1. 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

2. 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

3. 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

4. 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

6. 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

7. 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?

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

9. Etanercept Savings Since Launch

10. Etanercept:
Regional Uptake

11. 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

12. Biosimilar growth in market share

13. 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

14. 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)

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

16. 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

17. 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  

18. ‘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

19. ‘Best value biologicals’ – Adalimumab SPS website 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 ….

20. Adalimumab toolkit for commissioners and providers https://www. sps
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

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

22. 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

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

24. Questions?