Chiquita Brooks-LaSure

The Centers for Medicare & Medicaid Services is considering whether to establish a national Medicare coverage policy for monoclonal antibody drugs that treat Alzheimer’s disease, including the newly approved drug aducanumab (Aduhelm). 

CMS on Tuesday announced that it has opened a National Coverage Determination analysis, or NCD, a formal process that will allow it to review and determine potential coverage policy for monoclonal antibodies, which target amyloid beta — a brain hallmark of the disease.

Coverage decisions have the potential to place certain restrictions on drug access, but a major advocate for patients with Alzheimer’s is hailing the decision. “An NCD would help prevent regional and community level disparities due to barriers that would be difficult to overcome, particularly by those who have greater challenges accessing healthcare services,” the Alzheimer’s Association wrote in a statement, also released Tuesday.

A well-designed analysis would create “rapid, open access to crucial information regarding efficacy, safety and equity to help ensure that everyone who might benefit has access,” the organization said. In the meantime, it is calling on CMS to provide immediate guidance to help healthcare providers and patients navigate access to coverage. 

“Patients and their families are understandably eager for treatment to begin now; providers need to understand what will be covered as we wait for an eventual NCD,” it stated.

Coverage determinations for aducanumab currently are made at the local level by Medicare Administrative Contractors, according to CMS. The agency’s NCD analysis will include a 30-day public comment period.

“Alzheimer’s is a devastating illness that has touched the lives of millions of American families,” CMS Administrator Chiquita Brooks-LaSure said. “We want to consider Medicare coverage of new treatments very carefully in light of the evidence available.”