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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.

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