Biogen Seeks Dialogue With US CMS About Alzheimer's Drug Coverage Decision

By Manojna Maddipatla

January 14, 2022

(Reuters) - Biogen Inc's chief executive officer on Thursday said the company wants a dialogue with the U.S. Centers for Medicaid and Medicare Services (CMS) ahead of a final decision on coverage of its controversial Alzheimer's disease drug in April.

The comments follow a draft decision on Tuesday by CMS, which runs the government's Medicare health plan for people age 65 and over, saying it would cover Aduhelm and similar treatments for the mind-wasting condition only for patients enrolled in approved clinical trials - a decision that would likely severely limit use of a drug struggling to gain sales traction.

So far, there have been no top-level discussions between the company and CMS over changing the coverage decision before it becomes final on April 12, Biogen CEO Michel Vounatsos said during a conference call with analysts.

Should the CMS' final decision resemble the draft, the company will be flexible with cost-cutting measures and other strategic options, Vounatsos said.

But he added, "I do not believe that this would be the case in terms of similar outcome than this dramatic draft."

The CMS's draft decision is followed by a 30-day open comment period during which the company, physicians and patients can express their view about the policy.

Vounatsos called for patients to "make their voice heard" during the period to allow for a "broader and more equitable access" to the therapy.

The agency's final coverage terms are expected to apply to all drugs in the class, including medications being developed by Eli Lilly and Co, Roche Holding AG and Eisai Co Ltd, which some patient advocacy groups and drugmakers have criticized.

Biogen and Japanese partner Eisai strongly opposed the draft decision, saying the proposal would severely restrict Medicare beneficiary access for the foreseeable future to all drugs in this class. Aduhelm, given as a monthly infusion, is a monoclonal antibody designed to remove a type of brain plaque associated with Alzheimer's Disease.

Aduhelm's sales so far have been weak and the company in December said it expected roughly 50,000 patients may begin treatment with Aduhelm in 2022 - a target now at risk.

Biogen had been banking on the government's coverage decision to help drive sales of Aduhelm, which was approved by the U.S. Food and Drug Administration in June, despite a vote by the agency's outside advisers that the treatment's clinical benefits had not been proven.

The therapy's high price has raised concerns over the toll it might take on the Medicare program since Alzheimer's is an age-related disease and around 85% of the people who might use the drug are in the government plan. The company last month cut Aduhelm's list price by about half to $28,200 per year.

The U.S. government said earlier this week it was looking into lowering premiums due to the price cut.

processing....