GOVERNING BODY LEAD: Fergus Keegan, Director of Quality, Kingston & Richmond CCGs REPORT AUTHOR: Sue Lear, Acting Deputy Director of Commissioning ATTACHMENT: AGENDA ITEM: D2 RECOMMENDATION: The Governing Body are asked to support in principal Option 3 retaining the current eligibility criteria and reviewing the fertility pathway. GOVERNING BODY MEETING DATE: 5 th September 2017 CHOOSING WISELY FOR KINGSTON PROPOSED CHANGES TO LOCAL HEALTHCARE - IVF EXECUTIVE SUMMARY: NHS Kingston CCG invited views on the proposals set out in the Choosing Wisely for Kingston engagement document between 15th March 2017 and 14th July 2017 which was paused between 20th April and 8th June due to General Elections (Appendix 1). This paper covers the feedback and recommendations for in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) services following engagement. Choosing Wisely for Kingston engaged with local people in the borough and those who may be affected by the proposals outlined in the document (see Appendix 1). No decisions have yet been made and the Governing Body is asked to agree the recommendations made in this report. The survey results found that 52% strongly agreed or agreed and 48% disagreed or strongly disagreed that the local NHS should only make IVF available in exceptional circumstances. The full results of the engagement are included as in appendix 2 to this document. One of the themes emerging from the engagement was as to whether the CCG would explore other options to enable a level of NHS funded IVF to be maintained in Kingston borough. As a result of the feedback received and advice from the Assisted Conception unit, an additional consideration has been identified, namely to review current eligibility criteria and review access to the fertility pathway. As part of the Richmond CCG consultation process, discussions with the Assisted Conception Unit at Kingston Hospital have suggested that the fertility pathway could be revised restricting access for those people whom evidence would suggest would not benefit from fertility treatment based on the expected clinical outcomes. The Governing Body is asked to take the opportunity between today and the next Governing Body meeting in November to evaluate and discuss the proposal to: Align the eligibility criteria within Kingston and Richmond Version: Final D2-1
Align the pathway for access to fertility services based on the recommendations from the Assisted Conception Unit KEY SECTIONS FOR PARTICULAR NOTE: Appendix 1 Choosing wisely for Kingston full engagement document Appendix 2 Choosing wisely for Kingston full Patient and Public Engagement report Appendix 3 Choosing wisely for Kingston Equalities Analysis report RECOMMENDATIONS: The Governing Body is asked to take the opportunity between today and the next Governing Body meeting in November to evaluate and discuss the proposal to: Align the eligibility criteria within Kingston and Richmond Align the pathway for access to fertility services based on the recommendations from the Assisted Conception Unit RISKS IDENTIFIED: If there are any changes to the current eligibility or access criteria in all of the options available, this may be an unpopular option to people who require fertility investigations and do not meet the access criteria. FINANCIAL IMPLICATIONS: NHS Kingston CCG commissions NHS funded fertility services for assisted conception including IVF and ICSI fertilisation from the Assisted Conception Unit at Kingston Hospital Foundation Trust under a cost per case contract of 2997 per cycle. In 2016-17 102 cycles were carried out at a total cost to the CCG of 317,682. Table 1- activity and cost 2016-17 Year 2016/17 Code ACU Cycles Actual Activity Value 102 305,694 If no changes are made to the current eligibility or access criteria, then no reductions in cost would be achieved. The attached paper illustrates the potential cost reductions from each of the options identified through the Choosing Wisely engagement process. KINGSTON CCG OBJECTIVES for 2016-18: Please indicate below all the categories which the paper provides evidence for: 1. Better Health 2. Better Care 3. Sustainability 4. Leadership EQUALITY IMPACT ASSESSMENT: Age: all women up to age 43 who would have otherwise been eligible for NHS funded treatment. Disability: Mental health impact on individuals who cannot access specialist fertility services Version: Final D2-2
through the NHS and the potential knock on effect on relationships, employment, increased need for primary care and mental health services for conditions such as depression and anxiety. Socio-economic: It may disproportionately affect those on low incomes who will be less able to self-fund fertility treatment. BME: Some BME groups may be disproportionally affected by the option to fund IVF in limited circumstances only, in part due to external factors including income, social and health inequalities. The full draft EINA report can be found at Appendix 2 PRIVACY IMPACT ASSESSMENT: NA Please indicate whether any engagement has been carried out regarding this service change (tick appropriate box) Yes X No Version: Final D2-3
Options Appraisal for NHS Kingston CCG Governing Body to consider in relation to proposed changes to In Vitro Fertilisation and Intra-cytoplasmic Sperm Injection 1.0 Background The NHS is faced with a number of challenges nationally and locally. As a result, our clinicians need to ensure we commission services that will meet the greatest health needs in our communities. People are thankfully living longer lives but are often living the latter part of their lives with a number of illnesses and conditions. It is important therefore, that the CCG budget is spent where care is needed most and invested in developing services that meet the priorities Kingston residents have previously identified. To ensure that Kingston CCG remains within its allocated budget and that everyone in Kingston has equal access to necessary care; and to treatment which offers value to our population, the CCG identified a number of areas where it could make potential savings. The proposals were set out in the engagement document Choosing Wisely for Kingston, proposed changes to local healthcare Have your say. Within the Choosing Wisely engagement the CCG proposed a change to the access criteria for in vitro fertilisation (IVF) and intra-cytoplasmic sperm injection (ICSI) so that it is funded in exceptional circumstances only for example infertility as a result of cancer treatment or to prevent transmission of chronic viral infections such as Hepatitis C or HIV subject to an individual funding request. This proposal is in line with neighboring CCG s across South West London. 2.0 Current Effective Commissioning Policy NHS Kingston CCG currently funds one fresh cycle and two frozen cycles of IVF/ICSI at the Assisted Conception Unit at Kingston Hospital for women up to their 40 th birthday who have received a maximum of two previous self-funded cycles OR women aged 40 up to their 43 rd birthday where they have had no previous self-funded cycles. Although there is NICE Fertility Pathway guidance (CG156), many other CCGs have recently implemented changes to their local policies following local consultations and in effect, reduced the scope and availability of NHS funded specialist assisted conception services as part of their QIPP plans. Nationally, four CCGs do not routinely provide funding for IVF and ICSI for their local populations. All but one CCG in London offers one cycle of IVF+/-ICSI (NHS Camden CCG offers three cycles). Only NHS Wandsworth CCG in London has extended the age range for treatment to 42 years. NHS Kingston CCG accepts referrals for women up to the age of 42 who have received no previous selffunded cycles. Nationally, a number of CCGs are reducing the provision of IVF cycles to one cycle in order to reduce expenditure or support an increase in the age range. Nationally there is also a variation in the number of frozen embryo transfers that are funded from unlimited down to no embryo transfers funded. Across south west London two CCG s Croydon and Richmond have reviewed their commissioning of IVF: NHS Croydon CCG Following a formal consultation which ended on the 1st March 2017 the CCG took a decision at their Governing Body meeting in public on 14th March 2017 to fund IVF and ICSI for those people Version: Final D2-4
with exceptional clinical circumstances only. The CCG committed to look again at their ability to fund IVF in a year s time to consider whether they would be in a financial position to be able to reinstate this funding. NHS Richmond CCG The CCG recently consulted with the public on whether to fund IVF in exceptional cases only but revised this position as a result of the consultation and based upon clinical evidence of successful outcomes to: Women must be aged between 23 and 38 Have received no previous self-funded cycles of IVF Neither partner must have any living children from this or previous relationships (including adopted children) Antimullerian hormone (AMH) levels must be >5.4pmol/l (this is an indicator of fertility and below this level there is less likelihood of success). The governing body may wish to consider this as an option. 3.0 Engagement The Choosing Wisely engagement exercise ran from 15 March through to 14 July 2017. The survey results found that 52% strongly agreed or agreed and 48% disagreed or strongly disagreed that the local NHS should only make IVF available in exceptional circumstances. The full results of the engagement are included as an appendix to this document. One of the themes emerging from the engagement was as to whether the CCG would explore other options to enable a level of NHS funded IVF to be maintained in Kingston borough. The options for the Governing Body have taken this into consideration. 4.0 Options Option 1 - No further change to the existing service This option would mean women who meet the criteria as outlined in our current policy i.e.: o o o women 40 years of age or below and have had a maximum of two previous selffunded cycles women who are aged between 40 up to their 43 rd birthday and have had no previous self-funded cycles neither partner must have any living child (including adopted children) from this or previous relationships Will continue to be offered one fresh cycle and two frozen cycles of IVF on the NHS Option 2 Change the access criteria for IVF so that it is funded in limited circumstances only Access to IVF would be limited to people who meet the criteria in option 1 and who can demonstrate exceptional clinical circumstances; these might include infertility following cancer treatment, or prevention of the transmission of chronic viral infections, such as HIV (among others). In addition to reviewing the IVF criteria the Choosing Wisely engagement asked whether people would support changes to access for specialist fertility services. Consultation Requirements if the Governing body recommends the adoption of either option 1 or 2 the CCG will need to seek health overview panel advice regarding the need to go out to a full public consultation. Version: Final D2-5
5.0 Financial Impact Assessment NHS Kingston CCG commissions NHS funded fertility services for assisted conception including Intra-cytoplasmic sperm injection and In vitro fertilisation from the Assisted Conception Unit at Kingston Hospital Foundation Trust under a cost per case contract of 2997 per cycle. In 2016-17 102 cycles were carried out at a total cost to the CCG of 317,682. Table 1- activity and cost 2016-17 Year Code Actual Value Activity 2016/17 ACU Cycles 102 305,694 6.0 Equality Impact Assessment An Equalities Impact Needs Assessment has been completed. The equalities impact needs assessment examined the potential impacts on the nine protected characteristics of option 2. All groups were considered but the groups with the highest potential impact were age, disability and socio-economic. We also assessed the socio-economic impact in line with ability to pay for treatment privately as an alternative to the NHS. This was highlighted as an area of concern in the responses to our Choosing Wisely engagement exercise. The following impacts were identified: Age: all women up to age 43 who would have otherwise been eligible for NHS funded treatment. Disability: Mental health impact on individuals who cannot access specialist fertility services through the NHS and the potential knock on effect on relationships, employment, increased need for primary care and mental health services for conditions such as depression and anxiety. Socio-economic: It may disproportionately affect those on low incomes who will be less able to selffund fertility treatment. BME: Some BME groups may be disproportionally affected by the option to fund IVF in limited circumstances only, in part due to external factors including income, social and health inequalities. The full draft EINA report can be found at Appendix 2 An additional risk which has been raised during the Choosing Wisely engagement is the potential unintended impact of potentially increasing the number of patients that receive multiple embryo transfers while undertaking self-funded fertility treatment abroad. 7.0 Options for Consideration Option 1- No further change to the existing service This option would mean women who meet the clinical criteria as outlined in our current policy i.e.: women 40 years of age or below and have had a maximum of two previous self-funded cycles women who are aged between 40 up to their 43rd birthday and have had no previous selffunded cycles; and neither partner must have any living child (including adopted children) from this or previous relationships Version: Final D2-6
Will continue to be offered one fresh cycle and two frozen cycles of IVF on the NHS Benefits If this option were selected it is predicted that 106 cycles per annum would be eligible for funding. Risks This option would not deliver any financial savings This is out of line with other SWL CCG s More people may choose to register with a Kingston GP to gain access to IVF and create a financial pressure Option 2 Change the access criteria for IVF to be funded in limited circumstances only Access to IVF would be limited to patients with exceptional clinical circumstances. These might include infertility following cancer treatment, or prevention of the transmission of chronic viral infections, such as HIV (among others). In this option each case would need to be considered on an individual basis via an Individual Funding Request. It has been estimated that this would equate to c.10 cycles of IVF based on the number of known oncology patients seen per year. However, this does not take into account any other patients who can make a case for exceptionality. Benefits No benefits identified Risks Difficulty in deciding what is deemed an exceptional clinical circumstance therefore numbers will probably increase (c.30 as an estimate). Savings are therefore less predictable. Increase the burden of the management of IFR cases. An increase in patients being referred for alternative investigative procedures e.g. fallopian tube patency. Reputational damage to the CCG Option 3 retain current eligibility criteria and reviewing the fertility pathway As part of the Richmond CCG consultation process, discussions with the Assisted Conception Unit at Kingston Hospital have suggested that the fertility pathway could be revised restricting access for those people whom evidence would suggest would not benefit from fertility treatment based on the expected clinical outcomes. Suggested fertility eligibility criteria: BMI less than 32 Age limit <42 The Assisted Conception Unit is keen to work with the CCG to streamline the pathway for fertility investigations. Benefits Eligibility is based on clinical evidence of outcomes Opportunity to work with the assisted conception unit for system benefit Easier to predict annual activity based on historical data Version: Final D2-7
Risks This may be an unpopular option to people who require fertility investigations and do not meet the access criteria 8.0 Financial Appraisal The table 2 below shows the costs and potential savings of each option against the baseline of spend for 2016-17. Due to the difficulty in predicting the number of exceptional cases in option 2 a best case based on known previously funded oncology cases and a most likely case is presented. Table 2 financial appraisal 2016/17 Option 1 Option 2 Option 2 Baseline Best case Most likely Predicted 102 102 10* 30** Activity Costs 305,694 305,694 29,970 89,910 Net Savings 0 275,724 215,784 *Plus other exceptional clinical circumstances **estimate number of cases 9.0 Recommendations Given the feedback from the Choosing Wisely engagement, the Governing Body are asked to support in principal Option 3 retaining the current eligibility criteria and reviewing the fertility pathway. If this option is approved, work on the revised fertility pathway will be taken forward during September and October with a report back to the Governing Body at the November meeting. Version: Final D2-8