Medicare proposes restricting coverage of Alzheimer's drug to clinical trials

Medicare officials on Tuesday decided a new Alzheimer's drug will be covered only for patients participating in approved clinical trials.

In a preliminary decision, the Centers for Medicare and Medicaid Services said the federal health insurance program should cover the Alzheimer's drug Aduhelm only for use in "CMS-approved randomized controlled trials" and trials supported by the National Institutes of Health.

"All trials must be conducted in a hospital-based outpatient setting," the CMS said.

Aduhelm is currently the only Food and Drug Administration-approved monoclonal antibody directed against amyloid beta for the treatment of Alzheimer's but the CMS said similar drugs provided outside of approved trials are also "nationally non-covered."

"CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders," CMS Administrator Chiquita Brooks-LaSure said in a statement.

Dr. Lee Fleisher, CMS chief medical officer and director of the Center for Clinical Standards and Quality, said that the decision was also made due to the presence of "potential for harm to patients" who use the drug.

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

The CMS will hold a public comment period for the next 30 days and is expected to announce a final decision on whether to cover the drug by mid-April.

Biogen, which makes the drug, criticized the CMS decision in a statement saying it "denies the daily burden of people living with Alzheimer's disease" and adding that a clinical trial requirement "will exclude almost all patients who may benefit."

In June, the FDA approved Aduhelm, which Biogen said is the first drug approved that is designed to attack the disease process of Alzheimer's -- by reducing the buildup of harmful plaques in the brain.

Biogen announced last month it would cut the price of the drug from $56,000 to $28,200 a year per patient as of Jan. 1, 2022, amid criticism of the price and months of low sales.