Agenda Item No: 13 Date of Meeting: 26 th November 2015 Governing Body Meeting Paper Title: East and North Hertfordshire CCG (ENHCCG) Policy on Fertility treatment and referral criteria for specialist level assisted conception - 2015 update Decision Discussion Information Follow up from last meeting Report author: Report signed off by: Dr Raj Nagaraj Alan Pond Purpose of the paper: Purpose: The purpose of this paper is to seek approval of the Governing Body on the revisions to ENHCCG policy on Specialist Fertility treatment. Context for policy update: 1. To consider ENHCCG criteria against recently published NICE evidence update in March 2015. https://www.nice.org.uk/guidance/cg156/evidence/fertilit y-evidence-update-2 2. ENHCCG has also received request for 1. Inclusion of Anti mullerian hormone (AMH) as a measure of ovarian reserve in place of currently used measure of Follicular Stimulating Hormone (FSH) 2. Clarity on the care pathway for same sex couple with regard to application of BMI criteria and smoking status 3. A public petition seeking a change to parental status and children from previous relationships. Following are the key recommendations: 1. Test for ovarian reserve- Anti mullerian hormone (AMH) to replace Follicular Stimulating Hormone (FSH) as a measure of ovarian reserve. A patient should have AMH of more than 5.4pmol/l to be eligible for treatment. 2. BMI criteria in female same sex couple will only apply to person undergoing fertility treatment 3. In same sex couple both partners need to be nonsmokers at the time of treatment 4. in parental status as defined in Section 1.3 (9) of the ENHCCG policy 1
Conflicts of Interest involved: Recommendations to the Governing Body: None 1.The Governing Body is asked to approve the revisions to the policy as set out in the paper 2. Governing Body to note the next revision to the policy will be undertaken after the NICE update in 2017 2
East and North Hertfordshire CCG Policy on Fertility treatment and referral criteria for specialist level assisted conception -2015 update Background: The ENHCGG specialist fertility treatment policy was originally agreed in January 2014 updated in December 2014 and was next due for review in October 2015. The ENHCGG Specialist Fertility Treatment policy is based on NICE guidelines published in 2013 and recommendations from the East of England Clinical subgroup on specialist fertility treatment. Available at http://www.enhertsccg.nhs.uk/sites/default/files/referrals/ivf/enhccg-ivf-policy.pdf NICE has published an evidence update in March 2015. https://www.nice.org.uk/guidance/cg156/evidence/fertility-evidence-update-2. This Evidence Update provides summary of selected new evidence published since 2013. NICE guidance is due for an update in 2017 and according to NICE a final decision on whether the guidance should be updated will be made by NICE according to NICE processes and methods. However the ENHCCG has also received requests from clinicians and members of the public to consider changes to certain criteria including: 1. Inclusion of Anti mullerian hormone (AMH) as a measure of ovarian reserve in place of currently used measure Follicular Stimulating Hormone (FSH) 2. Clarity on the care pathway for same sex couple with regard to application of BMI criteria and smoking status 3. A public petition seeking a change to parental status and children from previous relationships. Appendix 1 provides an assessment of ENHCCG policy criteria against current evidence and recommendations on the measures of ovarian reserve (FSH vs AMH) parental status and BMI and smoking criteria in female same sex couple. Following are the key recommendation 1. Test for ovarian reserve: the clinical group recommended change to anti- Müllerian hormone (AMH) as a measure of ovarian reserve inplace of FSH which is currently used. A patient should have AMH of more than 5.4pmol/l to be eligible for treatment The rationale for the change is: AMH is one of the NICE recommended measures of ovarian reserve AMH has significantly less inter- and intra-menstrual cycle variability compared with FSH testing, AMH can be measured at any point of the menstrual cycle unlike FSH, which is only interpretable when measured during the first few days of the cycle Estimation of AMH is based on a single measurement compared to serial testing for FSH The costs of AMH range from 45-100 compared to cost of FSH which ranges from 28-50. However as women undergo more than one FSH measurement AMH is a cost saving option 2. BMI criteria in same female sex couple should only apply to person undergoing fertility treatment. The rationale- in a same sex couple, the BMI of the untreated partner does not have any influence on the outcomes of fertility treatment of her partner. Therefore the BMI criterion will only apply to person undergoing fertility treatment. 3. However, in female same sex couple, as in heterosexual couple, both partners are expected to be non-smokers because of the impact of passive smoking on fertility. 3
4. in parental status as defined in Section 1.3 (9) of the ENHCCG policy. Section 1.3 (9) of the IVF policy covers parental status and states Couples are ineligible for treatment if there are any living children from the current or any previous relationships, regardless of whether the child resides with them. This includes any adopted child within their current or previous relationships; this will apply to adoptions either in or out of the current or previous relationships. The Governing body workshop received a public petition requesting to change this criteria. The petition is to amend the current policy specifically relating to the removal of any reference to patient s not being eligible to receive IVF treatment on the NHS if they have a child from a previous relationship. The rationale for the above recommendation are:: Any expansion of the eligibility criteria in the policy will lead to an increase in the number of couples seeking and receiving treatment and therefore costs. The CCG currently has no information on the scale of likely increase in referrals should the policy be changed and therefore additional resources required. NHS is currently under severe financial pressures, needing to make additional saving by limiting the demand and improving the efficiencies. In the context of current NHS financial constraints there is a very little scope for any additional investment to finance additional activity that could result from expansion of eligibility criteria. The purpose of policy is to maximise the benefits from limited resources and therefore infertile couples who have no children from their current or previous relationships and do not have an adopted child are prioritised. 4
Appendix 1 ENCGG Specialist Fertility treatment policy 2015 Update for consultation No Criterion Description *Evidence/Rationale to support change in criteria 1 Follicle stimulating hormone (FSH) level To be eligible, the patient should have an FSH of <9 IU/L) on day two of any menstrual cycle done within three months of referral from secondary care to a specialist IVF provider. Section 1.3.3.2 of NICE guidance contains following recommendation on testing for ovarian reserve: Use ONE of the following measures to predict the likely ovarian response to gonadotrophin stimulation in IVF: 1. total antral follicle count (AFC) of less than or equal to 4 for a low response and greater than 16 for a high response 2. anti Müllerian hormone (AMH) of less than or equal to 5.4pmol/l for a low response[ and greater than or equal to 25.0pmol/l for a high response 3. follicle stimulating hormone greater than 8.9IU/l for a low response and less than 4IU/l for a high response The current ENCCG policy is patient should have an FSH of <9 IU/L) on day two of any menstrual cycle done within three months of referral from secondary care to a specialist IVF Recommendation Clinical Group recommendation: Anti Müllerian hormone (AMH) as a measure of ovarian reserve. The threshold for AMH is a patient to be eligible should have AMH of more than 5.4pmol/l. Rationale: AMH is one of the NICE recommended measures of ovarian reserve AMH has significantly less inter and intra menstrual cycle variability compared with FSH testing, AMH can be measured at any point of the menstrual cycle unlike FSH, which is only interpretable when measured during the first few days of the cycle Estimation of AMH is based on a single measurement compared to serial testing for FSH 1
provider. The costs of AMH range from 45 100 compared to cost of FSH which ranges from 28 50. However as women undergo more than one FSH measurement AMH is a cost saving option 2 Maternal age and number of cycles: Women aged 23 to less than 40 years at the start of treatment three fresh cycles. If the woman reaches the age of 40 years during treatment, the current cycle will be completed, but no further cycles will be offered. Women aged 40 to less than 43 years may be entitled to one cycle if the following criteria are met: they have never previously had IVF treatment there is no evidence of low ovarian reserve there has been a discussion of the additional implications of IVF and pregnancy at this stage 3 Paternal age None specified 2
4 Embryo transfers: Women aged 23 to less than 40 years one embryo will be transferred during each cycle to reduce the risk of multiple pregnancies. A maximum of six embryo transfers (fresh plus frozen) will be funded. All frozen embryos should be used before a new fresh cycle is funded. Women aged from 40 to less than 43 years Up to two embryos may be transferred during each cycle. A maximum of two embryo transfers (fresh plus frozen) will be funded. 5 Minimum / Maximum BMI Women must have a BMI of between at least 19 and up to 30 and men must have a BMI of less than 35. Patients outside of this range will not be added to the waiting list and should be referred back to their referring clinician and/or general practitioner for weight management advice and support if required. In female same sex couple, BMI criteria should only apply to partner undoing fertility treatment. Rationale in a same sex couple relationship, the BMI of the partner not undergoing a fertility treatment does not have any influence on the outcomes of fertility treatment of her partner. Recommendations: Accept BMI criteria in same sex couple only applies to person undergoing fertility treatment.. 3
6 Duration of sub fertility Couples with a diagnosed cause of absolute infertility which precludes any possibility of natural conception, and who meet other eligibility criteria, will have immediate access to NHS funded assisted reproduction services. Couples with unexplained infertility must have infertility of at least three years of ovulatory cycles, despite regular unprotected vaginal sexual intercourse with the partner seeking treatment, or 12 cycles of artificial insemination over a period of three years. If the woman has a miscarriage, the couple will wait for a further 3 years of unexplained infertility from the date of the miscarriage to be eligible for NHS funded IVF. Couples with unexplained infertility should be referred from primary care after 12 months expectant management. 7 Previous fertility treatment Previous privately or NHS funded cycles and embryo transfers will count towards the total number of fresh cycles and embryo transfers funded by the NHS. 4
8 Smoking status Couples who smoke will not be eligible for NHS funded specialist assisted reproduction assessment or treatment, and should be informed of this criterion at the earliest possible opportunity in their progress through infertility investigations in primary care and secondary care. Couples presenting with fertility problems in primary care should be provided with information about the impact of smoking on their ability to conceive naturally, the adverse health impacts of passive smoking on any children and smoking cessation support should be provided as necessary. Both partners must be non smoking at the time of referral from secondary care to specialist IVF services and maintained during treatment. Smoking status should be ascertained by carbon monoxide testing in secondary care and specialist IVF services. and in same sex couple both partners should be nonsmokers because of the impacts of passive smoking. 5
9 Parental status Couples are ineligible for treatment if there are any living children from the current or any previous relationships, regardless of whether the child resides with them. This includes any adopted child within their current or previous relationships; this will apply to adoptions either in or out of the current or previous relationships. There is a public petition to change the criteria to allow infertile couple in a new relation but with previous children to be allowed access for IVF treatment. Recommendation: in parental statuses as defined in Section 1.3 (9) of the ENHCCG policy. Rationale: Any expansion of the eligibility criteria in the policy will lead to an increase in the number of couples seeking and receiving treatment and therefore costs. The CCG currently has no information on the scale of likely increase in referrals should the policy be changed and therefore additional resources required. NHS is currently under severe financial pressures, needing to make additional saving by limiting the demand and improving the efficiencies. In the context of current NHS financial constraints there is a very little scope 6
for any additional investment to finance additional activity that could result from expansion of eligibility criteria. The purpose of policy is to maximise the benefits from limited resources and therefore infertile couples who have no children from their current or previous relationships and do not have an adopted child are prioritised. 10 Previous sterilisation Couples are ineligible if previous sterilisation has taken place (either partner), even if it has been reversed. 7
11 Child welfare Providers must meet the statutory requirements to ensure the welfare of the child. This includes Human Fertilisation Embryology Authority (HFEA) Code of Practice which considers the welfare of the child which may be born and takes into account the importance of a stable and supportive environment for children as well as the pre existing health status of the parents. 12 Medical conditions Treatment may be denied on other medical grounds not explicitly covered in this document. 13 Residency status The couple should either be registered with a GP in the CCG for 12+ months, or if their GP registration is less than 12 month, they can be eligible if they can demonstrate residency of 12+ months in a CCG area 8
14 The minimum investigations required prior to referral to the Tertiary centre are: 15 Pre implantation Genetic Diagnosis Female: Laparoscopy and/or hysteroscopy and/or hysterosalpingogram or ultrasound scan where appropriate Rubella antibodies Day 2 FSH. Chlamydia screening Hep B including core antibodies and Hep C and HIV status and core, within the last 3 months of treatment and repeated every 2 years. Male: Preliminary Semen Analysis and appropriate investigations where abnormal (including genetics) Hep B including core antibodies and Hep C, within the last 3 months and repeated after 2 years. HIV status PGD and associated specialist fertility treatment is the commissioning responsibility of NHS England and is excluded from the CCG commissioned service. 16 Rubella Status The woman must be rubella immune 17 IUI (Unstimulated) Due to poor clinical evidence, IUI will only be offered under exceptional circumstances. 9
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