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 webinar in a few weeks.
For companies that apply for NUB for the first time and qualify for the criteria for the 137h benefit assessment, the most common outcome will be “potential benefit, not proven”. This results means that you could trigger a process that will lead to a clinical trial to demonstrate the benefit and to a comfortable reimbursement, if NUB preconditions are fulfilled. If the method is applied by a hospital and the company is not willing to sponsor the study, the procedure will be excluded from the German Healthcare system.
The company should cover the overhead cost for the study and there are discounts available for small and medium size companies.
There are some important changes that this implies:
- Do not submit NUB, unless you are prepared to sponsor the trial.
- Make very careful input to how you would like to have the study design and provide well founded reasons for this. , which creates a high risk that inappropriate input to the process may lead to bad study design.
- When you chose the hospitals to include in the NUB submission, you are also setting up the centers who should participate in the clinical study. This requires a much more thoughtful perspective of many aspects that have not been required before.