CMS proposes to restrict Medicare coverage of a high-profile new Alzheimer’s drug

The drug under consideration drew headlines in 2021 for both its proposed price and the process that led to its approval by the FDA.

Medicare will pay for use of a new drug to treat Alzheimer’s disease only in limited scenarios, CMS announced Jan. 11 in a highly anticipated preliminary coverage determination.

Biogen’s drug Aduhelm would be covered only for patients enrolled in approved clinical trials that are conducted in hospital outpatient settings. Coverage also would encompass related services such as PET scans.

Aduhelm, a monoclonal antibody treatment, gained attention in 2021 for both its price and the seemingly fast-tracked nature of its approval by the FDA. An FDA advisory panel had not recommended approval, saying the drug’s clinical benefits were unproven. The process that led to the final decision in June is under investigation by Congress and the HHS Office of Inspector General.

After FDA approval, Biogen established a list price of $56,000 before cutting the price in half in December following hospital pushback.

The initial price tag affected Medicare premiums, which rose by $22 for 2022. CMS said about half the increase was tied to the prospective cost of covering Aduhelm. In response to last month’s price reduction, HHS Secretary Xavier Becerra said the premium increase would be reassessed.

Aduhelm is the first monoclonal antibody-based treatment targeting amyloid for the treatment of Alzheimer’s disease. Lee Fleisher, MD, chief medical officer and director of the Center for Clinical Standards and Quality with CMS, said evidence review suggests the possibility of harmful effects from the drug. Hence the need for further evaluation through clinical trials.

“This harm may range from headaches, dizziness and falls to other potentially serious complications such as brain bleeds,” Fleisher said in a news release. “We believe that any appropriate assessment of patient health outcomes must weigh both harm and benefit before arriving at a final decision.”

The coverage determination is subject to change during a 90-day comment period.

Read the CMS memo announcing the determination and the FDA’s June 2021 announcement approving the drug, and submit comments at the Medicare coverage database.