How is the German market for digital health applications (DiGA) doing? In a written interview with the specialist service APM Health Europe, Malte Bucksch, managing director of QuickBird Medical, talked about the current regulatory hurdles, the lack of transparency in price negotiations and the future prospects for medical apps.
A central point of criticism in the digital health field remains the absence of a standalone, complete HTA process (health technology assessment) of the kind established for conventional medicines. Instead, the BfArM, the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) and the arbitration board follow the scientific method papers of IQWiG for medicines when they assess study results against criteria such as statistical significance or clinical relevance.
The “gold standard” for demonstrating medical benefit is still the randomised controlled trial (RCT). Because the BfArM’s regulatory requirements for the study design are high, Malte Bucksch advises developers to seek scientific advice early: “That is why we recommend coordinating with the BfArM in advance.”
Criticism of opaque prices and the “benchmark effect”
Another important topic of the interview is pricing in Germany. Many manufacturers criticise the lack of transparency and the low price level in the negotiations with the GKV-Spitzenverband that follow the first, freely priced year. That many apps settle at a reimbursement amount of around 200 euros per 90 days is, according to Bucksch, “currently hardly comprehensible to anyone”. He suspects that this price level established itself as a kind of informal benchmark in the early phase of the DiGA market from 2021 onwards and has been maintained ever since through the dynamics of negotiations and arbitration awards.
How narrow the scope for innovation can become as a result was shown by the example of the breast cancer app Optimune, which was withdrawn from the market because of the low reimbursement price it could expect, despite a proven improvement in quality of life.
Why the outlook nevertheless remains optimistic
Despite these hurdles, app developers are, according to Bucksch, optimistic about the German digital health market. A key reason for this is the Digital Act (DigiG), which came into force in March 2024. Extending reimbursability to apps in the higher risk class IIb and the option of integrating digital applications into structured treatment programmes (DMPs) open up entirely new market potential.
In addition, the BfArM’s strict evidence requirements could in the long run help to convince sceptical doctors to prescribe. The continued interest of the pharmaceutical industry is also encouraging, as it sees DiGA as an important tool for making direct contact with patient groups and generating valuable data for clinical research.
At the same time, Bucksch points out in the interview that new regulatory hurdles are already on the horizon, in particular through upcoming data protection requirements and expensive certifications in the area of data security.
The full interview appeared in July 2024 under the title “No HTA standard for health apps in Germany – medical app developer” at APM Health Europe.