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Value-Based Contracting: CMS Final Rule Leaves ‘Multiple Best Price’ Questions Unresolved

 
• By Cathy Kelly

Implementation of ‘multiple best price’ reporting approach to facilitate value-based payment arrangements postponed until 2022 to allow time for further guidance to be developed, but new definition of VBP arrangements is effective in March.

CMS To Address 'Multiple Best Price' Questions With Operational Guidance In 2021

The Centers for Medicare and Medicaid Services final rule addressing Medicaid value-based purchasing arrangements for drugs won’t move the needle much in the near term on advancing innovative purchasing arrangements for cell and gene therapy, an issue of increasing concern to Medicaid programs and other payers.

Published in the 31 December Federal Register, the final rule’s provisions aimed at supporting value-based payment arrangements are very...

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US FDA ANDA Priority Pilot ‘Practically Unusable’ Without Tweaks, AAM CEO Says

 
• By Sarah Karlin-Smith

Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.

NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

Novo, Lilly Lower GLP-1 Prices, ‘Enabling’ Medicare, Medicaid Coverage In Obesity

 
• By Cathy Kelly

The $245 price agreed to by both firms may be in line with the maximum fair price that Medicare negotiated for Novo Nordisk’s semaglutide products.

More from Pink Sheet

NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job

 
• By Sue Sutter

The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.