OBJECTIVES: In December 2019, legislative changes established a fast-track market access and pricing process for digital health applications (DiGAs) in the German statutory health insurance (SHI). Accordingly, after one year of free pricing by manufacturers, DiGA prices must account for the applications’ positive healthcare effects (pVE) in terms of a medical benefit or improvements in care structure and processes. However, the regulations do not indicate how the patient-relevant benefits of a DiGA should be translated into a reasonable, value-based price. Therefore, this study aims to present and discuss an approach for the practical implementation of value-based DiGA pricing.

METHODS: We present a pragmatic, evidence-based approach to value-based DiGA pricing that meets regulatory and procedural requirements.

RESULTS: In line with the IQIWG's efficiency frontier concept, our approach approximates the SHI’s willingness to pay by the (average) cost-effectiveness of one or more established therapy in a field of indication and considers the pVE of a DiGA. Relating both factors to each other, indifference prices can be determined at which a DiGA would have the same cost-benefit ratio as its comparator therapy. Sensitivity analyses can consider both effects, and cost ranges to reflect uncertainties about the costs and benefits of the therapy options to be compared. The application of the approach is illustrated using the example of a reimbursable DiGA for the treatment of fatigue in multiple sclerosis.

CONCLUSIONS: Our approach can fit into DiGA pricing processes under the given regulatory framework and provide objective guidance for price negotiations. However, widely-discussed points of criticism of the efficiency frontier concept also apply here. Furthermore, it is only one piece of the pricing puzzle, and numerous methodological and procedural issues are still open. Thus, it remains to be seen to what extent future DiGA prices will be value-based.