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Biogen stung as US limits coverage of Alzheimer's therapy

John Tozzi, Angelica Peebles and Robert Langreth, Bloomberg News on

Published in Health & Fitness

Biogen said the trial requirements would cut off access for people who could benefit from the drug.

“This draft coverage determination denies the daily burden of people living with Alzheimer’s disease,” the company said in an emailed statement. “This will significantly limit patient access to an FDA-approved treatment, especially for underserved patients.”

Reluctant Insurers

The FDA granted Aduhelm accelerated approval in June despite objections from its scientific advisers, who said the evidence didn’t warrant it. Since then, Medicare has been paying for Aduhelm on a case-by-case basis, with local contractors and private health plans that administer the program deciding whether to approve claims.

“This is a welcome development,” said Aaron Kesselheim, a top Harvard Medical School expert who quit the panel of FDA advisers in protest of the approval. “The only reasonable circumstance currently in which to offer aducanumab is in the context of a prospective, placebo-controlled trial, given that there’s no clear evidence that the drug works.”

Biogen’s drug is part of a new class that removes a protein called amyloid that accumulates in the brain of Alzheimer’s disease patients. Despite decades of research, there is no proof that amyloid is a major cause of cognitive decline or just a minor contributor. Two big trials of Aduhelm sponsored by Biogen produced contradictory results as to whether the drug can slow cognitive decline.

 

Private insurers in the U.S. have mostly declined to cover Aduhelm, saying they need more proof of its efficacy and that benefits outweigh risks like brain swelling. Regulators in the European Union and Japan have so far declined to approve the drug, which Biogen developed in partnership Eisai Co. Ltd.

Biogen had advocated for CMS to cover Aduhelm in patients similar to those studied in clinical trials and among people who are screened appropriately, Chris Leibman, Biogen’s senior vice president of value and access, said in an interview ahead of the draft policy’s publication.

Leibman said Biogen had told CMS it was opposed to requiring more evidence, such as additional studies, in exchange for coverage. He said that the company is already conducting another clinical trial of Aduhelm, required by the FDA as a conditional of the drug’s approval.

Patient groups said CMS’s action would limit access to treatment to those who can afford to pay out of pocket, cutting off many patient groups.

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