OBJECTIVES: Reasonable prices have been a controversial issue since the introduction of digital health applications (Digitale Gesundheitsanwendungen - DiGA) in Germany. If DiGA providers and the National Association of Statutory Health Insurance Funds (GKV-SV) do not reach an agreement on the reimbursement price of a DiGA, it will be determined by an arbitration board. This arbitration board has set 9 of 15 final reimbursement prices available (as of June 2023). It thus has a prominent role in the practical implementation of the few legal provisions for DiGA pricing. Our aim is to analyze and discuss the pricing model applied.

METHODS: Based on the arbitration awards available to date, this study analyzes how the arbitration board considers the regulatory requirements, especially the maxim of value-based pricing (VBP).

RESULTS: The arbitration board has developed a pricing model that refers to the costs of comparable care within the statutory health insurance (SHI) as a "price anchor" (PA). Most of the are for DiGA in mental health conditions (PA: cognitive behavioral therapy). However, the model has also been applied to the indications of back pain (PA: physiotherapy) and obesity (PA: multimodal obesity therapy). The indication-specific cost calculation can be based on study information, claims data, or literature sources and refers to the prescription period of the DiGA. Efficacy and quality of evidence as well as other optional factors (e.g., epidemiology), are considered as a lump sum via a percentage markup on the costs of the PA. Self-payer and European reference prices can be included with a slight weighting (up to 15%).

CONCLUSIONS: The DiGA arbitration board’s model can be applied across different indications and is intended to practically implement the unspecific legal requirements. However, to adequately account for the legally enshrined maxim of VBP, cost-effectiveness considerations for the DiGA and its PA should also be included.