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

The new date is Jan 11, 2022.

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 comes with potential dangers and few proven benefits.

The headquarters of Biogen is in Cambridge, Massachusetts.

John Tlumacki/Boston Globe.

If the decision is finalized, Medicare will only cover the drug for patients in hospital-based trials approved by the Centers for Medicare and Medicaid Services or supported by the National Institutes of Health, which will greatly reduce the number of people who take it.

The 30-day comment period began Tuesday and is expected to end in the next few days.

Devices like pacemakers and cochlear implants are only one of the 21 treatments that are designated for coverage by the Centers for Medicare and Medicaid Services.

Hospitals like the Cleveland Clinic, the University of California Los Angeles and the University of Michigan have decided not to offer patients Aduhelm because of a lack of evidence for its effectiveness.

A Biogen spokesman said the company would urge the government to make the drug accessible to patients as other therapies were granted FDA accelerated approval.

Aduhelm was approved by the FDA in June as an important, first-in-class treatment. Lawmakers argued that the FDA ignored the concerns of experts, including members of the agency's own Peripheral and Central Nervous System Drugs Advisory Committee, when approving the drug. The FDA approved the resignations of three members of that committee. In a statement last year, 18 dementia researchers and other experts argued that the FDA did not demonstrate that the drug had any meaningful benefits which would offset potentially dangerous side effects. An internal review of the FDA's handling of Aduhelm has been launched. By September, only about 100 patients had taken the drug, which was predicted to be 10,000 by the end of the year.

Sean R. Tunis was the former chief of the Centers for Medicare and Medicaid Services. There have not been a lot of FDA decisions that have been extensively questioned.

The number is big.

The price is $28,200. That is how much Aduhelm is costing Biogen. The price of the drug was $56,000.

There was aContra.

The FDA has declared Aduhelm safe and effective, so the advocacy group Us AgainstAlzheimer's wants the drug to be covered by the government. George Vradenburg, chair of Us AgainstAlzheimer, said that it was up to the Centers for Medicare and Medicaid Services to either cover Aduhelm or tell Alzheimer's patients and their loved ones they were on their own.

The New York Times reported that Medicare wants to cover only patients in clinical trials.

Medicare plans to restrict access to controversial, pricey Alzheimer's drug Aduhelm to patients in clinical trials.