FROM APPROVAL TO ACCESS: TIME TO REIMBURSEMENT DECISION FOR BIOSIMILARS IN THE EU-4
Author(s)
Aleksandra Kumichel, PhD1, Maria Dvorkina, PhD2, Katherine L. Gibbs, PhD2.
1Thermo Fisher Scientific, Paris, France, 2Thermo Fisher Scientific, London, United Kingdom.
1Thermo Fisher Scientific, Paris, France, 2Thermo Fisher Scientific, London, United Kingdom.
OBJECTIVES: Biosimilars present an opportunity to expand access to innovative biologic medicines while improving affordability. A 2024 systematic literature review undertaken by the ISPOR Biosimilar Special Interest Group identified substantial variation in health technology assessment (HTA) practices for biosimilars across markets and a need for clearer guidance on conducting HTAs. This study aimed to assess the impact of divergent HTA practices on time to reimbursement of biosimilars in the EU-4.
METHODS: Biosimilars approved in the EU were identified from the European Medicines Agency (EMA) website and information on pharmacotherapeutic group, therapeutic indication and marketing authorisation date were extracted. Dates of first reimbursement in each EU-4 market were extracted from the relevant national authority websites. Time to reimbursement was defined as the interval between the first reimbursement decision and the EMA marketing authorisation dates.
RESULTS: As of April 27 2026, 148 biosimilars have been authorised by the EMA. At the study cut-off, 70% were reimbursed in Spain, 80% in France, and 64% in Italy; in Germany, all prescription medicines are reimbursed immediately after market launch for statutory-insured patients. Mean time to reimbursement was 285 days in Spain, 276 days in France and 329 days in Italy. High heterogeneity in the minimum and maximum time to reimbursement was observed within each market (Spain: 45−2,081 days; France: 11−1,900 days; Italy: 22−1,843 days). Trends in time to reimbursement were observed across the study period. In particular, the mean time to reimbursement was considerably shorter across the markets during the period from 2018 onwards compared with 2006-2017.
CONCLUSIONS: Wide variation in time to reimbursement of biosimilars exists across the EU-4 markets. This likely reflects the lack of standardisation for the development of HTAs on biosimilars across jurisdictions. Clearer, more consistent HTA guidance could reduce access barriers and support faster patient access to biologics.
METHODS: Biosimilars approved in the EU were identified from the European Medicines Agency (EMA) website and information on pharmacotherapeutic group, therapeutic indication and marketing authorisation date were extracted. Dates of first reimbursement in each EU-4 market were extracted from the relevant national authority websites. Time to reimbursement was defined as the interval between the first reimbursement decision and the EMA marketing authorisation dates.
RESULTS: As of April 27 2026, 148 biosimilars have been authorised by the EMA. At the study cut-off, 70% were reimbursed in Spain, 80% in France, and 64% in Italy; in Germany, all prescription medicines are reimbursed immediately after market launch for statutory-insured patients. Mean time to reimbursement was 285 days in Spain, 276 days in France and 329 days in Italy. High heterogeneity in the minimum and maximum time to reimbursement was observed within each market (Spain: 45−2,081 days; France: 11−1,900 days; Italy: 22−1,843 days). Trends in time to reimbursement were observed across the study period. In particular, the mean time to reimbursement was considerably shorter across the markets during the period from 2018 onwards compared with 2006-2017.
CONCLUSIONS: Wide variation in time to reimbursement of biosimilars exists across the EU-4 markets. This likely reflects the lack of standardisation for the development of HTAs on biosimilars across jurisdictions. Clearer, more consistent HTA guidance could reduce access barriers and support faster patient access to biologics.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA162
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Biologics & Biosimilars