Medicare Seeks To Limit Coverage For Controversial Alzheimer’s Drug Aduhelm

Topline

The Centers for Medicare and Medicaid Services proposed limiting coverage for Alzheimer’s drug Aduhelm to patients participating in clinical trials Tuesday, after many medical experts claimed the drug — which U.S. regulators controversially approved last year — comes with potential dangers and few proven benefits.

Biogen headquarters in Cambridge, Massachusetts on March 21, 2019.

John Tlumacki/Boston Globe via Getty Images

Key Facts

If CMS’s decision is finalized, Medicare will only cover the drug — which is manufactured by Biogen — for patients in hospital-based trials approved by CMS or supported by the National Institutes of Health, greatly reducing the number of people who might otherwise take it.

CMS is expected to make a final decision following a 30-day comment period which began Tuesday.

CMS has designated only 21 other treatments for coverage restricted to clinical studies, including devices like pacemakers and cochlear implants.

Additionally, hospitals like the Cleveland Clinic, Johns Hopkins, the University of California Los Angeles and the University of Michigan have decided not to offer patients Aduhelm, citing a lack of evidence for the drug’s effectiveness, Stat reported.

A Biogen spokesperson said the company will urge CMS to help make the drug as accessible to patients as other therapies granted FDA accelerated approval, and said CMS’s proposed decision to limit coverage “denies the daily burden of people living with Alzheimer’s disease.”

Key Background

Billed as an “important, first-in-class” treatment, Aduhelm was approved by the Food and Drug Administration in June. Later that month, two congressional committees opened investigations into the FDA’s approval process for the drug, and lawmakers argued the FDA ignored the concerns of experts, including members of the agency’s own Peripheral and Central Nervous System Drugs Advisory Committee. Three members of that committee resigned following the FDA’s approval. In a statement last year, 18 dementia researchers and other experts argued the FDA did not demonstrate that the drug had any meaningful benefits which would offset potentially dangerous side effects like falling and brain bleeding. The FDA has also launched an internal review of its handling of Aduhelm. Though Biogen initially predicted that 10,000 patients would be taking the drug by the end of 2021, by September only about 100 patients had taken the drug, Stat reported.

Crucial Quote

“It’s a pretty darn unique situation,” former CMS chief Sean R. Tunis told the Washington Post. “There have not been very many FDA decisions that have been this extensively questioned both on process and on substance.”.

Big Number

$28,200. That’s how much Biogen is charging for one year of Aduhelm. Initially, the drug carried an annual price tag of $56,000.

Contra

Advocacy group UsAgainstAlzheimer’s urged CMS last week to cover Aduhelm as widely as possible, since the FDA has declared the drug safe and effective. CMS must either cover Aduhelm or “tell Alzheimer’s patients and their loved ones they’re on their own,” said UsAgainstAlzheimer’s chair George Vradenburg.