NICE Early Value Assessment: A New Avenue for Evidence Generation and Early Market Access in the Digital Therapeutics Space in the United Kingdom

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 14June-2024.

RESULTS: NICE review identified a diverse range of DTx covering the following conditions: anxiety, depression, weight loss, non-specific low back pain, agoraphobia, psychosis, and chronic obstructive pulmonary disease. These technologies were categorized into eight HTEs, each reviewing between three to twelve DTx. The evidence package assessed in each HTE included one to fourteen randomized controlled trials (RCTs). In total, 57 DTx were evaluated, leading to 71 recommendations: 52.1% were conditional, 39.4% were for research only, and 8.5% were either not recommended or excluded.

CONCLUSIONS: The challenge of achieving a conditional recommendation is shown by almost half of recommendations being for research only or not recommended, indicating the risk of submitting to EVA without a robust evidence package. Furthermore, even with a conditional recommendation, technology developers must adhere to evidence development plans and implement local access strategies to gain uptake. Overall, from health technology assessment policy perspective, the EVA sets out a standardized national level pathway for DTx, which positions NICE as a key influencer in this space. For DTx manufacturers, while the EVA process provides a pathway for early access and the opportunity to improve the evidence package, it is not without challenges.