Agenda Item 9 Appendix 1

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1 Agenda Item 9 Appendix 1 Appendix 1 Report provided by East and North Herts CCG Consortium Lead Specialist Fertility Services Contract Award Recommendations 1. Executive Summary 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 Consortium) with East & North Hertfordshire CCG (ENHCCG) acting as host commissioner. Existing 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 Consortium, led by ENHCCG, are looking 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. An event promoting the procurement to interested parties was held in February 2014 and a formal procurement process commenced in April This paper summarises the evaluation process of bids received together with the total scores achieved by bidders measured against Clinical, Access and Financial criteria. Contract Award recommendations, which all of the 19 East of England CCG Governing Bodies are being asked to accept or reject, are based on total evaluated scored. Evaluation has been broken down as 30% Clinical delivery, 30% (Patient) Access and 40% for financial affordability. The above scoring criteria is as detailed in the Invitation To Tender (ITT) issued in April 2014 as is the number of providers to be selected. As there are currently 5 Specialist Fertility Providers providing IVF and related services to East of England commissioners the same number of bids has been recommended to be approved for Contract Award and is also as detailed in the ITT. This should ensure there is sufficient capacity and choice of service provider. Section 10 details the 5 highest scoring bids which are recommended for Contract Award for the provision of Specialist Fertility Services for the 19 East of England CCGs. The Top 5 highest scoring bids recommended for Contract Award represent a significant change to current providers with only 1 of the existing 5 SFS providers recommended for Contract Award.

2 2. Specialist Fertility Services - Procurement background & information The Specialist Fertility Services procurement represents a Part B procurement under the Public Contracts Regulations An Invitation To Tender was advertised on Bravo Solutions (procurement vehicle/site) and a bidder Information Event held in late April Specialist Fertility Services (SFS) including In Vitro Fertilisation (IVF), Intra-Cytoplasmic Sperm Injection (ICSI) and Donor Insemination (DI) has previously been commissioned by the East of England Specialised Commissioning Group. From 1 st April 2013 East and North Hertfordshire Clinical Commissioning Group is the lead Clinical Commissioning Group for contracting and commissioning for SFS on behalf of all the Clinical Commissioning Groups in the East of England. 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 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. The procurement is intended to replace previous Specialised Commissioning Group arrangements for contracts which have been let since 2009 and in so doing ensure, based on extensive evaluation of submitted bids, that successful bidders provision of Specialist Fertility Services will ensure: 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. This Procurement is being co-ordinated by East & North Hertfordshire CCG in its capacity as host commissioner on behalf of itself and all EoE CCGs, i.e. : Basildon and Brentwood CCG Bedfordshire CCG Cambridge and Peterborough CCG Castle Point & Rochford CCG Great Yarmouth and Waveney CCG Herts Valleys CCG Ipswich and East Suffolk CCG Luton CCG Mid Essex CCG North East Essex CCG North Norfolk CCG Norwich CCG South Norfolk CCG Southend CCG Thurrock CCG West Essex CCG West Norfolk CCG West Suffolk CCG

3 3. Activity 3.1 Annual Activity to be undertaken as part of the SFS procurement The table below shows the total indicative annual activity levels. The historical activity shown represents the average number of annual cycles between 2010 and The Services relating to this Procurement will be commissioned as defined packages of care comprising all investigations, treatments and procedures and medication. Packages In Vitro Fertilisation (IVF) with or without Intracytoplasmic Sperm Injection (ICSI) Annual number of cycles (average of ) - 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) 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 There will be no guarantee of any minimum volume of activity and payment will be based solely on actual activity performed (if any). 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. Similarly, non-ivf speciality services relating to current activity, which represents approximately 10% of the total costs, are not expected to experience any significant fluctuations. 3.2 HFEA requirements on where activity is provided It is a pre-requisite requirement that all bidders must have a Primary Centre licensed by the Human Fertilisation and Embryology Authority (HFEA) and such Primary Centres are responsible for ensuring that any activity undertaken by Satellite Centres is also subject to the same license conditions, quality standards and guidance as stipulated by the HFEA Code of Practice.

4 4. Evaluation Process The evaluation process has been undertaken by members of the East of England Specialised Fertility Services Consortium (the EoE Consortium). 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 that the nominated leads for each of the 3 sub-categories could determine a consensus score. Nominated leads for the evaluation areas are: Clinical Dr Raj Nagaraj, Consultant in Public Health, Hertfordshire County Council Access Neil Hales, Assistant Director of Contracts, East & North Hertfordshire CCG Finance Teresa Maczugowska, Finance Manager, East & North Hertfordshire CCG Procurement support throughout the entire procurement process and evaluation element has been provided by Glenn Gooch of the East of England NHS Collaborative Procurement Hub. Further to consensus being reached for each aspect of the evaluation a review of the overall scores achieved for each anonymous bidder was then further discussed at the Contracts Award meeting held on 20 th August of the 19 CCGs in the EoE Consortium were represented at this meeting. 5. Clinical evaluation The Clinical evaluation carries 30% of the total marks available with individual weightings as noted below. Clinical assessment was undertaken by Public Health and GP colleagues. Latest available information from the HFEA has been used to score bidders clinical aspects including an assessment of their IVF success rate, i.e. the percentage of live births recorded against key age bands. The following questions (overleaf) were evaluated in relation to the Clinical evaluation of the SFS bids.

5 F.1 F.1.1 F.1.2 Clinical (30%) Confirm the Bidder s latest reported IVF and ICSI success rates for live births per treatment cycle for the age ranges show n. Describe how the Bidder plans to achieve improvements in their current rates, by the different age groups, to meet the outcomes described in the Service Specification, and as per the guidance below, for the follow ing areas: Weighting - 8% Weighting - 4% Raj Nagaraj / Pauline Brimblecombe / Clare Serale Raj Nagaraj / Pauline Brimblecombe / Clare Searle F.1.3 Provide details of: 1) any Critical or Major areas of non-compliance identified in the Bidder s or any Relevant Organisations or sub-contractors most recent HFEA Inspection Report; and Weighting - 8% Raj Nagaraj / Pauline Brimblecombe / Clare Searle F.1.4 Provide details of: 2) any improvement plans, along w ith supporting evidence, to address the Critical and Major areas of non-compliance identified above. Weighting - 6% Raj Nagaraj / Pauline Brimblecombe / Clare Searle Provide details of: F.1.5 professional translation services during clinical consultations, and translated materials describing procedures and clinical prognosis. Weighting - 4% Raj Nagaraj / Pauline Brimblecombe / Clare Searle procedures); and The highest score of was awarded to Bidder C. The lowest score of given to Bidder O.

6 6. Access The questions below and weightings were noted as part of the Access evaluation. The Access evaluation similar to Clinical evaluation was worth 30% of the overall scoring available. Q2.1 Concentrated on the bidders ability to provide the activity numbers required to EoE. Postcodes used in Q2.2 were used to calculate travelling times for East of England CCGs to bidders Primary and Satellite Centres. The closer proximity for EoE population to the centres where SFS services would be delivered the higher the score. This is illustrated in the table below: Methods Statistical Analysis - EoE travelling time to bidder postcodes Ranking Bidder ID Existing Provider Top 5 Bidder Primary only Primary & Satellite 25% of Satellite Overall (Primary + 25% Satellite) 1 C Existing Top D J H Top L Top G Top A Existing I N Top K Existing E M Existing O Existing F B If the Access criteria were calculated on travelling time alone there looks to be marked improvement between the Top 5 highest scoring bids and the 5 existing providers. Q2.3 calculated a further element of the evaluation by assessing overall capacity to provide SFS services with higher marks recorded to those providers who could fulfil a greater share of EoE activity requirements. The highest score achieved from this element of the evaluation was to Bidder C with the lowest being 103.6, Bidder B.

7 F.2 Patient Access (30%) F.2.1 From all of the Primary (HFEA) Centres stated in the Bidder s response to question A.4 Location of Services, and if applicable from all of the Bidder s Satellite/Transport Centres stated in the Bidder s response to question A3a Subcontractor details, describe how the Bidder w ould: accessible; Weighting - 4% Neil Hales/Jan Ashcroft/Michelle Ducker stated in the Bidder s response to question F.2.3 below F.2.2 Bidder should provide all of the Post Codes for the Primary (HFEA) Centres stated in the Bidder s response to question A.4 Location of Services, and if applicable for the Bidder s Satellite/Transport Centres stated in the Bidder s response to question A3a Subcontractor details. Weighting - 13% Neil Hales/Jan Ashcroft/Michelle Ducker F.2.3 Bidder should provide the capacity information requested (template for completion) Weighting - 13% Neil Hales / Jan Ashcroft /Michelle Ducker The Top 5 highest scoring bidders overall are also the Top 5 highest scoring from the Access perspective. 7. Finance 7.1 Finance Evaluation The Finance component of the evaluation is worth 40% of the overall marks available. The estimated cost of the service across all EoE CCGs as detailed in the ITT 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 per annum. The 15 bids received ranged between 7.2m and 14.3m. The highest score of being awarded the lowest price Bidder G. 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 7.2 Average prices comparison existing providers to Top 5 bids 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 Consortium CCGs overall. Existing providers: Prices 2,990, 3,109, 3,317, 3,400, limited activity* Average price 3,204 (based on 4 providers) Proposed Top 5 bidders: Prices 2,500, 2,875, 2,995, 3,340, 3,350 Average price 3,012 On average it is expected that the new SFS procurement will yield prices that are 6% lower than the existing services. * 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

9 8. Overall Scoring 8.1 Evaluation Summary and selected Top 5 bidders Upon completion of the evaluation steps noted above the final evaluation scores were recorded. Specialist Fertility Services Evaluation Summary Ranking Bidder ID Clinical Access Finance Evaluation Score Cycles Offered to EoE Prime Location(s) Satellite Location(s) 1 G ,000 London Wimbledon 2 C ,200 Cambridge, Colchester, Norwich Kings Lynn, Luton, Peterborough, Wickford 3 H London Brentwood, Bushey, Cambridge, Enfield, Harpenden, Norwich, Redbridge, Southend 4 L ,000 London n/a 5 N ,300 London n/a 6 J E M ,400 9 B K D O F A I Key: Successful - within Top 5 scoring bids Unsuccessful 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. The 5 highest scoring bids include, as highlighted by bold italic in the above table: the 2 best Clinical evaluations: Bidder C and Bidder H the 2 best Access evaluations: Bidder C and Bidder H the 2 best Finance evaluations: Bidder G and Bidder L

10 The 5 highest scoring bids for which Contract Award is recommended are: Bidder G Bidder C Bidder H Bidder L Bidder N 8.2 Unsuccessful bids The first 4 scores in the total evaluation where significantly ahead of the 5 th place bidder with the 4 th placed bid scoring compared to 661 for 5 th placed. A sensitivity check was undertaken between the 5 th, 6 th, 7 th and 8 th bids however given that there was less than 20 points separating them. The 5 th bid was better in terms of both clinical and access criteria than 6 th and 7 th bids though was more expensive, i.e. had a lower financial score. The 8 th bid was also compared to the 5 th bid. Though the 8 th bid had a higher clinical score, representing the third best in terms of clinical evaluation, it had significantly worse access and a marginally lower finance score than the 5 th bid. As the evaluation exercise has been based on total evaluation and the procurement is limited to 5 successful providers it is not possible to include the 6 th, 7 th and 8 th bidders in the Contract Award recommendation as this would leave the EoE Consortium open to legal challenge, i.e. by operating outside its own procurement intentions as stipulated in the Invitation To Tender. 9. Risks The procurement s Invitation To Tender (ITT) has been very specific in that Contract Award should be made to 5 bidders. There are currently 5 service providers providing Specialist Fertility Services and as such commissioners took the view pre-procurement that awarding new contracts to the same number would ensure there was sufficient capacity throughout East of England as well as provide patients with choice of provider. ENHCCG are cognisant, in its capacity as host commissioner, that the highest scoring Top 5 bids overall represent different geographical mix from previous contracted arrangements. The Top 5 bids will provide Primary Centres, i.e. centres where all elements of the pathway can be delivered from and specifically where IVF implantation is performed, in: Cambridge, Colchester, Norwich, and 4 centres in London. As noted above in the Access evaluation the Top 5 highest scoring bids represent greater access to IVF services for East of England as a whole however its recognised that access may be variable for individual CCGs.

11 A Contract Award meeting was held on 20 th August 2014 at which 16 of the 19 EoE CCGs were represented. All parties indicated at that meeting that they were minded to recommend the EoE Consortium s recommendations as noted in this paper, i.e. the Top 5 highest scoring bids from the overall evaluation. However, given that some CCGs may feel the new recommended providers give a less local service to them or may impact negatively on their relationship with local interested parties / providers it remains for individual CCG Governing Bodies to determine whether or not to accept the EoE Consortium s recommendations. Should a CCG decide to reject the EoE Consortium s recommendations it will leave itself open to legal challenge from those selected Top 5 scoring bidders / providers. Its recognised though that challenge to the procurement may also come from existing providers whose bids are unsuccessful. The above factors suggest that potential legal challenge to the procurement process is high however we are confident and have received reassurance from the 16 CCG participants taking part in the 20Aug Contract Award discussion that a robust, open and transparent process has been undertaken by the EoE Consortium, led by East & North Herts CCG. 10. Recommendations / Decision for Governing Bodies As noted in the Section 8 Overall Scoring, and in accordance with the procurement s Invitation To Tender CCG Governing Bodies are required to: i) Agree Contract Award for the provision of Specialist Fertility Services for East of England CCGs based on the highest scoring evaluate bids. These are: Bidder G Bidder C Bidder H Bidder L Bidder N OR ii) Reject the EoE Consortium recommendations for Contract Award. CCG Governing Bodies are asked to note that rejection of the EoE Consortium recommendations will necessitate: The CCG concerned removing themselves from the EoE Consortium The CCG concerned entering into its own contractual and procurement arrangements for the provision of Specialised Fertility Services for its resident population. 11. Proposed contract start dates

12 In recognition that this Contract Award paper is required to be reviewed by all and approved by a consensus of all 19 CCG Governing Bodies for CCGs within East of England and that such meetings will operate through til late September proposed contract start dates have been moved back from initial assumptions of starting from 1 st October. Proposed start date for new contracts, which may require mobilisation of new services in addition to the required 10 day standstill period post Contract Award, is intended as 1 st December This date is dependent however on consensus of CCGs having agreed to the EoE Consortium recommendations for Contract Award and subject to any procurement challenge that may be lodged. 12. Contract length 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. 13. Existing patients In order to preserve continuity of patients care new contractual arrangements will impact on new referrals only from the start date of the new services, proposed as above as 1 st December For example, a patient who s care has already started infertility treatment with one provider who no longer provides care under the new contractual arrangements from 1 st December 2014 onwards will still have their entire package of care, e.g. upto 3 IVF cycles, with that initial provider. 14. Next steps All 19 CCGs within East of England are to review this paper and their Governing Body is required to formally adopt the EoE Consortium recommendations re Contract Award for the Top 5 bids received for the provision of Specialist Fertility Services or request to be removed from the Consortium arrangements. As CCG Governing Bodies meet at varying times in late August and throughout September the EoE Consortium will only be able to reach a decision on Contract Award, i.e. be in a position to formally award such contracts, when a consenus opinion of 10 of 19 has been reached. It is expected such a determination may be reached by early October. As noted above any existing patients would continue to be seen with their existing provider regardless of whether that provider holds a new EoE SFS contract once the procurement has been concluded, i.e. after Contract Award stage. In order to ensure there is no break in provision for Specialist Fertility Services for EoE CCGs the 5 current providers have been contacted to extend their current contracts to end on 30 th November Neil Hales Assistant Director of Contracts East & North Herts Clinical Commissioning Group 21 st August 2014

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