Washington, DC—Based on its initial proposal, Medicare coverage for a new Alzheimer's disease drug and others in its class would be significantly limited.

The Centers for Medicare & Medicaid Services (CMS) recently released a proposed National Coverage Determination (NCD) decision memorandum that doesn't mention Aduhelm, the recently approved Biogen drug, by name but describes its class and situation. The proposed policy would cover FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer's disease. Specifically, it describes coverage with evidence development (CED), which means that FDA-approved drugs in this class would be covered for Medicare beneficiaries only if they are enrolled in qualifying clinical trials.

The proposed NCD is open to public comment for 30 days.

"Alzheimer's disease is a devastating illness that has touched the lives of millions of American families. Throughout this National Coverage Determination process, CMS has been and remains committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients," said CMS Administrator Chiquita Brooks-LaSure in press release. "CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders."

Dr. Brooks-LaSure said views of Medicare patients, family members and caregivers, patient advocacy groups, medical experts, states, payers, and industry professionals would be taken into account before a final decision is made.

Under the proposed National Coverage Determination, CMS would review each submitted clinical trial to determine whether it meets specific criteria. All CMS-approved clinical trials would be posted on the agency's coverage website. National Institutes of Health (NIH)-sponsored clinical trials also would be covered under the proposal.

Medicare patients participating in the trials would be eligible to receive coverage of the drug, related services, and other routine costs, which might include PET scans if required by a clinical trial protocol.

"This proposed National Coverage Determination is the result of robust evidence analysis conducted through a thorough review process that found while there may be the potential for promise with this treatment, there is also the potential for harm to patients. This harm may range from headaches, dizziness, and falls, to other potentially serious complications such as brain bleeds," advised Lee Fleisher, MD, CMS chief medical officer and director of the Center for Clinical Standards and Quality.

The proposed NCD is the result of analysis begun last July to determine whether Medicare will establish a national policy for coverage of monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease. As part of that, CMS held two national listening sessions attended by more than 360 people and reviewed 131 public comments and more than 250 relevant peer-reviewed documents.

As it stands now, without a national coverage policy, the Medicare administrative contractors decide whether the drug is covered on a claim-by-claim basis.

Currently, aducanumab, marketed as Adulhelm by Biogen, is the only monoclonal antibody directed against amyloid beta approved by the FDA for the treatment of Alzheimer's disease. The company responded strongly to the proposed limitations.

"Alzheimer's patients and their families deserve to have choice and access to FDA-approved treatments," it said in a press release. "Biogen believes that the proposed coverage with evidence development (CED) decision for anti-amyloid therapies denies nearly all Medicare beneficiaries from accessing ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use, the first FDA-approved treatment for Alzheimer's disease since 2003, as well as future amyloid-directed therapies."

Biogen adds, "It is imperative to change this draft decision to be aligned with reimbursement for other therapies for progressive diseases, where patients have immediate and equal access to medicines approved by the FDA. The FDA's accelerated approval was supported by clinical data showing that ADUHELM impacted the underlying pathology of Alzheimer's disease. This includes a robust reduction in pathological hallmarks of Alzheimer's disease, specifically for both amyloid plaques and neurofibrillary tangles in the brain."

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