The Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) of December 2019 has enabled physicians and physiotherapists to issue prescriptions for digital applications in Germany. These apps are available to the 73 million Germans that receive statutory health insurance.
To be prescribed by healthcare providers, the app must be listed as an approved digital health application (Digitale Gesundheitsanwendung, DiGA) by Germany’s Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). Listing in BfArM’s DiGA directory enables healthcare technology companies that distribute and sell their products in Germany to be reimbursed by the German health insurance system. To qualify as a DiGA, the product must be a CE-marked medical device that aids the detection, monitoring and treatment of diseases, injuries or disabilities. The product must demonstrate a positive healthcare effect (positiver Versorgungseffekt, pVE) in one of two ways: either a medical benefit (medizinischer Nutzen, mN) or a patient-relevant improvement of structure and processes (patientenrelevante Struktur- und Verfahrensverbesserung, pSVV) in healthcare.
As of 14th April 2021, BfArM has assessed 68 DiGA applications since the assessment procedure began in May 2020. Twelve applications successfully achieved either a provisional or final listing in the DiGA directory. Two applications have received negative decisions and 25 applications have been withdrawn by the applicant. As a new procedure with a relatively low success rate to date, one key challenge for manufacturers is understanding how to engage with BfArM effectively prior to submission. It is important for manufacturers to invest in extensive preparation for BfArM DiGA consultations in order to understand the shortcomings of unsuccessful attempts and enhance the quality of the application. Another challenge is successfully aligning BfArM’s requirements with the design of a study to prove the positive healthcare effect of the product.
Vitaccess has experience with digital innovation and has worked on 2 DiGA applications which are currently being processed by BfArM. We also have extensive experience with data capture studies, which BfArM requires to demonstrate the medical or structural benefits of prospective DiGA products. As a result, we are able to work with manufacturers to navigate BfArM’s requirements and build the best chance of achieving reimbursement by the German health insurance system.
References:
https://www.bfarm.de/EN/MedicalDevices/DiGA/_node.html
https://www.openaccessgovernment.org/digital-health-innovators/101218/
By Akosua Ofori
