OBJECTIVES: As of December 2019, digital health applications in Germany can be reimbursed by statutory health insurance (SHI) under the Digital Healthcare Act. To qualify for reimbursement, a DiGA must be listed in a directory of reimbursable digital health applications after assessment by the Federal Office for Drugs and Medical Devices (BfArM). Our objective was to gain an understanding of the clinical evidence submitted for those DiGAs with a permanent and provisional listing.

METHODS: Records for DiGAs listed on the directory website (https://diga.bfarm.de/de) on 20/06/2022 were screened and analyzed for the type of listing, therapy area, and clinical evidence parameters such as study design, population sample size, and study outcomes

RESULTS: Total of 53 DiGAs were listed in directory: 18 (34%) permanent, 29 (55%) provisional, and 6 (11%) were removed from the directory. The therapy areas with the most frequent DiGAs were mental health (n=22, 42%), skeletal system (n=7, 13%), hormones, and metabolism (n=5, 9%). All DiGAs with permanent listings provided evidence from RCTs. For provisional listings, 55% (n=14) provided evidence from RCTs, 41% (n=4) provided non-comparative evidence, and 3% (n=1) provided evidence from a comparative pilot study. The study population size varied from the median of 171 (range, 50- 1237) for RCTs and the median of 80 (range, 37-153) for non-comparative studies. The medical benefits demonstrated by permanently listed DiGAs were improvement in health status (n= 53, 100%) and QoL improvement (n= 5, 28%).

CONCLUSIONS: This analysis shows that the provision of (planned) RCT data to BfArM remains the gold standard when it comes to listing in the directory. Moreover, for DiGAs to be listed permanently in the directory, BfArM Germany seeks evidence on the improvement in health status and improvement in quality of life as outcomes.