Centers for Medicare and Medicaid Services (CMS) finalized its decision to restrict coverage for Biogen Inc's (NASDAQ: NASDAQ:BIIB) Alzheimer's drug Aduhelm and other amyloid-targeted drugs to just patients participating in clinical trials.
"Monoclonal antibodies directed against amyloid that FDA approves for Alzheimer's disease based upon evidence of efficacy from a change in a surrogate endpoint (e.g., amyloid reduction) considered as reasonably likely to predict clinical benefit may be covered in a randomized controlled trial conducted under an investigational new drug (IND) application," CMS said in its final decision summary.
For drugs similar to Aduhelm, the CMS said it would allow coverage if the medication is approved after a standard review by the FDA.
Related: CMS Proposes Coverage Of Biogen's Alzheimer's Drug, With Conditions Apply.
Part of that modification means that CMS will not require a separate randomized controlled trial that duplicates an RCT conducted for the FDA's accelerated approval. Biogen already agreed on a protocol.
"This unprecedented CMS decision effectively denies all Medicare beneficiaries access to Aduhelm, the first and only FDA-approved therapy in a new class of Alzheimer's drugs. It may also limit coverage for any future approved treatment in the class," Biogen said.
Read Next: Biogen Shares Aduhelm Data In Alzheimer's Disease At 128 Weeks.
"When additional data from this new class of treatments become available, Biogen urges CMS to reconsider today's decision for all FDA-approved amyloid-beta targeting therapies," the Company added.
Price Action: BIIB shares closed at $211.64 on Thursday.
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