NORCOM COMMISSIONING POLICY

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1 NORCOM COMMISSIONING POLICY North Derbyshire, South Yorkshire and Bassetlaw Commissioning Consortium NHS Eligibility Criteria for In vitro fertilisation (IVF) Intracytoplasmic sperm injection (ICSI) and Intra-uterine insemination (IUI) treatment for people with infertility in North Derbyshire, South Yorkshire and Bassetlaw Primary Care Trusts. Completed: November 04 Effective date: 1 April 2005 Reviewed October 2005:.1Extended to 31 March 2006 (11 November 2005 NORCOM meeting) Reviewed January 2006: Extended to 31 March 2007 (10 February 2006 NORCOM meeting) Reviewed January 2007: Extended to 31 March 2008 (12 January 2007 NORCOM meeting) Reviewed March 2008 Reviewed September 2008 Extended to 30 September 2008 (14 March 2008 Y&H SCG South meeting) Extended to 31 March 2009 (12 September 2008 Y&H SCG South meeting) Reviewed January 2009 Updated and Extended to 31 March 2010 (9 January 2009 Y&H SCG South meeting) ORIGINALLY PREPARED BY ROTHERHAM PCT ON BEHALF OF NORTH DERBYSHIRE, SOUTH YORKSHIRE AND BASSETLAW COMMISSIONING CONSORTIUM (NORCOM). UPDATED BY THE SCT ON BEHALF OF ROTHERHAM, SHEFFIELD, DONCASTER AND BARNSLEY PCTS. 09.doc - 1 -

2 Introduction This paper sets out the criteria for access to NHS funded specialist fertility services for patients who are the responsibility of the 4 PCTs covered by the South Yorkshire Commissioning Consortium (SCG South). It sets out the minimum entitlement for NHS funding of In vitro fertilisation (IVF) Intracytoplasmic sperm injection (ICSI) and Intra-uterine insemination (IUI) across the consortium. There are currently differences between the PCTs in respect of existing specialist fertility treatment policies. Phased introduction will be required to bring all health communities up to a common policy. It is envisaged that each PCT will adopt at least the minimum eligibility criteria. It is not intended that any PCT or health community adopt a more restrictive policy than their current policy. Initial investigation of patients is usually carried out by a network of specialist gynaecologists at District General Hospitals throughout the SCG South area. In any healthcare system there are limits set on what is available and on what people can expect. Primary Care Trusts (PCT s) are required to achieve financial balance; they have a complex task in balancing this with individuals rights to health care. It is the purpose of the criteria set out here to make the limits on fertility treatment fair, clear and explicit. Nationally this is undertaken through the work of the National Institute for Clinical Excellence (NICE) and this paper reflects this. The paper should be read in conjunction with the NICE Fertility Guidance available on their web site at CG011niceguideline.pdf.url (for ease of reference the NICE Guidance practice algorithms are included as part of this document at Appendix C). The NICE Guidance places NHS assisted fertility services firmly in the mainstream of NHS provision. Patients as a result will expect the NHS to provide this. This document includes recommendations for the first part of the phased introduction of the Guidance. Further phases of the implementation will be defined in the light of future Department of Health requirements and the prioritisation and availability of resources. EXCEPTIONAL CIRCUMSTANCES Each PCT in SCG South has a procedure for dealing with patients who consider themselves exceptions to these criteria. These patients may approach their PCT or General Practitioner who will be aware of these arrangements. Abbreviations used in the document are explained in Appendix A. Definitions of technical terms are contained in Appendix B. 09.doc - 2 -

3 Eligibility Criteria 1. Availability of In vitro fertilisation (IVF), Intracytoplasmic sperm injection (ICSI) Couples suffering from infertility will be eligible for IVF and ICSI. Infertility is the failure to conceive after regular unprotected sexual intercourse for 2 years. Where there is clear reproductive pathology, couples with infertility of any duration will be considered. This will include couples who cannot achieve full sexual intercourse due to disability. To achieve full compliance with the NICE Guidance an increase in the availability of IVF and ICSI will require phased introduction. No element of surrogacy related infertility treatment will be eligible for NHS funding. Any cycle of infertility treatment whether self or NHS funded will be taken into account when determining NHS funding entitlement. Initial Phase All women aged 23 to 39 who meet the NORCOM eligibility criteria will be offered a minimum of one full cycle of IVF. This includes ovarian stimulation, egg recovery, embryo transfer and frozen embryo transfers until all frozen embryos are used. Couples who have a definitively diagnosed cause of their infertility of any duration, or unexplained infertility of at least three years duration, and where the woman s age is 39 years and 364 days or less should be offered one complete full cycle. Unexplained infertility includes mild endometriosis and mild semen abnormality. One complete full cycle of IVF is ovarian stimulation, egg recovery and embryo transfer and frozen embryo transfers. Where frozen embryos are available they should be transferred before the next stimulated treatment cycle. 09.doc - 3 -

4 2. Existing Children Only couples with no children (including adopted children) living with them 1, who fulfil all other criteria, will be eligible. In the interests of welfare of the child where a previous child has been taken into care as a result of child protection procedures and is not living with that parent then that parent will not be eligible. 3. Female age Assisted reproductive technology will be available to women aged 23 to 39 years and 364 days at the start of a treatment cycle. A treatment cycle begins with the administration of drugs for IVF, IUI and hormone replacement treatment. 1 st definitive treatment within specialist fertility services should commence within 18 weeks of the referral into tertiary care. Where further tertiary treatment is required, this should be completed within 18 weeks of the decision to treat (Scenarios enclosed in Appendix D). Once treatment is started a woman will be entitled to one full cycle even if they reach age 40 during treatment. All treatment will cease by the woman s 42 nd birthday. 4. Male age Assisted reproductive technology will be available to men aged less than 55 years and 0 days at the start of a treatment cycle. 5. Availability of Intrauterine Insemination (IUI) Couples who fail to conceive after 2 years unprotected sexual intercourse and fulfill the eligibility criteria for IVF may be offered intrauterine insemination if clinically appropriate. Couples will normally be offered no more than 6 IUI treatments. Couples who do not conceive after IUI will have a full entitlement to IVF in line with the stated eligibility criteria. 1 1 The definition of living with should be interpreted in consistence with the Community Charge Benefits (General) Regulation 1989, which states that, (2) Where a child or young person spends equal amounts of time in different households, or where there is a question as to which household he is living in, the child or young person shall be treated for the purposes of paragraph (1) as normally living with- (a) the person who is receiving child benefit in respect of him; or (b) if there is no such person- (i) where only one claim for child benefit has been made in respect of him, the person who made that claim, or (ii) in any other case the person who has the primary responsibility for him. 09.doc - 4 -

5 6. Obesity Women with a body mass index of more than before starting a course of IVF ICSI or IUI will not be eligible. Women with a body mass index of more than 29 are likely to take longer to conceive. 7. Low Weight Women with a body mass index of less than 19.0 before starting a course of IVF ICSI or IUI will not be eligible. Women with a body mass index of less than 19 are less likely to conceive. 8. Donor Sperm This will be funded only where the male has azospermia or severe oligospermia or to avoid transmission of inherited disorders to a child where the couple meet the other eligibility criteria. This would mean up to 4 cycles of donor insemination. In addition IUI if required and in addition IVF entitlement if required. 9. Donor Egg This will be available to women who have undergone premature ovarian failure due to an identifiable pathological or iatrogenic cause before the age of 40 or to avoid transmission of inherited disorders to a child where the couple meet the other eligibility criteria. 10. Egg and Sperm Storage Egg and Sperm will be stored according to HFEA Guidance. This includes freezing of sperm for patients undergoing chemotherapy and radiotherapy. Patients whose sperm has been frozen prior to chemotherapy or radiotherapy will be entitled to NHS funded infertility treatment provided they meet the eligibility criteria. 11. Sterilisation Couples where one or both partners have been sterilised will not be eligible for treatment. 12. Review 09.doc - 5 -

6 These treatment criteria were reviewed in October 2005, January 2006, January 2007, March 2008, September 2008 and January The treatment criteria will be reviewed again as part of a full review of fertility commissioning policy across Yorkshire and The Humber during 2009/ Future Phasing Further phases of the implementation of the NICE Guidance will be defined in the light of future Department of Health requirements and the prioritisation and availability of resources. 27 October 2004 Updated 9 January doc - 6 -

7 Appendix A Abbreviations used BMI DI GP HFEA ICSI IUI IVF NICE PCT Body Mass Index Donor Insemination General Practitioner Human Fertilisation and Embryology Authority Intracytoplasmic sperm injection Intra-uterine insemination In vitro fertilisation National Institute of Clinical Excellence Primary Care Trust 09.doc - 7 -

8 Appendix B Definitions Term Definition 1 Further information BMI The healthy weight range is based on a measurement known as the Body Mass Index (BMI). This can be determined if you know your weight and your height. This calculated as your weight in kilograms divided by the square of your height in metres. In England, people with a body mass index between 25 and 30 are categorised as overweight, and those with an index above 30 are categorised as obese. BBC Healthy Living NHS Direct ICSI IUI Intra Cytoplasmic Sperm Injection (ICSI): Where a single sperm is directly injected into the egg. Intra Uterine Insemination (IUI): Insemination of sperm into the uterus of a woman. Glossary, HFEA As above IVF In Vitro Fertilisation (IVF): Patient's As above eggs and her partner's sperm are collected and mixed together in a laboratory to achieve fertilisation outside the body. The embryos produced may then be transferred into the female patient. DI Donor Insemination (DI): The introduction of donor sperm into the vagina, the cervix or womb itself. As above 09.doc - 8 -

9 09.doc - 9 -

10 Appendix D Scenarios to accompany the 18 Weeks Fertility Commissioning Pathway The scenarios in this document should be read to aid understanding of the application of 18 Weeks rules to the fertility commissioning pathway. This should be read in conjunction with local guidelines for the commissioning of fertility services. Scenario 1 GP refers a couple, both under 35 years old, for investigations into infertility of three years standing, after performing baseline investigations. The semen analysis is abnormal. Consultant repeats the semen analysis in 3 months time for clinical reasons. Outcome A: repeat sample is abnormal, decision to treat with IVF/ICSI Outcome B: repeat semen analysis normal, further investigations confirm unexplained fertility. s Clock start on receipt of referral (or conversion of UBRN if via Choose and Book) Clock stop for active monitoring on date seen in outpatients where the decision to repeat the semen analysis in 3 month is made (as per NICE guidelines). Outcome A: New clock start at Decision to Treat with IVF/ICSI. Outcome B: New clock start at decision to undertake further investigations. Scenario 2 Couple have been trying to conceive for 12 months, GP sends into secondary care after completing baseline investigations all normal. Couple seen by Consultant in secondary care, where following further investigations no reason for their infertility can be found. Consultant sends couple back to GP and advises referral after a further 12 months trying to conceive naturally (as per PCT guidelines) Clock starts on receipt of referral in secondary care, or UBRN conversion, and stops: For no treatment at referral back to GP If the couple are being referred for counselling or other support in secondary care then the clock stops at the first counselling (or other) appointment Scenario 3 G:\Commissioning Policies\Commissioning Policies - Draft version\norcom Fertility Policy Jan 09.doc

11 GP refers a couple to secondary care after preliminary investigations for infertility. Investigations in secondary care confirm tubal disease and a referral is made to tertiary care to consider IVF. In tertiary care a baseline scan demonstrates what appears to be a hydrosalpinx. A laparoscopy confirms the hydrosalpinx, which is surgically removed, and a few weeks later the patient commences treatment with IVF. Clock starts on receipt of referral in secondary care and stops at the removal of the hydrosalpinx, as this is the start of the definitive treatment process. Providers must ensure that systems are in place to protect the patient toensure there is no undue capacity and/ or funding related delay before she commences IVF treatment. Scenario 4 GP refers a couple for investigation for infertility after completing preliminary tests as per local protocol. Further investigations in secondary care indicate polycystic ovaries with anovulation. Both fallopian tubes are patent. Ovulation induction therapy commences with clomifene, monitored by ultrasound, but is unsuccessful, despite increasing the dose of clomifene. Gonadotropin therapy is successful in inducing ovulation, but there is no conception after 6 cycles. Consultant in secondary care refers couple for IVF. Couple seen in tertiary care and counselled about the procedures and risks of IVF. Outcome A: Couple wish to proceed immediately with treatment and treatment starts during the next menstrual cycle Outcome B: Couple wish to proceed immediately with treatment but the trust that cannot start treatment for 6 months due to capacity restraints Outcome C: Couple wish to have time to consider their options for a week before proceeding with treatment Clock starts on receipt of referral in secondary care, or conversion of UBRN, and stops at the start of treatment with clomifene. A new clock starts upon receipt of the referral / conversion of UBRN for IVF and stops or continues in the examples: Outcome A: Clock stops using active monitoring at the DTT. Due to the different types of treatment available and the variation of menstrual cycle and treatment start dates within the cycle, treatment can very often not start immediately. Outcome B: The clock keeps ticking as use of active monitoring to stop the clock where there are capacity (or funding) restraints is inappropriate. Outcome C: There is difference between wanting time to think (not a clock stop), and taking an active decision to delay (patient initiated active monitoring). The default position is that the clock should continue but that local access policies may, with agreement of the patients, stop the clock as patient initiated active monitoring should they wish to take longer than the amount of time agreed in the local policy. Therefore, in outcome C, the clock continues. Had the couple wanted to delay for longer, then Patient Initiated Active Monitoring could be applied. Scenario 5 A couple present in primary care with a failure to conceive after one year of unprotected intercourse. Preliminary investigations demonstrate the man has G:\Commissioning Policies\Commissioning Policies - Draft version\norcom Fertility Policy Jan 09.doc

12 azoospermia. GP refers the couple direct to tertiary care. Further investigations indicate obstructive azoospermia is the likely diagnosis. The man is offered a diagnostic surgical sperm retrieval (SSR) with a view to freezing recovered sperm. Outcome A: IVF/ICSI offered when sperm successfully recovered Outcome B: Further investigations confirm the man has congenital absence of the vas deferens due to a cystic fibrosis mutation. His partner is screened and the couple are referred for genetic counselling. Clock starts on receipt of referral in tertiary care/conversion UBRN. Outcome A: First clock stops at the offer of IVF/ICSI after SSR if clinically appropriate (as per scenario 4). Outcome B: Clock stops at commencement of genetic counselling, and IVF/ICSI commences when patient willing and able with a new clock start. Scenario 6 GP refers to secondary care for investigation into infertility. Secondary care performs a diagnostic HSG, which is inconclusive. Outcome A: A diagnostic and operative laparoscopy confirms bilateral tubal occlusion not suitable for surgery and the patient is referred for IVF. Outcome B: A diagnostic and operative laparoscopy confirms peritubal adhesions that are divided restoring patency. Patient is advised to continue to try and get pregnant during an agreed time period. Patient returns to hospital at the end of this given time period after failing to conceive, and is referred to specialist centre to consider IVF treatment. Clock starts on receipt of referral in secondary care/conversion of UBRN. Outcome A: If patency is not restored during the laparoscopy then clock continues ticking with the referral to specialist centre for IVF Outcome B: Where tubal patency restored, pregnancy might occur naturally, therefore the clock stop is after the laparoscopy using active monitoring. If no conception within agreed time period receipt of referral for IVF starts a second clock. Scenario 7 GP refers couple with two years of primary infertility to infertility clinic in secondary care after completing preliminary investigations. The patient s history and examination suggest endometriosis. At laparoscopy the diagnosis of endometriosis is confirmed (ASRM grade II disease), and all visible lesions are treated by diathermy. The couple are asked to try to conceive naturally for nine months. After nine months, the couple return to clinic as the woman has not conceived. Consultant refers to tertiary care for consideration of IVF. First clock starts when referral received/ubrn converted and stops when woman has a diagnostic and treatment laparoscopy. Second clock starts when referral received/ubrn converted requesting G:\Commissioning Policies\Commissioning Policies - Draft version\norcom Fertility Policy Jan 09.doc

13 supraspecialist treatment of infertility. Scenario 8 GP refers couple with two years of primary infertility to infertility clinic in secondary care after completing preliminary investigations. The patient s history and examination suggest endometriosis. At laparoscopy the diagnosis of endometriosis is confirmed (ASRM grade IV disease). Surgery is arranged in a tertiary centre and pelvic disease removed. Post-operative ovarian suppression with GnRH analogue (Zoladex) for 6 months is recommended, followed by IVF. Clock starts when referral received / UBRN converted and stops when has definitive surgery in tertiary centre. At end of 6 months IVF should be initiated without need for clock to restart. As for scenario 3, providers must ensure that systems are in place to protect the patient to ensure there is no undue capacity and/or funding related delay before she commences IVF treatment. Scenario 9 GP refers a couple directly through to tertiary care as the woman is known to have premature ovarian failure. The couple request egg donation and after appropriate counselling the couple decide they would like to proceed with egg donation. There is a shortage of egg donors. The clock starts when received / UBRN converted and stops with active monitoring when they are offered egg donation. This is similar to other specialities where donor organs are in short supply. G:\Commissioning Policies\Commissioning Policies - Draft version\norcom Fertility Policy Jan 09.doc

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