Insight into HTA Decision Making Behind the EU's Current Crop of Biosimilars

Published Apr 28, 2014
London, UK - The development of biosimilars has gained momentum in recent years, with sixteen biosimilars in total approved by the European Medicines Agency (EMA) since the licensing of the first biosimilar Omnitrope in 2006. The market adoption of biosimilars, however, has varied within Europe and may be influenced by different approaches to reimbursement of biosimilars by respective health technology assessment (HTA) agencies in different countries. Researchers from Mapi Group conducted a qualitative analysis of HTA guidance documents for each of the sixteen approved biosimilars to examine the approach taken by HTA agencies in the appraisal of biosimilars. Although the EMA provided broad licensing for indications based on extrapolation of the evidence on clinical comparability, reimbursement of biosimilars differed between countries, with some HTA agencies restricting recommendation for particular indications. Comparability in quality, efficacy and safety of the biosimilar to its reference product, and cost-effectiveness, were found to be the main decision driving factors for reimbursement. “In countries using HTA to appraise biosimilars, different factors were seen to influence reimbursement decisions, leading to variations in the recommendations for each of the licensed indications. This may have implications for the uptake of biosimilars in different markets based on the approach taken by the respective reimbursement systems,” said Shamika de Silva, PhD, an author on the study. The findings are published in the March/April issue of ISPOR Connections, “Insight into HTA Decision Making Behind the EU’s Current Crop of Biosimilars.”

ISPOR CONNECTIONS (ISSN 1538-5108), the bimonthly news & technical journal of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), strives to provide timely communications on methodological and health policy issues of interest to Society members.

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a nonprofit, international, educational and scientific organization that strives to increase the efficiency, effectiveness, and fairness of health care resource use to improve health.

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