Schmidt L, Pawlitzki M, Renard BY, Meuth SG, Masanneck L. The three-year evolution of Germany’s Digital Therapeutics reimbursement program and its path forward. NPJ Digit Med. 2024;7(1):139. doi:10.1038/s41746-024-01137-1
Germany’s 2019 Digital Healthcare Act established an expedited process between digital therapeutics and reimbursement. The Digital Health Applications, known in German as ‘Digitale Gesundheitsanwendungen’ (DiGA) allows approved digital interventions to be added to a directory and once added, automatically eligible for prescription and reimbursement. This article provides an overview of the DiGA applications and insights into precursor steps that may aid others in developing and implementing policy changes to increase digital therapeutics’ scalability and access through similar approval fast-tracks. Since its start in September 2020, and as of 2024, the directory contains 29 permanent and 24 provisional listings. Listings predominantly focus on mental health (n=25), followed by musculoskeletal disorders (n=8). Provisional listings require the submission of preliminary efficacy evidence and may remain in the directory for 12 months or adequate evidence has been provided. If the 12 months pass without sufficient evidence, the digital therapeutic is removed from the list and is no longer eligible for fast-track prescribing or reimbursement. From 2020-2023, 374,000 DiGA prescriptions have been written and reimbursed. Most of the active DiGA therapeutics include a combination of lifestyle/condition-specific advice, educational modules, behavior tracking, and cognitive behavioral therapy elements. Almost all (28/29) of the permanent listings are prescribed for 90 days. As the program continued, more DiGA therapeutics were added, and pricing stabilized to be similar across different therapeutics. While the program is generally successful, there have been reported complaints from manufacturers about delayed payments from insurers, and insurance providers over perceived ineffectiveness of the digital interventions. Patients have also complained of delayed access to care and inadequate integration into the broader German healthcare system. These key learnings are currently being addressed with proposed legislative changes to be implemented through 2026.