OBJECTIVES: Since June 2020 there is a specific market access and reimbursement pathway for digital health applications (“DiGAs”) in Germany. Systematic results on the DiGA availability and process effectiveness are currently missing.

METHODS: BfArM website, national laws and regulations were systematically screened by conducting targeted literature searches.

RESULTS: In Germany, a new legislation has been implemented for DiGAs with the opportunity of permanent or temporary reimbursement with evidence generation. The BfArM registry inclusion process lasts maximum of 3 months. After the successful inclusion within the BfArM registry the DiGA can be launched with free pricing. By June 2021, 17 applications have been accepted. The largest group with 53% applications are mental and behavioural disorders. 29% (n=5) were permanently accepted. These permanently accepted have RCT proven effectiveness compared to a waiting list (standard of care). The range of patients included in these RCTs varied from 56 to 1‘013 per study (mean 376 patients). 71% (n=12) reached a preliminary acceptance with evidence generation. For a preliminary listing, observational data or pilot study data (range 20-70 patients) were used. Evidence generation for all DiGAs has been agreed on German RCTs.

There are four possible reimbursement periods to choose from (days: 30; 60; 90; lifelong). All DIGAs have selected a 90 days reimbursement period. Launch prices varied from 203.97 € to 743.75 € with a mean of 443.42 €. With permanent inclusion, the price negotiation starts after 6 months. The first DiGAs have started their negotiations in summer 2021.

Due to the fact, that negative or withdrawn decisions are not published, no justifications for these can be identified.

CONCLUSION: The DiGA process is a rapid and effective reimbursement procedure in Germany. Final assessment of the process can only be drawn after availability of the first price negotiations.