Medicare Coverage Determination for Alzheimer's Drug Is Underway

CMS has started a national coverage determination analysis and will establish Medicare coverage policies for the new Alzheimer’s drug, aducanumab.

Aducanumab is a monoclonal antibody that targets amyloid to treat Alzheimer’s disease. The Food and Drug Administration (FDA) approved the drug in early June 2021 despite mixed trial results and, according to some stakeholders, a lack of sufficient evidence for the drug’s efficacy.

A key next step is for CMS to decide if Medicare health plans will offer coverage for aducanumab. If a large payer like Medicare agrees to cover the drug, public perception surrounding the treatment could shift favorably.

The national coverage determination analysis results will apply to aducanumab and any other future monoclonal antibodies that target amyloid for Alzheimer’s treatment.

“Alzheimer’s is a devastating illness that has touched the lives of millions of American families and as CMS opens our National Coverage Determination analysis, we invite interested stakeholders to participate,” Chiquita Brooks-LaSure, CMS administrator, said in the press release.

“We want to consider Medicare coverage of new treatments very carefully in light of the evidence available. That’s why our process will include opportunities to hear from many stakeholders, including patient advocacy groups, medical experts, states, issuers, industry professionals, and family members and caregivers of those living with this disease.”

To aid in the decision-making process, CMS is holding a 30-day public comment period which began on July 12. Individuals can submit comments on the CMS website. There will also be two public listening sessions this month to solicit feedback from stakeholders.

In order to reach coverage policy decision CMS will analyze the clinical evidence on aducanumab such as published studies and professional society guidelines. When offering coverage for a service, Medicare’s law requires that the service be “reasonable and necessary for the diagnosis or treatment of illness or injury,” the press release explained.

After reviewing the evidence and public comments, CMS will post a proposed national coverage determination within the next six months detailing their coverage policy for the drug. Following the proposed national coverage determination there will be another 30-day comment period before CMS reaches a final decision. The final national coverage determination is expected within nine months.

Medicare administrative contractors are currently regulating Medicare coverage decisions for aducanumab at the local level. If CMS can establish a coverage policy, it will affect Medicare plans nationally.

The national policy could take shape in more than one way. CMS could choose to offer full coverage for the drug or offer no coverage. The agency could also choose a limited coverage path and cover the drug based on effectiveness or defer the policy to the Medicare administrative contractors.

Establishing a national coverage determination for aducanumab is no small task and the results have the potential to fuel the ongoing controversy surrounding the treatment. Since the drug received approval, three FDA committee members have resigned, stating the FDA administrators ignored their concerns about aducanumab’s efficacy.

The potential financial burden should be weighed as well. Offering coverage for aducanumab would significantly increase Medicare spending, as Biogen has set a $56,000 list price for one year of the drug. 

With some Medicare beneficiaries already overwhelmed by high premiums and out-of-pocket healthcare costs, a decision to fully cover aducanumab could adversely affect Medicare beneficiaries’ finances. Full coverage could also lead to higher premiums for Medicare Part B beneficiaries.

Taxpayers could likewise face financial repercussions. If one million Medicare members received aducanumab, the cost during one year would surpass $57 billion, according to a Kaiser Family Foundation brief. That is more than the combined spending on all other drugs covered under Medicare Part B.

CMS will post the proposed and permanent national coverage determinations with policy details and rationales for the decisions on its coverage website, the press release concluded.