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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.

But the agency is likely to steer clear of applying the policy in the future to oncology drugs because that...

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Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

 
• By Derrick Gingery, Francesca Bruce, Cathy Kelly, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.

Medicare Part D LIS Access Threatened By House Budget Bill’s Medicaid Obstacles

 
• By Cathy Kelly

An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.