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BioCentury
ARTICLE | Product Development

First solid win for amyloid could lead CMS to rethink controversial NCD

Full approval of Eisai’s lecanemab in Alzheimer’s could persuade CMS to re-assess requirements for class

September 28, 2022 1:28 AM UTC
Updated on Oct 1, 2022 at 12:35 AM UTC

After over two decades of clinical trials testing amyloid-lowering agents to treat Alzheimer’s disease, Phase III data from Eisai’s anti-amyloid mAb lecanemab has brought the field to a tipping point, making possible to say with confidence that dramatically reducing brain deposits of β-amyloid can slow clinical decline at least a little bit.

With a full approval for lecanemab almost certain, the findings could convince CMS to re-evaluate its controversial coverage with evidence requirements for the anti-amyloid drug class that came with the also controversial approval of Aduhelm aducanumab-avwa from  Biogen Inc. (NASDAQ:BIIB)...

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BCIQ Target Profiles

Beta amyloid