Access to IVF Help us decide Discussion paper South Central Specialised Commissioning Group 1 C - 1
Access to IVF treatment Contents 1. Background 3 2. Developing a single policy for NHS South Central..4 3. What local people have told us so far...5 4. What changes are being proposed?...6 The woman s age How long has the couple been infertile? Storage of frozen embryos Previous infertility treatment Storing eggs and sperm 5. What are the other changes to the policy?...8 Donated eggs IVF using frozen embryos Intra-uterine insemination HIV infection and sperm washing Surgical sperm retrieval 6. How do I have my say?...9 7. How will the decision be taken? 9 APPENDIX A: Feedback form 10 APPENDIX B: Areas where the policy does not change.13 2 C - 2
Access to IVF treatment: help us decide 1. Background Trying for a baby Although most women fall pregnant within two years of trying for a baby, around 8% of couples are unsuccessful. This is called infertility. There are numerous reasons why couples don t conceive within two years including a whole range of medical conditions in either the man or woman, the women s age, obesity and/or lifestyle factors such as excessive smoking or drinking. There are a number of potential treatments for infertility including a range of drug treatments or surgery. However, some couples can only conceive via in-vitro fertilisation (IVF). IVF treatment IVF involves drug treatments, ultrasound-guided egg collection from the woman, mixing of eggs and sperm in the laboratory and implantation of a fertilised egg(s) into the woman s womb. Any surplus embryo(s) can also be frozen for future use. NHS funding for IVF The South Central Specialised Commissioning Group (SCSCG) commissions IVF services on behalf of Hampshire PCT, Isle of Wight PCT, Southampton City PCT, Portsmouth City Teaching PCT, Berkshire East PCT, Berkshire West PCT, Milton Keynes PCT, Buckinghamshire PCT and Oxfordshire PCT. Each of these PCTs has finite resources to fund a whole range of health services and treatments. IVF is an expensive treatment which can often be unsuccessful. We need to balance funding for this treatment with the many other pressures on NHS funding by making sure that we offer IVF in the most effective way for people trying to have a baby. This is not straightforward trying for a baby is an emotional time and there are a number of issues which influence the clinical and cost effectiveness of IVF. At the moment the policies for Hampshire and the Isle of Wight and Thames Valley (Berkshire, Buckinghamshire and Oxfordshire) are slightly different, so local people do not currently get the same access to IVF on the NHS. The cost of IVF One cycle of IVF costs on average 3,871. In 2007/2008, Hampshire and the Isle of Wight (including Portsmouth and Southampton) spent 503,000 on IVF and Thames Valley (Berkshire, Buckinghamshire, Milton Keynes and Oxfordshire) spent 688,000. Number of people in South Central receiving IVF treatment on the NHS The following table shows how many people received IVF funding on the NHS in the last two years. PCT 2007/8 2008/9 (estimate)* Hampshire 110 110 Isle of Wight 2 2 Portsmouth 7 8 Southampton 11 11 Berks East 56 42 Berkshire West 68 66 Buckingamshire 69 70 3 C - 3
Milton Keynes 12 28 Oxfordshire 84 96 *based on figure to end December 2008 NICE guidance In 2004 the National Institute for Clinical Excellence (NICE) produced guidance which said that: 1. Couples in which the woman is aged 23 39 years at the time of treatment and who have an identified cause for their fertility problems or who have infertility of at least three years duration should be offered up to three stimulated cycles of IVF treatment. 2. To balance the chance of a live birth and the risk of multiple pregnancy and its consequences, no more than two embryos should be transferred during any one cycle of in-vitro fertilisation treatment. If this guidance were to be funded across Oxfordshire, Berkshire, Buckinghamshire (including Milton Keynes) and Hampshire and the Isle of Wight (including Portsmouth and Southampton) it would cost the local NHS approximately 16million per year. 2. Developing a single policy for NHS South Central The South Central Specialised Commissioning Group has received many queries, comments, challenges, and appeals from patients, GPs, referring consultants and IVF providers concerning the polices currently in operation. We recognise that we need a single policy to make sure that everyone gets the same treatment across Hampshire, Isle of Wight, Berkshire, Buckinghamshire and Oxfordshire. Last year the Public Health Resource Unit Priorities Team was asked to review the existing policies and make recommendations to four Priority Committees in Oxfordshire, Berkshire, Buckinghamshire (including Milton Keynes) and Hampshire and the Isle of Wight (including Portsmouth and Southampton). Priorities Committees are groups of doctors, nurses, pharmacists, NHS commissioning staff and lay representatives who consider all the evidence on the clinical effectiveness of treatments and drugs and make recommendations about whether funding them is the best use of finite NHS resources. The four Priority Committees were asked to discuss and review the various options for IVF and assisted conception and develop recommendations for the whole of the area. The review has been focussed specifically upon the issues which have caused confusion or contention. The aim was to: take into account the views of local people maximise the effectiveness of the treatment take account of national policy and guidance maintain affordability for the local NHS develop a consistent policy across NHS South Central 3. What have local people have told us so far? The issues which have caused confusion or contention are set out below together with how the proposed changes address these. What you told us Patients in the Thames Valley who have How we ve listened This is why we are proposing in the new 4 C - 4
previously funded their own IVF have told us that we are unfairly excluding them from NHS funding. Local GPs, gynaecologists and infertility specialists have also said this is unfair. A very large number of patients and clinicians have told us that the present eligible age range (currently 36-39 years in Hampshire and IOW and 35-38 years in Thames Valley) is unfair and illogical. The effectiveness, and consequently costeffectiveness, of IVF falls rapidly from age 35, as female fertility declines. Patients have told us that it is unreasonable for women to have to wait until they reach the age when IVF is less likely to be successful before they become eligible to start IVF. Many couples where the woman is unable to produce eggs have asked us to fund IVF using donor eggs. In most cases this has been agreed, but the existing assisted conception policies do not address the issue of egg donation. Many patients about to undergo clinical treatments likely to make them infertile (particularly cancer treatments) have told us that they want sperm storage or egg storage. Because of this we have looked very carefully at the research evidence. We have received many queries and comments concerning whether frozen cycles will be funded, and whether previous frozen cycles will affect couples eligibility for NHSfunded IVF. Patients have told us that using any frozen embryos before starting a further fresh cycle of IVF should not be allowed to affect their eligibility for an NHS-funded cycle of IVF. Patients have also told us that the NHS should fund the transfer of any stored frozen embryos as a result of their NHSfunded fresh cycle of IVF. Some couples have asked us to fund sperm policy that every couple will be entitled to one cycle of NHS-funded IVF as long as they have not had more than two previous fresh cycles, and meet the other eligibility criteria. The Committees considered clinical evidence which shows that IVF is more effective in women under 35 years old and much less effective in women over 40. They also took into account the views of couples and the recommendation is that IVF be available from 30-34 years inclusive. There will be phased arrangements for women born between April 1, 1972 and March 31, 1976 provided treatment commences by March 31, 2010 to ensure that those who were waiting until they were 35/36 years old to receive funding under the current policies are not excluded from treatment. We are proposing to that egg donation should be funded under the new policy. In the light of the evidence we are proposing that we should fund sperm storage where the circumstances make this appropriate, but that egg and ovarian tissue storage are still experimental treatments with low success rates and should not be funded until there is more evidence to support them. We are proposing that we continue to consider requests for IVF and embryo storage on an individual basis, taking full account of the circumstances in each case. We have considered these comments very carefully. In the end, we have proposed that in the interests of fairness the first priority should be to extend the eligible age range, before funding second, frozen cycles for women aged 30-34. However, we are proposing to offer to fund freezing and storage of surplus embryos for up to three years, so that couples have the option to selffund future, frozen cycles if they wish to do so. We looked at the research evidence for this, 5 C - 5
washing and IVF to reduce the risk of transmission of viruses such as HIV and hepatitis B from an infected male partner to non-infected female partner, and subsequently to the unborn child. A number of couples have asked for surgical sperm retrieval in cases where the male partner is producing sperm but it is absent from the semen and concluded that there was insufficient evidence to support it. We therefore are not proposing to include sperm washing within the new policy. Surgical sperm retrieval incurs a significant additional cost. We looked at the research evidence for this, and concluded that there was insufficient evidence to support it. We therefore are not proposing to include surgical sperm retrieval within the new policy. 4. What changes are being proposed? The four Priorities Committees have recommended that many of the criteria in the current policy remain the same (see page 10). But there are a number of areas where changes are being proposed (see below). This section sets out each of these changes and asks for your views on these by posing a series of questions. There is a feedback form at Appendix A (page 11) or you can do this on line at http://www.smart-survey.co.uk/v.asp?i=9812zjqej Many local couples are have told us that they are frustrated by the length of time that the policy review has taken because they are waiting for the outcome of the review before taking a decision about what to do next. For this reason we are keen to hear views on the proposed new policy so that we can agree criteria new policy as soon as possible. The woman s age In Thames Valley the eligible age range is 35-38 years. In Hampshire and Isle of Wight the eligible age range is aged 36-39 years. We need to make sure that IVF funding is available where it is most likely to benefit people trying to have a baby. The Committees considered clinical evidence which shows that IVF is more effective in women under 35 years old and much less effective in women over 40. They also took into account that women under 35 years who have already been told that they cannot conceive naturally have told us they do not see why they should wait until they reach an age at which IVF is less effective before being allowed to receive it free of charge. The recommendation is that IVF be available from 30-34 years inclusive. This is not in line with guidance from the National Institute of Clinical Excellence because the Committees felt this was not the best use of finite local NHS resources. There will be phased arrangements for women born between April 1, 1972 and March 31, 1976 provided treatment commences by March 31, 2010 to ensure that those who were waiting until they were 35/36 years old to receive funding under the current policies are not excluded from treatment The cost of the proposed policy for women age 30-34 years inclusive would be about the same as our current spend of just under 1.4m. It is estimated that this would fund 448 women and produce 109 live births compared to the current 420 women funded producing about 80 live births. 6 C - 6
The cost of funding women age 30-39 years would be 2.86m. This would fund 754 women and produce 133 live births. Q1: Within finite resources is 30-34 years the most appropriate age range to focus on? The cause and length of infertility Currently couples with a diagnosed cause of infertility are required to have been infertile for one year before they qualify for NHS funding for IVF. These people have told us that it is unreasonable to expect them to wait until they reach the eligible age range before they start IVF. The Priorities Committees considered these comments very carefully but decided that it would be unfair to couples without a diagnosed cause for their infertility if we discriminated in favour of couples with a diagnosis. We are therefore proposing that the same criteria be applied to everyone regardless of their cause of infertility. In the previous policy couples with a diagnosed cause of infertility had to wait one year before they qualified for access to IVF, while others waited three years. Under the new policy we are proposing that couples are treated equally and all couples must have at least three year s infertility. Q2: Within finite resources is it appropriate for couples to have had three years infertility before they qualify for funding? Storage of frozen embryos A full cycle of IVF may produce several embryos; surplus embryos may be frozen for future use. Currently in Thames Valley the NHS funds the storage of frozen embryos for one year or the woman s 40 th birthday (whichever is sooner). In Hampshire and the Isle of Wight the NHS funds the storage of these frozen embryos for up to three years or the woman s 40 th birthday (whichever is sooner). Under the new policy it is proposed that the NHS funds the storage of frozen embryos for up to three years or the woman s 40 th birthday (whichever is sooner). Q3: Is it appropriate that the NHS funds the storage of frozen embryos for up to three years or the woman s 40 th birthday (whichever is sooner)? Previous infertility treatment Under the existing policy couples in Thames Valley who have previously had either NHS or privately funded IVF do not qualify for NHS funding for further IVF treatment. While in Hampshire and Isle and Wight those who ve had previous NHS treatment do not qualify but those who ve previously paid privately for IVF do qualify for one NHS funded IVF cycle. People in Thames Valley who have previously funded their own IVF have told us that we are unfairly excluding them from NHS funding. Local GPs, gynaecologists and infertility specialists have also said this is unfair. We are therefore proposing that across the whole region people who have previously funded no more than two IVF cycles themselves will be eligible for one NHS funded cycle. Those who ve previously received NHS funded IVF will not qualify for further treatment. Q4: Within finite resources should the NHS fund treatment for those who have previously self funded up to two cycles? 7 C - 7
Storing eggs and sperm Many patients about to undergo clinical treatments likely to make them infertile (particularly cancer treatments) have told us that they want sperm or egg storage to be funded. Because of this we have looked very carefully at the research evidence. Sperm storage is a well-established technique. However, techniques for human egg preservation are of very limited effectiveness (live birth rate around 1%), and are still the subject of research. Ovarian tissue preservation is at present exclusively experimental, and has no proven success in humans. In the light of the evidence we are proposing that we fund sperm storage where appropriate. But that egg and ovarian tissue storage are still experimental treatments with low success rates and should not be funded until there is more evidence to support them. We are proposing that we continue to consider requests for IVF and embryo storage on an individual basis, taking full account of the circumstances in each case. Q5: In light of the clinical evidence do you agree that we should fund sperm storage but not egg storage? 5. What are the other changes to the policy? There are a number of issues which were not covered by the previous policies. This section sets out each of these issues and asks for your views on these by posing a series of questions. There is a feedback form at Appendix A (page 11) or you can do this on line at http://www.smart-survey.co.uk/v.asp?i=9812zjqej Donated eggs Some women cannot ovulate, so IVF using donated eggs is the only means by which they can conceive. The additional cost of IVF using donated eggs is around 5,000. The existing policy does not cover donated eggs. It is proposed that IVF using donated eggs from UK clinics licensed by the Human Fertilisation and Embryology Authority (HFEA) will be funded. Q6: Should the NHS fund IVF using donated eggs? IVF using frozen embryos A full cycle of IVF may produce several embryos suitable for transfer; these surplus embryos may be frozen for future use. IVF using stored embryos costs less than a complete fresh cycle. However, the success rate for frozen cycles is lower than that for fresh cycles and frozen cycles are less likely to result in a live birth. This is not covered in the existing policy. Because the use of frozen embryos is less effective the new policy proposes that only fresh cycles of IVF are funded on the NHS. (However the NHS will fund the freezing and storage of embryos for up to three years so that couples have the option of self funding frozen cycles in the future if they wish to. For funding of storage of frozen embryos see above. Q7: Should the NHS only fund fresh cycles of IVF? Intra-uterine insemination Intra-uterine insemination (IUI) is used to treat male infertility and infertility of unknown cause. It involves using a catheter to introduce sperm into the cervix or uterine cavity, either from the woman s partner or a sperm donor. Under the current policy IUI is available in Thames Valley but not in Hampshire and the Isle of Wight. Not many couples have asked us to fund IUI and gynaecologists and fertility specialists have told us that because the success rate is low most 8 C - 8
couples prefer to have IVF. The Priorities Committees therefore recommended that IUI is not funded by the NHS as IVF is a more effective treatment. Q8: Within finite resources and given the limited effectiveness of IUI is it appropriate for it not to be funded? HIV infection and sperm washing Semen contains human immunodeficiency virus (HIV), the cause of AIDS. Therefore, unprotected intercourse between an HIV-positive man and an HIV-negative woman risks infecting the latter. The only way such partners can conceive safely is via IVF. Nevertheless, there remains a risk that HIV in the sperm will be transmitted to the woman or the child. Semen can be processed to reduce the amount of HIV which it contains. Having considered clinical studies of this procedure the Priorities Committees concluded that there is insufficient evidence to be sure that sperm-washing prevents HIV transmission and the new policy therefore proposed that it should not be funded. Q9: Given the lack of clinical evidence is it appropriate not to fund sperm washing? Surgical sperm retrieval Surgical sperm retrieval is a technique for collecting sperm in cases of male sub fertility. This is not covered by the current policy. The Priorities Committees considered a number of reviews of this procedure and concluded that there was insufficient evidence of its effectiveness for it to be recommended. The proposed policy therefore does not fund surgical sperm retrieval. Q.10: Is it appropriate for surgical sperm retrieval not to be funded given the lack of clinical evidence? 6. How do I have my say? We are asking local people to comment on the proposed new policy by April 17, 2009. We will also be attending a number of local groups to talk to local people about the proposed changes to the policy. There are a number of ways that you can do this: On line You can give your views on the ten questions above at http://www.smart-survey.co.uk/v.asp?i=9812zjqej Or by completing the feedback form attached to this document and sending it to the address below. In writing: You can write to us at: FREEPOST NHS Hampshire (Please note: this address looks too short but it is correct) 9 C - 9
By email: You can email us at: yourviewscount@hampshirepct.nhs.uk The closing date for comments is: April 17, 2009. 7. How will a decision be taken? The South Central Specialised Commissioning Group will collate all the comments received and a decision on the next steps will be taken on May 7, 2009 and presented in public to the Hampshire PCT Board on May 28, 2009. Any updates and details of the next steps will be posted at www.hampshirepct.nhs.uk during May 2009. 10 C - 10
FUNDING IVF HELP US DECIDE Q1 Within finite resources is 30 34 years the most appropriate age range to focus on? YES / NO DON T KNOW COMMENTS Q2 Within finite resources is it appropriate for couples to have had three years infertility before they qualify for funding? Q3 Is it appropriate that the NHS funds the storage of frozen embryos for up to three years or the woman s 40 th birthday (whichever is sooner)? 11 C - 11
Q4 Within finite resources should the NHS fund treatment for those who have previously self funded up to two cycles? Q5 In light of the clinical evidence do you agree that we should fund sperm storage but not egg storage? Q6 Should the NHS fund IVF using donated eggs? Q7 Should the NHS only fund fresh cycles of IVF? 12 C - 12
Q8 Within finite resources and given the limited effectiveness of IUI is it appropriate for it not to be funded? Q9 Given the lack of clinical evidence is it appropriate not to fund sperm washing? Q10 Is it appropriate for surgical sperm retrieval not to be funded given the lack of clinical evidence? 13 C - 13
APPENDIX B: Areas where the policy does not change Issue Age of male partner Women in same sex couples/ and women not in a partnership Childlessness Sterilisation BMI No upper age limit for male partner (as per adoption laws). Criterion Sub fertility treatment will be funded for women in same sex couples or women not in a partnership if those seeking treatment are demonstrably sub fertile. In the case of women in same sex couples in which only one partner is sub fertile, clinicians should discuss the possibility of the other partner receiving treatment before proceeding to interventions involving the sub fertile partner. NHS funding will not be available for access to insemination facilities for fertile women who are part of a same sex partnership or those not in a partnership. In circumstances in which women in a same sex partnership or individuals are eligible for sub fertility treatment, the other criteria for eligibility for sub fertility treatments will also apply. Women in same sex couples and women not in a partnership should have access to professional experts in reproductive medicine to obtain advice on the options available to enable them to proceed along this route if they so wish. Treatments for sub fertility will be funded if the couple does not have a living child from their relationship or from any previous relationship. This includes a child adopted by the couple or in a previous relationship. It is estimated that 66% of all couples attending out patient clinics with fertility problems are both childless. One partner is childless in a further 16% of couples attending sub fertility clinics. Once accepted for treatment, should a child be adopted or a pregnancy leading to a live birth occur the couple will no longer be eligible for treatment. Fertility treatment will not be available if the sub fertility is the result of a sterilisation procedure in either partner. In addition, the surgical reversal of either male or female sterilisation will not be funded except in exceptional circumstances. If the individual s situation is thought to warrant such consideration, the patients general practitioner should contact the relevant PCT so that such an application might be made. Women must have a BMI of between 19.0 and 29.9 inclusive for a period of 6 months or more before receiving any treatment. They should be informed of this criterion at the earliest possible opportunity in their progress through infertility investigations in primary care and secondary care. GPs are encouraged to provide unambiguous and clear information about BMI criteria to infertile couples. 14 C - 14
Issue Criterion Smoking Only non-smoking couples will be accepted on the IVF treatment waiting list. They must be informed of this criterion at the earliest possible opportunity in their progress through infertility investigations in primary care and secondary care. GPs are encouraged to provide unambiguous and clear information to infertile couples. A statement should also be issued at the time of publishing the eligibility criteria, emphasising the importance of an active, healthy lifestyle and highlighting the dangers of smoking and passive smoking, obesity, alcohol and caffeinated beverages as important causes of infertility. HFEA Code of Ethics Couples not conforming to the HFEA s Code of Ethics, will be excluded from having access to NHS funded assisted fertility or other treatment. This includes consideration of the welfare of the child which may be born which may take into account the importance of a stable and supportive environment for children as well as the pre-existing health status of the parents. 15 C - 15
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