NHS England, National QIPP Delivery Programme, Medicines Management & Optimisation

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1 NHS England, National QIPP Delivery Programme, Medicines Management & Optimisation Biosimilars National Surveys; CCGs and NHS Trusts Summary Report - April Background This report summarises the two national biosimilars surveys carried out during 2017/18. The following outputs are available from this work; Workshop slides (18 th April 2018) Report of a North West NHS Trust learning meeting Report of the CCG surveys (34 pages) Report from the NHS Trust surveys (50 pages) 1.1 CCG Survey A questionnaire was developed by the NHSE Policy Department together with Regional teams. 134 CCGs completed this survey between December 2017 and 31 st March A collaboration of CSUs worked together to analyse and produce this report. 1.2 Trust Survey A Trust survey was developed by the CSUs working with the NHSE Policy Unit and Regional teams. This work was informed by a learning interview undertaken with a Trust in the North West; the outputs of which are available in a separate report. 20 Trusts, 5 per region, were surveyed to gain an understanding of the learning themes and barriers to biosimilar uptake. It was noted that the sample size of 20 of 152 Trusts was too small to reach statistical conclusions but was sufficient to enable learning themes. The survey was delivered by interviews conducted face to face or by phone with the Chief Pharmacist (or delegated senior pharmacist) to enable open discussion. A range of Trusts were selected to include those with different levels of biosimilar uptake. Not all Trusts answered every question but there was a good response rate. The results were coded and analysed to identify themes for the report. 2.0 Discussion and themes To enable benchmarking and comparison between the two surveys; 15 Statements were developed from the Commissioning Framework for Biological Medicines (including biosimilar medicines i ) to assess progress with national implementation. The two surveys did not address all the Statements, and this is highlighted in the discussion. The Statements and themes are outlined below; Statement 1: Patients are encouraged to ask their clinician if a clinically suitable biosimilar is available. Neither survey identified whether patients are empowered or informed to request biosimilars. The Trust survey indicates that patient satisfaction is neutral (88%) or increased (6%) where biosimilar switching has occurred. Trusts are effective at engaging patients regarding Page 1 of 5

2 medication changes, and it is helpful to understand from pharmacy leads that patients generally find biosimilar switching acceptable. Trusts have reported that they produce their own patient information leaflets and called for more best practice sharing. Statement 2: Prescribers are requested to keep up to date with communications from commissioners, and know where to find local switch policies 56% of Trusts had their clinical strategy for switching agreed with relevant clinical specialities such as dermatology, gastroenterology & rheumatology. 90% of Trusts have good systems in place to recommend a biosimilar when an originator has been prescribed. Statement 3: Providers are asked to ensure they know the local spend on biologic and biosimilar medicines Trusts are aware of the percentage uptake of biosimilars, so it is reasonable to conclude they are aware of their annual spend. 93% of CCGs receive some sort of usage data from the Trusts. However, there appears to be some differences in understanding between some CCGs and Trusts in relation to opportunity savings and biosimilar uptake. There is a lack of standardised benchmarking data available across both commissioners and providers to show a unified view of both uptake and opportunity savings. Statement 4: Providers are asked to work with clinicians to develop a local switch policy and engage them in the commissioning process In many Trusts, Pharmacies take the lead in producing switch policies and for many, the relevant clinical specialities are also involved in their development. Statement 5: Strategy and stakeholders; Commissioners should work with all stakeholders to plan ahead to identify the optimum approach in their area. Senior clinical leadership should be identified early on. Chief pharmacists and finance directors should also be involved at an early stage. Engagement with patient representatives should be encouraged. All Trusts have an awareness of the national drive and have prioritised biosimilar uptake with Board or executive involvement. Only around half (54%) of CCGs have engaged their governing body, but 81% have engaged their Area Prescribing Committee or equivalent. Statement 6: Horizon Scanning; Commissioners and providers are expected to be aware of originator patent expiry dates and potential launch dates of biosimilars All CCGs and Trusts have methods for horizon scanning in place; UKMI Prescribing Outlook was highlighted as a resource and Trusts also engage with their Procurement Leads for advice. Statement 7: RMOCs will support commissioners, providers, clinical teams and patients to work closely to quickly and consistently adopt the recommendations made to support the uptake of best value biologics Page 2 of 5

3 Some CCGs requested more clarity about resources being produced by Regions (6 CCGs) and some requested that a national approach is made to support uptake (5 CCGs). Concerns were raised about duplication of work across large numbers of CCGs. 68% of Trusts supported the idea of conducting clinically-led workshops to engage local stakeholders. Statement 8: Incentives to providers; NHS England supports the establishment of appropriate financial arrangements to incentivise providers to support early adoption of best value biologics 65% of Trusts report that they have put in additional resources in place to deliver biosimilar uptake. However, four Trusts reported significant difficulties with achieving financial agreements with their commissioners, leading to delays in implementation in some cases. Only 57% of CCGs had allocated additional resources, however this situation may have improved since the initial cohort of responses (December 2017). The surveys identified that some Trusts have progressed their switch plans to a degree, even where additional funding has not been agreed. Where funding agreements are in place, the main themes are; over 70% use incentives, 13% fund specific staffing, 4% have block contacts. Further relevant survey findings include; o Negotiations to achieve financial agreement can take significant time. o Not all areas have developed a financial model that can be used for further biosimilars; creating fatigue with negotiations. o There are scarce examples of up-front funding provided for Trusts despite the known resource requirements, meaning that off-payroll workers are used in some Trusts leading to increased overall costs and less effective use of resources. It was observed from the surveys that best practice occurred where Trusts and CCGs have achieved an amicable and sustainable financial agreement quickly, that is in place, but which can be adapted for future biosimilars, and supports a high-quality switch approach to include medication review with patients. Statement 9: Commissioners should consider the additional provider workload when reviewing contractual arrangements for biologics and biosimilars There are several reports that funding does not go to the relevant department in the Trust for the work and this can create a barrier for clinicians to motivate delivery. 55% of Trusts indicated that they had a biologics team pharmacist/technician to support this work. Statement 10: Commissioners should liaise with regional pharmacists and procurement specialists to seek better value opportunities via the Commercial Medicines Unit There were concerns raised by Trusts and CCGs about a lack of plurality of the market. There were suggestions that it may be more prudent to award contracts for different cost-effective biosimilars in some regions to ensure a range of market providers remain in the market long term. The surveys demonstrate that Trusts work closely with procurement specialists but there appears to be little engagement between procurement leads and CCGs. Page 3 of 5

4 Statement 11: Clinical pathways; Commissioners and providers should work together to establish pathways to identify the likely place in therapy biosimilar products will sit, and where switching may be appropriate, for existing patients. They should understand the capacity for clinical teams to implement changes. The surveys show that commissioners and providers are working together, but in some cases, relationships have been hampered by difficulties with successfully negotiating financial arrangements. Statement 12: Ensure that the pharmaceutical product and clinical support is assessed and ready for the clinical change programme, e.g. formulation, homecare package, nursing support There were few comments from CCGs about the formulations or clinical change programme. 50% of CCGs cite clinician engagement as a significant barrier, whereas Trusts cite clinician engagement as less of a concern after financial agreements and staff resources. Concerns were raised by some Trusts that they have experienced a lack of understanding by commissioners on the workloads required to successfully and safely deliver introduction of biosimilars There were consistent views from Trust and CCGs about the impact of not having all strengths available at initial launch of a biosimilar, which causes delays and adds complexity to switch programmes. Statement 13: The decision to prescribe a biological medicine for an individual patient rests with the responsible clinician The survey responses did not assess this Statement Statement 14: Ensure that all key stakeholders are engaged to assist with the identification of opportunities and challenges to the commissioning approach and solutions to these challenges The main barriers identified by CCGs include; o Lack of clinician engagement o Limited endorsement by Royal Colleges o Provider lack of funding or capacity to switch o Patient resistance o Logistical or practice issues for delivery o Availability of a biosimilar o Biosimilars not being sufficiently cost effective to make switching worthwhile o Lack of national direction/mandate o Safety concerns The obstacles identified by Trusts include; o Financial agreements o Lack of staff resources/time o Lack of engagement from some clinical specialities o Patient engagement o Supply chain difficulties o Lack of evidence or clinical concerns, o Limited clinician engagement o Operational delivery issues Page 4 of 5

5 Statement 15: Commissioners and clinicians should consider which national and local databases and registries may be used to support monitoring for safety There were limited comments about biosimilar registries. Comments received raised concerns where a functioning registry is not in place for a biosimilar. 3.0 Conclusion and Recommendations This report documents and quantifies the issues regarding biosimilar uptake from both CCGs and Trusts perspectives as well as on the national position. This has highlighted areas where a focus is needed to support CCGs and Trusts with uptake. The key recommendations include; 1. STPs and RMOCs should work closely with Trusts to enable benchmarking and shared data on uptake, to enable both commissioners and providers to have a unified view on the current position. 2. Patient engagement, procurement and homecare are all specific workstreams that need a strategic national focus to support Trusts. 3. There is a call from organisations to increase best practice sharing and reduce duplication. This may include networking biosimilars teams/leads, a library for sharing of tools such as financial models, business cases, operating procedures, patient information leaflets and the development of implementation tools for use nationally. 4. Ongoing communication and sharing of best practice would benefit stakeholders and could be achieved through provision of workshops/webinars. i Page 5 of 5