Commissioning Policy For In Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) within Tertiary Infertility Services

Transcription

1 Commissioning Policy For In Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) within Tertiary Infertility Services Reference No: Version: 2 Ratified by: EMSCGP006V2 EMSCG Date ratified: 25 March 2011 Name of originator/author: Name of responsible committee/individual: David Giffard EMSCG Clinical Priorities Group Date issued: 1 April 2011 Review date: 31 March 2012 Target audience: PCT Commissioners, Providers of Service Distributed via: Postmaster Website: Page 1 of 1

2 East Midlands Specialised Commissioning Group Commissioning Policy for Tertiary Infertility Services incorporating IVF/ICSI Draft Section/Para/ Appendix Version Control Sheet Version/Description of Amendments Date 1 1 st Draft DG 2 Criteria Woman s age amended to reflect current position 3 Contents The statement Patients who have been referred by their GP for infertility treatment on or after 1 December 2010 will be treated in accordance with this policy. Those referred prior to this date will be treated in accordance with the EMSCG Commissioning Policy for IVF/ICSI within tertiary Infertility Services policy issued on 1 August 2008 has been removed Treatment Within the definition of a completed IVF/ICSI cycle the term viable pregnancy has been replaced with live birth The statement Viable Pregnancy = To be established by an ultrasound scan before the end of the 8 th week of pregnancy has been removed Resources Implications Review Table amended to reflect drug & treatment costs combined Review date changed to reflect amendments to policy DG DG Author/Amended by Page 2 of 2

3 East Midlands Specialised Commissioning Group Commissioning Policy for Tertiary Infertility Services incorporating IVF/ICSI Contents i. Version control sheet Section Page 1 Policy 4 2 Criteria 4 3 Treatment 5 4 Epidemiology 6 5 Resource Implications 7 6 Evidence Base (and Health Benefits) 7 7 Mechanism for Funding 7 8 Review Date 7 9 Glossary 8 10 References 9 Page 3 of 3

4 1 Policy IVF can be a legitimate medical intervention as part of NHS provision where a couple have a medical reason for being unable to conceive a child. The SCG accepts that it may not always be possible to identify the precise nature of the medical reason and thus infertility is defined as failure to conceive after frequent unprotected sexual intercourse for one to two years in couples in the reproductive age group or by undertaking 6 cycles of Donor Insemination without conceiving or by having a defined tubal blockage thereby preventing conception. Couples who are able to demonstrate this and fulfil the following criteria will be eligible for tertiary infertility treatments under this agreement. All other treatments that may be required before couples are referred for IVF/ICSI treatment are PCT commissioned and are not covered by this policy. These include Donor Insemination, Intra Uterine Insemination & Ovulation Induction. Patients should be referred and treated in accordance with the 18 week pathway rules. 2 Criteria Woman s Age years (Stimulation treatment must take place before the patients 40th birthday) Man s Age 55 years or younger Woman s BMI >19 BMI <30 Man s BMI BMI <35 Welfare of Child The welfare of any resulting children is paramount. In order to take into account the welfare of the child, the centre should consider factors which are likely to cause serious physical psychological or medical harm, either to the child to be born or to any existing children of the family. This is a requirement of the licensing body, Human Fertilization and Embryology Authority. Family Structure No living children from current or previous relationship(s), including adopted children, but excluding foster children. There needs to be an explicit and recorded assessment that the social circumstances of the family unit have been considered within the context of the assessment of the welfare of the child. Smoking Both partners must not be a current smoker The establishment of the access criteria should be undertaken by the patients GP utilising the EMSCG GP referral form before onward referral to the appropriate provider for further Page 4 of 4

5 investigations and treatment and the patient should be informed of their likely eligibility for tertiary infertility treatment. The secondary care provider, where separated from the Tertiary provider, should in addition establish the patient s eligibility for IVF/ICSI treatment before onward referral. Couples should have a prognostic estimate that the successful outcome of an IVF/ICSI cycle will be greater than 10% In addition to the previous criteria the following patients will not be eligible for NHS funded IVF/ICSI treatment: Sterilised patients and those patients who have had a sterilisation reversed Surrogacy is not commissioned as part of this policy 3 Treatment Couples meeting the above criteria will be eligible to receive a maximum of 1 completed cycle of IVF/ICSI*. In addition couples who have self funded will be entitled to one NHS complete cycle provided they have not received more than two completed cycles of privately funded treatment. Abandoned cycles and the transfer of frozen embryos will not constitute a cycle for the purposes of establishing entitlement to NHS funding. Where couples have previously self funded and frozen embryos exist, the couple must utilise any viable embryos, rather than undergo ovarian stimulation, egg retrieval and fertilisation again. *Definition of a completed/abandoned cycle: Completed IVF/ICSI cycle = ovarian stimulation, egg recovery, fertilisation and SINGLE fresh embryo transfer. This includes the provision for further transfers of frozen embryos where the initial procedure does not result in a live birth and the subsequent storage of embryos. For frozen embryos only, patients may have a maximum of two embryos implanted per transfer in conjunction with discussions with the treating clinician regarding the best clinical option based on embryos available. The NHS will fund all frozen embryo transfers until all are used or a live birth occurs regardless of age, however initial egg stimulation for FER must take place before the patient reaches their 40 th birthday Abandoned IVF/ICSI cycle = Prior to egg retrieval, usually due to lack of response (where less than 3 mature follicles are present) or excessive response to gonadotrophins; failure of fertilisation and failure of cleavage of embryos. Couples will be eligible for one abandoned cycle as part of their treatment. In addition to the above certain patients may require additional clinical services to enable the IVF/ICSI treatment to be carried out. Where these are deemed to be clinically appropriate the following treatments will be commissioned as part of this policy: Surgical Sperm Recovery, Sperm & Egg Freezing, Donor Sperm, Egg Donation Page 5 of 5

6 4 Epidemiology Around 84% of couples attempting to conceive are successful after trying to one year, after two years this figure rises to 92%. Female fertility declines with age and for women aged 38, only about 77 out of 100 who have regular unprotected sexual intercourse will get pregnant after 3 years. At any point in time, the estimated prevalence of infertility is one in seven couples in the UK. A typical Primary Care Trust can expect about 230 new consultant referrals (couples) per 250,000 head of population per year. The need for such services may increase due to the trend towards later first pregnancies and an increasing number of remarriages. Demand is increasing due to more public awareness of treatment possibilities. It is likely that there is unexpected and/or unmet demand, particularly from women with secondary infertility (those who have conceived before but do not necessarily have a child). The following table summarises the expected demand per year for the East Midlands of infertile couples based on new consultant referrals (only a proportion of these referrals will lead to IVF/ICSI treatments): Area Total Population Demand estimate per year (230 couples per 250,000 head of population) Bassetlaw PCT 108, Derby City PCT 285, Derbyshire County PCT 712, Leicester City PCT 342, Leicestershire County & Rutland PCT 660, Lincolnshire PCT 715, Northamptonshire PCT 680, Nottingham City PCT 305, Nottinghamshire County PCT 650, East Midlands Total 4,457, Page 6 of 6

7 5 Resource Implications Currently East Midlands PCTs pay the following prices for tertiary infertility treatments: Treatment 2010/11 Cost per cycle IVF 2,600* (includes all associated drug costs) ICSI 3,100* (includes all associated drugs costs) FER 900 (includes all associated drugs costs) Surgical Sperm Recovery 850 Donor Sperm 600 per ampoule Donor Egg IVF 1,500 (in addition to IVF & drugs package) Donor Egg ICSI 1,700 (in addition to ICSI & drugs package) *includes blastocyst treatment where clinically appropriate (and meets the required definition) also includes embryo storage and freezing up to 3 years. 6 Evidence Base (and Health Benefits) Please refer to the National Institute for Health & Clinical Excellence (NICE) Clinical Guideline Fertility assessment and treatment for people with fertility problems (CG11) for further information 7 Mechanism for Funding Activity will be funded via PCT contributions to the Specialised Services Budget. 8 Review 31 March 2012 Page 7 of 7

8 9 Glossary of terms: Term In Vitro Fertilisation (IVF) Intra-cytoplasmic Sperm Injection (ICSI) Embryo Blastocytes Frozen Embryo Replacement (FER) Cleavage stage embryo s Embryo transfer Human Fertlisation and Embryology Authority (HFEA). Foetus Gonadotrophins Ovarian Stimulation Oocyte Donor Insemination (DI) Body Mass Index (BMI) National Institute for Health & Clinical Excellence (NICE) Meaning This is a process whereby eggs are removed from the ovaries and fertilised with sperm in the laboratory. It is utilised in the PGD process in order for the fertilised eggs (embryo s) to be tested for a specific genetic abnormality, with an unaffected embryo subsequently being placed in the woman s womb. (HFEA, 2009). This is a technique that can be used in IVF whereby a sperm is injected into the egg to assist in fertilisation. (NHS Direct, 2009). A fertilised egg. Any undifferentiated embryonic cell (Lawrence, 2000: 75) Where an excess of embryos is available, these embryos may be cryogenically frozen for future use. Once thawed, these embryos are transferred to the patient as a frozen cycle. This is when the fertilised cell has started to divide. The replacement of embryos back into the female patient UK s independent regulator overseeing the use of gametes and embryos in fertility treatment and research. (HFEA, c, 2009) The unborn child after the end of the eighth week of pregnancy to the moment of birth.(nsc, 2009) Hormones that stimulate the function of the organs in which reproductive cells are produced (Lawrence, 2000; 254) A technique used in IVF to assist in egg retrieval. A not yet fully developed egg cell. The introduction of donor sperm into the vagina, the cervix or womb itself Body Mass Index (BMI) is a number calculated from a person's weight and height. BMI provides a reliable indicator of body fatness for most people and is used to screen for weight categories that may lead to health problems. NICE is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health. Page 8 of 8

9 10 References NICE Clinical Guideline 11, Fertility: assessment and treatment for people with fertility problems (2004) Derbyshire County and Derby City infertility policy (2006) Protocol for the provision of a specialised assisted conception service for Leicester, Leicestershire and Rutland primary care trusts (2006) TrentCOM Commissioning Policy for in vitro fertilization (IVF) and Intracytoplasmic sperm injection (ICSI) (2005). Page 9 of 9