Germany’s digital healthcare market is about to open up, thanks to the Digital Healthcare Act (DiGAV) which puts in place a solid reimbursement pathway for digital health solutions. In this blog post, we answer some frequently asked questions, relevant to market access, with insights from recently published documents/conferences on the topic.
(N/B: The following is Centivis’ understanding based on publicly available documents. As the law has just been passed and implementation is nascent, changes may occur. Timelines cited here are also indicative, based on our current understanding of the law and available guidance.)
What is the new reimbursement pathway for digital healthcare apps in Germany and how does it work?
In general, digital health companies have to apply to be listed on the DiGA registry, which acts as Germany’s positive list that sieves out high-quality healthcare apps with the potential for reimbursement.
They can apply through a fast track application process where their technology will be assessed for technical aspects like safety, quality, functionality, privacy and data security, as well as positive care effects for the German patient.
The German Federal Institute of Drugs and Medical Devices (BfArM) then decides in 3 months if the app should be entered into the official DiGA (digital applications) registry.
If the digital health solution does not fulfill technical requirements, the DiGA application is rejected.
If the digital health solution fulfills both technical and positive care effect requirements (supported by evidence), then it is admitted to the DiGA list.
If the digital health solution fulfills technical requirements but questions remain on positive care effects, then it may be provisionally listed, subject to a 12 month market trial. However, the firm will need to show a plausible evaluation plan to assess care effects during this market trial, with analysis conducted by an independent institution.
During these 12 months, the digital health solution will be reimbursed by insurers at a price set by the producer. After the market trial, BfArM will assess the real-world evidence, relevant to the German market, provided by digital companies. If requirements are fulfilled, a final listing is confirmed. After this, the firm can negotiate a price with the National Association of Statutory Health Insurance Funds (GKV-SV) for further reimbursement.
Before companies kick-start the application process, they can also consult BfArM on questions for a fee.
What kind of apps will be regulated under this pathway?
Class I and Class IIa medical devices (low to low/medium risk; with or without a measuring function)
Centered on patients (possibly including prescribing physicians)
Relies on digital technologies
Detection/monitoring, treatment, reduction of pain, aid to disabilities, etc.
What technical aspects will the regulator check for when a company applies to be listed as a DiGA?
The BfArM will usually check for the CE Mark, proof of consumer protection, data security (e.g. compliant to EU’s General Data Protection Regulation), robustness (e.g. that data remains consistent in case of an unforeseen mobile shut-down), user-friendliness (patient/doctor), interoperability, quality of medical content (i.e. must be able to cite the medical sources of digital health content).
A complete checklist can be found here, on PDF pages 12-31 of the DiGAV legal document.
What constitutes positive health effects?
Medical Benefit: E.g. Shortening of illness duration, increase in survival, improvement in the quality of life. Improvement in patient-relevant endpoints mortality, morbidity, or quality of life should be shown.
Patient-relevant structural/procedural effects: E.g. improvement in adherence, facilitating access to care, coordination of treatment processes, improvement in health literacy, reduction in the burden on families, etc. In short, the regulator is looking at how the app supports positive patient behaviors linked to medical processes and therapy goals.
The examples above are not exhaustive. Note that all evidence used to support positive health effects must be relevant to the German market, meaning studies should be carried out in Germany. An exception may apply if the company is able to demonstrate that a foreign study population or healthcare situation is comparable to Germany. Specific requirements depend on what is being claimed.
BfArM guidance indicates that economic factors will not be considered when enrolling for the DiGA but this is useful for later price negotiations with the National Association of Statutory Health Insurance Funds (GKV-SV).
Which key events have taken place in relation to the digital health reimbursement process?
Nov 2019: The DVG (Digital Supply Act) was passed, paving way for a reimbursement process for digital healthcare solutions
Feb 2020: A DiGA summit was held in Heidelberg where the authorities provided a clearer overview of the DiGA registration process and spoke with healthcare industry players on the importance of real-world evidence and data security. The event included a “Researchathon”, which invited scientists to discuss study designs for the evaluation of hypothetical DiGAs.
March 2020: The BfArM guidelines were published, which provides detailed answers to common questions asked, hypothetical practice examples, and deeper insight into the regulator’s thinking on the registration process.
April 2020: The DiGAV was brought to law. This ordinance is linked to the overarching legal framework and includes examples of application forms for transparency. A virtual digital DiGA summit was also held, explaining the BfArM guidelines and confirming that the fast track process will be iterative as authorities learn and adjust over time.
May 2020: The DiGA online portal opened for application.
What factors should be considered when developing evidence for DiGA application and reimbursement?
Digital players will likely rely on real-world evidence in the evaluation. Studies should be done in Germany or applicable to the German care context. But first, think of a plausible hypothesis and an independent institution that can perform the analysis.
In general, proof of positive care effects should be based on evidence-based medicine. Both retrospective and prospective studies are accepted, but if retrospective data is not convincing, prospective data might be needed. If the DiGA is a diagnostic device, it should show sensitivity and specificity.
At a DiGA summit talk, experts Dr. Lars Hemkens (Deputy Director, Basel Institute of Clinical Epidemiology and Biostatistics) and Dr. Naomi-Fujita Rohwerder (Research Associate iQwiG) noted several aspects to consider in real-world evidence:
Beware of spurious correlations: Conclusions from data should be backed up by sound medical logic.
Written protocols are encouraged: This ensures transparency and prevents authors from slicing and dicing the data or meddling with it beyond the agreed analysis to produce positive effects
Beware of confounders: E.g. In a single-arm study, outcomes of a group of hand arthritis patients using a DiGA were compared to outcomes without the DiGA. Outcomes with the DiGA were measured during summer whereas outcomes without DiGA were measured in winter. Here, the weather could be a confounder and the effects of the DiGA are unclear. In the case of confounding, additional confounder analysis would be required or another trial was undertaken.
Slides from Dr. Hemkens’ and Dr. Rohwerder’s talks are available here.
Further questions about Germany’s digital health reimbursement process? Drop us an email at info@centivis.com