Medical Technology

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

(Reuters) – Biogen Inc.’s chief executive officer stated on Thursday that Biogen would like to have an open dialogue with the U.S. Centers for Medicaid (CMS) before making a final decision on the coverage of its controversial Alzheimer’s drug in April.

The comments come after an unofficial decision made on Tuesday by CMS which manages the government’s Medicare health insurance plan for those who are 65 or older, saying it would include Aduhelm and similar treatments for the mind-wasting condition only for patients who are enrolled in approved clinical trials and would likely severely limit usage of a drug that is struggling to get sales.

So far, there are no high-level discussions between Biogen and CMS over changing the coverage decision prior to when it becomes final on April 12. Biogen CEO Michel Vounatsos said during a conference call with analysts.

If the CMS final decision mirror the draft, the company will be flexible in cutting costs and other options for strategic planning Vounatsos stated.

But he added, “I do not believe that this is the case with respect to the same outcome as this dramatic draft.”

The CMS’s draft decision will be followed by a thirty-day period of open comments where patients, doctors and the company are able to comment on the policy.

Vounatsos advised patients to “make it heard” during the time to ensure “broader and more equitable access” for the therapy.

The final terms of coverage for the agency are expected to be applicable to all drugs within the class, including those 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 its Japanese partner Eisai strongly opposed the draft decision. They argued that the proposal could severely restrict Medicare beneficiaries access to all drugs in this class for the near future. Aduhelm is a monoclonal antigen that is administered as a monthly injection to treat a type of brain plaque closely linked to Alzheimer’s Disease.

Aduhelm’s sales to date have been sluggish and the company said in December it was expecting that 50,000 patients may begin treatment with Aduhelm in 2022, a target now at risk.

Biogen was betting on the government’s coverage decision to boost sales of Aduhelm. The U.S. Food and Drug Administration approved the treatment in June despite an opinion by external experts that the treatment’s clinical benefit was not proven.

The therapy’s high price has raised questions about the impact it will have on the Medicare program, as Alzheimer’s is a disease that affects the elderly and around 85 percent of those who may benefit from the treatment are in the government plan. Last month, Aduhelm’s price was cut in half to $28,200 an annum by the company.

The U.S. government stated earlier this week that it was considering the possibility of lowering premiums to reflect the price decrease.

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