Who should pay for new Alzheimer’s drug?

The Food and Drug Administration’s June 7 approval of aducanumab, for Alzheimer’s disease, set off a firestorm of controversy over the drug’s effectiveness—and its price.

The FDA’s independent advisory committee recommended against approving the drug because of concerns about its effectiveness, but the FDA took the unusual step of overriding the committee’s decision. A month after it approved the drug, the FDA restricted its use—another rare move—and limited it to those with early or mild cases of the disease.

“If this new product came to market at a $1 a day, there would still be concerns about the safety and efficacy of this therapy for patients with Alzheimer’s disease.”

Substantial disagreement lingers over payment for the drug—which Biogen, its developer, plans to sell under the brand name Aduhelm for $56,000 for a yearlong regimen—and whether Medicare should pick up the tab, given that many scientists believe it’s largely ineffective and has significant safety concerns.

In an article published in JAMA, Kevin Schulman, professor of medicine and a director of the Clinical Excellence Research Center, or CERC, at Stanford University; Michael Greicius, professor of neurology and neurological sciences; and CERC visiting scholar Barak Richman, examine what’s at stake for regulators, payers, and patients.

Here, Schulman answers five questions surrounding the controversy regarding the drug’s efficacy, safety, and cost:

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