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A bipartisan group of 20 U.S. senators called on the Biden administration on Friday to broaden the Medicare coverage for FDA-authorized amyloid targeting monoclonal antibodies for Alzheimer’s disease.
In April 2022, the Centers for Medicare and Medicaid Services (CMS) issued a national coverage determination (NCD) to restrict Medicare coverage for the drug class.
The decision came months after the FDA authorized Aduhelm, a similar Alzheimer’s therapy developed by Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) (OTCPK:ESALY) under controversial circumstances.
Other amyloid-targeting monoclonal antibodies include the duo’s recently authorized Alzheimer’s therapy, lecanemab.
“Unless CMS reconsiders the April 2022 NCD, access to lecanemab and other disease-modifying therapies for Alzheimer’s disease will be extremely limited,” the group led by Senator Susan Collins (R-ME) and Shelley Moore Capito (R-WV) wrote in a letter to Health Secretary Xavier Becerra and Chiquita Brooks-LaSure and CMS administrator Chiquita Brooks-LaSure.
“Given the progressive nature of this terminal disease, we encourage you to take steps now to ensure patients have immediate access to FDA-approved treatments if the patient and clinician decide it is right for the patient,” they added.
Other amyloid-targeting monoclonal antibodies include donanemab from Eli Lilly’s (NYSE:LLY) and gantenerumab from Roche (OTCQX:RHHBF) (OTCQX:RHHBY) and MorphoSys (MORF) (OTCPK:MPSYF), both of which are currently undergoing studies for Alzheimer’s.
In January, the FDA declined to consider accelerated approval for donanemab, and Roche (OTCQX:RHHBY) has faced several trial failures for gantenerumab.