Biogen’s Alzheimer’s drug to be covered under Medicare if approved next month
New England Council member, Biogen, has announced that if its new Alzheimer’s drug is granted full FDA approval next month, the drug will be covered under Medicare.
Currently, both drugs produced by Biogen, Leqembi and Aduhelm, are currently available through the FDA’s accelerated approval pathway. This is a conditional form of approval that uses a surrogate endpoint as a predictor of clinical benefit, requiring a drug’s sponsor to run a confirmatory trial. After this testing, Leqembi will be considered for full approval, based on the result that suggests the drug slows cognitive decline by 27% over an 18-month period. With this, the U.S. Center for Medicare and Medicaid Services stated Thursday that Medicare coverage “would begin on the same day the FDA grants traditional approval” for this specific drug.
“Alzheimer’s disease takes a toll on not just the people suffering from the disease but also on their loved ones and caregivers in a way that almost no other illness does. CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease,” said CMS Administrator Chiquita Brooks-LaSure. “If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered,” she said.
The New England Council commends Biogen for its commitment to the fight against Alzheimer’s.
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