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Last Chance To Influence Changes To NICE Methods & Processes In England

 
• By Francesca Bruce

Companies selling gene therapies and other high-cost, long-term treatments may be disappointed but unsurprised to learn that NICE will not immediately introduce any change to discount rates, which are used in health technology appraisals to better understand the long-term costs and benefits.

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NICE sets out the case for change

NICE, the health technology appraisal (HTA) institute for England and Wales, has today published its final consultation on changes to its health technology assessment methods and processes. The document gives more clarity on modifiers used to increase cost-effectiveness thresholds for severe diseases and provides more detail on how to handle uncertainty in specific situations.

“The consultation is the culmination of the most wide-ranging and comprehensive review NICE has ever carried out, which has involved...

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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.”

Denmark: QALY Brings HTA Transparency But Industry Wants More Willingness To Value Innovation

 
• By Francesca Bruce

Rare disease drugs with limited evidence are most likely to be awarded a negative reimbursement recommendation in Denmark following a QALY-based health technology assessment, finds an analysis from industry group LIF.

AI’s Attempt To Decode EU Pharma Reform Called A ‘Car Crash’

 
• By Eliza Slawther

Sanofi’s EU regulatory science and policy head draws on a “nightmare” experience with using a generative AI tool to compare versions of the draft EU pharma reform text to explain the benefits and limitations of artificial intelligence tools in regulatory affairs.

More from Geography

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.