Shelley Jazowski

Jul 10, 2023 | jamanetwork.com | Shelley Jazowski |Avi U. Vaidya |Julie M. Donohue |Stacie B. Dusetzina

Commercial Health Plan and Enrollee Out-of-Pocket Spending on Accelerated Approval Products in 2019 Under the accelerated approval program, the US Food and Drug Administration (FDA) may approve a drug based on surrogate end points and requires manufacturers to complete postmarketing studies to confirm a drug’s clinical benefit.1,2 Accelerated approval products, including those of low3 or uncertain therapeutic value, have cost Medicare and Medicaid billions of dollars annually.1,2 Given the...