by ZACHARY BRENNAN
CMS on Tuesday said it will only pay for Biogen’s Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies for Alzheimer’s disease under CMS-approved randomized controlled trials.
In a draft national coverage decision, which insurers nationwide are likely to follow, CMS said it’ll be looking for randomized controlled trials that “demonstrate a clinically meaningful benefit in cognition and function.”
Similar to trials previously run by Biogen that offered mixed efficacy results, CMS said the companies must enroll patients who have a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia; and evidence of amyloid pathology consistent with AD.
Holly Fernandez Lynch, a bioethics professor at the University of Pennsylvania, told Endpoints News that she thinks CMS made the right decision in going for coverage with evidence development (CED) and requiring the trial.
“I didn’t think outright refusal of any coverage was genuinely on the table. This is a pretty strong rebuke of FDA as it is,” she said.
The announcement is a blow for Biogen, which will likely have to design and run another clinical trial in addition to its confirmatory trial to satisfy the FDA’s accelerated approval requirements. Biogen’s stock dropped about 8% Tuesday afternoon.
“This draft coverage determination denies the daily burden of people living with Alzheimer’s disease,” Biogen said in a statement emailed to Endpoints, adding:
Coverage with evidence development (CED) under a randomized clinical trial will exclude almost all patients who may benefit. This will significantly limit patient access to an FDA-approved treatment, especially for underserved patients as evidenced in other CED determinations. CEDs can take months to years to initiate, and hundreds of Alzheimer’s patients – the majority of whom are Medicare beneficiaries – are progressing each day from mild to moderate disease stages, where treatment may no longer be an option.
CMS also lays out very specific trial requirements that Biogen, Roche, Eli Lilly and any other amyloid contenders will have to meet, noting that it’s aware of at least three other anti-amyloid mAbs currently approaching Phase 3 trials.
“The diversity of patients included in each trial must be representative of the national population diagnosed with AD,” CMS says.
The news comes as Biogen recently cut Aduhelm’s price in half, after selling just $300,000 of Aduhelm in the early months, and coming under heavy criticism for the $56,000 price tag that forced CMS to prep for record-high premium increases for seniors.
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