Skip to main content
Premium Trial:

Request an Annual Quote

CMS Coverage Plan for Anti-Amyloid Alzheimer's Drugs Overlooks Testing Needs, Imaging Group Says

NEW YORK – The Medical Imaging & Technology Alliance (MITA) is raising concerns that the US Centers for Medicare & Medicaid Services' coverage plans for anti-amyloid Alzheimer's disease drugs overlook reimbursement for critical testing services.

CMS last week announced that it plans to cover monoclonal antibody drugs that treat Alzheimer's by targeting amyloid once they are granted traditional approval from the US Food and Drug Administration, as long as they are administered in clinical settings that agree to collect real-world data on long-term outcomes and usefulness of the drugs.

However, CMS did not address Medicare coverage for diagnostic tests that are used to determine whether or not patients have amyloid plaque buildup in their brains and thus qualify for such therapies, which will hinder access, according to MITA. Beta-amyloid PET imaging, for example, remains under the agency's restricted coverage with evidence development policy.

"As it stands today, CMS's plan for beneficiary access to FDA-approved Alzheimer’s drugs does not make clear how physicians will have access to this critical diagnostic tool to determine appropriate patient selection," MITA, a trade group representing medical imaging equipment and radiopharmaceuticals manufacturers, said in a statement on Monday.

No such anti-amyloid treatments have received traditional FDA approval so far, but two drugs from Biogen and Eisai have received accelerated approval: Leqembi (lecanemab) and Aduhelm (aducanumab), both of which were approved based on their ability to clear amyloid plaque in the brain and are thought to slow disease progression.

Eisai has submitted a supplemental biologics license application to the FDA to convert its accelerated approval for Leqembi into a traditional approval. While Aduhelm is still available to patients, Biogen has ceased commercialization efforts for the drug.