Agenda Item 8.0a PART I MEETING OF THE CASTLE POINT & ROCHFORD CLINICAL COMMISSIONING GROUP GOVERNING BODY ON 29th MAY 2014 SPECIALIST FERTILITY SERVICES Submitted by: Kevin McKenny, Chief Operating Officer Prepared by: Emily Hughes, Head of Commissioning Status: For Approval EXECUTIVE SUMMARY i. Recommendations Members of the Governing Body are invited to approve the changes to the Specialist Fertility Services policy for south Essex. ii. Overview Until March 2013 specialist fertility services, including In-vitro fertilisation (IVF), Intra- cytoplasmic sperm injection (ICSI), and Donor Insemination (DI) were commissioned by the East of England Specialised Commissioning Group (EoE SCG). In April 2013, commissioning responsibility for specialist fertility services transferred to CCGs. East and North Hertfordshire CCG (ENCCG) are the lead CCG for contracting and commissioning specialist fertility services on behalf of all the CCGs in the East of England region (EoE). The EoE policies were adopted by the CCG and have remained in place across Essex until now, pending review. NICE (National Institute for Health and Care Excellence) clinical guidance on Fertility was recently updated in February 2013, Fertility CG156 updates and replaces NICE clinical guideline 11 published in 2004. The publication of the NICE update, which differs from the currently used EoE fertility guidelines, has given rise to variation in interpretation and commissioning of the service. The intention of this paper is to outline the key differences between the current EoE policy and the NICE update and to ask for approval to accept the updated policy across south Essex. This is particularly significant at this time as the region is about to begin a procurement exercise for the provision of specialist fertility services. This proposal has been reviewed and supported by both the Castle Point and Rayleigh & Rochford Locality Commissioning Groups. iii. Key Issues The significant changes that are proposed with regards to the EoE policy are as follows: Adopt the NICE approach of recommending fertility treatment for couples unable to achieve full sexual intercourse Offer one cycle of IVF to women aged 40-42 years Offer two full cycles of IVF for women aged 23-39 years Bringing the CCG policy for specialist IVF services in line with the rest of Essex, and much of the region, will have minimal financial implication for the CCG. It is important to note that the new policy will begin with the award of the new contract. The current eligibility criteria will apply to those who have been referred under it, and will continue to apply until they have used all the cycles they are entitled to or need. Patients referred after the new contract start date, will be subject to the new policy. iv. Risks Continuing with the current provision and not extending the eligibility criteria will not comply with current Equality and Diversity requirements which are enshrined in law. If the proposed amendments to the policy are not approved by all the south Essex CCGs there will be inconsistent provision in services leading to poor patient perception of ‘postcode lottery’, particularly as the changes have been approved across the other Essex CCGs. Without a shared policy across south Essex, the planned procurement and commissioning of services will be much more complex and it will be difficult to ensure compliance by Providers and facilitate the Individual Funding Request process. v. Associated Papers Appendix 1 – Proposed Specialist Fertility Services. 2 BOARD MONITORING INFORMATION Internal governance The Castle Point and Rayleigh & Rochford Locality Commissioning Groups support the proposed policy changes. Stakeholder and Community Engagement Stakeholder and Community Engagement will be undertaken as appropriate. Resource Implications Resource implications are outlined within the paper. Legal Implications Legal implications are outlined within the paper. NHS Constitution This report supports the following NHS Constitution principles: Principle 2: Access to NHS services is based on clinical need, not an individual’s ability to pay Principle 4: NHS Services must reflect the needs and preferences of patients, their families and their carers Principle 6: The NHS is committed to providing best value for taxpayers’ money and the most effective, fair and sustainable use of finite resources Equality and Diversity Implications An initial equality impact assessment has been completed by ENCCG. Further Information For further information about this report, contact Emily Hughes on 01268 594548. 3 Agenda Item 8.0a PART I MEETING OF THE CASTLE POINT & ROCHFORD CLINICAL COMMISSIONING GROUP GOVERNING BODY ON 29th MAY 2014 SPECIALIST FERTILITY SERVICES Submitted by: Kevin McKenny, Chief Operating Officer Prepared by: Emily Hughes, Head of Commissioning Status: For Approval 1.0 Background It is estimated that infertility affects 1 in 7 heterosexual couples in the UK. Since the original NICE guideline on fertility published in 2004 there has been a small increase in the prevalence of fertility problems, and a greater proportion of people now seeking help for such problems. The main causes of infertility in the UK are (percent figures indicate approximate prevalence): unexplained infertility (no identified male or female cause) (25%) ovulatory disorders (25%) tubal damage (20%) factors in the male causing infertility (30%) uterine or peritoneal disorders (10%). Until March 2013 specialist fertility services, including In-vitro fertilisation (IVF), Intra- cytoplasmic sperm injection (ICSI), and Donor Insemination (DI) were commissioned by the East of England Specialised Commissioning Group (EoE SCG). In April 2013, commissioning responsibility for specialist fertility services transferred to CCGs. East and North Hertfordshire CCG (ENCCG) are the lead CCG for contracting and commissioning specialist fertility services on behalf of all the CCGs in the East of England (EoE). The EoE policies were adopted by the CCG and have remained in place across Essex until now, pending review. NICE (National Institute for Health and Care Excellence) clinical guidance on Fertility was recently updated in February 2013, Fertility CG156 updates and replaces NICE clinical guideline 11 published in 2004. The publication of the NICE update, which 4 differs from the currently used EoE fertility guidelines, has given rise to variation in interpretation and commissioning of the service. The intention of this paper is to outline the key differences between the current EoE policy and the NICE update and to ask for approval to accept the updated policy across south Essex. This is particularly significant at this time as the region is about to begin a procurement exercise for the provision of specialist fertility services. 2.0 Provision of specialist fertility treatments in the East of England The NICE guidance (2013) defines infertility as: “A woman of reproductive age who has not conceived after 1 year of unprotected vaginal sexual intercourse, in the absence of any known cause of infertility”. The management of infertility falls into 3 main types: Medical treatment to restore fertility (for example, the use of drugs for ovulation induction) Surgical treatment to restore fertility (for example, laparoscopy for ablation of endometriosis) Assisted reproduction techniques – any treatment that deals with means of conception other than vaginal coitus. It frequently involves the handling of gametes or embryos and mainly includes in vitro fertilisation (IVF), intra- cytoplasmic sperm injection (ICSI), and Donor Insemination (DI). While the medical and surgical management is usually provided at a secondary care setting the assisted reproduction techniques, also called specialist fertility services, are provided only at selected centres across the country. Specialist fertility services for the EoE population are currently provided by: Barts and the London NHS Trust Bourn Hall Clinic, Cambridge Imperial College Healthcare NHS Trust Oxford Fertility Unit University Hospitals of Leicester NHS Trust Historically, the majority of south Essex patients have accessed specialist fertility services at Bourn Hall clinic, Cambridge. There is currently variation in the outcomes of the five providers and a procurement exercise is currently under way across all CCGs in the region to ensure high quality and efficient service provision. 5 3.0 Current activity and cost The access criteria for fertility treatments are currently guided through the EoE fertility policy, adopted by the EoE CCGs in April 2013. Those patients who do not meet the access criteria can appeal to commissioning bodies for funding under Individual Funding Request schemes. These are mainly for intrauterine insemination, donor insemination, egg and sperm storage for patients undergoing cancer treatments, surgical sperm extraction, and pre-implantation genetic diagnosis (PGD). It is estimated there are 1-2 individual funding requests for IVF per month for a population of about 500,000 of which 10-20% are approved for treatment. (Suffolk and Hertfordshire IFR team, 2013). In the EoE approximately £11 million is spent annually on all specialist fertility related treatments, of this nearly £10 million is spent on IVF related procedures and treatments. (ENCCG 2013). The other £1 million is spent mainly on procedures not included within the EoE policy and funded predominantly through individual funding request or exceptional funding routes. The average annual spend on all specialist