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FDA, CMS And Accelerated Approval: Flipping The Script

 
• By Michael McCaughan

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.

The plan is one of three projects unveiled last month by the Health and Human Services Department in response to a White House executive order last fall. (Also see "

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