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 order to effectively utilize this, it is time to start now to provide sufficient time for each of the steps. Read prior blog.
Synergus RWE together with the support of Dr Martin Braun can support you through each of the steps:
1, Evaluate the NUB eligibility / probability
The first step is to evaluate the eligibility of the NUB process, followed by an assessment of the probability of success in the application. Based on the extensive experience we have the capability to provide unique insights in this step, which are crucial in the strategy moving forward.
Out-put:
- NUB eligibility
- NUB probability for success
- Strategy for the consequent steps
2, Evaluation of 137(h) assessment
Starting with an internal analysis of the eligibility for the process, followed by a formal request to G-BA to clarify eligibility to the process. Some of the variables are rather straight forward to assess, but the most challenging to assess in the understanding of a “new scientific concept”
Output:
- Internal 137(h) eligibility assessment
- Formal assessment by GBA regarding eligibility. (Only if required)
3, Evaluation of decision maker requirements for clinical study
If you qualify for the 137(h) process, you are likely be required to participate in a government sponsored clinical trial in Germany, unless an adequate international study is already planned or underway. The aim of this trial is to establish a high level of evidence in order to assess if the technology should be provided in Germany. This will be a rigours trial with high methodological requirements.
Output:
- Analysis of evidence requirements of G-BA
4, Scientific meeting with G-BA to clarify essential issues regarding the potential study
G-BA offers the possibility to have a scientific meeting to evaluate different questions relating to a potential study. This provides an essential step to ensure that the study that eventually will come out of this process will be relevant and well designed.
- Conclusions from scientific meeting.
5, Prepare for the process 2020
When you have clarified all the prior steps it is time to start preparing for the actual submission process of the NUB, which hospitals to select etc. This process should preferably start April 2020.
Click here to contact us to start the process to get consulting support.
Here is a brief summary of Dr Martin Braun’s experience:
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, including the NUB decisions. 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.