The U.S. Centers for Medicare and Medicaid Services (CMS) on Friday removed a policy that limited the use of a type of brain scan called amyloid PET to once per lifetime, a change that affords patients a non-invasive test to determine if they are eligible for newly developed Alzheimer's drugs.
The new drugs include Eisai and Biogen's Leqembi, and an experimental drug from Eli Lilly known as donanemab, which work by removing a protein called beta amyloid from the brain.
Clumps of amyloid plaques are considered an early hallmark of Alzheimer's, a disease that gradually destroys memory and thinking skills. Previously, amyloid positron emission tomography, or PET, scans were only accessible for use in a clinical trial.
“Amyloid PET scans are a proven tool and can be an important part of Alzheimer’s diagnosis and treatment,” Maria Carrillo, chief science officer of the Alzheimer’s Association, said in a statement.
Broader access will enable earlier, more accurate diagnosis of Alzheimer's, she said, something that is especial to determine eligibility for new, FDA-approved treatments.
Confirmation of amyloid in the brain is required for people to be eligible for government reimbursement for Leqembi and similar treatments through a national data collection registry run by CMS.
Previously, the only other CMS authorized method to measure amyloid in the brain was through an invasive cerebrospinal fluid test, which requires a lumbar puncture.
Under the new policy, coverage decisions for PET scans will be made by local Medicare Administrative Contractors, or MACs.
"This decision empowers millions of Alzheimer’s patients and their families to make more informed decisions about their health,” George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s, said in a statement.
"This is particularly important because of Medicare’s requirement of an Alzheimer’s diagnosis in order for patients to receive coverage for disease-modifying drugs like Leqembi," he said.
RBC Capital Markets analyst Brian Abrahams said the change provides clarity around reimbursement for PET scans.
"While it will likely take some months for the MACs to establish their own reimbursement terms, PET scans have been one of the key initial bottlenecks for Leqembi uptake," he wrote in a note to clients.