NICEs new methods and processes manual
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UK: ABPI responds to publication of NICE’s new methods and processes manual


The National Institute for Health and Care Excellence (NICE) on 31st January 2022 published its new combined methods and processes manual and topic selection manual. The manuals incorporate changes to the way medicines and other health technologies are evaluated which were approved by NICE’s Board on 19th January 2022. The changes came into effect on 1st February 2022 for new evaluations and “will give patients earlier access to innovative new treatments by allowing greater flexibility over decisions about value for money and consideration of a broader evidence base”, according to NICE.

ABPI Response

Reacting to the changes, the Association of the British Pharmaceutical Industry (ABPI) comments, “There are a number of areas where the new Manual should, if implemented by NICE and its Appraisal Committees with the right intent, provide much needed flexibility and pragmatism. However, there are significant missed opportunities and changes that have been made which do not reflect feedback from industry and other stakeholders made to the consultation”.

The ABPI identifies a number of areas for concern “which require ongoing focus as a priority”, namely:

  • NICE’s decision not to change the discount rate is “hugely disappointing” and a missed opportunity to value the longer-term benefits medicines provide. According to the ABPI, it “risks the UK not being seen as a priority market to launch new medicines”.
  • The implementation of the severity modifier in an “opportunity cost neutral” way means some end-stage cancer patients may miss out on last resort treatments. “Monitoring the application of the modifier in practice and progressing the additional work NICE has identified as necessary to inform further broader evolution of the modified needs to be a high priority”.
  • Further work on a health inequalities modifier is needed.
  • The revision to the HST selection criteria risks preventing some medicines treating very rare diseases from entering the programme.
  • Some rare disease medicines will not meet the HST entry criteria or benefit from the new severity modifier.

The ABPI goes on to call for swift implementation of the new Manual “with a fair approach to managing the transition from previous to new methods”.

Full article: UK: NICE Board approves changes to its methods and processes as of 1st February 2022 


  1., “ABPI analysis on NICE’s changes for evaluating new medicines: Next steps”, 31st January 2022
  2., “NICE publishes new combined methods and processes manual and topic selection manual for its health technology evaluation programmes”, 31st January 2022

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