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The National Institute for Health and Care Excellence (NICE) has published a significant revision to its primary methods document, the NICE health technology evaluation: the manual (PMG36). This updated guidance, released on 17 December 2025, represents a fundamental shift in how health technologies are appraised in the United Kingdom. Professor Jonathan Benger, the Chief Medical Officer at NICE, issued the update to ensure that the institute’s methods keep pace with rapid developments in digital medicine and to resolve historical delays in patient access.
This latest version of the manual integrates several modular updates that have been under development throughout 2025. It specifically expands the framework to provide much-needed detail for the evaluation of ‘HealthTech’, which includes medical devices, diagnostics, and digital technologies such as AI-driven software. Previously, these products often lacked a clear, dedicated pathway that matched the rigour of pharmaceutical appraisals. The manual now aligns with the newer NICE HealthTech programme manual, creating a unified standard for all technologies seeking entry to the health system.
A central pillar of the announcement is the formalisation of measures designed to speed up the assessment process. A core ambition of the update is to facilitate ‘aligned decisions’ between NICE and the Medicines and Healthcare products Regulatory Agency (MHRA). Under the previous sequential system, a medicine would often wait months for a value assessment after receiving its safety license. The new framework supports an aligned pathway where regulatory and health technology assessments occur in parallel. Data are shared between the two bodies throughout the review, with the goal of achieving same-time publication of the marketing authorisation and the final NICE guidance.
This acceleration is further supported by the introduction of integrated scientific advice. Developers can now engage both the MHRA and NICE simultaneously during the early stages of product development. This ensures that clinical trial data are robust enough to satisfy both safety regulators and those determining cost-effectiveness, reducing the risk of a ‘no’ decision later in the cycle. The manual also formalises the ‘proportionate approach’ for technologies with lower complexity or a wealth of existing evidence. This streamlined route allows for faster committee decisions, potentially cutting the wait for innovative products by three to six months.
Furthermore, the manual now includes the final ‘Health inequalities’ modular update, following a consultation window that concluded in early 2025. This requires appraisal committees to consider how a new technology might affect underserved populations, ensuring that access is not just faster, but also fairer. These changes took immediate effect for all new submissions in late 2025, with a broader transition for ongoing evaluations scheduled for completion by April 2026.
The impact of these measures is a significantly more predictable and rapid transition from clinical success to front-line availability. By reducing the gap between licensing and reimbursement, the new manual provides developers with a clearer commercial timeline and reduces the administrative burden of duplicate data submissions. The move to a parallel, aligned assessment model creates a more attractive environment for global launches, ensuring that the health system can adopt high-value innovations without the lengthy delays that characterised the previous decade.
Source: National Institute for health and Care Excellence
Link: NICE health technology evaluation: the manual (PMG36)
Date: 17 December 2025
