June 15, 2021

New Alzheimer’s Drug Approved as Debate Heats Up Over Its Cost, Effectiveness

The Food and Drug Administration (FDA) recently authorized Aduhelm, a controversial new Alzheimer’s disease treatment created by Biogen. Aduhelm is the first new treatment approved for Alzheimer’s after a nearly 20-year hiatus in new therapies for the condition. It is projected to cost $56,000 a year per patient.

Alzheimer’s disease is estimated to affect roughly 6 million people in the United States, most of whom are over 65 and therefore eligible for Medicare. Aduhelm will be reimbursed under Medicare Part B as an intravenous infused medicine delivered by physicians.

FDA experts originally said there wasn’t enough data to warrant the approval of the medication. The drug, designed to be given to individuals very early in the course of the disease before they develop dementia, did not appear to assist at all in early studies. The Aduhelm clinical trials were even halted in 2019 due to a lack of evidence that the medicine was effective.

Three members of the FDA’s Central Nervous System Advisory Committee have resigned over the agency’s approval of Aduhelm. Dr. Aaron Kesselheim, a professor at Harvard Medical School, said the agency’s decision on Aduhelm “was probably the worst drug approval decision in recent U.S. history” and said “this (decision) will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the healthcare system” in his resignation.

When Biogen re-analyzed the trial data, its researchers found that some patients who received large doses of the medicine did not improve, but their symptoms increased at a slower rate than other patients experienced. Gayatri Devi, a neurologist at Lenox hospital in New York, said she believes the drug has a real chance at slowing memory, thinking and functional problems but caution was “the most important thing.”

Trials have also shown that some patients treated with the drug had side effects including brain swelling, minor bleeding and headaches while taking the medication.

Decision-makers at the Centers for Medicare & Medicaid Services (CMS) may now choose to undertake a National Coverage Determination process that could set some limits on the conditions of Medicare coverage for Aduhelm based on its clinical effectiveness.

“Alzheimer’s is a cruel disease affecting millions of Americans and new treatments are desperately needed,” said Robert Roach, Jr., President of the Alliance. “At the same time, patients and their families need to be fully educated on the risks and benefits of this drug and any others.”