• Publication Date: 04/01/2009
  • Article Type: Technical Articles
  • Subjects: Industry Issues and Trends, Product Development/Formulation
This article discusses how the Outcomes Based Analysis used by US healthcare payers to determine what they will pay for drugs affects patient access to OINDPs and what developers need to know about how payer strategies affect the potential success of products.

Focusing the early stages of development programs on obtaining regulatory approval and expecting that marketing efforts will convince physicians and patients to use the product, a paradigm that worked over the past several decades, now represents a strategic error, contends Balekdjian. US payers now play such an important role in the pharmaceutical marketplace that you can take the exact same compound and follow two different development paths, one that fails to take payers into account and one that focuses on outcomes, he suggests, and the first path will lead to a drug that fails to live up to expectations, like Exubera, and the second to market success.

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