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European Biopharmaceutical Review

Pricing and Reimbursement Strategies for Biopharmaceuticals

The international market potential for new biopharmaceuticals is expanding rapidly. However to be successful in these growing markets, manufacturers must develop effective strategies to address the exigencies of price regulation and government sponsored reimbursement schemes. Biopharmaceuticals face unique challenges. For these products, there are significant research and development costs and premium pricing is often required to offset the initial investment. Moreover, clinical trials for these products are typically designed to demonstrate safety and efficacy, but not superiority over existing agents. All countries are becoming increasingly interested in technology assessments and economic evaluations of pharmaceuticals and other medical interventions as they try to make difficult decisions on allocating funds. A lack of evidence demonstrating superiority is often cited by drug plan managers as the reason products are not included on drug plan formularies.


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By Susan Neale and W. Neil Palmer of Palmer D'Angelo Consulting Inc

Susan Neale is a Policy Analyst with Palmer D'Angelo Consulting Inc in Ottawa, Canada. She researches emerging issues in the pharmaceutical industry and reviews health care policies in Canada and internationally.

Ms Neale has written articles and reports on a wide range of issues including pricing and reimbursement in Canada, drug plan cost drivers and global pricing strategies. She holds an MBA from York University in Toronto.

W. Neil Palmer is Principal Consultant with Palmer D'Angelo Consulting Inc, a Canadian-based consulting firm that provides strategic advice on the pricing and reimbursement of pharmaceuticals in Canada, the US and Europe. Mr Palmer is the Chair of the BIOTECanada committee concerned with price regulation of biopharmaceuticals in Canada.

He has written extensively on pricing and reimbursement issues and is a frequent speaker at pharmaceutical conferences in North America and Europe. Mr Palmer worked with the Canadian Patented Medicine Prices Review Board (PMPRB) for six years, first as a consultant and then as a senior staff member.

At the PMPRB his responsibilities included policy development, overseeing the price review of patented medicines and conducting economic research. Prior to this, he worked with the Health Division of Statistics Canada where he was responsible for economic and statistical analysis of health care costs and utilisation. After completing his studies at the University of Western Ontario, Mr Palmer began his career in Montreal with the research group of the Kellogg Centre for Advanced Studies in Primary Care.


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