April 11, 2022

Medicare Limits Coverage of Aduhelm to Patients in Clinical Trials

Citing data showing the new Alzheimer’s drug Aduhelm has serious safety risks and may not help patients, Medicare officials decided Thursday to limit coverage of the drug to patients in clinical trials. The decision is extremely unusual for Medicare, which traditionally pays for drugs that the Food and Drug Administration has approved, at least for the medical conditions designated on labels.

According to The New York Times, some advocacy groups had said that Medicare must pay for a drug approved by the FDA. However, many Alzheimer’s doctors and experts cautioned against broadly covering a treatment that scientific evidence shows has uncertain benefit and serious safety risks. Individual patients and families weighed in emotionally from both sides.

Last year, Medicare’s actuarial division, acting without knowing what the coverage decision would be, imposed one of the biggest-ever increases in Medicare Part B premiums for 2022. The Centers for Medicare and Medicaid Services (CMS) said that half of the 14.55% increase in the premiums for 2022 was due to the cost of Aduhelm, which was then priced by its manufacturer, Biogen, at $56,000 a year.

Since then, Biogen, facing weak sales of the drug after many hospitals and doctors chose not to prescribe it, lowered the price to $28,800 a year, still much higher than what many analysts have said is defensible.

Xavier Becerra, Secretary of the U.S. Department of Health and Human Services, said previously that he would consider lowering Medicare Part B premiums after the final coverage decision for Aduhelm is made, adding, “We’re going to make sure that seniors don’t pay more than they have to.”

On Thursday, Chiquita Brooks-LaSure, the administrator of CMS, said, “The secretary told us to look at it, and we are going to engage in the process of reviewing the Part B premium.”

“Allowing Medicare to negotiate the cost of prescription drugs would go a long way toward diminishing the effect Aduhelm has on Medicare premiums,” said Richard Fiesta, Executive Director of the Alliance. “It would make a lot more sense to make decisions based on numbers that include giving Medicare that ability.”