Commissioning guidelines for access to sperm washing for HIV+ men

Transcription

1 Greater Manchester Sexual Health Network (GMSHN) c/o NHS Manchester, Newton Silk Mill, Holyoak Street, Manchester, M40 1HA. Tel: Fax: Commissioning guidelines for access to sperm washing for HIV+ men Date completed (version 20) Approved by GMSHN PAG 5 (HIV Services) Approved by GM Sexual Health Commissioning Leads Group Approved by GM Exceptional Use of Resources Group Not circulated as changes minor. Previous version approved (by ) Not circulated as changes minor. Previous version approved (by ) Not circulated as changes minor. Previous version approved (by ) Approved by GM Sexual Health Network Board Primary author(s) Version version 20 ( ) Supercedes v.19 ( ) Related documents Date for review January 2014 Not circulated as changes minor. Previous version approved (by ) Sarah Doran (Public Health Manager, NHS Manchester) Sarah Stephenson (Project Manager (Commissioning), Greater Manchester Sexual Health Network) Guidance for the investigation of fertility for HIV patients (including access to sperm washing) Sperm Washing Panel: Operational Procedure Page 1 of 14

2 Section Contents Detail Page number 1 Introduction 3 Scope of these guidelines 3 HIV infection and sperm washing 3 Fertility investigations prior to sperm washing 3 2 Access criteria 4 Clinical eligibility criteria for sperm washing 4 Commissioning eligibility criteria for sperm washing 4 Patients not eligible for NHS treatment 4 Age range 4 Number of cycles 5 Banking cycles 5 Existing children 5 Same sex couples 6 Surrogacy arrangements 6 3 Funding and application arrangements 6 NHS funding 6 Mixture of private and public funding 6 Application procedure 6 Appeals 7 Waiting Times 7 Sperm Washing Panel 7 4 Provider units 7 5 Couples responsibilities 8 Smoking 8 Drugs and alcohol 8 Healthy weight 9 Patient responsibility and HIV prevention 9 6 Drafting Notes 9 Eligibility for NHS funding 9 Number of cycles 9 Same sex couples 9 Age range of female partner 9 7 Annex A Decision-making pathway 10 8 References 13 9 Background reading 14 Page 2 of 14

3 1. Introduction Scope of these guidelines a. These guidelines cover commissioning arrangements for access to sperm washing for HIV+ men. They do not cover fertility treatment (including IVF). Local protocols for these therapies are managed by individual Hospital Trusts. b. The Primary Care Trusts (PCTs) in Greater Manchester (GM) have decided to adopt a unified commissioning approach for sperm washing services (to prevent HIV infection) both in the interests of the public (to streamline decision-making processes and ensure equitable access across GM) and service providers. These are the first guidelines of their type in England. c. These guidelines should be read in conjunction with the clinical guidelines for accessing sperm washing (Guidance for the investigation of fertility for HIV patients (including access to sperm washing)). HIV infection and sperm washing d. The change in the natural history of HIV infection, and reduction in mother-tochild transmission as a result of anti-retroviral therapy (ART) and the development of sperm washing techniques has meant that parenthood is a realistic option for couples where one or both partners is HIV+. As a result, demand for reproductive care and sperm washing is rising among this group of patients 1. e. The main objectives in offering reproductive care and sperm washing are to minimise the risk of transmission of HIV to the uninfected partner and future child, and where relevant, to ensure the safety of healthcare workers and other patients attending the fertility centre 2. In addition, it is estimated that, the monetary value of preventing a single onward transmission is between 0.5 million and 1 million in terms of individual health benefits and treatment costs 3. Fertility investigations prior to sperm washing f. Where sperm washing is provided to reduce the chance of infection with HIV, patients fertility needs to be investigated prior to any attempt at conception. This is in order to clarify that there are no underlying fertility problems which would require treatment prior to sperm washing. g. Normally couples are advised to attempt to conceive prior to fertility investigations but given the risk of infection with HIV, early access to fertility investigations is necessary. Creating a delay in access to sperm washing might increase the likelihood of risk-taking behaviour. GM protocols for access to fertility investigations need to be mindful of this scenario and this will be progressed separately. Page 3 of 14

4 h. Intra-uterine insemination (IUI) is included as part of sperm washing treatment. If the couple need other fertility investigations then this is part of the infertility pathway which is outside of this guidance. i. A patient information leaflet will be widely available to inform couples of the funding procedure and what sperm washing involves. 2. Access criteria Clinical eligibility criteria for sperm washing a. Clinical eligibility criteria are included in the document, Guidance for the investigation of fertility for HIV patients (including access to sperm washing) which should be read in conjunction with this document. This is guidance for clinicians to use when referring patients for funding for sperm washing. Commissioning eligibility criteria for sperm washing b. Criteria for funding sperm washing are separate to criteria and funding for assisted conception: these guidelines do not cover sub-fertility. Local protocols for these therapies are managed by individual Hospital Trusts (see paragraph 1a). c. Sperm washing, in this instance, is either to prevent HIV infection in HIVfemale partners or to prevent transmission of resistant virus in seroconcordant couples. Sperm washing is not recommended in couples where the female partner is HIV+ and the male partner is HIV- (see Guidance for the investigation of fertility for HIV patients (including access to sperm washing). Patients not eligible for NHS treatment d. We recognise that preventing access to sperm washing might increase the likelihood of risk-taking behaviour and the risk of transmission to the uninfected partner. Clearly the financial impact of transmission creates an avoidable cost for the NHS and should be avoided. Therefore, all patients, regardless of their eligibility for NHS IVF treatment will be able to access sperm washing. Age range e. Sperm washing will be offered to men whose female partner is at the time of treatment. There is no specific age criterion for the male partner (the age of the male partner should be considered with reference to the overall welfare of the child). If, during investigations, sub-fertility is identified, then funding will be made according to the eligibility criteria for infertility treatments. Page 4 of 14

5 Number of cycles f. Men are entitled to a maximum of 6 cycles of sperm washing with IUI funded by the NHS. We recognise that couples may have accessed IUI privately but we do not have the mechanisms to verify this information and our primary concern is infection control. g. If a man has changed partner after his sperm washing application is approved, please see paragraph k below. h. Eligible patients are entitled to a maximum of 6 NHS-funded sperm washing with IUI cycles but are also able to fund private sperm washing cycles themselves. i. The 6 cycles offered exclude any sperm washing required as part of other assisted conception techniques (such as in-vitro fertilisation (IVF)). It is expected that where sperm washing is required as part of IVF, that this is would be available even if a man has used up his 6 allocated sperm washing with IUI cycles. Banking cycles j. Men can bank unused cycles to be used later on with the same partner. For example, if a couple achieve a pregnancy on the second sperm washing cycle, the man can bank his remaining 4 unused sperm washing cycles to be used later on if required. k. If a man changes partner, he is still only able to access up to a maximum of 6 cycles of sperm washing. The new partner would need to have investigations completed to ensure she is not sub-fertile before the banked sperm washing cycles are used. Existing children l. Men will be offered up to a maximum of 6 cycles of sperm washing with IUI regardless of the number of his or his partner s existing children. This decision has been made as sperm washing is an infection control issue in order to protect the health of the HIV- mother (if relevant) and unborn child. m. It is essential that existing children are HIV tested if necessary. Page 5 of 14

6 Same sex couples n. Same sex couples are not excluded from access to sperm washing. We would consider their individual circumstances by reviewing their application e.g. one partner of a male-male partnership applying for sperm washing with a surrogate. Surrogacy o. The NHS will not be involved in, nor take any responsibility for, surrogacy arrangements. 3. Funding and application arrangements NHS funding a. Sperm washing will be funded by the man s PCT. b. If fertility treatments are required for either partner then they will need to be considered separately in line with their local PCT s guidelines. c. The Greater Manchester PCTs will only fund sperm washing treatment that takes place in English provider units and all sperm washing treatments will take place in English provider units. This is to ensure that standards of care are maintained and that patients can access care closer to home. Mixture of private and public funding d. Couples can still be eligible for NHS funding of sperm washing even if they are privately funding assisted conception treatments (for example because they are ineligible for NHS-funded assisted conception treatment). These treatments are for two separate clinical needs: sperm washing is to prevent infection whereas assisted conception is to treat infertility. e. However, where a patient requires intra-uterine insemination (IUI) for subfertility this is already part of, and included in the cost of, the sperm washing package. Please note that sperm washing with IUI is only offered as an unstimulated cycle (i.e. no fertility drugs are administered). Application procedure f. The attached flowchart outlines the application procedure and decisionmaking process for sperm washing (Annex A, p.11). g. The couple apply to the Sperm Washing Panel for approval for sperm washing using the agreed application form (Template A). The Panel will make a funding decision as all the Greater Manchester PCTs have given the Panel delegated authority to do so. Page 6 of 14

7 h. The Sperm Washing Panel will liaise with the patient s PCT where appropriate - to ensure a decision is made as soon as possible. The Panel will keep the patient s HIV doctor informed of progress. Appeals i. We recognise that couples may wish to appeal against a decision to refuse funding for sperm washing. Appeals must be made in writing to the Sperm Washing Panel within eight weeks of the decision date. Waiting Times j. These guidelines aim to ensure that sperm washing applications are considered in a timely fashion and that the Sperm Washing Panel aims to make decisions within 6 weeks. Decisions will be delayed if further information is required from applicants or if cases have to be referred to the patient s PCT for decision. k. Application forms will be returned to the referring clinician for re-submission if the correct referral process (outlined in Guidance for the investigation of fertility for HIV patients (including access to sperm washing)) has not been followed. This is not limited to, but will include: the wrong application form being used; there is missing information or; the form has been submitted by a clinician other than the HIV+ patient s HIV doctor. l. The Sperm Washing Panel cannot control decision-making processes within PCTs but will liaise with PCT colleagues to promote timely decision-making as required. m. Waiting times will be regularly reviewed by the panel. Sperm Washing Panel n. The Sperm Washing Panel is a formal sub-group of the Greater Manchester Sexual Health Network Sexual Health Commissioning Leads Group. It has delegated authority from the Greater Manchester Primary Care Trusts (PCTs) via the Greater Manchester Sexual Health Network Board to make decisions or recommendations in respect of funding for appropriate individual applications. o. Patients will submit an application form to request funding via their HIV doctor. The Sperm Washing Panel s remit is to consider funding sperm washing for infection control. Applications for assisted conception are outside its remit. However, where a couple requires both sperm washing and assisted conception, the Panel will forward their request for assisted conception to the relevant Greater Manchester Primary Care Trust (PCT) where required. p. The document, Sperm Washing Panel Operational Procedure outlines how recommendations are reached. Page 7 of 14

8 4. Provider units a. The Human Fertilisation and Embryology Authority (HFEA) licenses the processing and handling of all gametes and embryos within the UK, including sperm washing. It will inspect premises, staff and patient information to ensure it is in accordance with the Human Fertilisation and Embryology Act and the HFEA Code of Practice. Within the code of practice of the HFEA are requirements for clinics to have regard to both the welfare of individuals seeking treatment and that of any child who may be born or affected as a result of treatments. Our provider unit must meet this requirement regardless of any eligibility criteria established by any commissioning body. b. Our provider unit is Liverpool Women s Hospital NHS Foundation Trust. Sperm washing and IUI is also provided at Chelsea and Westminster NHS Foundation Trust but it is rational and sensible to refer patients to Liverpool so that they can conveniently access services closer to home. c. Where other local centres demonstrate competence to provide sperm washing treatments, the Panel will consider referring patients for treatment. At present, the nearest centre is Liverpool. d. Separate laboratory facilities exist in Liverpool, Coventry and Chelsea and Westminster to wash HIV+ sperm in order to isolate samples and prevent cross-contamination. e. Sperm washing activity is provided through a Non-Contracted Arrangement with Liverpool Women s Hospital. NHS Manchester will explore alternative contracting arrangements as the level of activity increases. 5. Couples responsibilities a. National Institute for Health and Clinical Excellence (NICE) guidance 4 recommends that patients accessing fertility treatment maintain a healthy lifestyle in order to maximise the effectiveness of treatments. Since sperm washing is combined with intra-uterine insemination (IUI), we would expect patients to adhere to the following healthy lifestyle guidance although it is recognised that it will not be practical for the Sperm Washing Panel to actively monitor patients lifestyles. b. Patients should recognise that they can make a significant contribution to their own and their family s good health and wellbeing and we would expect patients to take responsibility in line with the NHS Constitution 5. Page 8 of 14

9 Smoking c. Both partners must be non-smoking in order to access any treatment and must continue to be non-smoking throughout. Providers should seek evidence from referrers and confirmation from couples. Providers should also include this undertaking on the consent form and ask couples to acknowledge that smoking will result either in cessation of treatment or treatment costs being applied. d. Smokers should be referred to smoking cessation support. Drugs and alcohol e. Couples will be asked to give assurance that their alcohol intake is not excessive and that they are not using recreational drugs. NHS guidelines recommend that men should not regularly drink more than 3-4 units of alcohol a day and that women should not regularly drink more than 2-3 units a day 6. f. NICE guidance 7 recommends that women who are trying to conceive should aim to drink no more than one or two units of alcohol once or twice a week. Healthy weight g. It is recommended that women achieve a body mass index (BMI) of before commencing sperm washing treatment in line with local and national guidelines 8 9. Patient responsibility and infection control h. Access to sperm washing is limited to a maximum of 6 cycles and couples must be responsible for preventing HIV and sexually transmitted infections by practising safer sex and using condoms properly, as guided by their doctors. Page 9 of 14

10 6. Drafting Notes Eligibility for NHS funding a. Men will be entitled to a maximum of 6 cycles of sperm washing with IUI funded by the NHS. We recognise that couples may have accessed sperm washing with IUI privately but we do not have the mechanisms to verify this information and our primary concern is infection control. Number of cycles b. After discussion with clinical and commissioning colleagues it is felt that 6 cycles of IUI is a reasonable limit. Same sex couples c. Female-female couples where one or both partners is HIV+ would need sperm donation. Sperm donations are screened for HIV so this would be outside the remit of this guidance. The Sperm Washing Panel and Greater Manchester Sexual Health Network cannot be involved in, nor take responsibility for sourcing sperm donations. d. Male-male couples where one or both partners is HIV+ would be advised by clinicians to use the HIV- partner s sperm for insemination. Where both partners are HIV+, one partner would need to apply for sperm washing with the surrogate. The NHS cannot be involved in, nor take responsibility for surrogacy arrangements. Age range of female partner e. A pragmatic approach has been taken to determine the age bracket for female partners and an upper age limit of 45 has been set to recognise that a woman s fertility declines with age. Page 10 of 14

11 7. Annex A Application and decision-making pathway (v.15 ( )) Fertility treatment only Couple (one or both HIV+) asks GU physician about conception. Clinician follows Guidance for the investigation of fertility for HIV patients (including access to sperm washing) HIV+ female HIV- male HIV+ female HIV+ male Timed AI* at home If both have documented WT* virus or identical RT* profiles then UPSI* If both have discordant resistance profiles If female <35 to try to conceive for 6-12/12 If female >35 to try to conceive for 6/12 If female <35 to try to conceive for 6-12/12 If female >35 to try to conceive for 6/12 If no fertility problems identified refer for sperm washing If unsuccessful conduct fertility investigations and refer to gynaecology for decision on appropriate treatment If unsuccessful conduct fertility investigations and refer to gynaecology for decision on appropriate treatment GU/HIV clinician writes to GM Sperm Washing Panel to request funding for appropriate fertility treatment using Template A. GU/HIV clinician writes to GM Sperm Washing using Template A to request funding for sperm washing Continued overleaf Continued overleaf Fertility treatment and/or sperm washing * Key HIV- female HIV+ male Conduct fertility investigations and refer to gynaecology before couple attempt to conceive If fertility problems identified refer for sperm washing and appropriate fertility treatment GU/HIV clinician writes to GM Sperm Washing using Template A to request funding for sperm washing and appropriate fertility treatment Continued overleaf AI = artificial insemination GU = genito-urinary RT = resistance test UPSI = un-protected sexual intercourse WT = wild type Page 11 of 14

12 Application fits the PCT s criteria for automatic referral This is Process 1 Application does not fit the PCT s criteria for automatic referral SW Panel write to referring clinician and referring PCT outlining decision using Letter 1 SW Panel write to PCT asking for a decision using Letter 2 PCT makes decision and informs clinician, SW Panel and patient Sperm Washing Panel updates database and sets review date This is Process 1 SW Panel considers sperm washing application against policy criteria This is Process 2 Does not meet criteria Meets criteria Decision within PCT delegated limits? Decision outside PCT delegated limits? SW Panel write to referring clinician and PCT outlining decision using Letter 5 SW Panel write to referring clinician and PCT outlining decision using Letter 3a SW Panel write to PCT asking them to make decision using Letter 3 PCT makes decision and informs clinician, SW panel and patient Sperm Washing Panel updates database and sets review date SW Panel considers sperm washing application using Process 2 above SW Panel considers fertility treatment application using Process 1 above N.B. Check the sperm washing and fertility treatment criteria before sending out any letters. Clinicians should only receive one letter outlining next steps for both applications. If both funding applications approved SW Panel write to referring clinician and couple s PCT(s) outlining decision using Letter 6 If only sperm washing criteria met SW Panel write to referring clinician and couple s PCT(s) using Letter 7 If only fertility treatment criteria met SW Panel refer to couple s PCT(s) using Letter 8 PCT makes relevant decisions and informs clinician, SW panel and patient Sperm Washing Panel updates database and sets review date Page 12 of 14

13 8. References 1 British HIV Association (BHIVA), British Association for Sexual Health and HIV (BASHH) and the Faculty of Family Planning and Reproductive Healthcare (FPP) (2007), UK Guidelines for the Management of Sexual and Reproductive Health (SRH) of People living with HIV Infection; (British HIV Association (BHIVA). BASHH: London, p British HIV Association (BHIVA), British Association for Sexual Health and HIV (BASHH) and the Faculty of Family Planning and Reproductive Healthcare (FPP) (2007), UK Guidelines for the Management of Sexual and Reproductive Health (SRH) of People living with HIV Infection; (British HIV Association (BHIVA). BASHH: London, p Department of Health (2003), Effective Commissioning of Sexual Health and HIV Services, Department of Health, London, p.9. Available at: s/digitalasset/dh_ pdf. Accessed: 10 November National Collaborating Centre for Women s and Children s Health (2004), Fertility: Assessment and treatment for people with fertility problems. National Institute for Clinical Excellence (NICE). Available at: Accessed: 7 June Department of Health (2010), The NHS Constitution: The NHS belongs to us all. Department of Health: London. Available at: aspx. 6 NHS Choices (2010), Effects of Alcohol. Available at: Accessed 21 June National Collaborating Centre for Women s and Children s Health (2004), Fertility: Assessment and treatment for people with fertility problems. National Institute for Clinical Excellence (NICE). Available at: Accessed: 21 June Carroll, P. (unknown), Draft North West SHA Proposal: Assisted conception eligibility criteria. Unpublished. 9 National Collaborating Centre for Women s and Children s Health (2004), Fertility: Assessment and treatment for people with fertility problems. National Institute for Clinical Excellence (NICE). Available at: Accessed: 7 June Page 13 of 14

14 9. Background reading Cheshire, S., O Donnell, C., Nelson, S., Goodship, H., Stacy, D., Young, C., Lewis- Jones, C. (2010) Final Report of the Expert Group on Commissioning NHS Infertility Provision (unpublished) Department of Health (2010), The NHS Constitution. London: Department of Health Fakoya, A., Lamba, H., Mackie, N., Nandwani, R., Brown, A., Bernard, E.J., Gilling- Smith, C., Lacey, C., Sherr, L., Claydon, P., Wallage, S., Gazzard, B., (2007) UK Guidelines for the management of sexual and reproductive health (SRH) of people living with HIV infection. Available at: [Accessed 7 June 2010] Modi, A., O Donnell, C. (2009) Interim Guidance for North West PCTs: Assisted Reproductive Techniques to prevent transmission of viral disease (unpublished) NHS Manchester (2009) Individual Funding Requests (IFR) Policy and Operational Procedure (unpublished) Ray, S. (2006) Sperm Washing for HIV Discordant Couples (unpublished) Greater Manchester and Lancashire and South Cumbria Assisted Conception Taskforce (2006) An Integrated Approach to NHS Funded Treatment of Subfertility: Eligibility criteria (unpublished) Carroll, P. (2009) Draft North West SHA Proposal: Assisted conception eligibility criteria (unpublished) Page 14 of 14