Insurers Seek Accelerated Approval Reform Following New Spending Studies

By Gabrielle Wanneh / December 8, 2021 at 2:12 PM
Insurers are pressing for changes to the accelerated approval pathway in the wake of research that shows accelerated approval drugs comprise a growing share of Medicare drug spending. America’s Health Insurance Plans says lawmakers should create more enforcement controls for the accelerated approval pathway as Congress considers renewing the Cures Act . AHIP didn’t specify the enforcement controls it seeks. For breakthrough drugs, the recently unveiled Cures 2.0 bill primarily is concerned with improving communication between FDA and CMS. The...


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