Criteria for NHS Funded Assisted Conception Treatments for Sub-fertility For CCGs within East Sussex

Transcription

1 Criteria for NHS Funded Assisted Conception Treatments for Sub-fertility For CCGs within East Sussex 1

2 Title Ref No Document objective Audience Dissemination Document Details Criteria for NHS Funded Assisted Conception Treatments for Sub-fertility for CCGs within East Sussex C02 The following criteria describe the characteristics of patient who can be offered NHS assisted conception treatments. All CCG staff and officers (including temporary and seconded staff and contractors) All policies will be published on the intranet and the CCG website, in the staff newsletter and staff induction pack. Author Reviewed by Individual Funding Request Officer Approval process Governance Committee Date of review 8 February 2017 Approved by Governing Body Date of approval 22 March 2017 Equality Impact Assessment Category Review date Version number There are no negative impacts of this policy on people with protected characteristics Commissioning 2 years Version History Date Amendment By whom 0.1 January 2017 Individual Funding Request Officer 1.0 March 2017 Ratified Governing Body 2

3 Contents Section No. Section title 1. Summary 4 2. Scope of Services Provided Criteria for the Provision of Services Clinical Criteria Social and other criteria 7 Page 3

4 Summary Criteria for NHS funding of assisted conception treatment in East Sussex CCGs Scope These criteria apply to the following forms of assisted conception in eligible patients: Intra-uterine insemination (IUI) In vitro fertilisation (IVF) Intracytoplasmic sperm injection (ICSI) The criteria will apply to all three forms of treatment unless otherwise stated. Clinical criteria Duration of subfertility Age of woman IUI, IVF and ICSI will be funded in couples that have been attempting to conceive for at least 24 months unless they have an identifiable cause and unless clinical judgement dictates otherwise. Funding is available for couples where the woman is aged at the time of treatment. An exception will be made for women who are aged 39 at the point of referral to an IVF unit but they must be treated with six months of their 40 th birthday. For women undergoing full cycles that include subsequent frozen embryo transfers (if the initial fresh cycle was unsuccessful), then the same age stipulation applies, i.e. that they must commence the final frozen cycle within six months of their 40 th birthday. Previous cycles Couples will not be funded if either partner has already had two previous fresh cycles of IVF/ICSI (irrespective of how these were funded). This means that couples will be funded: For up to six cycles of initial IUI, as clinically indicated and at the discretion of the referring gynaecologist; For two fresh cycles of IVF or ICSI if no previous fresh cycles have been undertaken; For one fresh cycle of IVF or ICSI if the couple has already received one fresh cycle. Overall, eligible couples will be funded for a maximum of six cycles of IUI and four embryo transfers (including no more than two transfers from fresh cycles). Body Mass Index Women must have a Body Mass Index (BMI) within the range Social and other criteria Previous children Neither partner in a couple should have a living child from their relationship or any previous relationship. A child adopted by the couple or adopted in a previous relationship is consider having the same status as a biological child. Child refers to a living son or daughter irrespective of their age or place of abode. Previous sterilisation Assisted conception will not be provided to couples if their sub-fertility is the result of sterilisation in either partner. 4

5 2. SCOPE OF SERVICES PROVIDED These criteria apply to the following forms of assisted conception in eligible patients: Intra-uterine insemination (IUI) In vitro fertilization (IVF) Intracytoplasmic sperm injection (ICSI) The criteria will apply to all three forms of treatment unless otherwise stated. The details of these treatments can be found in the National Institute for Clinical Excellence Clinical Guideline 11. Other forms of assisted conception that are not part of the standard NICE recommended guidelines are not included. Any new treatments or research trial treatment are not included patients taking part in trials of new treatments will be considered separately and will be within the governance arrangements of that research trial. New developments in assisted conception treatment will be dealt with through the national reviews of evidence and revisions to the national NICE guidelines. Future updates of these criteria will take these into account. These criteria are applicable to couples who have clinically-defined sub-fertility and who require specialised fertility treatments. They do not apply to: Investigations of general fertility problems and the primary treatment of conditions found during such investigation. These are managed within usual primary and secondary care provision. Those seeking to use assisted conception techniques for reasons other than the treatment of sub-fertility (e.g. as part of a screening process to exclude abnormalities as in pre-implantation genetic disorders (PGD)). PGD uses the technology of IVF but not for infertility reasons. It is a method of testing embryos for genetic disorders (that the parent may carry the genes for) and only transferring those that are healthy and disease free. NICE therefore, understandably, excluded this from its remit on infertility. Patients who require fertility because they are undergoing gonadotoxic treatments (e.g. cancer treatments). 3. CRITERIA FOR THE PROVISION OF SERVICES The following criteria describe the characteristics of patient who can be offered NHS assisted conception treatments. These can be divided into: Clinical criteria i.e. the clinical characteristics that are associated with effective outcomes of treatment (as shown by the NICE clinical guideline and related review of evidence). Social and other criteria i.e. those criteria which are based on current values in healthcare commissioning, such as prioritising according to patient needs, equity etc.

6 3.1 Clinical criteria Duration of Subfertility Age of woman Previous cycles IVF and ISCI will be funded in couples that have been attempting to conceive for least 24 months unless they have an identifiable cause and unless clinical judgement dictates otherwise. Funding is available for couples where the woman is aged at the time of treatment. An exception will be made for women who are aged 39 at the point of referral to an IVF unit but they must be treated within six months of the 40 th birthday. For women undergoing full cycles that include subsequent frozen embryo transfers (if the initial fresh cycle was unsuccessful), then the same applies, i.e. that they must commence the final frozen cycle within six months of their 40 th birthday. Couples will not be funded if either partner has already had two or more previous cycles of IVF/ICSI (irrespective of how these were funded). This means that couples will be funded: The likelihood of couples conceiving increases with time. In the general population, it is estimated that 84% of women would conceive within one year of regular unprotected sexual intercourse. This rises cumulatively to 92% after two yeas 93% after three years 1, 2. The likelihood of a live birth following IUI, IVF and ICSI falls with the age of the female partner. The Human Fertilisation and Embryology Authority (HFEA) publish data on the live birth rates following IVF and ICSI. The live birth rate is the number of births achieved for every 100 IVF treatment cycles commenced. It is expressed as a percentage. The most recent data from the HFEA suggests that the live birth rate for IVF/ICSI amongst women of less than 39 years is 27.3% whereas for women aged between years this rate is 11.1 decreasing to 4% in women over 44 years 3. Most live births (82%) following IVF occur within the first two fresh cycles of treatment 4. The birth rate drops at the third and subsequent attempts. For up to six cycles of initial IUI, as clinically indicated and at the discretion of the referring gynaecologist. 1 te Velde, ER.,Eijkemans, R & Habemma, HDF (2000) Variation in couple fecundity and time to pregnancy, an essential concept in human reproduction. Lancet:355:1928-9; 2 Brosens, A.,Gotdts, S.,Valeknburg, M., Puttemans, P.,Ca\mpo, R & Gordts, S (2004) Investigation of the infertile couple: when is the appropriate time to explore female infertility? Human Reproduction, 19(8); ; 3 HFEA annual data for 2006; 4 Templeton, A., Morris, J.K. and Parslow, W (1996) Factors that affect outcome of in-vitro fertilisation treatment. Lancet,348: ; 6

7 Clinical criteria for NHS funding of assisted conception treatment For two fresh cycles of IVF or ICSI if no previous cycles have been undertaken. Rationale and comments For one fresh cycle of IVF or ICSI if the couple has already received one fresh cycle. Body Mass Index Overall, eligible couples will be funded for a maximum of six cycles of IUI and four embryo transfers (including no more than two transfers from fresh cycles). Women must have a Body Mass Index (BMI) within the rage Weight loss programme has been associated with improvements in ovulation and pregnancy outcomes in obese sub-fertile women for all forms of fertility treatment 5, 6. Higher body mass index has been associated with decreased changes of pregnancy following IVF treatment 7, Social and other criteria Social and other criteria for NHS funding of assisted conception treatment Previous children Neither partner in a couple should have a living child from their relationship or any previous relationship. A child adopted by the couple or adopted in a previous relationship is considered to have the same status as a biological child. Child refers to a living son or daughter irrespective of their age or place of abode. Rationale and comments It is recognised nationally that NHS organisations need to focus their budgets on patients who have the most need and can obtain the maximum health gain. Local priority is therefore being given to those who are completely childless. 5 Clark, A.M., Ledger, W.,Galletley, C., Tomlinson, L., Blaney, F. and Wang, X Weight loss results in significant improvements in pregnancy and ovulation rates in anovulatory obese women. Human Reproduction ; 6 Clark, A.M., Thornely, B., Tomlinson, L., Galletly, C. and Norman R.J. Weight loss in obese infertile women results in improvement in reproduction outcome for all forms of fertility treatment. Human Reprodcutino ; 7 Dokras A, Baredziak L, Blaine J, Syrop C, VanVoorhis BJ, & Sparks A (20006)Obstetric outcomes after in vitro fertilisation in obese and morbidly obese women. Obstetrics & Gynecology, 108/1(61-9); 8 Gillet WR, Putt T, Farquhar CM (2006) Prioritising for fertility treatments-the effect of excluding women with a high body mass index (BJOG: An International Journal of Obstetrics & Gynaecology, 113/10( ).