(Reuters) – The U.S. Centers for Medicare and Medicaid Services (CMS) on Monday proposed a broader coverage for a type of brain scan, used to identify a key Alzheimer’s disease protein, that will be needed for doctors to determine whether patients are eligible for newly developed drugs.
The agency proposes to remove the once-per-lifetime limit on beta amyloid PET scans that restricted their use to clinical trials. The changes will permit Medicare beneficiaries to seek reimbursement for the tests.
New Alzheimer’s treatments, such as Eisai and Biogen’s Leqembi, and an experimental drug from Eli Lilly known as donanemab, work by removing beta amyloid from the brain. To qualify for treatment for Leqembi, patients must have evidence of the protein in their brain.
“Today’s announcement about Medicare coverage of amyloid PET scans fulfills CMS’ commitment to allow broader coverage of this diagnostic test,” said CMS Administrator Chiquita Brooks-LaSure. “PET scans are an important part of diagnosis and treatment of Alzheimer’s disease, and this decision is an important part of CMS’ mission to help improve the lives of Americans we serve.”
TD Cowen analyst Eric Assaraf said Medicare’s proposal indicates that beneficiary access to beta amyloid PET scans is unlikely to be a major hindrance to the coverage of monoclonal antibodies for treating Alzheimer’s disease.
The proposal leaves coverage to regional contractors, which could lead to some confusion and may force the agency to eventually revisit the decision, Assaraf noted.
(Reporting by Julie Steenhuysen and Sriparna Roy in Bengaluru; Editing by Shailesh Kuber)
