The three-year evolution of Germany's Digital Therapeutics reimbursement program and its path forward.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 38789620.
- Also identified by DOI 10.1038/s41746-024-01137-1 and PMC identifier 11126413.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
The 2019 German Digital Healthcare Act introduced the Digital Health Application program, known in German as 'Digitale Gesundheitsanwendungen' (DiGA). The program has established a pioneering model for integrating Digital Therapeutics (DTx) into a healthcare system with scalable and effective reimbursement strategies. To date, the continuous upward trend enabled by this framework has resulted in more than 374,000 DiGA prescriptions, increasingly cementing its role in the German healthcare system. This perspective provides a synthesis of the DiGA program's evolution since its inception three years ago, highlighting trends regarding prescriptions and pricing as well as criticisms and identified shortcomings. It further discusses forthcoming legislative amendments, including the anticipated integration of higher-risk medical devices, which have the potential to significantly transform the program. Despite encountering challenges related to effectiveness, evidence requirements, and integration within the healthcare system, the DiGA program continues to evolve and serves as a seminal example for the integration of DTx, offering valuable insights for healthcare systems globally.