What’s driving the uptake of biosimilars in Europe and what still needs to be done?
The European market for biosimilars has seen a year of progress and change, with more therapies available and changing attitudes from many payers. Driven by the pressing need to control drug costs, payers have notably moved their position in key areas such as interchangeabilty and indication extrapolation. But where are the sticking points? What are the critical factors for success? What more could the biosimilar industry do to help its cause?
This report identifies the issues that payers identify as critical to the continued growth and adoption of biosimilars. Biosimilars: European Payer Perspectives is informed with candid insights of 15 European payers from the five leading European markets and packed with actionable information. It is essential reading for all commercial and research planners in branded and biosimilar manufacturers.
“The key reimbursement challenge at the moment comes down to the four-letter word of cost: every healthcare organisation is really struggling to contain cost.”
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For this report FirstWord has interviewed 15 payers, 3 from each EU5 country. Payers interviewed have direct experience of assessing biosimilars for inclusion on formulary, either as part of a committee or as the lead decision-maker./Paragraph>
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Table of Contents
for Biosimilars: European Payer Perspectives (2016)
2 Executive summary
3 Research objectives and methodology
4 Biosimilars in Europe: Where we currently stand
4.1 Biosimilar approvals in Europe to date
4.2 Uptake and usage of biosimilars in Europe
5 Awareness and perceptions of biosimilars
5.1 Key insights
5.2 Awareness of biosimilars at the payer level is generally high, and physician awareness is increasing
5.3 Physician acceptance on the rise, but varies by disease area, with biosimilars most common in acute settings
6 Key influencers on biosimilar adoption in 2015
6.1 Key insights
6.2 Biosimilar adoption buoyed by local policy changes, prescribing initiatives over the past year
6.3 Payers identify clinical and real-world data as leading reason for improved biosimilar adoption
6.4 Physicians and HTA bodies are pushing biosimilar acceptance, but patient advocacy groups are not providing much support
6.5 How has the biosimilar regulatory approval timeline changed over the past 12 months? 15
6.6 How has the importance of the potential cost savings associated with biosimilars changed in the past 12 months?
7 The current regulatory environment
7.1 Key insights
7.2 Regulatory data requirements mostly satisfy payers, but some would prefer additional clinical comparability data and information on interchangeability
7.3 Small, clinically non-significant differences between biosimilars and their reference products are permissible
7.4 Real-world, interchangeability data could provide assurance that biosimilars are comparable to reference products
8 Recent policy events shaping the biosimilars market
8.1 Key insights
8.2 EMA’s guideline on biosimilars goes into effect, provides guidance on clinical trial comparators
8.3 European Biosimilars Group asks EFPIA to clarify its policy on off-patent biological drugs
8.4 NHS England position statement seeks to define concept of biosimilar medicine
8.5 Ireland’s HPRA published guide on biosimilars, outlining recommendations for indication extrapolation and interchangeability
8.6 Finland’s Fimea proposes hospital-level interchangeability, but rules against pharmacy-level substitution
9 Biosimilar naming rules
9.1 Key insights
9.2 Payers argue benefits of existing name proposals, suggest alternative traceability strategies
9.3 Payers express concern that WHO’s Biological Qualifier proposal could add layer of confusion
9.4 Biosimilar naming should promote traceability without drawing attention to differences, payers suggest
10 Interchangeability, substitution and indication extrapolation
10.1 Key insights
10.2 Payers agree that physicians should have the final say on substitutions, but say there is room for regulatory oversight
10.3 Payers undecided when switching should be permissible
10.4 Additional data on switching outcomes could boost biosimilars, but not yet clear who should collect such data
10.5 Barriers to greater biosimilar interchangeability are varied
10.6 Other factors limiting interchangeability:
11.1 Key insights
11.2 How biosimilars are reviewed for inclusion on formularies
11.3 Payers suggest formulary decision-making process will be streamlined by experience
11.4 Requirements for adding biosimilars to formularies vary by country, but do not differ
11.5 significantly from traditional medicines or generics
11.6 Payers increasingly comfortable with adding biosimilars to formularies, but could limits on numbers be imposed?
12.1 Key insights
12.2 How decisions on biosimilar prices are made
12.3 Payers suggest 20 percent discount for biosimilars is a good place to start
12.4 Norway, Denmark’s near 70 percent discount for infliximab turns heads, but not likely to be replicated
12.5 Not yet clear which European countries are leading the way on biosimilar pricing
12.6 Payers remain unclear on appropriate level of pricing discounts for biosimilars, but price matching not likely
12.7 UK payers question longevity of Pharmaceutical Price Regulation Scheme to hold down costs
12.8 Prescribing targets and quotas may boost biosimilar prescribing, but results mixed to date
13 Future challenges and opportunities for biosimilars
13.1 Key insights
13.2 Potential future trends, challenges and opportunities for biosimilars in Europe
13.3 Europe likely to remain gold standard as it relates to biosimilar regulation, experts suggest
14.2 Experts interviewed for this report
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