Senators urge CMS to rethink narrow Medicare coverage for Alzheimer's drugs

A group of senators is urging the Biden administration to rethink its restrictive coverage determination for emerging Alzheimer's disease treatments.

The letter (PDF) to Department of Health and Human Services Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure is signed by 20 senators comprising 18 Republicans and two Democrats.

In it, the legislators said they're echoing calls from patient advocates as well as the Alzheimer's Association to make it easier for people with the disease to access monoclonal antibody drugs that target amyloid. They warn that delays could prevent patients from seeing the benefits associated with these therapies.

"This overdue CMS action will ensure Medicare beneficiaries living with mild cognitive impairment due to Alzheimer’s disease and early stage Alzheimer’s disease have immediate access to FDA-approved treatments if the patient and clinician decide it is right for them," the senators wrote.

The coverage issue stems from the first monoclonal antibody approved, Aduhelm, which was co-developed by Biogen and Eisai and debuted with a controversial accelerated approval from the Food and Drug Administration amid concerns from experts about its efficacy. The drugmakers quickly brought the drug to market at a high price, and many commercial payers opted not to include it on their formularies.

CMS later issued a restrictive coverage determination for Aduhelm in Medicare that applied to other drugs in its class, much to the dismay of the pharmaceutical industry and patient advocates.

However, since then, Biogen and Eisai have secured accelerated FDA approval for a second monoclonal antibody drug, lecanemab, which is under the brand name Leqembi. Eisai executives said the company is planning a "careful" launch and set a price tag half of that of Aduhelm.

The senators noted that a group of 200 Alzheimer's researchers and experts joined the Alzheimer's Association in expressing faith in clinical trial data on the drug, arguing that there should be "no barriers" to access should lecanemab secure full FDA approval.

"Unless CMS reconsiders the April 2022 [national coverage decision], access to disease-modifying therapy for Alzheimer’s disease will be extremely limited or nearly nonexistent," the senators wrote.