New Alzheimer’s drug draws attention from federal, independent groups

About Kerry Dooley Young and Joseph Burns

Kerry Dooley Young is an independent journalist and AHCJ's core topic leader on patient safety. Joseph Burns, a Massachusetts-based independent journalist, is AHCJ’s topic leader on health insurance.

Group of Alzeimer's patients on a walk with caregivers

Photo: Global Panorama via FlickrGroup of Alzeimer’s patients on a walk with caregivers

Liz Seegert, AHCJ’s topic leader on aging, contributed to this article.

Federal policy experts and the influential Institute for Clinical Effectiveness (ICER) have announced separate discussions this month of the Biogen drug aducanumab (Aduhelm) to treat Alzheimer’s disease.

On July 15, ICER will ask one of its expert panels, the California Technology Assessment Forum, to consider the evidence available for aducanumab’s benefits and risks and vote on a series of questions about its effectiveness and value. ICER’s reports have clout because insurers use them to help determine how to cover drugs and medical treatments. The independent group earlier released a report critical of the evidence presented to date about aducanumab. Biogen, which told AHCJ it disagrees with ICER’s opinion of its drug, plans to have a representative speak at the meeting.

On July 19, the federal Advisory Council on Alzheimer’s Research, Care, and Services will discuss the “implications of and opportunities presented by the approval of aducanumab,” according to a notice from the Office of the Assistant Secretary for Planning and Evaluation (ASPE). The office functions as an in-house policy shop within the Department of Health and Human Services (HHS).

Experts have questioned the FDA’s decision to approve aducanumab, as AHCJ core topic leaders Liz Seegert and Tara Haelle have written about in “Alzheimer’s drug approved Monday by FDA raises questions for journalists” and “FDA approves new Alzheimer’s drug, but controversy persists.”

STAT reporters Adam Feuerstein, Matthew Herper and Damian Garde on June 29 published a detailed account of Biogen’s behind-the-scenes work to get the drug approved, including the drugmaker’s creation of a “back-channel relationship” with the FDA.

The FDA cleared aducanumab for U.S. sales based on data that suggests it may help people with Alzheimer’s disease by using a surrogate marker, in this case, a measure of the reduction of amyloid plaque to indicate that disease progression had slowed or even reversed. But the agency also directed Biogen to do another study on the effectiveness of aducanumab, with a 2030 target date set in the agency’s approval letter for the submission of a final report on this trial. Matthew Perone of the Associated Press has reported on concerns this timeline could slip.

Further data on aducanumab may be needed to persuade some doctors to prescribe it. Medscape in June reported results of a reader poll that estimated 78% of U.S. physicians and 81% of neurologists at this point were opposed to routine use of the drug.

Biogen intends to sell aducanumab at a yearly cost in the United States of about $56,000.

Medicare coverage still a question 

About 80% of people eligible for aducanumab are enrolled in Medicare, Tufts University researchers wrote in a blog for Health Affairs. Although aducanumab studies only focused on patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia, the FDA granted the treatment a broad label for its use in treating the disease. That raised questions about which patients might benefit from this drug, for which potential side effects include temporary brain swelling. In their blog, the Tufts researchers outlined various options Medicare would have to pay for aducanumab use selectively. (On July 8, Biogen announced that the U.S. prescribing label for the drug had been revised to emphasize that it should be given to patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.)

In response to a question from AHCJ about Medicare’s plans for covering the drug, a spokesperson for the Centers for Medicare & Medicaid Services (CMS) said the agency “is reviewing the FDA’s decision regarding aducanumab and will have more information soon.”

STAT on June 28 published an overview of estimates of how much aducanumab may cost Medicare, which ranges from $29 billion per year if 500,000 Medicare patients take the drug to more than $100 billion if it is more widely adopted.

HHS Secretary Xavier Becerra has acknowledged the debate about aducanumab. “Whether or not that drug will be covered by Medicare and Medicaid is an outstanding question, something HHS will have to deal with,” Becerra said in a live-streamed interview on June 24.

Leave a Reply