LEARNING WHILE USING: EVIDENCE EXPECTATIONS UNDER NICE'S REFORMED HEALTHTECH PROGRAM
Author(s)
Ting Yi Wong, LLM, Abi McArthur, PhD.
OPEN Health HEOR & Market Access, London, United Kingdom.
OPEN Health HEOR & Market Access, London, United Kingdom.
OBJECTIVES: NICE Early Value Assessment (EVA) programme has recently been reframed as early-use HealthTech guidance and moved into implementation following the 2025 programme launch. This study updates a 2025 review of NICE EVAs, examining changes in recommendations, evidence requirements and the implications for developers seeking NHS access.
METHODS: EVAs and early-use HealthTech assessments published between 1 June 2025 and 1 June 2026, including updates, were identified from the NICE website. Guidance and evidence generation plans were reviewed by a single reviewer, with data extracted on technologies, evidence, evidence gaps and benefits. Findings were analysed descriptively and thematically, and compared with the 2025 review.
RESULTS: Twelve EVAs and early-use assessments (89 technologies) were identified, including seven digital self-management/rehabilitation interventions, four diagnostic/triage or reporting technologies (AI or algorithm-based), and one digital front-door assessment technology. Eleven assessments recommended at least one technology for NHS use with evidence generation (41 technologies); only one AI-assisted echocardiography EVA for heart failure received no positive recommendation. Indications spanned respiratory, musculoskeletal, cardiovascular, mental health, oncology and fracture detection pathways. Assessments suggest continuity in NICE’s core evidence concerns, including limited comparative evidence, uncertainty around NHS generalisability, and unclear cost/resource impact. However, following the launch of the HealthTech programme, these uncertainties appear to be framed more explicitly around whether technologies can be safely used in NHS pathways while evidence is generated. Evidence generation plans were specified in 11 assessments and also emphasised adoption issues, including implementation, uptake, engagement, resource use, safety monitoring and real-world evidence generation.
CONCLUSIONS: NICE’s early-use approach reframes value as managed adoption: not simply whether a technology is promising, but whether residual uncertainty can be safely contained within NHS pathways. To gain conditional approval, developers must pair resolution of clinical or economic uncertainty with evidence of pathway fit, implementation feasibility, relevant outcomes, and credible real-world evidence generation.
METHODS: EVAs and early-use HealthTech assessments published between 1 June 2025 and 1 June 2026, including updates, were identified from the NICE website. Guidance and evidence generation plans were reviewed by a single reviewer, with data extracted on technologies, evidence, evidence gaps and benefits. Findings were analysed descriptively and thematically, and compared with the 2025 review.
RESULTS: Twelve EVAs and early-use assessments (89 technologies) were identified, including seven digital self-management/rehabilitation interventions, four diagnostic/triage or reporting technologies (AI or algorithm-based), and one digital front-door assessment technology. Eleven assessments recommended at least one technology for NHS use with evidence generation (41 technologies); only one AI-assisted echocardiography EVA for heart failure received no positive recommendation. Indications spanned respiratory, musculoskeletal, cardiovascular, mental health, oncology and fracture detection pathways. Assessments suggest continuity in NICE’s core evidence concerns, including limited comparative evidence, uncertainty around NHS generalisability, and unclear cost/resource impact. However, following the launch of the HealthTech programme, these uncertainties appear to be framed more explicitly around whether technologies can be safely used in NHS pathways while evidence is generated. Evidence generation plans were specified in 11 assessments and also emphasised adoption issues, including implementation, uptake, engagement, resource use, safety monitoring and real-world evidence generation.
CONCLUSIONS: NICE’s early-use approach reframes value as managed adoption: not simply whether a technology is promising, but whether residual uncertainty can be safely contained within NHS pathways. To gain conditional approval, developers must pair resolution of clinical or economic uncertainty with evidence of pathway fit, implementation feasibility, relevant outcomes, and credible real-world evidence generation.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR272
Topic
Health Policy & Regulatory, Health Technology Assessment, Medical Technologies
Topic Subcategory
Coverage with Evidence Development & Adaptive Pathways, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas