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NICE Braces For HTA-Related Challenges Posed By UK’s International Recognition Procedure

 
• By Vibha Sharma

The health technology assessment body for England and Wales will need more resources to deal with the ‘surge’ in UK licenses in the early days of the new IRP. While measures are being put in place to mitigate challenges posed by the procedure, there could be long delays in HTA appraisals, more negative NICE decisions and more managed access agreements.

A calendar with an attached red thumbtack with a tape tag and the words save the date written in black marker
NICE process requires early notification of expected regulatory timings to support its technology appraisals program • Source: Shutterstock

The UK’s new International Recognition Procedure (IRP) presents exciting opportunities in terms of earlier licensing of medicines, but also poses big challenges from a health technology assessment perspective that may test the agility of the current system run by the HTA institute, NICE.

The IRP could result in NICE not having clarity on companies’ pipelines, which can make it difficult for the institute...

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