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Medicare’s ‘Aduhelm’ Policy A Precedent For Accelerated Approvals But Not Cancer Drugs – Gottlieb

 
• By Cathy Kelly

CMS has long been interested in applying Medicare coverage with evidence development requirements to drugs, the former US FDA commissioner and CMS senior advisor suggests.

precedent
Confirming Fears About A Troublesome Precedent For Accelerated Approvals • Source: Shutterstock

The Centers for Medicare and Medicaid Services has established a precedent regarding Medicare Part B coverage for accelerated approvals with its decision triggered by Biogen, Inc.’s Aduhelm to only cover that class of Alzheimer’s treatments when patients are enrolled in a clinical trial, according to former US Food and Drug Administration Commissioner Scott Gottlieb.

Key Takeaways

  • Medicare coverage with evidence development is now ‘established’ policy for Part B drugs with accelerated approvals and will likely be used by CMS going forward, Gottlieb predicted.

  • Oncology drugs are likely to be excluded because CMS already relies on medical compendia for coverage of indications that are not traditionally approved by FDA

But the agency is likely to steer clear of applying the policy in the future to oncology drugs because that would upend Medicare’s current reliance on medical compendia to determine its coverage of uses that are not traditionally approved, he

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