(Bloomberg) — The U.S. government limited coverage of Biogen Inc.’s Alzheimer’s disease treatment and similar drugs through Medicare to patients who are enrolled in clinical trials, a move that will curb access to a controversial treatment that regulators approved last year.
Coverage of Biogen’s therapy, sold under the brand name Aduhelm, and other amyloid-targeted Alzheimer’s therapies, will be limited to people participating in qualifying clinical trials, the Centers for Medicare & Medicaid Services said in a statement on Tuesday.
Biogen shares were down 6.4% to $225.55 in late trading in New York. The company didn’t immediately comment on the decision.
The decision was the result of a thorough analysis that found that while Aduhelm could help patients with the memory-destroying disease, there is also the potential for harm, officials said in the statement.
“This harm may range from headaches, dizziness, and falls, to other potentially serious complications such as brain bleeds,” said Dr. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality.
The U.S. Food and Drug Administration 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.
Premium Increase
In November, ahead of the national coverage decision, Medicare increased premiums to cover the potential cost of Aduhelm and drugs like it, asking beneficiaries to pay about $11 a month more this year.
Biogen then cut Aduhelm’s $56,000-a-year list price in half in December to address the potential financial strain on the health system. Health and Human Services Secretary Xavier Becerra on Monday directed CMS to review its premium increase in light of the price cut.
Biogen has said it expects 50,000 people to start getting monthly infusions of the medication in 2022. Early sales have been negligible — about $300,000 in the third quarter — and Biogen shares have given up the gains they recorded when the drug was approved. The company had estimated as many as 2 million Americans would be candidates for the drug.
The draft Medicare policy will set national rules for how the program treats Aduhelm and similar drugs that may follow. After a public comment period, the Centers for Medicare and Medicaid Services is expected to publish final coverage rules in April.
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