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US Medicare Agency Clarifies View Of Accelerated Approval

 
• By Michael McCaughan

CMS says it has not changed its historical policy towards drugs granted Accelerated Approval. The agency does, however, appear to be suggesting grounds for skepticism towards novel uses of the regulatory pathway.

CMS_accelerated_approval
The Medicare agency says it is standing pat on its approach to accelerated approval. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

The US Centers for Medicare & Medicaid Services is reassuring oncology patient advocates that it is not changing its historic approach to coverage of medicines approved via the Accelerated Approval pathway.

CMS is facing bipartisan criticism for its restrictive coverage policy for beta amyloid targeted therapies to treat Alzheimer’s, which deems drugs approved via the Food & Drug Administration’s AA process...

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More from Government Payers

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Will International Prices Influence Medicare Price Negotiation?

 
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