Medicare's limits on Aduhelm coverage sparks questions about future drugs – Axios

The Biden administration's decision Thursday to offer limited Medicare coverage for Biogen's controversial Alzheimer's drug Aduhelm raises questions about what's ahead for other new and costly drugs.
Driving the news: The Biden administration announced Medicare will cover Aduhelm, but will limit the coverage to patients enrolled in a clinical trial in order to access the drug.
"There is potential for promise with this treatment. However, there's not yet enough evidence of clinical benefit to say it is reasonable and necessary for people with Medicare," said CMS chief medical officer Lee Fleisher in a call with reporters.
Catch up quick: Aduhelm received "conditional" approval from the FDA in June with the requirement that further trials show the drug slows cognitive decline and is safe.
What they're saying: "The big question will be 'Is this really just CMS talking about one class or is CMS going to expand this out and consider this for accelerated approval for other drugs?" Chris Meekins, a former HHS official who is now an analyst at Raymond James, told Axios.
Yes, but: Others say there are more far-reaching precedents.
The other side: "This unprecedented CMS decision effectively denies all Medicare beneficiaries access to Aduhelm," Biogen said in a statement. "These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas."
What to watch: This decision will limit the overall number of patients who will likely access the drug.


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