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Senate Finance Committee senators call for hearing on Medicare coverage of aducanumab

By Brian Buntz | June 24, 2021

U.S. Capitol

Photo by Thuan Vo from Pexels

Senate finance Committee members Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) are pushing to have a hearing to discuss the Medicare coverage of Aduhelm (aducanumab), Biogen’s controversial Alzheimer’s treatment, which recently won FDA approval.

In a letter addressed to Senate Finance chair Ron Wyden (D-OR) and ranking member Mike Crapo (R-ID), Warren and Cassidy express concern that the drug could cost Medicare $37 billion to $90 billion annually. “This level of potential new spending, particularly for just one product with limited evidence of clinical efficacy thus far, tests the program’s resiliency,” they wrote.

The letter also recommends that Medicare consider limiting the use of the drug to patients most likely to benefit from it. The clinical trials for aducanumab focused on Alzheimer’s patients with mild cognitive impairment.

Biogen has yet to provide rigorous clinical evidence to tie the drug to improved cognitive performance in Alzheimer’s patients. FDA approved the drug based on a surrogate endpoint  — namely, reduction of amyloid beta plaques in the brain.

Warren and Cassidy also hint that Congress reform Medicare spending to be “value-based,” linking prescription drug pricing to clinical effectiveness. The two also entertain the possibility that Medicare could refuse coverage of the drug.

The senators are concerned that up to six million Alzheimer’s patients in the U.S. could use the drug in perpetuity. The list price of the drug is $56,000.

FDA could technically rescind approval if the drug does not yield a verifiable clinical benefit in a Phase 4 study.

 

About The Author

Brian Buntz

The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. Before coming to WTWH, he served as content director focused on connected devices at Informa. In addition, Brian covered the medical device sector for 10 years at UBM. At Qmed, he overhauled the brand’s news coverage and helped to grow the site’s traffic volume dramatically. He had previously held managing editor roles on two of the company’s medical device technology publications. Connect with him on LinkedIn or email at bbuntz@wtwhmedia.com.

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