OBJECTIVES: To assess how digital therapeutics (DTx) have been evaluated by the National Institute for Care and Health Excellence (NICE) in the Early Value Assessment (EVA) process.

METHODS: A targeted literature review was conducted on the NICE website for EVAs for digital therapies and the resulting health technology evaluations (HTE) published until 20-June-2023 were analysed for evidence submitted and reimbursement outcomes.

RESULTS: DTx were grouped according to their indication and population in 3 HTEs. HTE3 evaluated 5 DTx for treating mild to moderate symptoms of anxiety or low mood in children or adolescents. The evidence base consisted of 7 studies and 2 conference abstracts, of which there was 1 randomized controlled trial (RCT). 4 DTx received conditional recommendations and 1 was not recommended. HTE8 evaluated 6 DTx for treating depression in adults. The evidence base consisted of 46 articles, of which there were 14 RCTs. 3 DTx received conditional recommendations and 3 were recommended for research only. HTE9 evaluated 11 DTx for treating anxiety disorders in adults. The evidence base consisted of 19 published studies, of which there were 4 RCTs. 12 recommendations were made: 6 conditional and 6 for research only. Overall, 16 DTx were given 27 recommendations, with 48% receiving conditional recommendations, 48% in research only, and 4% not recommended. Of the total evidence submitted, 32% of studies came from RCTs.

CONCLUSIONS: The EVA process provides a route for DTx to be assessed early in evidence development and receive conditional reimbursement while additional confirmatory data is collected. This enables local patient access and may have positive effects in markets that look to NICE guidance. However, by submitting early and potentially less mature data, an ‘only in research’ recommendation is possible. Manufacturers need to consider this speed versus access trade-off in their product development journey.