Title of meeting Governing Body Agenda item 14 Date of meeting 29 September 2016 Confirm part one/two or n/a One Title of paper Review of Specialist Fertility Services - Level 3 Responsible director Catherine Byford, Director of Commissioning & Quality Author Kathryn Griffiths, Clinical Commissioning Manager Action required Approval Decision Discussion Information Purpose of the report: Executive summary (maximum 500 word limit) To propose a reduction in provision of Level 3 Fertility Services following the outcome of an engagement exercise. Commissioning responsibility for this service sits with CCGs. Currently GYWCCG funds Level 3 fertility services in line with NICE Guidance 156 (February 2013) and funds three treatment cycles. The CCG spent 226k on Level 3 fertility treatment in 2015/16. 1 P a g e Only five CCGs in the East of England now provide a NICE compliant service with regard to the number of cycles funded, with an additional two adding tighter restrictions and one CCG not funding any cycles of treatment. Thirteen CCGs fund up to two cycles. Within Norfolk, the other four CCGs fund up to two cycles; albeit one has included additional restrictions. Given this situation it would be appropriate to review fertility services at Level 3 within this CCG, to determine if any changes should be made and to take into account activity, expenditure and where possible, the need to align commissioning criteria for these services with other CCGs in Norfolk. The CCG also needs to take into account services which deliver clinical effectiveness and value for money. A review of Level 3 fertility services has taken place and presented to CEC on 1 September 2016. The recommendation was to reduce the number of IVF cycles and strengthen the criteria with regard to embryo transfers and children from current or
Rare Unlikely Possible Likely Almost Certain previous relationships. It was however recommended that an engagement process should take place to inform the final decision to be made by the Governing Body. There were a total of 9 responses, of which 55.56% (n=5) stated that they agreed with the proposal of a reduction from three cycles to two cycles. The recommendation is to: 1. To reduce the number of cycles from three to two 2. To reduce the number of embryo transfers from four to six 3. Couples with a living child from a current or previous relationship will not be eligible including adopted children Related to the CCG strategic objectives: Links to the CCG strategic risk register: Effectiveness Quality Improved experience Make a difference for local people Reduce inequalities and delivery Sustainable financing None Risk scoring and description: Consequence (impact) 1 2 3 4 5 1 Negligible 1 2 3 4 5 2 Minor 2 4 6 8 10 3 Moderate 3 6 9 12 15 4 Major 4 8 12 16 20 5 Catastrophic 5 10 15 20 25 The risk assessed in the increase in complaints or challenge to the decision to reduce the threshold and number of funded cycles Consequence 2 x Likelihood 3 = 6 Primary care conflict of interest Conflict of interest exists (Y/N) Potential conflict of interest exists (Y/N) No No Impact Quality and safety Positive Negative Neutral Patient experience Positive Negative Neutral Whilst a reduced access to IVF services may result in a perceived reduced patient experience, there is recognition that the CCG needs to consider all commissioned services in order to meet the statutory financial duty. Clinical/operational No impact effectiveness 2 P a g e
Financial/performance (see business case template attached where applicable) QIPP/better care fund Statute/compliance/ governance issues Reduction in expenditure if it is decided to reduce the number of cycles, embryo transfers and change the eligibility criteria regarding living children If the decision is approved, this may result in a QIPP saving. Should the CCG alter its current commissioning position then the CCG would no longer be compliant with NICE guidance 156 (February 2013). NICE make it clear that they expect commissioners to provide a clear rationale for non-compliance. NHS Constitution N/A Equality impact Positive Negative Neutral An equality impact assessment may be needed. Human resources Patient engagement System incl. primary care, NHS providers, local authority, voluntary sector etc. N/A An engagement process has taken place; the results of which are included in this report There will be an impact on stakeholders and providers as a result of a reduction in eligibility criteria and agreed provision. Supporting documents (List all appendices or further attachments) Communications Strategy (How this initiative will be disseminated) Appendix 2 - Engagement outcome report Providers and GPs will be notified of these new arrangements and asked to inform patients when discussing possible referrals and/or treatment plans Acronyms and abbreviations used in the report GYWCCG IVF ICSI NICE SNCCG NEECCG IFR ENHCCG JPUHFT QEHKLFT Great Yarmouth and Waveney Clinical Commissioning Group In-vitro fertilisation Intracytoplasmic Sperm Injection National Institute for Clinical Excellence South Norfolk Clinical Commissioning Group North East Essex Clinical Commissioning Group Individual Funding Request East and North Herts Clinical Commissioning Group James Paget University Hospital Foundation Trust 3 P a g e
Queen Elizabeth Hospital King s Lynn Foundation Trust HFEA Human Fertility and Embryo Authority Directorate involvement and sign off prior to submission to committee / board. Please state role titles or state n/a if appropriate Assessment/Forms Included in the report (Y/N) Finance John Bailey Equality & Diversity Impact Assessment N Commissioning Cath Byford Formal Risk Assessment N QIPP and Delivery IG Risk Form N Information Dean Palmer Clinical Quality Risk Assessment N Contracting Privacy Impact Assessment N Engagement Rebecca Driver Sustainability N Governance Business Case Template N Quality and Safety Cath Byford QIPP Business Case Template N Conflict of Interest Form N 4 P a g e
1. Background / History Infertility is accepted to mean the failure to conceive after 2 years during which there has been regular intercourse and no use of contraception. Approximately 1 in 6 couples across the UK need some assistance with conceiving and although there appears to be very little change in the prevalence of infertility, the demand for assistance has increased. There are significant demographic changes with regard to fertility rates demonstrated in particular reduction in fertility is greatest in women in their late 30s, with those aged 35 to 39 years having a 50% less chance of conceiving spontaneously than women aged 19 to 26 years. This issue is a key factor in the planning and provision of fertility services, as women s age is the single most important variable affecting the success of conception. 2. Fertility Services at Level 1 and 2 Level 1 services are provided by General Practice and patients are offered support and guidance. Level 2 services offer a range of infertility investigations and treatments 3. Definition of a treatment cycle in Level 3 Service The definition of a full cycle of IVF treatment, with or without ICSI sperm injection will comprise 1 episode of ovarian stimulation and the transfer of any resultant fresh and frozen embryo(s). 4. Cost of a treatment cycle in Level 3 Service The typical package of care at Bourn Hall (where all GYW patients have chosen to access this service) is 4,390 per cycle. Some additional services may be required however this would be determined by the individual patients needs and would result in an additional cost. 5. Local Uptake Table 1 below indicates the number of new patients accessing Level 3 services from Jan 2013 June 2016 Referrals into Level 3 vary depending on the number of patients referred from Level 2 There is no correlation between the number of referrals and the number of patients receiving fertility treatment. Referrals are used as a proxy for numbers treated to estimate costs 5 P a g e
Table 1 New Referrals 2013-2016 Financial Year April May June July August Sept Oct Nov Dec Jan Feb March Total 2012/2013 1 6 4 11 2013/2014 12 11 1 2 5 3 2 2 4 3 9 2 56 2014/2015 3 9 2 3 9 2 3 9 2 0 2 3 47 2015/2016 0 2 3 0 2 3 0 2 3 4 4 5 28 2016/2017 3 2 7 12 Grand Total 154 Table 2 shows the budget and overall expenditure for 2015/16. There was a 113,846 underspend in year. Table 2 Finance overview - Actual Year Total Expenditure Budget Variance to budget 2013/14 215,253 2014/15 346,467 2015/16 226,153 340,000 ( 113,846) 2016/17 226,160 Total Spend by Financial Year 400,000 350,000 300,000 250,000 200,000 150,000 100,000 50,000 0 2013/14 2014/15 2015/16 Total 215,253 346,467 226,154 6. Success rates 2015/16 Table 3 6 P a g e
Shows positive pregnancy test rates at Bourn Hall Great Yarmouth & Waveney CCG Fresh 1st Cycle 2nd Cycle Positive Pregnancy Test % 58% 60% Positive Pregnancy Test 18ⁿ 3ⁿ Number of Cases 31 5 Frozen 1st Cycle 2nd Cycle Positive Pregnancy Test % 70% N/A Positive Pregnancy Test 7ⁿ N/A Number of Cases 10 0 In 2015/16 no patients had a third cycle See appendix 1 for costs in 2015-16 and projected costs in 2016-17 using positive pregnancy tests and birth rates as a measure of success. The HFEA publish success rates for fertility clinics based on live births; and these are shown in appendix 1 for comparison with the positive pregnancy tests. Bourn Hall live birth rates are within the predicted range of success. Projected costs are also shown for live births. 7. Provision by other CCGs within the consortium Table 4 sets out the policy for the provision of IVF cycles for each CCG in the East of England. Currently 5 CCGs including GYW provide NICE compliant levels of treatment i.e. up to three cycles. 2 CCGs will only offer a service under exceptional circumstances. We are aware of 3 CCGs that are planning to either decommission the service or reduce the number of cycles. Table 4 CCG Number of cycles Basildon and Brentford Up to 3 (however the CCG is currently consulting on decommissioning the service) Bedfordshire Up to 2 - (however the CCG is currently consulting on decommissioning the service) Cambridgeshire Up to 2 and Peterborough Castlepoint and Up to 2 7 P a g e
Rochford East and North Herts Up to 3 Herts Valley Up to 2 Ipswich and East Suffolk Luton Up to 3 Mid Essex North East Essex North Norfolk Up to 2 Norwich Up to 2 Southend Up to 2 South Norfolk Thurrock Up to 3 West Essex Up to 2 West Norfolk Up to 2 West Suffolk Up to 2. (CCG is consulting on reducing the number of cycles to either 1 or 0 ) 0 cycles Mid Essex CCG has restricted IVF Treatment and only funds IVF in clinically exceptional circumstances. Up to 2 cycles within this more restrictive criteria. Only offered to patients undergoing cancer treatments or who have a disease or condition requiring medical or surgical treatment that has a significant likelihood of making them infertile. Couples who meet the current eligibility criteria in which the male partner has a chronic viral infection where there is a high risk of viral transmission to the female partner and potentially any unborn child (such as HIV or Hep C), would also be offered ICSI. Up to 2 cycles within this more restrictive criteria. Only offered to patients undergoing cancer treatments or who have a disease or condition requiring 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). Up to 2 (CCG is consulting on reducing the number of cycles to either 1 or 0) Table 5: Summary of treatment cycles by CCG Number of cycles Number of CCGs 0 cycles 1 Up to 2 cycles 13 (includes 2 with restrictions) Up to 3 cycles 5 (includes GYW) Total 19 Table 6: Expected savings assume 36 patients entering the service To reduce the number of cycles of IVF from three to two The CCG will no longer be compliant with NICE clinical guidance 156 (Feb 13). The CCG s position would be more consistent with most 8 P a g e
CCGs within the consortium and will provide a similar level of service to the other Norfolk CCGs. The CCG would save 74,630 but there could be additional costs associated with the individual package of care (assuming projected activity for 2016/17) 8. Engagement exercise An engagement exercise was undertaken from 12 September and 22 September 2016. The public were asked for their views on the reduction of the number of IVF cycles from three to two. There were a total of 9 responses and 55.56% (n=5) stated that they agreed with the proposed reduction. It should be recognised that the low number of responses does not provide a significant picture of the views of the public. The completed report is available in appendix 2. 9. Proposal The CCG considers the commissioning approach for IVF based on the above information. However other factors to consider are: Positive: A reduction to two cycles for new patients will make us more consistent with most other CCGs. This will support the move for a consistent approach in the number of services commissioned by CCGs. Aside from current patients receiving treatment there is no contractual commitment to identified levels of activity with providers. A reduction in commissioned cycles could contribute to continuing supporting services that have a positive impact on a greater number of patients. Adverse: The relatively low levels of savings if the proposed change is to reduce to 2 cycles only The potential for adverse media/reputation (the CCG will note the recent coverage by the HSJ/BBC regarding the Bedfordshire and Basildon and Brentwood CCGs consultation that is currently in place. 10. Conclusion Success rates from 2015/16 show that 61% of patients received one or two cycles in order to go on to a successful pregnancy. The CCG spent a total of 226,153 on Fertility Services in 2015/16. 9 P a g e
There is an opportunity to make savings (assuming no increase in demand) if the number of commissioned cycles is reduced and changes to criteria. A reduction to two cycles would make the CCG more consistent in its policy with many of the CCGs in the consortium including the 4 other Norfolk CCGs. The CCG has undertaken an engagement exercise and whilst the response rate was very low (9), 55.56% support the proposed reduction in number of cycles. 11. Recommendation For Governing Body to approve and ratify the decision of CEC to reduce the number of cycles of IVF and to strengthen the criteria in terms of embryo transfers and living children 10 P a g e
Appendix 1 Costings and Activity for reduction in number of cycles Summary Sheet: IVF projected expenditure and savings (36 patients) 3 cycles 364,370 drop to 2 cycles 289,740 saving of 3 to 2 74,630 Fertility treatments : activity and costings Referrals/ Year Tariff Charge Referrals/ year for 16/17 (12 for Q1) 36 4,390 158,040 of which 58% Successful ( positive pregnancy test) 21 and 42 % unsuccessful 15 therefore requiring 2nd cycle 15 4,390 65,850 of which 60% successful 9 and 40% unsuccessful 6 therefore requiring 3rd cycle 6 4,390 26,340 However, not all positive pregnancy tests will result in live birth published success rate = 27% 250,230 Therefore, patients will require further treatment for live birth: of the 58% successful at cycle 1 21 27% will have a live birth 6 therefore, remainder will require cycle 2 15 4,390 65,850 27% will have a live birth 4 therefore remainder will require cycle 3 11 4,390 48,290 Total 364,370 If remain on 3 cycles 364,370 if 2 cycles 289,740 Therefore savings from reducing from 3 to 2 treatment cycles 74,630 11 P a g e
Appendix 2 Norfolk and Waveney fertility services questionnaire FEEDBACK REPORT Sep 2016 Ian Wakefield Sep 2016 12 P a g e
Norfolk and Waveney fertility services questionnaire Feedback Report Content Page Executive summary 2 Background 2 Questionnaire Feedback overview 3 About you? 3-6 About changes to fertility treatment 6-8 Any further comments? 8 Executive summary The quantity of feedback was not significant enough to reach any meaningful conclusions. However, the feedback received does highlight two contrasting views. Firstly that it is justified to reduce the number of IVF cycles, in order to save 70k, as it will affect such a small number of people. Secondly the amount of money saved is so small, that the service should be left as it is to give people the best chance of conceiving. There is roughly a 50/50 split between the two camps. Background Both locally and nationally the NHS is facing a challenging future as demand for services increase. We know that we need to make tough decisions around future health services as the CCG continues to face unprecedented financial pressures. The CCG has already made a range of changes to improve efficiency without compromising on the quality of services local people receive, such as introducing new models of out-of-hospital care and reducing back office functions wherever possible. One way that we could make some savings is to review our fertility services. In total, approximately one in six couples across the UK need some assistance with conceiving and although there appears to be very little change in the prevalence of infertility, the demand for assistance has increased. 13 P a g e
NHS Great Yarmouth and Waveney currently provide three cycles of IVF treatment to women who have been unable to conceive after two years. The number of patients who were referred into the service for treatment in the Great Yarmouth and Waveney area varies every year: 2013/14: 56 2014/15: 47 2015/16: 28 However, we know that the majority of patients will get pregnant after one or two cycles of IVF treatment. However, we know that only 27% will have a successful birth. (source: HFEA website, Q2 2014) The CCG is proposing that from the end of September 2016 we should only provide two cycles of IVF treatment which would help the CCG to save around 70,000 each year. Fertility Services from GPs and the James Paget Hospital will remain unaffected by these proposed changes. Our Governing Body is going to consider this proposal at their meeting in public on Thursday, 29 September. Questionnaire Feedback overview The survey was created on 02 September 2016 using SmartSurvey. It was opened for responses on 12 September and closed on 22 September at 9 am. Links to the survey were sent out in a press release on 8 September which went to 289 local media contacts. It was also shared on the CCG Website, Facebook and Twitter accounts. We have evidence that the press release and link was published in the following places: Healthwatch Suffolk, website and social media Waveney District Council Facebook page BBC local news, Norfolk & Suffolk websites There were 9 online responses collected. About you? Details of those who responded to the survey: Question 1 What is your post code? Only 8 respondents recorded their locations, these are shown on the map below. They show a good spread in geographical area across the CCG patch, although two 14 P a g e
of the markers are outside the CCG boundaries, we welcome opinion and feedback from all contributors. 2. What is your age? 15 P a g e
3. How would you describe your sexual orientation? 4. Which ethnic group do you consider you belong to? 5. Do you consider yourself to have a disability? 16 P a g e
About changes to fertility treatment 6. The CCG is proposing to move from three IVF cycles to two. Do you agree with this proposal? 7. Please give us your views about this proposal? 17 P a g e
Comment 1 Seventy thousand a year is the equivalent of one management contract. Surely this is more cost effective than punishing couples trying to have children. We already know the NHS is bloated in respect to managers so this is the simple answer. Theme 1,4 2 With such stretched resources I believe 2 is a fair compromise bearing in min it's not a life threatening or life limiting condition 3 I was unable to receive NHS funding for IVF treatment but I was fortunate to conceive on 1 round which is very lucky. It's proven that women need at least 2 cycles for a chance of success so in principle, I agree with the proposal. I do however acknowledge that it is generally those who haven't experienced infertility who make this decision and would therefore ask the CCG to engage with those affected by the decision. 4 I think money can be saved elsewhere rather than take cuts from people who want IVF. If is often need due to no fault of the couple. Yet people ate given treatment for other problem's which could have been helped by choice.. i.e. stopping smoking drinking or eating healthy. So why penalise people who have no control over those that do. 5 Infertility is a distressing condition for couples to go through. The repercussions of not being able to have children follow people throughout their lives. I believe that couples should be given every opportunity to have a much wanted child, and the reduction proposed provides a very small cost saving, on an already rationed service, that in reality will not make any significant impact on health service finances. I recognise that infertility is not a life threatening condition - but it is a life altering/changing one - and there are many many procedures that are routinely funded in other areas of care that try to ensure patients lives are not altered adversely. Also, whilst NICE guidance recommends three cycles, I believe the position of the CCG in continuing to work to this guidance is one that is nationally respected and should be celebrated. 6 Is it really such a saving when last year there were only 28 couples referred. 5 2 3 4 5 Key themes 1. NHS has too many managers, cut one of these instead 2. Agree that reducing from 3 cycles to 2 is reasonable and fair 3. More engagement needed with those who may be affected by the decision 4. Money should be saved from elsewhere 5. Not a significant enough saving to be worthwhile 8. Given the fact that the NHS is facing considerable financial pressure. Do you think that fertility services such as IVF should be funded by the NHS? 18 P a g e
Any further comments Comments 1 For some it's a medical need. You will continue to treat smokers, drug addicts and alcoholics, so why not persevere with someone looking to do good and bring a life into the world 2 The impact of infertility on a person's mental health IS significant and should not be ignored. Unless you have experienced the chance you may never conceive, you are unlikely to understand the implications. I also feel that the NHS should consider funding options e.g. loans for those who may require support. Theme 1 2,3 Key themes 1. Bringing life into the world should be celebrated not managed 2. Consider loans for those affected 3. Consider effect on mental health too. Summary Nine responses is not a significant enough number to be representative of the 237,000 that the CCG services, but gives us a flavor of the issues and views surrounding the funding of IVF. The key point from the survey is that 55.56% (n=5) of respondents felt that it was reasonable to restrict the number of IVF cycles to two, although those opposed, felt that more consultation should take place with those who may be effected by the change in policy and the implications on mental health for those denied the third cycle. 44.44% (n=4) of respondents though that IVF should not be funded by the NHS. 19 P a g e