NHS England Biosimilar Implementation Steve Brown Regional Pharmacist, NHS England / NHS Improvement, South West and South East England AWTTC Biosimilar Best Practice Day; 21st January 2019

How to get maximum value from the spend on medicines Value is… measurable improvement in patient outcomes while maintaining an affordable medicines bill Making sure patients get access to and choice of the most effective treatments, and the outcomes that matter to them Improving the quality (safety, clinical effectiveness, patient experience) of prescribing and medicines use Making how we purchase and supply medicines more efficient, while ensuring the NHS retains its position as a world-leader in medicines

The Medicines Value Programme has been set up to respond to these challenges Following the Next Steps on the NHS Five Year Forward View and Carter Report The NHS wants to help people to get the best results from their medicines – while achieving best value for the taxpayer Savings will be reinvested in improving patient care and providing new treatments to grow the NHS for the future The NHS policy framework that governs access to and pricing of medicines 1 The commercial arrangements that influence price 2 Optimising the use of medicines 3 Developing the infrastructure to support an efficient supply chain 4 A whole system approach…. NHS England, NHS Improvement, NHS Digital, Health Education England Regional offices link with STPs, ICSs, CCGs, and providers Nationally coordinated with AHSNs, Getting It Right First Time, NHS Right Care and NHSCC

Commissioning Framework for Biological Medicines Published September 2017 In partnership with industry, patients, clinicians, NICE and regulators To support commissioners to act promptly to make the most of the opportunity presented by increased competition in biological medicines, including biosimilar medicines Sets out actions which can be taken by patients, prescribing clinicians, care providers and commissioners to realise the therapeutic and economic opportunities of biological and biosimilar medicines In particular, seeks to set out the importance of a collaborative approach

The importance of biosimilars Biosimilars are biological medicines, highly similar to another biological medicine already licensed for use To be licensed, a biosimilar must have no clinically meaningful differences from the originator medicine in terms of quality, safety and efficacy Where NICE has recommended the originator biological medicine, the same guidance will normally apply to a biosimilar

Clinical Senate questions: To what extent and how should the transition to use of biosimilar medicines be prioritised to enable the provision of best value care in the NHS? Do we support the uptake of biosimilar medicines at pace and how can their best practice use be maximised? https://www.sps.nhs.uk/wp-content/uploads/2018/03/2017-12-06-Senate-Recommendations-Biosimilars-FINAL.pdf

Biosimilar Savings Adalimumab biosimilar will provide savings exceeding £250m per annum

Etanercept Savings Since Launch

Etanercept: Regional Uptake

Opportunity Costs Complex clinical changes involving medicines such as biosimilars require better planning Tools have been developed to identify how much the NHS lost monthly before delivering to 80% uptake Support information & communication under development to implement at scale & pace See http://cancervanguard.nhs.uk/biosimilars-adoption/

Biosimilar growth in market share

Reduced spend and increased use Reduced spend (and increased use) of individual medicines is tracked monthly Monthly spend on 3 high cost biologics is reducing due to move to biosimilars The 3 drugs (Infliximab, Etanercept and Rituximab) show a reduced spend but increased usage Reduction from circa £41m/month to £24m Total volume of product used has increased (14.5Kg to 16.8Kg/month) £41m Cost £24m Volume

Supporting the NHS system Working with partners to support implementation of the ‘Commissioning Framework for Biological Medicines’ with clinical and patient engagement at the forefront: In September 2015, published What is a biosimilar medicine? guidance to support local uptake of biosimilars Established a National Biosimilars Programme Board to ensure a collaborative approach Raising the profile of biosimilar medicines amongst patients and the public The uptake of biosimilar medicines is one of the top priorities for new Regional Medicines Optimisation Committees Working with professional bodies to engage with the professions The NHS national Cancer Vanguard is also pioneering a partnership with the pharmaceutical industry to make better use of medicines, including biosimilars National Adalimumab Working Group set up Biosimilars a standing agenda item at Regional Executive meetings 101 CCG submitted plans in relation to uptake CSU support mobilised – analyses of CCG plans and Define data to identify 20 CCGs/trusts (4 outliers/1 high performing in each region)

NHS Improvement: Model Hospital Top 10 medicines include: Infliximab Etanercept Imatinib Rituximab Trastuzumab Adalimumab

Adalimumab implementation strategy Procurement strategy: Contract specification and timing overseen by the Pharmaceutical Marketing Supplies Group’s (PMSG) Branded and Biosimilar Subgroup; aiming at best price and plurality Incentivisation strategy: Reference pricing Homecare strategy: Subgroup of the PMSG Branded and Biosimilar Subgroup with support from the National Homecare Medicines Committee Engagement and sign up by both providers and commissioners across the NHS in England Communications strategy: SPS website briefings Patient groups teleconferences Professional network teleconferences Healthcare service webexes Significant learning from transitions to other biosimilars Excellent supporting work by the Cancer Vanguard Ongoing liaison between the four RMOCs and supporting Specialist Pharmacy Service (SPS) infrastructure to maintain a coherent approach across England More focused RMOC work through the subgroups   South West Clinical Senate Commissioning support unit work programme Model hospital – Top 10 Medicines Review

Specialised commissioning: Medicines Optimisation CQUIN To support the faster uptake of best value medicines in specialised commissioning: Aligns with Carter Review recommendation: Trusts should also seek to reduce their medicines bill through best choices and from actively monitoring market developments, such as the launch of biosimilar products Trigger 1 targets: Adoption of best value generic/biologic products in 90% new patients within one quarter of guidance being made available Adoption of best value generic/biologic products in 80% of applicable existing patients within one year of being made available (except if standard treatment course is < 6 months) Cancer Vanguard: Example of collaborative and system wide leadership Improved healthcare professionals’ understanding of biosimilars Helped them to better inform patients about their use   Website includes a process timeline for adoption with accompanying guidance, resources and template documents to support the NHS   https://cancervanguard.nhs.uk/biosimilars-adoption/

‘Best value biologicals’ – Adalimumab Current position: - c50,000 patients; majority Homecare Planning: - RMOC briefings; Patient FAQs; Toolkit Procurement: - October 16th patent expiry; contract start date 1st December Service delivery: - Homecare Communications: - Patient and clinician engagement

‘Best value biologicals’ – Adalimumab SPS website https://www.sps.nhs.uk/medicines/adalimumab/ Adalimumab barriers to uptake: results of national survey Adalimumab toolkit for commissioners and providers Adalimumab press release RMOC briefing on adalimumab – October 2018 Adalimumab commissioning intentions Adalimumab resources to use with patients RMOC briefing on adalimumab – July 2018 ….

Adalimumab toolkit for commissioners and providers https://www. sps Adalimumab toolkit for commissioners and providers https://www.sps.nhs.uk/articles/adalimumab-toolkit-for-commissioners-and-providers/ Biosimilar Adalimumab Toolkit (updated October 2018) Best Value Biologic Implementation Plan template (for local adaptation) Template DTC application form for biosimilar adoption Template Terms of Reference for Best Value Biologic Adalimumab Implementation Group Best Value Biologic (including biosimilars) savings calculator & tracker An example home care patient permission letter An example home care risk assessment tool

Adalimumab best value biological implementation Next steps: - Contract implementation - Product choice - Commissioning intentions - Reference pricing

Company Product name Licences 20mg strength available Citrate excipient EMA link for further product details Abbvie Humira®   Yes No Humira Amgen Amgevita® Same as Humira®, except paediatric uveitis Amgevita Mylan / Fujifilm Kyowa Kirin Hulio® Same as Humira® Hulio Samsung Biogen Imraldi® Imraldi Sandoz Hyrimoz® Hyrimoz

Regional Medicines Optimisation Committee Best Value Biological Subgroup RMOC Agenda: - Biosimilar insulins - Biosimilar to biosimilar switching - Nocebo guidance Best Value Biological toolkit ………..

Questions? Stephen.Brown17@nhs.net