Presentation (CTI)

OBJECTIVES: The National Institute for Health and Care Excellence (NICE) has introduced a unified HealthTech programme, changing how medical devices, diagnostics, digital health technologies, and interventional procedures are evaluated in the UK. This study aims to outline key changes, clarify evidence and process expectations, and provide practical guidance to help manufacturers navigate the pathway.
METHODS: A targeted review of NICE’s HealthTech programme manual (PMG48) and supporting guidance was conducted. Key features were synthesised and compared to legacy programmes. Insights were translated into a practical framework covering lifecycle positioning, evidence planning, and engagement strategy, with a focus on implications for manufacturers.
RESULTS: The HealthTech programme introduces five critical shifts: 1) Unified framework replaces three legacy pathways, 2) Lifecycle-based assessment (early, routine, existing-use) aligns evidence expectations to maturity, 3) Increased emphasis on cost-effectiveness and system impact, 4) Multi-technology assessments as standard practice, 5) NICE-driven evaluation process: Topic selection is nationally prioritised, with greater use of External Assessment Groups conducting independent evidence reviews and less reliance on purely manufacturer-led submissions. Evidence requirements vary by lifecycle stage, but all routes demand a clear value proposition supported by clinical effectiveness, economic modelling, and increasing use of real-world evidence. Early-use pathways allow greater uncertainty but require structured plans for evidence generation within defined timeframes. Existing-use assessments incorporate additional elements such as user preference data and optimisation within current practice. Recommendations range from routine adoption to use with evidence generation, research-only use, or non-adoption, creating both opportunities for accelerated access and risks of delayed uptake, depending on evidence readiness.
CONCLUSIONS: The new NICE HealthTech programme creates earlier access opportunities but requires earlier, more strategic preparation. Manufacturers should prioritise proactive evidence planning, lifecycle alignment, and readiness for multi-technology comparisons. Expert support can play a key role in shaping value strategy, building economic evidence, and navigating NICE processes.