FDA, CMS And Accelerated Approval: Flipping The Script

The US Medicare agency’s restrictive coverage policy for Alzheimer’s antibodies is a clear threat to the FDA accelerated approval pathway. Now the payor is going to try a different approach to strengthen the pathway.

reversal
The new CMS payment trial could help make the FDA's accelerated approval more common going forward. • Source: Shutterstock

A proposal for the US Medicare program to lower payments for drugs granted accelerated approval stands out as the most innovative in a series of new administrative approaches that could rein in drug pricing.

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