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Aduhelm Overkill: Broad Medicare Policy Is Unreasonable – And Unnecessary

 
• By Michael McCaughan

Medicare has clearly won the battle when it comes to prevent the Alzheimer’s therapy Aduhelm from consuming billions in taxpayer spending based on data that the payor agency finds unconvincing. But in finalizing a policy that has broad implications for all FDA approved therapies, it may be starting a war that it cannot win.

CMS chess brain
Did CMS overthink its Alzheimer's NCD? • Source: Nielsen Hobbs; the Pink Sheet | Alamy images

The US Centers for Medicare & Medicaid Services is taking a remarkable stance in its final coverage policy on beta amyloid targeted Alzheimer’s therapy.

The agency is asserting that its coverage standard – whether a drug is “reasonable and necessary” for the Medicare population – would not be met by a product that received...

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More from Review Pathways

User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget

 
• By Derrick Gingery

The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
• By Sue Sutter

The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.

More from Pathways & Standards

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
• By Sue Sutter

The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.