The Institute for Clinical and Economic Review (ICER) published a whitepaper discussing the Food and Drug Administration’s Accelerated Approval Pathway (AAP). The paper suggests policy reforms that could improve the regulatory process, as well as action points aimed at payers and pharma. The authors also propose basing AAP drug prices on healthcare outcomes.
“This paper aims to create a clearer understanding of both the opportunities and challenges inherent in the accelerated approval pathway (AAP), and to present an analysis of the potential risks and benefits of a range of reform options that policymakers may consider in efforts to strengthen the AAP moving forward.” Read more here.
(Source: ICER, 4/26/21)