Regulation and Reality of the Market Access Process for Digital Health Applications (DiGA) in Germany

OBJECTIVES: In 2019, reimbursement of digital health applications (DiGA) was introduced in Germany. Part of this is a 12-month temporary market authorization to collect evidence for permanent approval and pricing. We conducted an initial evaluation of how DiGA reality relates to the requirements.

METHODS: Formal market access requirements are compared with empirical data of the reimbursement process. These include data from the national DiGA directory, clinical study registers, and the arbitration board for price negotiations. They are related to requirements of the Digital Health Care Act (DVG), Digital Health Applications Ordinance (DiGAV), and guidelines by the decision-making body BfArM.

RESULTS: 47 DiGA were listed in May 2023, thereof 18 permanently. All 47 conducted RCTs. Most studies compared to treatment as usual or waitlist, with ≤150 participants per group. 39 studies claim positive medical effects, one only study structure or process improvements, seven a combination of both. For 38% of DiGA, the temporary period was extended. Starting prices ranged from €204-€744. 55% of final prices were set by the arbitration board, ranging from €189-€235.

CONCLUSIONS: All manufacturers conducted RCTs, above the requirement of retrospective study designs. Small sample sizes challenge the requirement to reflect the care reality. Frequent extensions of the temporary period suggest the initial 12 months are too short for evidence collection. The narrow corridor of final prices calls for an approach reflecting the heterogeneity of DiGA products. We found a lack of clear methodological guidelines for evidence generation and pricing.