Final Version COMMISSIONING POLICY Tertiary treatment for assisted conception services Designated providers for patients registered with a Worcestershire GP BMI The Priory Hospital, Birmingham - 1 -
Commissioning Policy 1. Range of treatments included in this policy This policy covers the tertiary treatments of intrauterine insemination (IUI), In vitro fertilisation (IVF), intra cytoplasmic sperm injection (ICSI) and egg donation. The policy was written following the publication in February 2004 of NICE clinical guidance entitled Fertility, assessment and treatment for people with fertility problems and updated in September 2006. 2. Funding Eligible couples will be funded for: Up to three cycles IUI and /or Up to 2 full fresh cycles of IVF (or IVF with donor sperm) or up to 2 full fresh cycles of ICSI (or ICSI with donor sperm) with/without egg donation as clinically appropriate. (Couples² will only be entitled to a second cycle of treatment if the first cycle of treatment does not result in a live birth) For men with obstructive azoospermia the PCT will fund either one needle aspiration or one open testicular biopsy. Treatment options will depend on diagnosis and clinical appropriateness. For example, if clinically appropriate, women with true unexplained fertility problems will be referred for upto 3 * cycles of IUI initially. If unsuccessful, a couple would then be eligible for up to 2 cycles of IVF/ICSI with/without egg donation whichever is clinically appropriate. Alternatively women may be referred initially for IVF, ICSI or egg donation rather than IUI. To be eligible for NHS funding under this policy a woman s Follicle Stimulation Hormone (FSH) level must be 10 or below. If the FSH level is more than10 it is to be repeated in another cycle. If the repeat FSH is 10 or less the woman will be accepted for treatment. If however the repeat level is more than 10 no treatment will be provided. The FSH level must be checked between days 3 5 of the cycle. One cycle of IVF/ICSI treatment is defined as one full fresh cycle including ovulation induction, egg retrieval, fertilisation and embryo transfer 1. The PCT does not fund the transfer of frozen embryos. Contracts with tertiary providers * NICE recommend up to 6 cycles IUI. 3 cycles is a move towards this. 1 Exceptions to this definition would be in rare cases where: a) a patient with a normal Follicle Stimulation Hormone (FSH) level fails to respond adequately in the first cycle of stimulation. These patients would be eligible for one further cycle at maximum dose gonadotrophins. If the patient fails to respond during the second cycle they should be considered for egg donation via the PCT s Complex Case Panel. b) IVF has not resulted in an embryo transfer (except freeze all embryos). These patients would be eligible for one cycle of ICSI. If the ICSI cycle did not result in embryo transfer, the PCT will not fund additional fertility treatment. ²Couple refers to the relationship the patient is currently involved in - 2 -
include coasting ^ when clinically appropriate to avoid over stimulation of the ovaries and to help couple s achieve a full cycle. Cancelled cycles are chargeable and rates have been agreed with tertiary providers. If a cycle is cancelled for medical reasons or by the patient for other reasons then couples will not be eligible for further NHS funded cycles. 3. Patient eligibility 3.1 Maternal age Funding will be provided for women in the age range 23 to 39 at the time of treatment, i.e. upto 40 th birthday. Referrals into the service should be made in appropriate time to ensure that treatment can take place by the woman s 40 th birthday. 3.2 Maternal Weight To secure funding women should have a body mass index (BMI) in the range 19 to 30 inclusive. There is clinical evidence to demonstrate that a BMI within this range improves pregnancy rates. Couples should be informed of this criterion at the earliest possible opportunity in their progress through infertility investigations in primary and secondary care. 3.3 Defining infertility Infertility should be defined as failure to conceive after regular unprotected sexual intercourse for 2 years in the absence of known reproductive pathology. ** 3.4 Living children Treatments for sub fertility will be funded if the couple have no children living in the household. This includes a child adopted by the couple or a child from a previous relationship. Once accepted for treatment, should a child be adopted or a pregnancy leading to a live birth occur, the couple will no longer be eligible for NHS funded treatment. 3.5 Previous assisted conception treatment Couples who have received 3 or more cycles (whether fresh or frozen) previously for fertility problems, regardless of whether the treatment was funded by the NHS or privately funded, will not be eligible for NHS funding. *** ^ Coasting is defined as discontinuing stimulation injections, measuring blood oestrogen hormone levels daily and then proceeding with treatment when blood oestrogen hormone levels have dropped to a safe level. ** definition of infertility taken from NICE. Summary document, page 10, section 1.2.1.1. *** NICE the chance of a live birth following IVF treatment is consistent for the first 3 cycles of treatment, but the effectiveness after 3 cycles is less certain. Summary page 24, section 1.10.1.1-3 -
3.6 Sterilisation NHS funded fertility treatment will not be available if sub fertility is the result of a sterilisation procedure or reversal of sterilisation in either partner. 3.7 HFEA Code of Practice Couples not conforming to the HFEA s Code of Practice, will be excluded from having access to NHS funded assisted fertility treatment. **** This includes consideration of the welfare of the child which may be born. This will take account of a person s ability to provide a stable and supportive environment for a child and family medical histories. Tertiary treatment centres undertake this assessment. 3.8 Same sex couples Worcestershire PCT does not support assisted conception treatment for single persons not in a partnership or same sex couples where there is no discernible fertility problem. For a single individual or same sex couple to be considered for NHS funded assisted conception treatment, sub-fertility would have to be demonstrated. Subfertility in this instance can be defined as: A failure to conceive, resulting in a live birth, following insemination at or just before the known time of ovulation, on at least 10 non-stimulated cycles or six cycles of clinically delivered insemination; or A defined fertility problem that is confirmed by an NHS gynaecologist or specialist in infertility following appropriate clinical investigations. Where a single individual or same sex couple has demonstrated proven subfertility as defined above, the other criteria for access to NHS funded assisted conception treatment will be applied when considering their eligibility for NHS funding. In the case of a same sex couple where one partner is defined as sub-fertile, clinicians should also discuss the possibility of the other partner becoming the biological parent before undertaking any interventions on the sub-fertile partner. Single individuals and same sex couples identified as eligible for NHS funded assisted conception treatment should be provided with access to professional experts in reproductive medicine for advice on the treatment options available in relation to their assisted conception treatment. **** HFEA Code of Practice, 6 th edition - 4 -
4. Co funding The practice of supporting private patients using NHS funding is not supported. This is in line with Department of Health guidance and reiterated in the National Plan: The NHS is funded out of public expenditure, primarily taxation. This is a fair and efficient means for raising funds for healthcare services. Individuals will remain free to spend their own money as they see fit, but public funds will be devoted solely to NHS patients, and not be used to subsidise individuals privately funded healthcare. The only exception to this would be where viable embryos created during an NHS funded cycle but not transferred at that stage, are then frozen and may be transferred to the woman at a later date. In this instance couples would be expected to meet the cost of freezing and storing additional embryos, together with the cost of any subsequent transfer (NB: a maximum of 2 embryos may be transferred at any one time). 5. Initial GP Assessment and referral 5.1 An initial assessment of a couple s sub fertility should be undertaken by their GP. This should include lifestyle advice in compliance with NICE recommendations, for example on BMI, smoking cessation, occupational hazards, alcohol and caffeine consumption and prescribed, over the counter and recreational drug use. For example: Couples should be informed that the consumption of more than one unit of alcohol per day reduces the effectiveness of assisted reproduction procedures, including in vitro fertilisation treatment. Couples should be informed that maternal and paternal smoking can adversely affect the success rates of assisted reproduction procedures, including in vitro fertilisation treatment. Couples should be informed that caffeine consumption has adverse effects on the success rates of assisted reproduction procedures, including in vitro fertilisation treatment. 5.2 In cases where couples meet all of the commissioning criteria, they should be referred to secondary care. Patients may choose a provider from the gynaecology choice menu. However, Worcestershire PCT recommends referral to a Consultant Obstetrician and Gynaecologist with a special interest in infertility at Worcestershire Acute Hospitals NHS Trust. Referrals should be marked Infertility Clinic. A range of diagnostic tests will be undertaken within secondary care, including measurement of FSH levels. - 5 -
5.3 Following secondary clinical investigation, individuals who require tertiary treatment will be referred to BMI The Priory Hospital, Birmingham. 5.4 In cases where a woman is approaching 40 and to ensure a patient s treatment is completed by the time of her 40 th birthday, GPs may refer direct to BMI The Priory Hospital, Birmingham. 6. Exceptions and complex cases Any patient, whose GP considers them to be an exception to the above criteria, will need to provide full details to the PCTs Complex Case Panel. For example people preparing for cancer treatment. Author: Helen Edwards, Commissioning& Redesign Manager, Worcestershire PCT Date: 05.09.06 Updated : 03.09.08 Review date: 31.08.10-6 -