A Review of the Recommendations & Evidence Gaps Reported Across NICE’s Early Value Assessments for Medtech

OBJECTIVES: The National Institute for Health and Clinical Excellence (NICE) Early Value Assessment (EVA) for digital health & medical technologies was introduced to provide a rapid assessment based upon clinical effectiveness and value for money whilst providing guidance on what further evidence is required. This review aimed to quantify the recommendations & evidence gaps that have been recorded across the EVA since onset.

METHODS: A systematic review of published evidence gaps & guidance by the NICE EVA until May 2024 program for England & Wales. Key information, including a description of the type of digital technology, disease area, number of technologies assessed and recommended for use in NHS alongside the highlighted areas that required further evidence were synthesized.

RESULTS: By May 2024, there were 14 published EVAs by NICE of which 6 (43%) had been updated since the original publication. Of the EVAs, 9 (64%) focused on therapies, 3 (21%) diagnostic and 1 (7%) on healthcare systems. The most common disease areas included mental health and oncology both having 3 (21%) associated EVAs each. The number of technologies assessed in each EVA ranged from 1 to 14 with a mean number of 7.1 (SD; 4.8) technologies per EVA. An overall total of 100 technologies have been assessed with a 41% rate of recommendation. Guidance on further evidence required was included for all 14 (100%) EVAs with the most common required areas including healthcare resource use & cost impact (11; 79%), clinical outcomes (10; 71%), health-related quality of life (7; 50%) and preference, experience & usability (7; 50%).

CONCLUSIONS: NICE has assessed a wide variety of digital technologies, with the majority not currently recommended for use in the NHS. Understanding and addressing the key areas where further evidence is required may assist future digital health & medical technologies who aim to be recommended.