AGENDA ITEM 8 GOVERNING BODY MEETING IN PUBLIC ON 25 TH SEPTEMBER 2014 SPECIALIST FERTILITY SERVICES CLINICAL CRITERIA & CONTRACT AWARD Date of the meeting 25 th September 2014 Author Sponsoring Board Member Purpose of Report Recommendation Reason for inclusion in Part II Stakeholder Engagement Caroline McCarron Dr Brian Houston To provide an overview of the procurement evaluation process recently completed for specialist fertility services (SFS) and to approve the clinical access criteria recommended by the Clinical Executive Committee. The Governing Body is asked to note the evaluation process for the procurement of SFS and approve the recommendation for resultant contract award and adoption of clinical criteria. N/A Progress of procurement process and options for clinical criteria reviewed at clinical executive and governing body. Community engagement exercise undertaken in respect of clinical criteria, survey developed and disseminated with the aid of Healthwatch and also via GPs, CCG website and local events. Previous GB / Committee/s, Clinical Executive Committee May, June & September 2014 Dates Monitoring and Assurance Summary This report links to the following Assurance Domains I confirm that I have considered the implications of this report on each of the matters below, as indicated: Quality Equality and Diversity Engagement Outcomes Governance Partnership-Working Leadership Yes [e.g. ] Any action required? Yes Detail in report All three Domains of Quality (Safety, Quality, Patient Experience) Board Assurance Framework / Risk Register Budgetary Impact Legal / Regulatory People / Staff Financial / Value for Money / Sustainability Information Management &Technology Equality Impact Assessment Freedom of Information No
1.0. Introduction 1.1. Prior to 1 st April 2013 Specialist Fertility Services were commissioned by the East Of England Specialised Commissioning Group. Post April 2013, the responsibility for commissioning Specialist Fertility Services, commonly referred to as IVF (In- Vitro Fertilisation), has transferred to Clinical Commissioning Groups. Specialist Fertility Services are commissioned via a Consortium covering all 19 East of England CCGs (the EoE Consortia) with East & North Hertfordshire CCG (ENHCCG) acting as host commissioner. 1.2. Existing Specialist Fertility Services (SFS) contracts have been in place since 2009 with contracts currently covering Primary Sites in Cambridge, Colchester, Leicester, London, Norwich and Oxford. The East of England Consortia, led by ENHCCG, aim to procure Specialist Fertility Services which will deliver: Excellent clinical outcomes and service quality; Improved success rates and live births; Patient access reduced waiting times to access services, geographical access and sufficient capacity to satisfy demand; Patient Choice and experience; and Value for money - reducing the overall cost of existing Services and increasing efficiencies. 1.3. This paper summarises the evaluation process of bids received together with the total scores achieved by bidders measured against Clinical, Access and Financial criteria together with the contract award recommendations. 1.4. Clinical access criteria for SFS remains outside of the remit of the procurement and is to be determined at individual CCG level. At the point of contract award all providers will be notified of the clinical access criteria applied by individual CCGs. NHS Southend CCG has undertaken a community engagement exercise to seek the views of local people, to understand any potential impact the proposed changes may have. 2.0. Specialist Fertility Services - Information 2.1. Specialist Fertility Services (SFS) include In Vitro Fertilisation (IVF), Intra- Cytoplasmic Sperm Injection (ICSI) and Donor Insemination (DI). SFS will provide assisted conception services for couples who are registered with East of England GPs and who have been referred into such services by named GPs with a specialist interest (GPSI s) and Consultant Gynaecologists. Referrals from outside of the East of England will be accepted provided that couples are registered with an East of England GP, meet eligibility criteria defined in the SFS service specification and for whom appropriate diagnostics have been completed. 3.0. Clinical Access Criteria 3.1. National Institute for Health and Care Excellence (NICE) 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 of the service. This is particularly significant at this time due to the current procurement for specialist fertility services. 3.2. The proposed policy changes for NHS Southend CCG include adoption of some but not all new NICE guidance. 2
3.3. The table below notes current policy vs NICE recommendations vs proposed policy: Age at which IVF is available as standard Access to IVF for unexplained fertility following investigation Cycles of IVF routinely offered Eligibility criteria Current position as per EoE policy Up to 39 years NICE recommendations from Guidance CG156 Up to 42 years Proposed policy Up to 42 years 3 years 2 years 3 years 3 cycles No allowance for same sex couples 3 cycles (one cycle 40-42) Include couples who are unable or would find it difficult to achieve full vaginal intercourse 2 cycles (one cycle 40-42) Include couples who are unable or would find it difficult to achieve full vaginal intercourse 3.4. NHS Southend CCG has undertaken a community engagement exercise to seek the views of local people, to understand any potential impact the proposed changes may have. 3.5. With the support of Healthwatch we maximised our engagement opportunity to reach our target audience, this is coupled with promotion at a recent public event, circulation to all GP practices and promotion on the CCG website. Despite this extensive programme only a small number of responses (16) were received. 3.6. Based on the responses received there was no overwhelming consensus for or against the proposals. Please see a summary copy of the engagement survey responses in Appendix 1. 3.7. The Clinical Executive Committee recommended approval of the proposed policy as noted above. 4.0. Activity 4.1. The table below shows the total indicative annual activity levels. The historical activity shown represents the average number of annual cycles between 2010 and 2013. The Services relating to this Procurement will be commissioned under a new approach as defined packages of care comprising all investigations, treatments and procedures and medication. Packages Annual number of cycles (average of 3
In Vitro Fertilisation (IVF) with or without Intracytoplasmic Sperm Injection (ICSI) 2010-13) - Units 2,597 Frozen Embryo Transfer 456 Embryo/Blastocyst Freezing and Storage 729 Surgical Sperm Recovery (Testicular Epididymal Sperm Aspiration (TESA)/Percutaneous Sperm Aspiration (PESA) including storage where required) 46 Intrauterine Insemination (IUI) - unstimulated 13 Donor Oocyte Cycle 45 Refunds for abandoned cycles 29 Donor Sperm Insemination 75 Egg and Sperm Storage for Patients Undergoing Cancer Treatments 4.2. There will be no guarantee of any minimum volume of activity and payment will be based solely on actual activity performed (if any). 4.3. With the move to defined care packages, i.e. specified pathway elements, combined with other factors such as revised access criteria and entitlement, it is not anticipated that there will be any significant change in future activity levels. 5.0. Evaluation Process 5.1. The evaluation process has been undertaken by members of the East of England Specialised Fertility Services Consortia (the EoE Consortia). Individual evaluations of each of the 15 bids received were undertaken independent of each other for their given area only, i.e. Clinical colleagues scored the clinical aspect of the bids only. Moderation discussions were held subsequent to individual evaluations in order to determine a consensus score. 6.0. Clinical evaluation 6.1. The Clinical evaluation carries 30% of the total marks available with individual weightings. Latest available information from the HFEA has been used to score 100 bidders clinical aspects including an assessment of their IVF success rate, i.e. the percentage of live births recorded against key age bands. 7.0. Access 7.1. The Access evaluation carries 30% of the total marks available with individual weightings. The postcodes submitted by providers for all primary and satellite sites were used to calculate travelling times. The closer proximity for EoE population to the centres where SFS services would be delivered, the higher the score. 8.0. Finance 4
8.1. Finance Evaluation 8.1.1 The Finance component of the evaluation carries 40% of the overall marks available. The estimated cost of the service across all EoE CCGs as detailed in the ITT (Invitation to Tender) is 10m per annum. This is predicated on an expected number of IVF cycles, i.e. the most expensive component of SFS treatment, of 2,597 cycles per annum. 8.1.2 The 15 bids received ranged between 7.2m and 14.3m. The highest score being awarded the lowest price Bidder. Remaining scores were then judged in relation to this highest mark. Hence Bidder I s 14.3m highest bid scored only 2.0 points given it was over 40% higher than the expected cost indicated in the ITT as well as almost double that of the lowest bid. 8.2. Average prices comparison existing providers to Top 5 bids 8.2.1 There are no guaranteed volumes of activity for successful bidders as part of the SFS procurement but equally there is no guarantee of where, given Patient Choice, individual CCGs activity will be provided. It is not possible therefore to gauge the precise financial impact of the new Specialist Fertility Services procurement on individual CCGs. However the following average IVF cycle prices as noted below give some indication of the better value for money the new procurement will achieve for EoE Consortia CCGs overall. Existing providers: Prices 2,990, 3,109, 3,317, 3,400, limited activity* Average price 3,204 (based on 4 providers) * As very limited activity is currently being undertaken by one provider they have been excluded for comparative purposes in order to give a more meaningful current average price Proposed Top 5 bidders: Prices 2,500, 2,875, 2,995, 3,340, 3,350 Average price 3,012 8.2.2 On average it is expected that the new SFS procurement will yield prices that are 6% lower than the existing services. 9.0. Overall Scoring 9.1. Evaluation Summary and selected Top 5 bidders 9.1.1 Upon completion of the evaluation steps noted above the final evaluation scores were recorded. 5
Specialist Fertility Services Evaluation Summary Ranking Bidder ID Clinical Access Finance Evaluation Score Cycles Offe to EoE 1 G 196.0 218.0 400.0 814.0 4 2 C 233.0 300.0 236.0 769.0 3 3 H 232.0 235.3 290.0 757.3 4 L 192.0 215.3 325.0 732.3 1 5 N 208.0 225.0 228.0 661.0 1 6 J 191.0 200.6 255.0 646.6 7 E 192.0 158.3 295.0 645.3 8 M 220.0 197.0 224.0 641.0 3 9 B 219.0 103.6 297.0 619.6 10 K 192.0 206.3 184.0 582.3 11 D 208.0 178.1 179.0 565.1 12 O 179.0 107.9 274.0 560.9 13 F 200.0 104.9 246.0 550.9 14 A 190.0 180.2 141.0 511.2 15 I 208.0 182.3 2.0 392.3 Key: Successful - within Top 5 scoring bids Unsuccessful 9.1.2. The 5 highest scoring bids highlighted above in green represent maximum capacity of 10,300 IVF cycles against an EoE requirement of 2,597 per annum. 10.0. Proposed contract start dates 10.1. Proposed start date for new contracts, which may require mobilisation of new services, is intended as 1 st December 2014. The NHS Standard Contract 2014/15 shall be used for all successful bidders. Contract length is for 3 years with an option to extend by a further 2 years. 11.0. Existing patients 11.1. In order to preserve continuity of patients care, a patient who has already started infertility treatment with one provider who no longer provides care under the new 6
contractual arrangements from 1 st December 2014 onwards will still have their entire package of care, e.g. up to 3 IVF cycles, with that initial provider. 11.2. In order to ensure there is no break in provision for Specialist Fertility Services for East of England CCGs the 5 current providers have been contacted to extend their current contracts to end on 30 th November 2014. 12.0. Recommendation 12.1. Clinical Access Criteria 12.1.1 Members of the Governing Body are invited to approve the adoption of the proposed changes to clinical access criteria for specialised fertility services as noted below: Age at which IVF is available as standard Access to IVF for unexplained fertility following investigation Up to 42 years 3 years Cycles of IVF routinely offered 2 cycles (one cycle 40-42) Eligibility criteria Include couples who are unable or would find it difficult to achieve full vaginal intercourse 12.2. Evaluation Process and Contract Award 12.2.2 Members of the Governing Body are invited to note the overview of the procurement evaluation process for the provision of Specialist Fertility Services and to approve contract award to the top five selected bidders based on the highest scoring bids as noted in section 9.1.1. 12.2.3 The Governing Body of each of the 19 CCGs within East of England is required to review the evaluation process and formally adopt the EoE Consortia recommendations re Contract Award for the Top 5 bids received for the provision of Specialist Fertility Services. Consortia will only be able to reach a decision on Contract Award, i.e. be in a position to formally award such contracts, when a consensus opinion of 10 of 19 has been reached. Author s name and Title : Caroline McCarron Date : 17th September 2014 APPENDICES Appendix 1 IVF Survey Summary September 2014 7