Medicare limits payments for new Alzheimer’s drug

The federal government on Thursday affirmed its plan to limit coverage for a costly new medication for Alzheimer’s disease, restricting it to Medicare patients enrolled in clinical trials.

Despite the Food and Drug Administration’s accelerated approval of the drug, Aduhelm, last June, the Centers for Medicare and Medicaid Services said it would limit payments for the drug to people in carefully controlled tests of the medication’s effectiveness for the progressive neurological disease.

Those trials could be approved by the FDA itself or by the National Institutes of Health, and would not have to be sanctioned by CMS, as originally proposed.

In a small victory for Alzheimer’s patients, CMS said if the FDA approves future drugs through a more traditional process, it would allow wider access to coverage for those medications. Those drugs also would target the amyloid plaques suspected of causing the devastating effects of Alzheimer’s.

The decision means Aduhelm will remain unavailable for now to some of the nation’s 6.2 million people with Alzheimer’s who had hoped to try it for mild cognitive impairment or dementia that results from the disease. The population with milder Alzheimer’s disease, the target group for the drug, is estimated at 1 million to 2 million people.

Aduhelm is the first Alzheimer’s treatment intended to slow cognitive decline.

Lee A. Fleisher, chief medical officer and director of CMS’s Center for Clinical Standards and Quality, said in a briefing for news media Thursday that “there is not currently enough evidence of clinical benefit to say [Aduhelm] is reasonable and necessary for people with Medicare.”

The decision reflects a wide spectrum of opinion on whether Aduhelm is effective enough to warrant greater distribution. A monoclonal antibody taken as a monthly infusion, the drug is the first new treatment for Alzheimer’s approved by the FDA since 2003. Its cost – $28,200 per patient, per year – also has raised concerns.

Alzheimer’s was the seventh-most-common cause of death in the United States in 2020, resulting in more than 134,000 fatalities.

The FDA’s approval and Medicare’s proposal in January to limit coverage have created twin furors over the medication. Alzheimer’s advocacy groups vowed to press for wider access to a drug that had offered the hope of slowing cognitive decline.

But some major health systems have refused to offer the medication, developed by the drugmaker Biogen, because some experts doubt its efficacy. The watchdog group Public Citizen – which frequently criticizes the FDA – called for three top FDA officials to resign.

Alzheimer’s advocacy groups fiercely fought CMS’s proposed coverage

restriction when it was announced in January, angered

that it would drastically limit the number of people who could receive the treatment.

Volunteer advocates with the Alzheimer’s Association have held an estimated 400 meetings on Capitol Hill. Groups such as the Global Alzheimer’s Platform Foundation said they have met

with CMS and other administration officials to make their case. And UsAgainstAlzheimer’s launched a seven-figure ad campaign targeting the Washington, D.C., and Baltimore media markets.

“Every treatment for every other disease has been covered when there has been an FDA approval, and to set a precedent on the backs of people with Alzheimer’s is just flatly wrong,” Harry Johns, chief executive of the Alzheimer’s Association, said hours before the announcement.

In addition, questions about the drug’s unusual approval process have prompted investigations by the Department of Health and Human Services’ inspector general, among others.