for Health and Clinical Excellence (NICE) has issued an update of their 2004 guidelines on fertility (CG11). A number of the eligibility criteria were based on the recommendations in the 2004 guidelines. The updated guidelines CG158 were issued in February 2013. This paper highlights the recommendations in CG158 that have an impact on the NHS NWL policy. It sets out the evidence base and other considerations for policy changes. It also projects the financial impact of any changes to policy. 2. STATUS OF NICE GUIDELINES NICE clinical guidelines are recommendations made by NICE to the NHS. They are guidance only and are not subject to a mandatory requirement regarding funding. CCGs should take account of the guidelines in making commissioning decisions and, if departing from the guidelines, should provide good reasons for doing so. The health departments in England and Wales can issue advice to the NHS on funding for the guidelines at the same time as the guideline itself is published.as at June 2013, NHS England (now responsible for NHS policy) had not issued any guidance for the NHS on the implementation of the update to NICE guidelines. 3. AREAS OF IVF GUIDANCE FOR CCGS TO CONSIDER 3.1 Increasing upper age limit to 42 3.1.1 Updated NICE Guideline The updated NICE guidance recommends offering one cycle of IVF to women aged 40-42 who have not had any IVF treatment. The table below describes the current NWL policy (also attached as Appendix 1) with regards to age of the female comparing it to the updated 2013 NICE Fertility guidance. Current NHS NWL Policy New NICE Fertility Guidance 2013 IVF treatment will be funded for couples where the female partner at least 23 years and not yet reached their 40th birthday by the time the treatment commences (defined as the start of the stimulating phase of the IVF cycle). It is the responsibility of service providers to ensure that eligible couples have commenced the woman s frozen In women aged 40 42 years who have not conceived after 2 years of regular unprotected intercourse or 12 cycles of artificial insemination (where 6 or more are by intrauterine insemination), offer 1 full cycle of IVF, with or without ICSI, provided the following 3 criteria are fulfilled: they have never previously had IVF treatment NWL CSU- PPwT Version 3 update- IVF Page 2 of 9
treatment before her 40th birthday. there is no evidence of low ovarian reserve (see recommendation 1.3.3.2) there has been a discussion of the additional implications of IVF and pregnancy at this age. [new 2013] 3.1.2 Basis for NICE recommendation In their document published in February 2013, NICE cite 2 pieces of evidence supporting the change of age criteria of the female partner. The first is a perspective article published by the New England Journal of Medicine in 2004 by Heffner which recognisesthat women in the USA are now generally healthier, and are physically able to carry a foetus later in life.however they comment that they are still at increased risk of miscarriage and congenital defects. Secondly, reference is made to the IVF success rate data published by the Human Fertility and Embryo Association in 2011 which is summarised below 1. Mean and Average age of women treated with IVF is increasing. The mean and median age of IVF treatment in 2011 was 35* 2. Live birth rates graph is shown below (reproduced from Fertility treatment in 2011 Trends and figures 2011) and shows thesuccess rate for IVF at all ages. 3.1.3 Cost effectiveness of IVF NWL CSU- PPwT Version 3 update- IVF Page 3 of 9
NICE also reviewed the evidence health economics of funding IVF and modelled the cost-effectiveness of increasing the age limit to 42 (page 257). It was not possible to break the age-ranges down any further NICE concluded that - Treatment with up to 3 cycles is cost-effective for women under 39 years. - IVF is cost effective for certain women aged 40-42. - IVF was not cost-effective for women aged 43 years or older. Given the uncertainties around some of the model inputs (e.g. utility of live birth, chances of spontaneous birth) the Guideline Development Group (GDG) used the evidence on cost-effectiveness to inform their discussions rather than directly leading to recommendations. The GDG also noted that consideration for funding for IVF may include objectives other than maximisation of Quality Adjusted life Years (QALYs). The recommendation to extend access to women aged 40-42 years was based on IVF being cost-effective for certain groups in this age group (those with no chance of spontaneous birth). 3.1.4 Requests for IVF funding received by IFR team 583 IVF requests were agreed via PPwT. There have been 60 individual funding request (IFR) applications for IVF between April 2011 and April 2013. IFR applications are necessary where patients do not meet the current NHS NWL IVF Policy. 46 cases were declined at panel or bounced back at IFR triage where no clinical exceptionality was demonstrated in the application. 10 cases were agreed at panel 2 were withdrawn or discharged Pie chart showing NWL IFR IVF Panel decisions between 2011 and 2013 Cases declined or rejected at IFR triage Case agreed Discharged or withdrawn NWL CSU- PPwT Version 3 update- IVF Page 4 of 9
Pie chart illustrating reason for NWL IFR IVF Cases being rejected or declined in 2011-2013 Age >40 Second cycle requested, first cycle miscarriage Second cycle requested, first cycle failure Previous children Miscellaneous The most common reason for cases being rejected was patient age, followed by requests for a second cycle of IVF where the first cycle had failed with no exceptional reasons being demonstrated in the application. 3.1.5 Projected financial impact of adopting NICE recommendation on increasing age limit It is difficult to predict the demand for IVF in the 40-42 age group and the NICE guidelines have not attempted to do so. We have attempted to project demand in the 40-42 age group based on existing demand in the 38-39 age group (table below) CCG Females 38-39 (taken from Exe Number of agreed IVF requests in patients in 38-39 age group (12/13 PPwT Demand in 38-39 age group (per 100,000 women) data) Brent Teaching PCT 5,094 19 372.99 Ealing PCT 6,3999 18 281.29 Hammersmith and Fulham PCT 3,578 9 251.54 Harrow PCT 3,368 9 267.22 Hillingdon PCT 4,1544 2 48.15 Hounslow PCT 4,446 14 314.89 Kensington and Chelsea PCT 3,4222 15 438.34 Westminster PCT 3,9599 22 555.70 TOTAL 34,420 108 313.77 Females 40-42 Expected demand for 40-42 age range if similar demand as for 35-39 age group 4,902 18 5,892 17 3,331 8 3,258 9 3,980 2 4,213 13 3,068 13 3,502 19 32,146 101 NWL CSU- PPwT Version 3 update- IVF Page 5 of 9
If demand were the same as for the 38-39 age group, an estimated 101 patients per annum would be expected to request IVF. This represents a17% increase in total PPwT IVF activity. There is no evidence that demand would be the same and our experience from IFR suggests that demand would be lower as there have been relatively few IFRs for first cycle IVF for patients over 40 (17 in the past two years, none of which were funded). However, it is recognised that the IFR process can be a significant barrier to requesting treatment. We have attempted to verify this using national data on IVF. The 2011 HFEA report notes that 14% of all IVF activity is in the 40-42 age group. Comparing the national demand to local demand, an estimated 100 additional cycles of IVF could be requested. However, national activity does not just include first cycle and will include second, third etc cycles. The HFEA has not made the data available by cycle. Therefore, the true demand will be less than 100 but it is not possible to say how much in the absence of the required granularity. Costs of projected demand The costs forafull cycle (which includes one fresh cycles, cryopreservation of supplementary embryos and one frozen cycle) is, on average, 4,000 (including ICSI). NICE has recommended one full cycle for this age group. Some patients will have a full cycle whereas as some will have a fresh cycle only (approx. 3000).We have included the costs for the full cycle for all patients in table below in order to present the worst case scenario. CCG Expected demand for 40-42 age range if similar demand as for 35-39 age group Estimated cost for a full cycle Brent Teaching PCT 18 72,000.00 Ealing PCT 17 68,000.00 Hammersmith and Fulham PCT 8 32,000.00 Harrow PCT 9 36,000.00 Hillingdon PCT 2 8,000.00 Hounslow PCT 13 52,000.00 Kensington and Chelsea PCT 13 52,000.00 Westminster PCT 19 76,000.00 TOTAL 101 404,000.00 NWL CSU- PPwT Version 3 update- IVF Page 6 of 9
Increasing the upper age limit to 42 will also increase demand for frozen embryo transfer. Currently, patients with frozen embryos from NHS funded fresh cycles will only be funded for embryo transfer up to their 40 th birthday. Increasing the upper age limit will allow patients to access the frozen embryo transfer until their 42 nd birthday. It is impossible to predict the demand for this with any accuracy.the cost for a frozen cycle (cryopreservation and transfer) is in the region of 1000. Assuming the worst case financial scenario, if 70% of the 38-39 age group has a failed IVF cycle (in line with national IVF success rates of 29% for this age group) but had viable embryos for a frozen cycle, an estimated 72 additional frozen cycles may take place, at a cost of 72,000 across NWL. Therefore, in all, the estimated increase in spend is likely to be 472,000. It should be noted that additional demand in the 40-42 age group is likely to be evident for the next two years during which patients who currently do not have access to NHS funded treatment may be expected to request access. Once this hump is over, demand will spread out across all age-groups. CCGs are asked to note that there are a number of limitations with the methodology used above to predict potential demand. We have tried to present the worst case scenarios and temper this with our experience. Making more accurate predictions would require detailed work and gathering of data that is not readily available. The projections given here are intended to be guidance only. 4. Removing the lower age limit The updated guidelines recommend that the lower age limit (that was proposed in the 2004 guidelines) is removed as there is no evidence for retaining a lower age limit. The rationale for including a lower age limit in the 2004 guidelines was a lack of robust data rather than evidence for ineffectiveness in the younger age group. This is no longer the case and data has become available to confirm eh association between age and likely success of IVF and NICE concludes that these data do not suggest a lower age limit for IVF. The cost-effectiveness modelling suggested that IVF is cost effective in women aged less than 23 years. There is also an equality argument for removing the lower age limit. The Equality Act 2010 includes provisions that ban age discrimination against adults (aged 18 or over) in the provision of services. The ban came into force on 1 October 2012 and it is now unlawful to discriminate on the basis of age unless: the practice is covered by an exception from the ban good reason can be shown for the differential treatment ( objective justification ) According to Government guidance The ban on age discrimination is designed to ensure that the new law prohibits only harmful treatment that results in genuinely unfair discrimination because of age. It does not outlaw the many instances of different NWL CSU- PPwT Version 3 update- IVF Page 7 of 9
treatment that are justifiable or beneficial..there are no specific exceptions to the ban on age discrimination for health or social care services. This means that any age-based practices by the NHS and social care organisations need to be objectively justified, if challenged. 1 There have only been two requests for IVF for 23 and under since April 2011. 5. Number of IVF cycles The current policy restricts the number of fresh IVF cycles to one. This also includes funding for a frozen cycle using embryos frozen during the fresh cycle should the fresh cycle fail and assuming viable frozen embryos are available. The updated NICE guidelines retain the recommendations made in 2004 to fund 3 cycles of IVF. The cost-effectiveness modelling for the 2013 guidelines supported this recommendation. It is assumed that CCGs do not wish to review the policy with regards to the number of cycles funded by the NHS. 6. Same Sex couples eligibility criteria Current policy states that same sex couples need to have tried six cycles of IUI before being referred for IVF. The new guidance recommends that In women aged under 40 years who have not conceived after 2 years of regular unprotected intercourse or 12 cycles of artificial insemination (where 6 or more are by IUI), offer 3 full cycles Taking this recommendation into account, the eligibility criteria for same sex couples should be changes to 12 cycles of artificial insemination (where 6 or more are by IUI. This makes the policy more restrictive for same sex couples. 7. Number of embryos to be transferred It is suggested that this section of the policy is made less detailed as much of this is clinical judgement and has no impact on costs. Current wording will be replaced with a requirement to consider NICE and HFEA guidance. 8. Fertility cryopreservation NICE guidance on fertility cryopreservation has introduced a number of changes which need to be reviewed. It is intended that the cryopreservation policy is separated from the IVF policy. A separate paper is attached on fertility cryopreservation. 1 https://www.gov.uk/equality-act-2010-guidance#age-discrimination (accessed 4.7.13) NWL CSU- PPwT Version 3 update- IVF Page 8 of 9
CCGs are asked to consider the following questions 1. Should the age limit for IVF be increased in line with NICE recommendations 2. Should the lower age limit be removed 3. Should the current policy to fund one full cycle of IVF be retained 4. Should the eligibility criteria for same sex couples be changed to be in line with new NICE recommendation 5. Should the specification on number of embryos to be transferred be removed NWL CSU- PPwT Version 3 update- IVF Page 9 of 9