Adoption and Evidence Generation in NICE Early Value Assessments (EVA) for Medtech: Trends Across 2023-2025
Author(s)
Amy Heptinstall, PhD, Precious Sitawa Wakhungu, BSc, Elizabeth Adkins, PhD.
Maverex Limited, Newcastle upon Tyne, United Kingdom.
Maverex Limited, Newcastle upon Tyne, United Kingdom.
OBJECTIVES: Early Value Assessment (EVA) by England’s National Institute for Health and Care Excellence (NICE) enables managed access to promising digital products, devices and diagnostics while real-world evidence is generated, so the NHS and patients can benefit sooner. This study examined trends across NICE EVA health technology evaluations (HTE) from 2023-2025 to identify patterns in adoption, evidence requirements, and post-assessment changes.
METHODS: All 23 NICE HTEs published between 01.02.2023-31.05.2025 were reviewed. Data were extracted on technology type, disease area, initial recommendation, evidence generation plans, and post-assessment recommendation changes. Thematic analysis identified trends in decision-making, evidence gaps, and barriers to National Health Service (NHS) adoption.
RESULTS: 86% (19/22) of technologies were conditionally approved for NHS use while further evidence was generated, with the remaining two restricted to research-only access. Digital therapies (36%), artificial intelligence (AI) and diagnostic tools (23%), and remote care technologies (14%) dominated HTE topics. Evidence gaps most cited included real-world comparative effectiveness (86%), implementation cost (64%), digital health equity (64%), and usability (50%). Three-year evidence cycles were required for conditional adoption under the EVA framework, and before-after or parallel cohort study designs were commonly recommended, with emphasis on diverse population representation and standardised outcome tracking. Additionally, Digital Technology Assessment Criteria (DTAC) and regulatory approvals were required before NHS deployment. Most recommendations emphasised diverse population representation and standardised outcome tracking. Nearly 40% of technologies experienced post-assessment changes, including withdrawal in 18% of cases.
CONCLUSIONS: High conditional approval rates in HTEs indicate the NICE EVA framework is facilitating patient access to innovative technologies. However, post-HTE withdrawals highlight risks to sustainability, and additional analysis once technologies have been reviewed by NICE in full guidance is required. Enhanced support for evidence generation challenges, clearer cost criteria, and earlier integration of health equity considerations are needed to ensure long-term success of EVA.
METHODS: All 23 NICE HTEs published between 01.02.2023-31.05.2025 were reviewed. Data were extracted on technology type, disease area, initial recommendation, evidence generation plans, and post-assessment recommendation changes. Thematic analysis identified trends in decision-making, evidence gaps, and barriers to National Health Service (NHS) adoption.
RESULTS: 86% (19/22) of technologies were conditionally approved for NHS use while further evidence was generated, with the remaining two restricted to research-only access. Digital therapies (36%), artificial intelligence (AI) and diagnostic tools (23%), and remote care technologies (14%) dominated HTE topics. Evidence gaps most cited included real-world comparative effectiveness (86%), implementation cost (64%), digital health equity (64%), and usability (50%). Three-year evidence cycles were required for conditional adoption under the EVA framework, and before-after or parallel cohort study designs were commonly recommended, with emphasis on diverse population representation and standardised outcome tracking. Additionally, Digital Technology Assessment Criteria (DTAC) and regulatory approvals were required before NHS deployment. Most recommendations emphasised diverse population representation and standardised outcome tracking. Nearly 40% of technologies experienced post-assessment changes, including withdrawal in 18% of cases.
CONCLUSIONS: High conditional approval rates in HTEs indicate the NICE EVA framework is facilitating patient access to innovative technologies. However, post-HTE withdrawals highlight risks to sustainability, and additional analysis once technologies have been reviewed by NICE in full guidance is required. Enhanced support for evidence generation challenges, clearer cost criteria, and earlier integration of health equity considerations are needed to ensure long-term success of EVA.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA24
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas