Comparison of health technology assessments for digital therapeutics in Germany, the United Kingdom and France.

Objective: Digital therapeutics (DTx) are promising technologies. However, current assessment and access frameworks, when they exist, are heterogeneous and fragmented. We analysed and compared health technology assessment (HTA) criteria for DTx across European countries that had assessed the same DTx products. This allowed us to conduct a direct comparison of these countries' DTx assessment frameworks. Methods: A scoping review identified HTA DTx documents from European HTA bodies with specific DTx frameworks in place. The HTAs of the same DTx products assessed across multiple countries were then extracted and analysed. Results: Deprexis and Velibra were the only DTx products assessed by multiple countries: Deprexis, indicated for depression, was assessed by Germany, the United Kingdom (UK) and France; and Velibra, indicated for anxiety, was assessed by Germany and the UK. There are notable differences among those frameworks, but what they share is an emphasis on the context-specific positioning of products within the disease landscape, choice of comparators and usage and usability data. Safety data are not a major focus in DTx assessments in these countries, but a request is often made for the addition and evaluation of risk-flagging systems. Conclusion: The majority of European countries do not have a specific framework in place for the assessment of DTx, and major differences exist among recently implemented frameworks. The current policy landscape at the European Union level offers an opportunity to establish a harmonized framework for the assessment of DTx and possibly faster access and integration of such promising technologies.