Medicare says coverage limits on Alzheimer’s drugs is not under review
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The Centers for Medicare and Medicaid Services (CMS) says it is not reconsidering last year's decision to severely restrict the coverage for FDA-authorized amyloid targeting monoclonal antibodies for Alzheimer's disease.
In April 2022, the CMS issued a national coverage determination (NCD) to restrict Medicare coverage for the drug class. The decision came months after the FDA authorized Aduhelm, an anti-amyloid monoclonal antibody developed by Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) (OTCPK:ESAIY) for Alzheimer's under the agency's accelerated approval pathway.
"We recognize that these medications are a unique, new class of drugs, and we regret that the decision could not be more favorable," CMS stated in a statement on Wednesday in response to a request from the Alzheimer's Association to reconsider the decision.
In Early January, Biogen (BIIB) and Eisai (OTCPK:ESALF) won the FDA's accelerated approval for a new Alzheimer's medication called lecanemab for the mild form of the disease. Eisai (OTCPK:ESALF) expects full approval for the anti-amyloid monoclonal antibody as early as July.
The CMS said it will "expeditiously review any new evidence that becomes available that could lead to a reconsideration and change in the NCDâ¦." The agency also pledged to offer swift coverage for the drug class if the medication is granted the FDAâs traditional approval for Alzheimerâs. 
Eli Lilly (LLY) and Roche (OTCQX:RHHBF) (OTCQX:RHHBY)/ MorphoSys (MORF) (OTCPK:MPSYF) are among other drugmakers focused on developing anti-amyloid monoclonal antibodies for Alzheimer's.
In January, the FDA declined to consider Lilly's (LLY) donanemab for accelerated approval in Alzheimer's. Meanwhile, Roche (OTCQX:RHHBY) has faced several trial setbacks for its Alzheimer's candidate, gantenerumab.