The U.S. government limited Medicare coverage of Biogen Inc.’s Alzheimer’s disease treatment and similar drugs to patients enrolled in clinical trials, a highly unusual move that will curb access to the controversial treatment approved last year.
Coverage of Biogen’s therapy, sold under the brand name Aduhelm, and other amyloid-targeted Alzheimer’s therapies, will be limited to people participating in qualified clinical trials, the Centers for Medicare & Medicaid Services said in a statement on Tuesday.
The decision is preliminary and will be followed by a 30-day public comment period. A final determination is due in April. The policy will set national rules for how Medicare treats Aduhelm and similar drugs that may follow.
Biogen shares were down 7.4% to $223.76 after the close of regular trading in New York.
CMS’s demand for more evidence before it will pay for Aduhelm, priced at $28,200 a year, comes six months after the Food and Drug Administration granted the drug an accelerated approval. The clearance was given on the condition that the drugmaker conduct an additional trial to confirm the drug’s benefits, but regulators said at the time that giving patients access to a potentially game-changing therapy was a priority.
However, CMS officials indicated that they see the balance of risks differently. The agency chose one of its most stringent standards for reimbursement, restricting coverage only to people in randomized trials.
The agency said it did a thorough analysis that found that, while Aduhelm could help patients with the memory-destroying disease, there is also the potential for harm. Headaches, dizziness, falls and even brain bleeds could be possible side effects, officials said in a statement.
“Our foremost goal is to protect beneficiaries from potential harm from an intervention without known benefits in the Medicare population,” said Dr. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality, on a call with reporters.
According to a summary posted on the Medicare website, qualifying studies must be randomized controlled trials, and must examine whether using amyloid therapies results in statistically significant difference in cognition and function for people with mild Alzheimer’s.
CMS officials emphasized that the trials must be representative of the population of Medicare patients with Alzheimer’s, which disproportionately affects people of color in the U.S.