OBJECTIVES: The 2019 German Digital Healthcare Act paved the way for the reimbursement of and access to digital health applications (DiGA). However, there is currently no transparent framework for setting DiGA prices. This research aims to determine which factors influence DiGA pricing in psychiatric disorders.

METHODS: Prices and assessment outcomes up to June 2023 for permanently listed DiGAs indicated for psychiatric disorders were extracted from the DiGA directory. Prices were compared across three domains: 1) study design, 2) claimed incremental medical benefit, and 3) price-setting pathway (i.e., negotiation or arbitration).

RESULTS: Of the 53 DiGAs listed in the directory, 10 (18.8%) were permanently indicated for psychiatric disorders.

All DiGAs demonstrated medical benefits through randomized-controlled trials (RCTs) with patient numbers ranging from 56 to 608. The average length of RCTs was 5.3 months. There was no significant relationship (P > 0.05) between DiGA prices and number of patients (R²=0.01 ± 0.33) in the RCTs, nor length of the RCTs (R²=0.04 ± 19.34).

There was also no significant relationship (p > 0.05) between DiGA prices and the claimed incremental medical benefits (R²=0.03 ± 4.11) compared to their respective control groups.

Six out of ten DiGAs were priced through negotiation with the GKV-SV, resulting in an average price reduction of 32% and an average price of €351. The remaining four DiGAs were priced through the arbitration board, leading to a higher overall price reduction of 48% and an average price of €214.

CONCLUSIONS: For psychiatric disorders, the price-setting pathway plays a more significant role in DiGA pricing than study design and claimed incremental medical benefits. Further research is needed to understand whether the current pricing framework is adequately rewarding clinical value and evidence robustness. This analysis should be updated as more DiGAs are permanently listed to increase the reliability of the findings.