Is Biogen Planning to Appeal CMS Aduhelm Reimbursement Decision?

Biogen_John Tlumacki/The Boston Globe via Getty

John Tlumacki/The Boston Globe via Getty

In early April, the U.S. Center for Medicare and Medicaid Services (CMS) implemented its guidance for Biogen's controversial Alzheimer's drug Aduhelm (aducanumab). The guidance significantly limited the drug's availability. CMS had issued the draft notice in January, providing several months of public responses.

The recommendation restricts Aduhelm to reimbursement only if used in a clinical trial, a very unusual move for a drug approved by the U.S. Food and Drug Administration. The agency also applied this guidance to an entire class of beta-amyloid-clearing medicines that have yet to be submitted for approval.

There is speculation that Biogen might appeal the decision. It was reported that the company hired William Clyburn Jr. of Clyburn Consulting, according to a federal lobbying disclosure. Clyburn's focus isn't usually healthcare. He was formerly commissioner of the U.S. Surface Transportation Board, having worked with former U.S. Senator Zell Miller on airport planning and infrastructure development projects. The company notes transportation and telecommunications as its primary areas of focus.

However, he is a relative of House Majority Whip Jim Clyburn, D-SC, which might be one of the reasons Biogen hired his firm. The filing indicated the specific lobbying issues Biogen was hiring him for were "Alzheimer's Disease treatment availability."

Biogen has also hired several other lobbyists to focus on Alzheimer's, including Federal Street Strategies and Capitol Counsel. It's not unusual for biopharma companies to employ lobbyists, but the timing does raise the question of whether the company will attempt to appeal the CMS decision.

In other news, Biogen's chief executive officer Michel Vounatos's bonus was chopped in half to "hold him accountable for the company's overall business performance in 2021," per a company filing. Vounatos received $1.5375 million in salary for 2021, up 2.5% from $1.5 million in 2020, which was consistent with other executives in the company except for Chirfi Guindo, the company's executive vice president, head of global product strategy & commercialization, whose base salary increased 10.2% from $567,100 in 2020 to $625,214 in 2021. The company reported the increase "reflects the annual merit increase and, in the case of Mr. Guindo, also includes a market adjustment based on our C&MD Committee's review of peer group and survey data."

The executives' non-salary compensation, i.e., bonuses, was based on company performance. As a result, Vounatos received a dividend of $1,153,125, about half of what he could potentially have earned. Biogen noted, "Notwithstanding Mr. Vountasos' essential individual contributions to Biogen in 2021, our Board of Directors believed it was important to hold him accountable for the Company's overall business performance in 2021. As a result, our Board of Directors approved an Individual Multiplier of 50% for Mr. Vountasos."

On a positive note, Biogen and partner Sage Therapeutics initiated a rolling submission of a New Drug Application (NDA) to the FDA for zuranolone for the treatment of major depressive disorder (MDD). The drug is a once-daily oral treatment for MDD and postpartum depression (PPD). They have submitted the nonclinical portion to the NDA and expect to submit the rest in the second half of this year.

"Zuranolone has the potential to help address a significant unmet medical need in depression as an innovative option in a therapeutic area where little has changed in the past 30 years," said Dr. Priya Singhal, M.D., M.P.H., Head of Global Safety and Regulatory Sciences and Interim head of R&D at Biogen. "We are committed to advancing the science and developing new approaches to treating mental health, a major public health challenge that was exacerbated by the COVID-19 pandemic."

The drug has been granted Fast Track and Breakthrough Therapy Designation for MDD as well as Fast Track Designation for PPD. It is being studied in the LANDSCAPE and NEST clinical development programs.

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