FACTORS SUPPORTING A SUSTAINABLE EUROPEAN BIOSIMILAR MEDICINES MARKET

Transcription

1 FACTORS SUPPORTING A SUSTAINABLE EUROPEAN BIOSIMILAR MEDICINES MARKET A study undertaken by GfK Market Access on behalf of the European Biosimilars Group, a sector group of EGA, about the future sustainability of the biosimilar medicines market Chris Teale, Vice President, GfK Hungarian Association of Generic Manufacturers and Distributors Budapest, 23 rd November 2015 Market Access

2 Biosimilar medicines are A major opportunity with significant benefits Saving costs throughout Europe Contributing to the sustainability of National Healthcare Systems (NHS) Improving patient access to innovative medicines To deliver these benefits in the long term, it is imperative that the biosimilar medicines market remains sustainable... Dependent on sustainability A sustainable biosimilar medicines market is one which is attractive and delivers continuing benefits to four key stakeholder groups (Physicians, Payers, Patients, and Industry) in BOTH the short and long term The concepts of attractiveness and benefit differ amongst stakeholders: Opportunities to treat more patients with appropriate therapies (Physicians); Cost savings and financial sustainability of healthcare systems (Payers); Improved access to medicines (Patients), and A reasonable return on investment and the continued attractiveness of R&D investment in innovative medicines development (Industry) 2

3 Project Goal: To provide a high-level, independent, expert opinion-based assessment of the factors that, together, would create a healthy and sustainable European biosimilar medicines market. Key Objectives To establish the key policy areas that would drive the establishment of a sustainable biosimilar medicines market To develop a high level transparent understanding of the interactions and dynamics within and between policy areas To identify a set of policy measures that should be implemented by politicians (National and European level) and other stakeholders that would contribute to the growth of the biosimilar medicines market To outline the benefits that these will bring - with particular focus on the benefits for European National Health systems (increased savings to the National Health systems whilst treating more patients) and the economy (growth impact and job creation) 3

4 The project scope Systematic Secondary Desk Research Primary Research Quantitative modelling of sustainability and stakeholder benefit Final report and recommendations Policies (EU, national, regional, local) Presentations Publications 71 interviews. Experts and Policy Influencers - Physicians, Payers, Pharmacists, Patients, and Industry 7 countries (Germany, France, Italy, UK, Spain, Poland, Hungary) Oncology and inflammatory disease Herceptin (trastuzumab) Humira (adalimumab) Avastin (bevacizumab) Factors Supporting a Sustainable European Biosimilar Medicines Market 4

5 The interview programme was composed of 71 stakeholders spanning 7 countries; the resultant insights reflect a broad range of perspectives The study was undertaken across 7 countries: France, Germany, Hungary, Italy, Poland, Spain, UK FR HU DE IT Conclusions are based on in-depth contributions from 71 experts and policy influencers The Stakeholder Groups Physicians - KOLs in oncology and rheumatology Pharmacists - hospital and retail PL UK ES Payers - including health economists and HTA agencies Patients - from patient advocacy groups Policy influencers/makers - regional, national and pan-eu 5

6 Qualitative Research 6

7 Stakeholder interviews focused on 7 major discussion areas Pricing Drivers of Utilisation Indication Extrapolation Evidence & Data Generation Sustainability Clinical Guidelines Biosimilar Assessment Incentivisation 7

8 4 areas of focus - the Sustainability Policy Framework Pricing Drivers of Utilisation Indication Extrapolation Evidence & Data Generation 4 Key areas of focus where closer policy alignment could lead to a sustainable biosimilar market and significant benefits for all stakeholders Clinical Guidelines Biosimilar Assessment Incentivisation 1. Education and understanding 2. Experience and use 3. Sustainable pricing 4. Rational decision-making 8

9 A European biosimilar industry based on stakeholder and policy alignment in 4 areas will be sustainable and deliver significant benefits to all stakeholders Education and Understanding Experience and Use Sustainable Pricing Rational Decision Making Clinical, Economic, & Patient Benefits Multi- Stakeholders Address Concerns & Establish Confidence Avoid an Unsustainable Pricing Environment By ALL Stakeholders National Health Systems Payers Targeted Approach Pro- Actively Maintain Competition Transparency Physicians Connected Demonstrate Value Create Headroom for Future Biologics Decisions Not Made on Price Alone Patients Balanced & Unbiased Transition Over Time Respect Margins & Ensure Efficiency Do Not Apply Generic Approaches Industry 9

10 Education and understanding Experience and use Sustainable pricing Rational decision making 1 Broad Multi-stakeholder Targeting doctors, other healthcare professionals, payers and patients 2 3 Targeted on 3 areas Connected Similarity Differentiation (Complex and expensive development and manufacturing process) Sustainability Connected: Policy to Behavior to Benefit Focus: Actions and consequences 4 Balanced and set in context Non-promotional from unbiased sources Incorporate into medical training 10

11 Education and understanding Experience and use Sustainable pricing Rational decision making 1 2 Address concerns and establish confidence Approach pro-actively Accelerate clinician exposure and experience Similarity, extrapolation, switching, etc. Indication extrapolation should be communicated to physicians and payers in a context and language that provides complete understanding Open meaningful communication channels with stakeholders to help educate Encourage and incentivise early use 3 Demonstrate value Collection and publication of Real World Evidence* Feedback results and disseminate Link to cost savings and health gains 4 Transition over time * In addition to the standard safety monitoring requirements of licensure (PSUR) - Post Marketing studies, Observation of Use studies, Retrospective Chart Reviews, Prospective Registries, Drug Utilisation Audits (DUAs). Such studies should, where possible, Copyright capture GfK UK outcomes Limited 2015 data. Proprietary Procurement and Utilisation Policies: Early Use: Predominantly Physician driven decision Intermediate Use: Physician / Payer / Pharmacist driven decision (multi-stakeholder approach) Well Established Use: Predominantly Pharmacist / Payer driven decision 11

12 Education and understanding Experience and use Sustainable pricing Rational decision making 1 2 Avoid artificial downward pricing pressure Encourage competition Biosimilar medicines should not be managed under the same policies as generics Maintain opportunity for ROI - do not undermine continued investment in R&D by biosimilar companies Ensure that policies create a level playing field Multi-faceted tenders, uniform tendering process, avoidance of exclusive tendering 3 4 Create headroom for future biologics Pay attention to margins and efficiency Provide governments with the ability to fund access to new drugs and innovations Maintain continued investment in originator biologics Recognise high development & manufacturing costs Ensure continuity of supply and attractiveness of future investment 12

13 Education and understanding Experience and use Sustainable pricing Rational decision making 1 By ALL stakeholders Payers, procurers. prescribers AND biologics industry Transparency Decisions not made on price alone Avoid generic / commodity approaches Procurement and pricing Frequency and duration of tenders Do not delay time to access decision Recognise differentiated product offerings and pricing propositions- drug delivery, point-of-care, etc Do not require HTA in situations where the assessment would not add value Future impact on funding and pricing of innovation Recognise higher level of investment & risk in developing a biosimilar medicine Avoid measures that lead to conflict between stakeholders 13

14 Policies must be analysed collectively, not just in isolation, to provide a true picture of what sustainability actually looks like Pricing Drivers of Utilisation Indication Extrapolation Evidence & Data Generation Clinical Guidelines Biosimilar Assessment What happens when policies come together? (stakeholder alignment / policy collision)? What are the benefits of a sustainable biosimilars market and the costs of an unsustainable one? Incentivisation 14

15 The sustainability index For each of the five stakeholder groups, multi-criteria scoring was used to produce a red, amber or green light for the attractiveness of the scenarios tested to that stakeholder group. Each of these lights has a score attached. Scores are summed and divided by the maximum possible score to produce a value out of 1 or a percentage of sustainability. Green lights are scored 2 Amber lights are scored 1 Ideal Case: All green lights; Score of 10 (5 stakeholders multiplied by 2) 1=maximum sustainability score (all green lights) Red lights are scored 0 Worst Case: All red lights; Score of 0 (5 stakeholders multiplied by 0) 0=minimum sustainability score (all red lights) For example a scenario scored as green, green, amber, red and red is viewed as 2,2,1,0,0. his totals 5. This divided by the maximum score (10) generates a sustainability index of

16 Cost Savings System dynamics modelling, which took into account how policies impact one another, indicates that significant cumulative cost savings are likely over the 10-year period from the entry of an originator product s first biosimilar medicine. The potential cumulative savings for the three products under the optimal policy combination identified in the study were: Molecule Cumulative 10 year Savings (EU5) adalimumab (Humira ) 26% bevacizumab (Avastin ) 24% trastuzumab (Herceptin ) 25% Higher cost savings would be possible, but would result in a less sustainable biosimilars market with a consequent decrease in the magnitude of benefits to all stakeholders, particularly the decline of continued attractiveness for R&D investment in new medicines development and reduced competition in the market. 16

17 Improved Patient Access The cost savings generated by the introduction of biosimilar medicines might be utilised in various ways to increase patient access to biological medicines dependent on country, product, and current clinical practice: 17

18 A winning picture: A combination of policies supportive of a sustainable market (Index = 0.9) Intensive programs to develop Education and Understanding (all stakeholders) Policies that encourage early use and growth of biosimilar medicines experience An efficient policy combination for a sustainable European biosimilars market Policies that encourage the capturing and communication of real world evidence (RWE) in order to build confidence and trust (but not as a requirement for access) A sustainable competitive pricing environment with price levels consistent with financial viability and a fair return on investment. Pricing and procurement policies transparent. Extrapolation to other Indication(s) is well understood and accepted by all stakeholders. Indication specific data in all of the reference indications not a requirement at launch for access or utilisation (underpinned by education / understanding and RWE programs) Utilisation policy which is evolutionary in nature. Early Use: Predominantly a physician driven decision; Intermediate situation: (Multi-stakeholder approach) where the decision is physician / pharmacist / payer driven; and Well established use: Predominantly a pharmacist/payer driven decision. 18

19 Summary of specifics highlighted in Hungarian analysis (Top 5) 1 The need to increase the quantity and quality of independent, unbiased, scientific information about Biosimilar medicines targeted at all stakeholders 2 The need to produce and publish a continuous stream of Real World Evidence (by Providers, Payers, Authorities and Pharmaceutical industry) 3 The need for a sustainable competitive environment 4 The need for transparency in procurement procedures 5 The need for multiple (multi-stakeholder) perspectives to be fully incorporated in policy formulation and decision-making 19

20 November A sustainability temperature check Pricing *** Drivers of Utilisation Indication Extrapolation Evidence & Data Generation Clinical Guidelines *** PRICING Discounts in the 5% to 70% range The specific framework for biosimilar medicines in Norway (specific tender process and reimbursement system which encourages prescribers to switch patients, years of investing in educating stakeholders, profound investment in NOR-switch study, etc.) is likely the reason for the high level of price decreases achieved and without a similar framework, it is unlikely that the same magnitude of price discounts for biosimilar medicines will be achieved in other European countries having their own healthcare infrastructure Biosimilar Assessment Incentivisation 1. Education and understanding 2. Experience and use 3. Sustainable pricing 4. Rational decision-making 20

21 Policies must be analysed collectively, not just in isolation, to provide a true picture of what sustainability actually looks like A European industry with stakeholder and policy alignment in 4 areas will be sustainable and deliver significant benefits to all stakeholders Benefits will include: Cost savings to national health systems Increased patient access (to biologic treatment option within a disease area) Opportunity to invest savings, and deliver consequent health benefits, in other disease areas A foundation for investment in future healthcare advances 21

22 GfK Market Access Contact: Christopher Teale BSc(Hons) MSIB MORS Vice President Europe Market Access Health GfK NOP Pera Business Park Nottingham Road Melton Mowbray LE13 0PB UK Telephone +44 (0) Mobile +44 (0) Web site: Acknowledgements: The EGA 71 Stakeholders Craig Taylor - Consultant, GfK Market Access Julia Glover - Consultant, GfK Market Access James Whitehouse - Senior Analyst/Health Economist, GfK Market Access 22