OBJECTIVES: To systematically identify and review HTAs of DHTs across France, Germany, and the UK.

METHODS: A systematic review of grey literature was conducted whereby national-level HTA websites from HAS, BfArM, and NICE were searched. The authors restricted inclusion to stand-alone DHTs falling under Tier C of the NICE assessment framework,¹ and/or under BfArM’s definition of digital health apps.² To improve consistency and minimize variability across assessments, we extracted and analyzed only HTAs of the same DHTs submitted and evaluated for the same indications across multiple agencies.

RESULTS: In total, 54 assessments were identified across the three agencies. Four were identified for France, 30 for Germany, and 20 for the UK. Consistently across the three countries, the disease area with the most submissions was mental/behavioral health, followed by cardiology, diabetes, and oncology. Only two products were assessed by multiple agencies, namely Deprexis and Velibra. Deprexis was first assessed in the UK (January 2018),³ followed by Germany (February 2021),⁴ and France (December 2021).⁵ Velibra was assessed in the UK (July 2019)^6,7,8 and in Germany (October 2020).⁹ Despite recognition of the high unmet need, the results of the Deprexis and Velibra assessments varied greatly across France, Germany, and the UK. While Deprexis was not recommended in France, both apps were recommended for reimbursement in Germany. In the UK, Deprexis was recommended for inclusion in the Improving Access to Psychological Therapies program but Velibra was not. The reasons for the divergence were related to the positioning of the products, the submitted evidence, and its quality, and chosen comparator treatments.

CONCLUSIONS: This review provides an overview of the status of HTA frameworks and evidence requirements for DHTs across three major European markets. Although every healthcare system is unique, a common European approach to HTA for DHTs could facilitate innovation and access.