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Drug Discov Today. 2012 Jun;17(11-12):615-22. doi: 10.1016/j.drudis.2012.01.021. Epub 2012 Feb 3.

Health economics and outcomes research within drug development: challenges and opportunities for reimbursement and market access within biopharma research.

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1
United BioSource Corporation, Hammersmith, London, UK. floortje.vannooten@unitedbiosource.com

Abstract

Healthcare decision makers who determine funding for new medical technologies depend on manufacturers to provide evidence of the technology's efficacy, safety and cost-effectiveness. Constrained budgets and increasing reliance on formal health technology assessment (HTA) have created an abundance of external hurdles that manufacturers must navigate to ensure successful product commercialization. These demands have pushed pharmaceutical companies to adjust their internal structures to coordinate generation of appropriate evidence. In this article we summarize internal and external opportunities for manufacturers to establish a foundation of evidence for successful market access, starting in Phase I of development and continuing throughout the post-approval product lifecycle.

PMID:
22366662
DOI:
10.1016/j.drudis.2012.01.021
[Indexed for MEDLINE]
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