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

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. 

colorful balloons
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.

More from Pricing Debate

Think Tank Suggests CMS, USTR Could Enforce Most Favored Nation, Other Drug Pricing Policies

 
• By 

A Republican think tank suggested variations of the Most Favored Nation and international reference policies in Medicare and Medicaid, as well as tariffs and other trade levers to rebalance drug pricing disparities between US countries and abroad.

CMS Nominee Oz Nears Confirmation Despite Concerns About Medicaid Cuts

 
• By 

Democrats opposed the nomination because they believe Mehmet Oz will not defend Medicaid from spending cuts. His pledge to continue lowering drug costs in Medicare and Medicaid did not offset the concerns.

Branded Pharma And Generics Industries At Odds Over UK VPAG Framework

 

The UK branded drug industry is calling for adjustments to be made to the UK voluntary scheme framework for branded medicines, after the payment rate increased to 22.9% for 2025. Meanwhile, the generics industry says the scheme is functioning “as intended” and opposes any changes.

‘Hope And Scientific Spillover’ – Cross-Atlantic HTA Alliance To Focus On Novel Benefits

 

An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.

More from Conferences

DTC Advertising: Industry Learning To Live With US FDA’s Clear, Conspicuous And Neutral Rule

 
• By 

Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.

Could PDUFA VIII Align With Trump’s Efficiency Emphasis?

 
• By 

Given the Trump Administration’s intense focus on cutting costs and increasing efficiency, industry and the FDA should focus on what is and is not working in PDUFA VII when negotiating the next agreement, lobbyists said at the BIO CEO and Investor Conference.

‘A Lot Of That, It’s Meant To Start A Conversation’: How To Work With Trump

 

Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.