The FDA recently granted accelerated approval for Biogen’s Aduhelm—the first Alzheimer’s treatment in 20 years. But the Centers for Medicare and Medicaid Services (CMS) proposed to restrict coverage to patients participating in clinical trials, setting a dangerous precedent for Alzheimer’s and other hard-to-treat diseases.
The news: CMS released a National Coverage Determination (NCD) for Biogen’s Aduhelm, proposing to restrict coverage to patients participating in clinical trials. As we previously reported, it’s the first treatment to address a likely cause of Alzheimer’s.
This was “crushing news” for Alzheimer’s patients,reports Bloomberg. Around 6 million Americans (including 200,000 under 65) have Alzheimer’s, half of whom “may have mild symptoms, the target group for Aduhelm.”
Most Medicare beneficiaries “would not be able to access the drug under this proposal,”said BIO President and CEO Dr. Michelle McMurry-Heath. “Limiting coverage only to patients enrolled in government-mandated randomized clinical trials means that most of those suffering from Alzheimer’s would be denied access to an approved medicine simply because of where they live or where they go for care.”
“But the biggest losers may actually be other drug makers readying treatments for the debilitating disease,”reports STAT News. The proposal “would require post-approval randomized controlled trials for all future drugs in this class, regardless of the type and volume of evidence demonstrated during FDA-required trials and regardless of whether future drugs are approved during an accelerated pathway or through traditional channels,” Dr. Michelle explained.
The next steps: Biogen said they believe the decision “denies nearly all Medicare beneficiaries from accessing” the drug and they plan to make a formal response to CMS.
The context: Aduhelm was approved under the Accelerated Approval Pathway, often one of the only regulatory pathways to address critical unmet need. However, as Dr. Michelle noted, “through this coverage announcement, CMS is pronouncing its disagreement with FDA’s gold-standard, science-based, safety and efficacy standards.”
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