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BIO Worried CMS’ Alzheimer’s Coverage Is ‘Trial Balloon’ For Lower Accelerated Approval Reimbursement

 
• By Sarah Karlin-Smith

In a Pink Sheet interview, BIO Chief Advocacy Officer Nick Shipley raised concerns that Medicare’s Alzheimer’s coverage decision is indicative of a broader agency view on accelerated approval that could limit drug reimbursement in both the public and private sector. 

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BIO is concerned about future drug reimbursement challenges due to CMS’ view of accelerated approval. • Source: Shutterstock

The Biotechnology Innovation Organization is concerned that Medicare’s restrictive coverage decision for new anti-amyloid Alzheimer’s drugs is indicative of a broader Centers for Medicare and Medicaid Services’ mindset that accelerated approvals are “lesser” and that such a belief may “bleed over” to the private sector or other CMS payment strategies.

In an interview with Pink Sheet at BIO’s annual convention in Boston, Chief Advocacy Officer Nick Shipley made clear the industry lobby is not operating under the assumption that CMS’ national coverage determination for Alzheimer’s drugs is a one-off problem for drug manufacturers

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