Submission to West Essex CCG consultation on IVF services (April 2014) NIAC and its aims are supported by the following organisations:

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1 Submission to West Essex CCG consultation on IVF services (April 2014) NIAC and its aims are supported by the following organisations:

2 In addition to this submission, NIAC would like to endorse the submission made by IVFyes in relation to IVF provision in West Essex dated 28 th April Consultation submission The 2004 and newly updated 2013 NICE guideline on fertility recommends the provision of three full cycles of IVF to eligible couples. NICE is tasked with balancing clinical effectiveness and cost effectiveness. NICE has been unusually prescriptive in its recommendation on the number of cycles to be provided and there are good evidence-based reasons for this. Three has been demonstrated to be the optimal number of cycles for maximising the chances of a successful pregnancy. Some couples may be placed at an immediate disadvantage if the number of viable embryos produced is low. Some may only yield one viable embryo for transfer. This is just one reason why it is essential that up to three cycles of treatment be provided. Each full cycle should include the subsequent transfer of any stored, frozen embryos, in accordance with the NICE guideline. It is important to remember that not everyone would be entitled to three cycles automatically. Only a small percentage of patients actually need this third cycle and the responsible clinician can still use their discretion if they feel it would not be in the patient s best interests to progress with a further cycle of treatment. Nevertheless, the option needs to be, at the very least, made available to clinicians and patients. Evidence used by West Essex CCG to justify a cut in the number of cycles NIAC is well aware of the Specialist Fertility Services. A discussion paper for the East of England, Clinical Commissioning Groups (2013) and the evidence used by the authors e.g. Malizia BA et al (2009). We have been in touch with the chief author of this report to make the following points: The NICE Guideline Development Group undertook a review of 492 academic studies on fertility, investigating 38 of these in detail. Four studies were included in the review of factors that predict the outcome of IVF (Leushuis et al., 2009; van Loendersloot et al., 2010; Nelson & Lawlor, 2011; Roberts et al, 2010a). Two of these were systematic reviews (Leushuis et al., 2009; van Loendersloot et al., 2010) and two were recent models (Nelson & Lawlor, 2011; Roberts et al, 2010a). The Group found that the chance of a live birth did decrease with the number of unsuccessful cycles increases, but the most significant drop in success rates was after 4 previous unsuccessful cycles. Direct quote from full NICE guideline (2013): The base case model suggests that 3 cycles of IVF is considered cost effective in women age 39 years and 2

3 younger with at least 2 years of infertility, who had no chance of conceiving spontaneously. Furthermore, sensitivity analysis suggested that funding 3 full cycles of IVF was cost effective in women age 39 years and younger in circumstances where there was a chance of conceiving spontaneously. The analysis does not provide strong evidence that current recommendations for treatment in women aged 39 years and younger should be changed on cost effectiveness grounds. It supports the existing recommendation of 3 full cycles of IVF for all women eligible for IVF age 39 years and younger and thus the GDG did not feel there was any need to change the recommendation from the 2004 guideline for women in this age category. The academic studies used in the Specialist Fertility Services. A discussion paper for the East of England, Clinical Commissioning Groups (2013) appear to be selective and chosen to support the argument that 2 cycles would be more costeffective than 3. The lead procurer for the region, East and North Hertfordshire CCG has acknowledged the above points and has made the statement below regarding its own decision to stick with 3 full cycles. We would strongly advise West Essex to contact this CCG to ask them for their reasoning: Despite the evidence presented in the NICE 2013 paper, the Clinical Group of the East of England Consortium concluded that the best decision would be to go for two full cycles of IVF instead of the recommended three. This decision was said to be based on the evidence presented in a Dr Ford and Dr Diu discussion paper, titled Additional information to the Specialist Fertility Treatments discussion Paper for Clinical Commissioning Groups. The evidence used by the Clinical Group to reach their conclusion, actually suggests that the chances of a successful IVF cycle outcome would stay the same, from the second to third cycle (then sharply decreasing for any cycle after the third. Therefore based on the evidence presented in the Dr Ford and Dr Diu discussion paper (i.e. no difference in the success rate between two and three cycles of IVF, better value for money), the NICE guidance on three cycles and the absence of any dissenting clinical evidence, it is recommended that East and North Hertfordshire CCG continue to offer three full cycles of IVF for women under the age of 40, in line with NICE recommendations /2.1%20Specialist%20Fertility%20paper.pdf 3

4 1 Cycle for Funding should be provided for couples where the woman is aged between 40 and 42. NIAC welcomes West Essex CCG s funding extension to this age group. It is important to remember however that this funding is intended for a select few patients i.e. those who have never previously had IVF treatment; where there is no evidence of low ovarian reserve; and who have not conceived after two years of regular unprotected intercourse or 12 cycles of artificial insemination. Extending funding for this age group is a welcome step. However given the small group of patients that would stand to benefit from this change and the proposed cut to 2 cycles for those aged under 40, we do not believe it is appropriate or entirely truthful for West Essex CCG to claim that more women will be eligible to receive and benefit from IVF services. Previous children In 2004, the then Secretary of State for Health, John Reid, announced that he would be asking the NHS to give local priority to couples who do not have any children living with them. Since then, a few commissioners in England have stretched this statement to include children from a previous relationship, despite the fact that neither NICE or the Department of Health have produced guidance to this effect. CCGs should move towards a position where funding is available for those who do not have a living child, including couples where one partner is childless. As investment in fertility services increases, funding may be available for IVF where both partners have a child/children from a previous relationship, but not from the current relationship. Infertility Network UK were asked by the Department of Health to produce a commissioning tool aimed at standardising access criteria for IVF treatment. The aforememtioned suggested policy was included in this document, which was endorsed by the Department of Health and approved by the then Public Health Minister, Gillian Merron MP. In all considerations of parental status, there should be an explicit statement that children adopted by either partner should have the same status as biological children. Conclusion Whilst the tone of this consultation response may seem critical NIAC only aims to encourage implementation of what has been recommended nationally by the UK s expert body, NICE. NIAC has written to several CCGs regarding their lack of transparency. We hope that West Essex CCG s renewed assisted conception policy is made readily available on the CCG s website and that future consultations are brought to the attention of patients as soon as possible. 4

5 About NIAC The National Infertility Awareness Campaign (NIAC) is an umbrella body which has the support of a number of organisations working in the field of infertility from professional bodies to patient support groups. For more than 20 years NIAC has campaigned for people to have comprehensive and equal access to a full range of appropriate NHS investigations and treatments for infertility; this includes the right to access up to three full cycles of IVF treatment free on the NHS. There is evidence that suggests the effects of infertility, both financially and emotionally, are devastating. Since its establishment, NIAC has pushed for recognition of the psychological effects of infertility, which if left untreated, can cause unnecessary and long-lasting harm to an individual s mental and general wellbeing. Contact NIAC Secretariat Mark Johnson Decideum Ltd Vicarage House Kensington Church Street London W8 4DB T : E: mark.johnson@decideum.com 5