The German NUB process, the most risky process for a start-up?
08 Feb 2022

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 NUB process has developed over time:

  • Before 2010 The golden device opportunity
    In the early days of the NUB funding, there was limited evaluation of the evidence by the insurance and the device companies were generally able to have a very low barrier to quick market uptake
  • 2010-Ongoing: NUB stopped by insurance companies
    Over time the insurance companies increased the scrutiny of the clinical evidence and started to reject payments in broad scale. Even though formally not included, high quality evidence became a requirement. This situation is still relevant for technologies qualifying for 137(h).
  • 2017-2020 – 137 (h) Version 1, to risky to apply
    With the initial introduction of the 137(h) process the barrier to qualify for a ‘coverage with evidence development program” (CED) was high. Companies who failed to meet criteria were excluded from payment in Germany. No companies dared to apply.
  • 2021 – 137 (h) version 2, hopeful future
    With the revised process for 137(h), the risk of being excluded is reduced. Considering the indirect requirement of RCT data for a long period, this is a very valuable opportunity for companies.
    The CED program can provide reimbursement for the device during the trial and the cost for the trial is covered by the authorities, as long it is an inpatient method.

The current situation is extremely favorable for the technologies who qualify for the new 137(h) process. It is now possible to establish reimbursement and to qualify for a government sponsored clinical trial of high quality (RCT) that will likely meet the requirements for payers across Europe.

We have been supporting the first company who had a directive for such trial established, with an estimate of 800-4000 patients to be included. If such trial would be done by a company it would like cost 10’s of millions of Euros.

So, what is the risk?

First of all, the technology should have the capacity to deliver a comparative benefit for outcomes aligning with the methodological framework by G-BA, focusing on Mortality, Morbidity and to some degree health related quality of life.

The risky part is that G-BA is responsible to develop the high-level protocol for the study design, which eventually will lead to a formal decree on how to the study should be carried out. The process is under extreme time pressure, where the evaluators have 1-2 months to develop recommendations for something that normally would take a year. As a company you can influence the result through the initial application and two feedback rounds.  For companies with limited experience in HTA type requirements, there is an imminent risk that the process may result in a clinical trial decree that could be devastating for the ability to demonstrate the benefit of the technology. In this scenario, the company has the option to agree to a trial where there is a high risk that technology will not be able to demonstrate a benefit and eventually kill the future for the technology. The other option is to withdraw from the trial and consequently leave the German Market.

There is currently one company who has a formal clinical trial decree in and 7 more that are in different stages of development.

If you are interested to learn more about how to get this right, don’t miss our upcoming webinar.