Between July 2019 and January 2022 the National Institute for Health and Care Excellence (NICE) held a review of the methods and processes they use to carry out health technology evaluations. During the review, BIA was represented by members on several Task and Finish Groups which looked in detail at the key areas for review. See the reports from all the groups.

In addition to the Task and Finish Groups, we also secured representation on the Methods Review Working Group which coordinated the development of NICE’s proposals. This work resulted in effective engagement between NICE, industry, and patient groups.

As part of the review, NICE also undertook a three-stage consultation process that was open to all stakeholders. By drawing on the expertise of our Rare Disease Industry Group (RDIG) and that of patient groups, the BIA has engaged with NICE throughout this process.   

Building on our position (see A rare chance for reform), we were able to provide robust and comprehensive feedback throughout the consultation process.   

Consultation timeline

1. 'Case for change'

During the first stage, NICE published the ‘case for change’, and sought stakeholder feedback on the proposals for changes to the HTA process.

2. Process guide and manual

During the second stage of the consultation, NICE sought stakeholder feedback on NICE’s proposed changes to its processes for health technology evaluations. The consultation explored four themes:

  • Alignment of the current processes
  • Opportunities for new process improvements and ways of working
  • Commercial and Managed Access processes
  • Objectives and visions of the Highly Specialised Technology programme
3. Proposals for change

During the final phase of the consultation process, NICE put forward their proposals for implementing changes to their methods, processes and topic selection used for health technology evaluations. At this stage NICE also published a draft programme manual for health technology evaluations to allow stakeholders to see how the changes to NICE’s methods, processes and topic selection would fit together in a new unified manual.

The BIA’s response to this consultation welcomed some of the positive proposals but emphasised that the proposals do not go far enough to meet the level ambition set out at the start of the Review, nor that promised in the Life Sciences Vision. In particular, the response focused on the limited effect that the current proposals will have in addressing the challenges faced by treatments for rare and ultra-rare disease treatments in the evaluation process.

After considering the consultation responses on the draft manual and proposals for change, NICE concluded the methods and process review in January 2022. The changes to health technology evaluations are expected to be implemented from February and the new programme manual published in full. See the BIA's response to the conclusion of the review.

What next?

Going forward, the BIA will continue to work with NICE as it implements changes included in the new manual. In the longer term, we look forward to engaging with NICE through its new "modular updates" approach.