Deprexis – Digital therapeutics (DTx) for depression has received DiGA fast-track approval for DTx prescription and reimbursement in Germany.
The innovative DiGA process allows for fast-track approval of digital therapeutics and is the first such program in the world. It was created by the 2019 Digital Healthcare Act and allows apps to be prescribed by doctors while costs will be reimbursed through German statutory health insurance.
The federal regulator, BfArM, manages DiGA. To get through DiGA, there are certain conditions:
- Safety and Suitability for Use confirmed by CE certification as a medical product in the lowest-risk classes
- Data Protection Conformity to data protection legislation (EU-wide GDPR and German Federal Data Protection Act (BDSG))
- Information security Assessment is based on the recommendations of the German Federal Office for Information Security (BSI) and specific parts of IT-Grundschutz (ITbasic data protection) catalogs designated for healthcare apps.
- Interoperability Related to German central IT standards directory available via online platform vesta, managed by gematik
- Availability of preliminary data on the health benefits provided. Data must show that patient-relevant endpoints, in particular morbidity, mortality, or quality of life, are positively influenced.
Check out the full guide for DiGA here.
At the time of writing this, there were 59 applications for DiGA listing, 40 for provisional listing, and 19 for the final listing. So far BfArM has approved 11 applications and rejected one. 25 applications have been withdrawn. In theory, the full approval process should take three months.
Deprexis, the 11th DiGA-approved application is interesting on its own. The manufacturer of the app is GAIA Group, an offspring of Airbus which builds its products on a proprietary AI platform called brocaⓇ.
The focus here is clearly not on UX, but on medical benefits. Deprexis may not have the nicest UX, but is a proper DTx providing a three-month-long highly individualized Cognitive Behavioral Therapy support program for patients with depression. Application is able to perform a dialogue with the patient, learning from the input on the way. It contains 10 content modules and is available online via desktop and mobile app interface.
Deprexis is backed by clinical data from at least nine studies, one of which had a sample of 3,800 patients, which does not sound much in pharmaceuticals, but it is a lot in DTx. While in Germany it just received reimbursement, in the US the price for treatment is $400 one-time payment, or $540 in three monthly installments of $135 each.