NICE are currently consulting on a number of proposals for changes to topic selection, the first of three planned consultations on health technology evaluation methods and processes.
Topic selection is the process for deciding which new products (such as medicines and medical technologies) NICE will produce guidance on, including the decision whether a medicine will be considered through the technology appraisal (TA) or highly specialised technology (HST) pathway.
The purpose of the proposals is to amalgamate and align the criteria, process and terminology used for topic selection for the various guidance development programmes, replacing the current confusing array of slightly different approaches.
The proposed changes include:
- consolidated criteria for whether a topic is suitable for NICE guidance, reflecting the new responsibilities for NICE that emerged out of the 2019 Voluntary Scheme for Branded Medicines Pricing;
- shifting the development of a scope for non-cancer medicines to after the product has been referred and selected for either the TA or HST pathways, to align the process for routing non-cancer medicines with that of cancer medicines and other types of NICE guidance;
- consolidating the existing three topic selection panels into a single panel, called the Topic Selection Oversight Panel, and extending its membership to include two lay members; and
- the introduction of a formal process for stakeholders to challenge topic selection decisions.
However, the consultation does not address the unclear and overly restrictive criteria for entry to the Highly Specialised Technologies evaluation programme, the aspect of topic selection of primary relevance to patients with rare conditions. We have been told that these are still under review and will be consulted on in due course.
The consultation is open until 19 November 2020 11:59pm and can be found here.
Genetic Alliance UK will be submitting a response. If you would like to share your views on this, or you have any questions, please contact Louise at [email protected].