OBJECTIVES: Digital health technologies (DHTs) allow patients to monitor, report and improve their own health and wellbeing through the use of mobile devices. Under the Digital Healthcare Act, Germany introduced the DiGA Fast Track Process, a rapid approval, testing, and reimbursement process for digital health apps. This research explores how the evidence presented for a DHT impacts reimbursement and pricing outcomes for it in Germany.

METHODS: We assessed the framework for the DiGA approval process, in parallel to DHT applications that had both failed and succeeded in gaining reimbursement. We analysed evidence generated during studies, study design and app design for each DHT and compared these data vs. DiGA criteria, for reimbursement, and GKV-SV (National Association of Statutory Health Insurance Funds) requirements for pricing. The correlation between the evidence package vs. reimbursement and pricing outcomes allowed us to identify the critical success factors in a DHT pricing and reimbursement application.

RESULTS: We found that the DiGA Fast Track Process sets out stringent criteria that must be adhered to in order for DHTs to be eligible for reimbursement. Obviously, technologies must demonstrate medical benefit, but showing long-term cost savings strengthens the pricing argument. Manufacturers who invest in appropriately designed intervention studies, with systematic data evaluation, prior to submission have been most successful in achieving approval. The majority of technologies which failed to achieve reimbursement do so due to inappropriate study design or inept data evaluation.

CONCLUSIONS: Digital applications must be evidence-based and guideline-compliant Ensuring regulatory, privacy and user friendliness requirements are aptly met is crucial for approval. This is in addition to showing an overall positive healthcare effect so as to optimize pricing and reimbursement negotiations.