Sen. Wyden presses HHS, CMS on access to new Alzheimer's therapies
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Sen. Ron Wyden (D-Ore.) is asking the heads of HHS and CMS for answers on how Alzheimer's patients can participate in a registry or submit data to take advantage of a policy that allows Medicare to cover new Alzheimer's treatments.
That policy is known as coverage with evidence development. CMS said it would allow coverage of new Alzheimer's therapies, such as Biogen's monoclonal antibody Leqembi (lecanemab), only if a patient is enrolled in a clinical trial.
"Medicare providers and patients need timely, critical information from CMS about how registry or other CED studies can be put in place for Alzheimerâs disease [monoclonal antibodies] and how providers will be able to enroll their patients in all areas of the country without excessive burden," Wyden, chairman of the Senate Finance Committee, wrote. "Physicians who administer these medications need a simple, direct way to submit data and provide treatment to qualifying patients."
CMS has indicated that more widespread coverage of Alzheimer's monoclonal antibody treatments could come once they receive full approval. That could happen for Leqembi by July 6. A FDA advisory committee meeting on that application is scheduled for June 9.
An executive from Eli Lilly (NYSE:LLY), which is developing its own monoclonal antibody for Alzheimer's, donanemab, said in April he believes CMS will change policy and cover new Alzheimer's therapies like any other drug.

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