Knowledge base
Archived articles from Synergus RWE, kept for reference.
14 articles
Class IIb and III – Clarify Eligibility for 137 (h) prior to submitting NUB in Germany!
In a recent post by G-BA, they reinforced to the hospitals are required to submit a 137(h) application for medical devices of class IIb or III, unless G-BA already has clarified that the product is not eligible. It is…
Reimbursement may not be the primary barrier for digital health!?
What can we learn from the critique of the insurance companies regarding the German DiGA experience? I am the first to recognize that there is a significant gap in most healthcare system regarding the process to…
The German NUB process, the most risky process for a start-up?
For many medical device companies, the German NUB process to fund innovative medical devices used in the hospitals, has been known as the most attractive option for a European launch. This is a brief overview of how the…
Five digital solutions approved for temporary reimbursement in Germany – Up to 2000 €/year in reimbursement
Germany has launched a reimbursement process for digital solutions focused on the patient and with regulatory class I or IIa according to the MDR. If you are interested to learn more about the process, these recorded…
How will the payer view the value of a digital solution in Germany?
How will the payer view the value of a digital solution in Germany? Coming back after an intense and inspiring day in Heidelberg about the new regulation for reimbursement of digital health I am very encouraged to see…
5 key-steps to unlock the potential for the new attractive reimbursement opportunity in Germany
5 key-steps to unlock the potential for the new attractive reimbursement opportunity in Germany The recent change that was announced in Germany regarding the process for innovation funding will become effective 2020. In…
German reimbursement opportunity for medical devices re-opens 2020 !
A change to the German legislation regarding the introduction of new innovative medical devices have just been implemented as of May 1 st . The new law will be applicable as of 2020. It is not clear how all aspects of…
6 E-health projects funded by G-BA in Germany (1,3-19,6 million €)
G-BA has an innovation fund that provides funding to specific projects. These are the 6 programs relating to e-health that they have provided funding for: ERIC – Enhanced Recovery after Intensive Care: 6.8 million €…
GKV-Spitzenverband says more high-risk medical devices should be assessed by G-BA in § 137h
Background With the introduction of § 137h SGB V in 2016, the German legislator introduced a systematic early assessment of new medical devices based on high-risk methods in the hospital sector. If a hospital applies…
The first submissions for NUB-related benefit assessments for high-risk medical devices
Background With the introduction of § 137h to the SGB V, hospitals have to hand in an extensive value dossier comprising information on the current scientific knowledge of the technology to the Federal Joint Committee…
The ability to demonstrate savings in the real world is very relevant for payer
The value of real world data is frequently debated. This is very much dependent on the perspective of the person who is reviewing the data. If you are able to use real world data to demonstrate to a payer that they can…
Introduction of benefit assessment requires complete rethink about how to handle nub-applications for new interventions
There are many aspects that are changing with the introduction of the new 137h process to assess the benefit of the new innovations coming to market. We will provide more information about all of these changes in a…
The changing landscape in Germany regarding HTA assessments
The changing landscape in Germany regarding HTA assessments The German landscape for introduction of new technologies and drugs is changing dramatic. For drugs, the introduction of the Amnog process has been a drastic…
Health technology assessments of in-vitro diagnostic tests
This study revealed similarities in evidence requirements for in-vitro diagnostic tests in health technology assessments in England and France. However, economic evidence is not a part of French assessments of new codes…