Vanderbilt Scientist and Aetion RWE Strategist Highlight Seven Solutions to Bolster FDA’s Accelerated Approval Process and Achieve Value-Based Pricing

Aetion’s Dr. Nirosha Mahendraratnam Lederer and Vanderbilt’s Dr. Stacie B. Dusetzina discuss how value-based pricing may be achieved using the Food and Drug Administration’s accelerated approval pipeline. They propose seven recommendations that can address many of the problems facing the FDA, including a call for greater transparency when selecting confirmatory trial endpoints.

The authors remark, “Together, these reforms would help ensure that the goals of increasing access to drugs for patients who have limited treatment options are balanced with protecting patients and taxpayers from overpaying for treatments that may have limited or no benefit. Moreover, we believe they show how the accelerated approval program may provide an unexpected pathway to value-based pricing.” Read more here.

(Source: Nirosha Mahendraratnam Lederer and Stacie B. Dusetzina, Health Affairs, 8/18/21)