Biosimilars are an important component of sustainable health systems as they provide alternatives to originator biological products once those products no longer have market exclusivity. Europe has the world’s largest biosimilar market, accounting for approximately 60% of the global market. European countries therefore serve as valuable examples of successful approaches to biosimilar policy [1]. Nevertheless, across Europe, the level of competition among biosimilars differs widely by country and by molecule, as does the extent of their use and their impact on pricing. Much of this variability can be linked to differences in health system policy elements that contribute to sustainable market conditions for biosimilars.
IQVIA Institute and the Biosimilar Medicines Sector Group of Medicines for Europe recently launched Country Scorecards for Biosimilar Sustainability. These scorecards analyse the pros and cons of biosimilar policies in 12 European countries: Denmark, France, Germany, Hungary, Italy, the Netherlands, Norway, Poland, Romania, Spain, Sweden and the UK. Specifically, the scorecards assess the level of competition, price evolution and volume development for seven key biological molecules – adalimumab, etanercept, infliximab, insulin glargine, insulin lispro, rituximab and trastuzumab – in each country. The scorecards also include a detailed sustainability assessment, including regulatory environment and clinical guidelines, awareness and education, incentives, pricing rules and dynamics, and purchasing mechanisms. Positive policy elements are specified for each country, as well as challenges and solutions. An Appendix provides detailed methodologies and explanations of the metrics and assessments incorporated into the scorecards.
By mapping these elements per country and measuring the overall contribution of biosimilars to the health system, this set of scorecards can help countries assess their current performance and identify areas for improvement.
European healthcare systems share commonalities but have specific differences, so policy scores should not be directly compared. To avoid misinterpretation or inaccurate comparison of countries, ‘The Sustainable Market’ scorecard has been developed to act as the gold-standard market to which country scorecards can compare themselves.
Commenting on the launch of the Country Scorecards for Biosimilar Sustainability report, Adrian van den Hoven, Director General of Medicines for Europe said‘This IQVIA Institute report is a helpful guide for policy makers to deliver sustainable access to biological medicines. While the report shows that policy measures should be tailored to national contexts, the report provides clear recommendations on how measures can be combined and adapted to deliver effective results. Our ambition is to use this guide to improve sustainable access to biosimilar medicines across Europe’.
Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science said ‘The importance of biosimilar medicines’ role is greater than ever, and the systematic tracking of their contribution is a critical means for policymakers and stakeholders to measure progress and achievement of goals for patients and the entire health system’.
A recent review found that in Europe, the most effective policies provide continuous information on biosimilars, stimulate manufacturer competition, guarantee a sufficiently broad choice of products, are non-discriminatory towards either originator or biosimilar medicines, and allow the treating physician to choose the most appropriate product in consultation with their patient [1].
By mapping these elements per country and measuring the overall contribution of biosimilars to the health system, this set of scorecards can help countries assess their current performance and identify areas for improvement.
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Reference
1. Schneider PJ, Reilly MS. Policy recommendations for a sustainable biosimilars market: lessons from Europe. Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(2):76-81 doi:10.5639/gabij.2020.0902.013
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