OBJECTIVES: Digital Health Applications (DiGA) are digital medical devices delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health. They are prescribed by healthcare providers and reimbursed by statutory health insurance (GKV-SV) in Germany. DiGA have become an essential component of modern healthcare, offering innovative solutions for managing chronic conditions, mental health, and other medical issues. This study analyzed the pricing trends of DiGA listed for reimbursement in Germany from September 2020 to 2023.

METHODS: Data was collected from the provisional and permanent reimbursement lists provided by BfArM, the Federal Institute for Drugs and Medical Devices in Germany, available on dedicated website. The analysis included average price changes, comparisons between provisional and permanent listings, and price evolution during the period considered.

RESULTS: The average provisional list price of DiGA increased significantly from €439 in 2020 to €645 in 2023. Similarly, permanent list prices increase from €219 to €645 over the same period. By 2023, the price gap between provisional and permanent list prices, which initially averaged 50% in 2020, had been completely eliminated. This convergence suggests that the initial prices set by manufacturers tend to converge over time with the final accepted prices. The study highlights a trend of escalating prices, but a stabilization and standardization of final reimbursement rates.

CONCLUSIONS: The analysis reveals significant growth in the average prices of DiGA from 2020 to 2023, along with a notable trend towards price parity between provisional and permanent listings. This suggests an evolving pricing strategy among manufacturers and a maturing market for digital health solutions. Understanding these trends is crucial for policymakers, HCPs and patients to make informed decisions regarding the adoption and reimbursement of digital health technologies and can assist the set-up of the adoption process of digital medical devices in other European countries.