German Digital Reimbursement Act (DVG) - The most important opportunity for digital solutions (globally)?
With the new legislation for national reimbursement of digital solutions, Germany has become the single largest market opportunity for reimbursed digital solutions. With one national decision, it will be possible to establish national reimbursement for your digital solution!
The key criteria for the scope of reimbursable products are:
- Medical device class I or IIa under the new MDR (with transitional rules)
- Main function relies on digital technologies
- Intended use is centered around the patient, possible to include the doctor
You can read more about the background here.
- Description of formal the pathway for the DIGA – The new pathway for digital reimbursement in Germany presented by Jan Brönneke, Director Law & Economics Health Technologies at Health Innovation Hub, Germany
- This includes a description of the background to the legislation, what has been defined thus far and the expected timelines for the next steps.
- Strategic preparation to support the decision-maker to select and promote the best solutions – Crucial insights to shape the agenda for your digital solution presented by Mattias Kyhlstedt, CEO and founder Synergus RWE
- From what is known about the legislation today, there is limited methodological framework in place to support the decision-maker on how to assess and reimburse the most relevant solutions.
The new pathway creates valuable opportunity, however, the development of an appropriate methodological framework is crucial for society as well as for those companies who have solutions with a relevant value in the healthcare system, to prevent solutions with little or no value from entering the system.
Synergus RWE has developed a methodological framework to support decision-makers to select the most valuable solutions and the methods to evaluate the effect. From an industry point, utilising this framework can create better predictability in the rather undefined landscape / process, but more importantly create protection against solutions that cannot demonstrate meaningful value.
The method to demonstrate the benefit and study design
It is intriguing that until the final decision about reimbursement is made (Coverage with Evidence Development), there is an initial period where evidence can be generated while being reimbursed in the statutory healthcare system. Generally, the use of digital solutions involves multiple evaluation approaches, since they have different modes of actions. Please read this prior blog about the Model for Assessment of Telemedicine (MAST) framework for evaluating digital solutions
Jan Brönneke (Director Law & Economics Health Technologies at Health Innovation Hub, Germany) - After interdisciplinary studies of economics (LL.B.) and social law (LL.M.) at the University of Kassel with positions at the Linköpings and the Koç University (Sweden / Turkey), Jan Brönneke decided for further research in the law of SHI. Here he dealt mainly with the CRC 597 with the method evaluation by the G-BA. This was followed by a station as a speaker at the G-BA; In search of new perspectives he came to the interdisciplinary health consultancy Dierks + Company as Legal Manager. Expertise, drive and solution search led him now to the interface perspective of hih.
Mattias Kyhlstedt (CEO and founder Synergus RWE) - A thought leader on digital, medical devices and diagnostic market access and the use of real world evidence for decision making. He has broad experience of this field, across Western Europe.