A Targeted Review Exploring How English and German Health Technology Assessment Agencies Differ in Their Appraisal of Digital Health Apps

OBJECTIVES: To understand how Health Technology Assessment (HTA) agencies in England and Germany assess digital health apps, both from the perspective of process and evidence considerations.

METHODS: Medical Technologies Guidance (MTG) reports published by England's National Institute for Health and Care Excellence (NICE) and assessments from the Digital Health Applications (DiGA) directory by Germany's Federal Institute for Drugs and Medical Devices (BfArM) were analysed. A targeted search was conducted for assessments published between May 2020 and May 2023, which identified chronic obstructive pulmonary disease (COPD) apps myCOPD in England and Kaia COPD in Germany, along with the insomnia-focused apps Sleepio in England and Somnio in Germany.

RESULTS: The assessment pathways between England and Germany differed, with the DiGA process granting Kaia COPD provisional approval for one year (subject to further data collection) and a permanent approval of Somnio. England's MTG assessment granted a positive recommendation for Sleepio, whilst myCOPD did not meet the adoption criteria (further evidence needed). The evidence assessed between the two agencies differed, with NICE requiring larger study sample sizes and longer study duration. BfArM placed a greater emphasis on data from RCTs for permanent approval, whilst NICE encouraged real-world evidence alongside RCT data. In the DiGA assessment, no economic evidence was required, whilst NICE required cost modelling data. The assessment by NICE considered other factors relating to the app itself, such as ease of use, training requirements, and whether it helped with patient engagement – such factors were not considered in the assessment by BfArM.

CONCLUSIONS: Whilst there are now established HTA pathways for assessments of digital health apps, the factors considered in assessments differ between HTA agencies. As more digital health apps come to market, we are likely to see further evolution in HTA processes, with continued divergence in evidence requirements and final recommendations for reimbursement.