This paper outlines the engagement activity that took place, and provides key themes from the 57 written responses received.

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Agenda item: 5.4 Subject: Presented by: Prepared by: Submitted to: Specialist Fertility Services Dr Dustyn Saint SNCCG Commissioning Team SNCCG Communications and Engagement Team SNCCG Governing Body Date: 24 th November 2015 Purpose of paper: Agreement Executive Summary: The CCG Governing Body agreed a period of online engagement would be held in order to understand the spectrum of opinions before making a decision to restrict the Specialist Fertility Services policy from 1 st January 2016. This paper outlines the engagement activity that took place, and provides key themes from the 57 written responses received. These include: Feedback on the proposed criteria Impact on the wider economy NICE Guidance Affordability Alternatives to the restriction Recommendation to Governing Body: The Governing Body is asked to: 1. Consider the feedback received 2. Provide comment regarding the criteria for patients with chronic viral infection 3. Make a decision as to whether the Specialist Fertility Services policy should be restricted 1

Key Risks Clinical: Finance and Performance: None identified. The CCG estimates that restricting the SFS policy would deliver a saving of 188,068. There is a risk for a potential increase in activity for mental health and wellbeing services, should the restriction be applied. Impact Assessment (environmental and equalities): Equality impact assessment: SFS EIA Reputation: If the SFS policy is restricted, SNCCG would be 1 of 3 CCGs in the country applying this restriction Legal: Resource Required: Reference document(s): NHS Constitution: Conflicts of Interest: None identified. No additional resource required. NICE Guideline (CG156) Fertility problems: assessment and treatment https://www.nice.org.uk/guidance/cg156 This paper does not promote awareness of the NHS Constitution. None identified. GOVERNANCE Process/Committee approval with date(s) (as appropriate) Governing Body 08/09/15 approval to proceed with feedback event 2

Level 3 Specialised Fertility Services Engagement Feedback 1. Introduction The CCG faces a significant financial challenge in 2016/17 and is working to identify 11m of QIPP savings. Specialist Fertility Services, also known as Level 3 Fertility Services, have been highlighted as an area of expenditure to be reviewed. The CCG Governing Body agreed a period of online engagement would be held in order to understand the spectrum of opinions before making a decision. This paper outlines the engagement that took place and provides the key themes from the feedback received. 2. Proposal The CCG proposes to restrict its policy from 1 st January 2016 to the provision of 2 full cycles to the following groups only: Patients undergoing cancer treatments Patients who have a disease or condition requiring a medical or surgical treatment that has a significant likelihood of making them infertile Couples who meet current eligibility criteria in which the male partner has a chronic viral infection where there is high risk of viral transmission to the female partner and potentially any unborn child (such as HIV or Hepatitis C), would also be offered ICSI. For clarity, this policy change will only affect patients referred from 1 st January 2016. Patients referred before this date and already receiving treatment will still receive 2 full cycles as per the 2014-17 CCG policy. The saving identified above will therefore be part year effect to take this continued provision into account. It should also be noted that access to Levels 1 and 2 fertility services are not affected by this proposal. These include initial GP consultation, advice and diagnostics. As with all treatment policies, if a patient does not meet the criteria and wishes to receive treatment, the patient s GP or clinician can submit an application to the CCG s Individual Funding Requests Panel to request funding demonstrating there are clinical exceptional reasons for the case. Clinical exceptionality is considered to occur when the patient: 1. is significantly different to the general population of patients with the same diagnosis/condition in question, and 2. is more likely to benefit from this treatment/ intervention than might be expected for the average patients with the diagnosis/ condition. The fact that a treatment may be efficacious for a patient is not in itself a basis for exceptionality. There is an appeals process available if the referring clinician or patient is unhappy with the IFR Panel decision. The CCG will review this policy on an annual basis. 3. Methodology The online engagement event took place from Friday 16 th October until Friday 13 th November. Details of the proposed restriction were made available on the CCG s website, (appendix 1) inviting comments on the following areas: 3

General feedback on the proposed changes to the CCG s SFS policy as outlined above Comments and thoughts regarding the amount of cycles made available to exceptional patients under the new policy The priority of Specialised Fertility Services within the wider context of what the CCG commissions Your experiences of Specialised Fertility Services, and the treatments and advice that was given to you The document was emailed to a variety of stakeholders, including: SNCCG Member Practices Level 2 SFS providers Organisations providing holistic fertility treatments A briefing outlining the details of the engagement event was provided to the Norfolk Health Overview and Scrutiny Committee (HOSC). At the HOSC meeting on 15 th October, the CCG received confirmation that committee members did not wish to be formally consulted on this matter. However, individual members may of course respond directly to the CCG via the online engagement event. The proposal attracted media interest which considerably helped increase the number of responses received. 4. Publicity Between period of 16 th October and Friday 13 th November, the CCG received media coverage from national and local newspapers, regional television and social media platforms regarding its proposal 5. Overview of feedback received The CCG is very grateful to those who provided feedback. A large number of respondents shared their previous experiences of receiving IVF treatment, allowing the CCG to have a valuable insight into the impact SFS services can have, both positive and negative. 5.1 Written responses The CCG received a total of 57 written responses, either by email or letter. The following table indicates a breakdown of these responses. Point of response Amount Public 47 Member Practices South Norfolk 4 Provider 2 Advocacy / support organisation 2 MPs and Lords 2 5.2 Petition responses An online petition, begun independently from the CCG s request for feedback on its proposal, generated 22,261 responses against the restriction, however only 200 people recorded their location as South Norfolk. The majority were from abroad. 8612 were from the UK and 1025 were from the East of England. Feedback from this petition is included within this report. 5.3 Feedback objecting to the proposed restriction 4

Most of the respondents acknowledged the financial challenge faced by the NHS, but felt that the proposed restriction is harsh and the CCG should not proceed. The main issues raised included the following: If implemented, the restricted criteria would create a local variation in services and does not adhere to NICE Guidelines The negative impact on mental health and wellbeing for couples who would no longer meet the criteria and the risk of an additional cost to the health economy Savings are small in comparison to the CCG s total budget The CCG should consider alternatives to restricting SFS services 5.4 Feedback in support of the proposed restriction Of the 57 written responses received, the CCG received 6 responses in support of restricting the SFS policy. These responses stated the following: Recognition of NHS financial pressures and that SNCCG needs to save money The CCG should focus its resources on care for the elderly, the disabled, terminally ill, chronic pain and those with life-limiting illness Couples should consider child adoption as an alternative to NHS funded IVF Respondents did not think IVF should be funded by the NHS Services should be focussed on the ill and injured 5.5 Feedback received in in respect of the proposed criteria The CCG received a considerable amount of feedback on the criteria being proposed, including the following concerns: A change in criteria would create a local variation in services, and the CCG would be one of the very few CCGs in the country restricting the criteria for SFS To reduce inequality of provision, a restriction of policy should only be considered if it is a Norfolk-wide decision The CCG would be unable to make a valued judgement regarding which causes of infertility warrant treatment. Considering the well-being of the unborn child, it would be far more preferable from the child s perspective to have healthy parents, NICE has clearly stated that HIV positive men and hepatitis patients who are receiving treatment have a minimal risk of transmission, and would not normally receive IVF. It does not appear to be an effective use of resources to restrict access to patients experiencing infertility, who do not need the specialist fertility services, and instead offer treatment to patients who may will not require any IVF at all. Couples with infertility should not be defined as less worthy of IVF if the individual does not have cancer or HIV etc. Impact on the wider economy The majority of responses received referred to the negative impact that infertility would have on individuals and their families and would therefore impact on the wider health economy due to: Mental health and wellbeing, including treatment of stress and depression Increase in the provision of counselling due to relationship breakdown Some feedback received, in particular from key infertility organisations and clinicians, raised that a restriction in policy would have a negative impact on the wider economy: In a country such as the UK where the birth rate is below a population replacement level, we are going to have a significant problem in years to come of a much greater 5

proportion of elderly retired people to those working. Reducing the birth rate further by restricting SFS will further exacerbate the problem. A risk that patients may seek cost effective alternatives overseas, and may well return with a multiple pregnancy. NICE guidance It was stated the CCG should be striving to achieve full NICE compliance, rather than reducing further It was stated that infertility is a disease recognised by the World Health Organisation and, as with any other medical condition, the South Norfolk CCG should provide treatment for it. Affordability Some respondents wrote that many couples would not be able to afford to pay for these services: IVF is hard enough mentally and physically already without adding a financial pressure Only wealthy couples will be able to afford SFS Alternatives to restriction Many respondents included a number of suggestions as to how SFS could continue to be funded. These included: Reduce to one cycle of IVF The CCG should review the cost per cycle Tightening of the current eligibility criteria e.g. couples should have lived in South Norfolk for 5 years Couples could be means tested for affordability, and the CCG could consider part funding treatment Reducing spend on cosmetic surgery Restricting availability of other services for conditions caused by poor diet and lifestyle choices e.g. bariatric surgery, diabetes medication 6

Appendix 1 Feedback on the commissioning of Specialised Fertility Services Introduction NHS South Norfolk Clinical Commissioning Group (CCG) is inviting feedback from patients, professionals, stakeholders and people living in South Norfolk on the future commissioning of Specialist Fertility Services. Context South Norfolk CCG, like other NHS organisations in England, is facing financial challenges. This is the reality at a time when there is increasing demand for services and a growing population. The CCG like every other NHS organisation has a statutory duty to operate within its budget and it must consider the effectiveness, value and outcomes of all services that it commissions. A background on the range of health services that the CCG commissions can be found on pages 8-13 of its Annual Report 2014-15. The CCG is proposing to restrict its Specialist Fertility Services policy. Specialist Fertility Services (SFS) are provided to people who are having difficulties in achieving pregnancy. SFS are provided at three levels: Level 1 Level 2 Level 3 Advice and support accessed via a GP A range of infertility investigations, advice and treatments are offered to couples, treatments including laparoscopic and hysteroscopy surgery. Couples are offered in vitro fertilisation (IVF) - 2 cycles for women aged under 40, and 1 cycle for women aged 40-42 What is the CCG proposing? The CCG is proposing to restrict Level 3 Specialist Fertility Services with the following exceptional circumstances: Patients undergoing cancer treatments/chemotherapy Patients who have a disease or condition requiring a medical or surgical treatment that has a significant likelihood of making them infertile Couples who meet current eligibility criteria in which the male partner has a chronic viral infection where there is high risk of viral transmission to the female partner and potentially any unborn child (such as HIV or Hepatitis C). Patients meeting this new criteria will receive the current level of provision i.e. 2 cycles of IVF. 7

This policy will only be applied for new referrals received by the provider after the policy has been implemented. Patients already receiving SFS treatment will not be affected and will continue to receive 2 cycles under the current policy. The restricted policy would also be reviewed on an annual basis. Impact The CCG commissions Level 3 SFS services from the following providers: Bourn Hall Create Health Guy s and St Thomas London Women s Clinic The Centre for Reproductive and Genetic Health In 2014-15, Bourn Hall reported that 47 South Norfolk patients attended a First Outpatient Appointment. If the restriction in policy is applied, approximately 5 couples in South Norfolk would be able to receive Level 3 fertility services, based on the assumption of applying 10% to the amount of patients likely to receive a First Outpatient Appointment under the restricted policy. Should the policy be implemented, the CCG estimates that 188,068 will be saved per year. How can I comment on this proposal? South Norfolk CCG is providing the opportunity to comment on the above proposal regarding Specialised Fertility Services between Friday 16th October and Friday 13th November. The CCG would like to know the following: General feedback on the proposed changes to the CCG s SFS policy described above Comments and thoughts regarding the amount of cycles made available to exceptional patients under the new policy The priority of Specialised Fertility Services within the wider context of what the CCG commissions Your experiences of Specialised Fertility Services, and the treatments and advice that was given to you Feedback can be sent to SNCCG.communications@nhs.net Or in writing to: NHS South Norfolk Clinical Commissioning Group Lakeside 400, Broadland Business Park Old Chapel Way, Thorpe St Andrew NR7 0WG What happens next? South Norfolk CCG s Governing Body will receive feedback and responses in time for its meeting in public on November 24, 2015, where it will make a decision on the proposal. The outcomes of the decision will be communicated to everyone that responds, as well as all affected professionals and stakeholders, after this date. 8