Many medical device companies are aware about the German innovation funding (NUB) for hospital-based procedures. Historically it has proven to be an attractive pathway to establish early reimbursement.
A few years ago, a new parallel process to the NUB was introduced, the 137(h) by G-BA. This requires a sub-group of products applying for NUB to also make a submission to G-BA. This will initiate a rapid HTA-assessment which will either lead to the result that the technology has a proven benefit or the need to carry out a clinical trial to prove the benefit. If a trial is initiated, the overhead cost of the study will be covered by G-BA and the product will be reimbursed through the DRG/NUB. If a trial is deemed necessary and the company choose to not collaborate regarding such trial, the product will not be reimbursed in Germany and may also be actively excluded from the system.
For some, this may appear as a significant barrier, but if properly utilized it will provide a very attractive route to a government sponsored clinical trial. However, if you start this process without due preparation there is a risk that you will terminate the potential market in Germany.
With this webinar, we want to share our experience from a few of these processes and provide guidance on the important steps to consider.
- The basics of the NUB process
- The 137 (h) process
- Possibly useful preparatory G-BA consultation procedure
- Preparing the dossier
- Understanding the relevant outcomes for a payer
- Modelling clinical trial scenario
- Engaging clinical societies
- Dr Martin Braun
- Mattias Kyhlstedt
Dr Martin Braun is a physician and expert for the health care system. His specialty is the health policy strategy for the reimbursement of hospital services.
He studied Medicine at the University of Heidelberg. He worked as a clinician in a hospital for 10 years and specialised in Internal Medicine, Gastroenterology and Diabetology. In the course of his postgraduate studies at the University of Heidelberg/Mannheim, he received a master’s degree in Health Care Management. Furthermore, he completed additional training in Quality Management in accordance with the requirements of the German Medical Association. Until 2000, he worked as a Consultant in the Ansbach Clinical Centre. In 2001, he moved to the German Hospital Federation in Düsseldorf, where he was the Assistant Head of the Medical Department. From 2003 to 2010, he was the Head of the Medical Department of the German DRG Institute (InEK GmbH) in Siegburg, where he was responsible for the development of the German DRG System. He, simultaneously, supervised the international collaboration, for example, with Switzerland and Cyprus. At the same time, he taught at several Colleges, e.g. Health Care Management Faculty at the University of Applied Sciences in Krefeld.
In January 2011, he founded a consulting company. He has been working as a Health Care Management Expert at a national and international level since that time. He advised a couple of countries, e.g. Thailand, Slovakia, Malta, Turkey and Serbia with respect to the financing of hospital services with the assistance of DRGs. Since 2012, he is consulting the Greek Ministry of Health on the introduction of a DRG System in Greece.