Unlocking Value Early: Insights Into NICE’s Early Value Assessments and Evidence-Generation Plans for Medical Technologies
Author(s)
Francesca K. Lewns, PhD1, Olivia A. Edwards, BSc1, Amrit Heir, MSci2, Ben D. McNally, PhD3.
1Costello Medical, London, United Kingdom, 2Costello Medical, Manchester, United Kingdom, 3Costello Medical, Edinburgh, United Kingdom.
1Costello Medical, London, United Kingdom, 2Costello Medical, Manchester, United Kingdom, 3Costello Medical, Edinburgh, United Kingdom.
OBJECTIVES: NICE developed an early value assessment (EVA) pathway to facilitate rapid assessment of promising medical technologies (MedTech). However, specific evidence requirements and criteria for evaluation selection are not well-defined. This study aimed to evaluate previous EVAs to determine evidence needs for positive recommendation.
METHODS: MedTech EVAs and evidence generation plans (EGPs) published between March 2023-May 2025 were reviewed. Decision parameters, existing clinical and economic evidence, and required evidence generation were assessed.
RESULTS: 21 EVAs were identified; digital were the most common type of MedTech appraised (n=19). Most EVAs were multi-technology (n=16), with psychiatry (n=5) the most common specialty. Seven appraisals received full support (FS), 12 partial support and two were not supported. Only three FS EVAs included technologies with a published randomised controlled trial (RCT). Six FS EVAs appraised economic evaluations - four developed by an external assessment group, and two published models identified during the appraisal. Of these, two FS EVAs included technologies that were deemed cost-effective, and the remaining four included technologies with potential to be cost-effective. In published EGPs for FS appraisals, NICE’s request for essential and desirable evidence for future committee decision ranged from 2-7 and 0-3 topic areas, respectively. Data pertaining to healthcare cost and resource utilisation were most requested (n=6), followed by clinical effectiveness/efficacy, and outcomes related to clinician experience/decision-making or organisational pathways (all n=5).
CONCLUSIONS: Our analysis shows that EVA represents a flexible appraisal pathway, adaptable to a variety of technologies and evidence levels. RCT evidence is not a prerequisite for positive recommendation, but potential for cost-effectiveness is important. Routing of MedTech for NICE appraisal remains ambiguous; given the wealth of evidence for robotic-assisted surgery and its recent EVA, there is a need for greater clarity on eligibility criteria and evidence needs for each NICE HealthTech programme.
METHODS: MedTech EVAs and evidence generation plans (EGPs) published between March 2023-May 2025 were reviewed. Decision parameters, existing clinical and economic evidence, and required evidence generation were assessed.
RESULTS: 21 EVAs were identified; digital were the most common type of MedTech appraised (n=19). Most EVAs were multi-technology (n=16), with psychiatry (n=5) the most common specialty. Seven appraisals received full support (FS), 12 partial support and two were not supported. Only three FS EVAs included technologies with a published randomised controlled trial (RCT). Six FS EVAs appraised economic evaluations - four developed by an external assessment group, and two published models identified during the appraisal. Of these, two FS EVAs included technologies that were deemed cost-effective, and the remaining four included technologies with potential to be cost-effective. In published EGPs for FS appraisals, NICE’s request for essential and desirable evidence for future committee decision ranged from 2-7 and 0-3 topic areas, respectively. Data pertaining to healthcare cost and resource utilisation were most requested (n=6), followed by clinical effectiveness/efficacy, and outcomes related to clinician experience/decision-making or organisational pathways (all n=5).
CONCLUSIONS: Our analysis shows that EVA represents a flexible appraisal pathway, adaptable to a variety of technologies and evidence levels. RCT evidence is not a prerequisite for positive recommendation, but potential for cost-effectiveness is important. Routing of MedTech for NICE appraisal remains ambiguous; given the wealth of evidence for robotic-assisted surgery and its recent EVA, there is a need for greater clarity on eligibility criteria and evidence needs for each NICE HealthTech programme.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
MT43
Topic
Economic Evaluation, Health Technology Assessment, Medical Technologies
Topic Subcategory
Digital Health
Disease
No Additional Disease & Conditions/Specialized Treatment Areas