A Call For Action: Integrating Payor Requirements Into Phase III Clinical Trials
Executive SummaryThe biopharma industry is facing a paradigm shift in which pivotal trials, which traditionally address regulatory requirements, must also supply payors with clinically meaningful data - or the industry will continue to struggle with market access and disappointed expectations. Easton Associates foresees a two-step process emerging to address payors' needs.
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The biopharma industry invests substantially in post-approval studies to convey information about the value of its products to constituents, but the majority of these efforts do not address core, real-world questions raised by payors. A new business model recognizing the strategic value of medical affairs to market access is needed to stem the tide of disappointing reimbursement decisions.