US removes coverage curb on PET scans for Alzheimer's patients

[October 14, 2023]  By Julie Steenhuysen

(Reuters) -U.S. health officials on Friday lifted curbs on reimbursement of a non-invasive imaging test called amyloid PET used to diagnose Alzheimer's, ending a once-per-lifetime limitation that clears the way for its use to determine eligibility for new treatments.

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, or plaques, are considered an early hallmark of Alzheimer's disease that gradually destroy memory and thinking skills. Previously, amyloid positron emission tomography, or PET, scans were only accessible for use in a clinical trial or patient registry.

“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, which is needed to determine eligibility for new, FDA-approved treatments, she said.

Amyloid confirmation is required for U.S. government reimbursement of Leqembi and similar treatments through a national data collection registry run by the Centers for Medicare & Medicaid Services (CMS).

Both Lilly and Eisai said in statements the change will advance treatment of people with Alzheimer's disease.

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.

"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.

Sue Peschin, president of the Alliance for Aging Research, said more than a third of patients deemed to have Alzheimer's dementia based on clinical symptoms were found to be incorrectly diagnosed after receiving a beta amyloid PET scan.

Dr. Seth Gale points out evidence of Alzheimer’s disease on PET scans at the Center for Alzheimer Research and Treatment (CART) at Brigham And Women’s Hospital in Boston, Massachusetts, U.S., March 30, 2023. REUTERS/Brian Snyder

Under the new policy, coverage decisions for PET scans will be made by local Medicare Administrative Contractors, or MACs.

RBC Capital Markets analyst Brian Abrahams said the change provides clarity around reimbursement for amyloid 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.

The decision followed a comment period in which some companies lobbied for a national coverage policy, instead of allowing MACs to make the calls.

"Together with industry partners, we have advocated for the broadest possible coverage of diagnostic imaging to aid in the administration of those new therapies," Catherine Estrampes, U.S. and Canadian head of GE Healthcare, said in an interview this week. GE Healthcare makes PET scanners and an amyloid PET imaging agent.

In public comments on the CMS website, GE Healthcare cited concerns that local decision making could result in regional variations in coverage.

A spokesman for Eli Lilly, which also makes an amyloid PET imaging agent, said the company looks forward to working with Medicare contractors "to ensure timely and uniform coverage implementation for all Medicare beneficiaries.”

(Additional reporting by Manas Mishra in Bengaluru; Editing by Arun Koyyur and Bill Berkrot)

[© 2023 Thomson Reuters. All rights reserved.]This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.