For a long time, Real-World Evidence (RWE) in healthcare hasn’t been accepted by the German authorities. However, a new “RWE instrument” has been available for German Health Technology Assessments (HTAs) since summer 2019. It is called the “erweiterte anwendungsbegleitende Datenerhebung” (extended application-accompanying data collection, or EAD).
This instrument was introduced by the new law GSAV (Gesetz für mehr Sicherheit in der Arzneimittelversorgung), and it allows the G-BA to request the collection of post-launch data accompanying the application of selected drugs. This means it will now be possible, for specific cases, that not just data from RCTs will be accepted but also data which has been collected in the “real world”.
Although this is just a small step, it is a first step in the direction of RWE in healthcare in Germany. Moreover, this is also a crucial test for the pharma companies in Germany, as the authorities want to see if RWE is a viable additional option. However, a clear statement was missing: about which method would be the best for the EAD. In order to evaluate suitable methods for the EAD, the G-BA therefore commissioned the Institute for Quality and Efficiency in Healthcare (IQWiG) to prepare a concept of how to best generate the needed data.
The key outcome of the corresponding Rapid Report published in January 2020 was that registry studies appear to be the most promising way to collect this data. After the IQWiG Rapid Report was published, many clients contacted us asking: ‘How should a registry be built, and a registry study designed, so that the HTA will be a success?’
In this white paper, registry experts from Kantar and ZEG-Berlin provide answers and an overview of what is needed for successful registry studies. It also outlines what is most important when a submission is planned in Germany in terms of the GSAV. To provide a full picture, this paper shares additional insights regarding the Pharmaceuticals Market Reorganisation Act (AMNOG) process and Market Access in Germany, especially when it comes to GSAV-related submissions.
There are a lot of aspects to consider, and we recommend carrying out a gap analysis together with our registry experts to further define your strategy. Working together with our experienced registry experts can be the key for successful submissions. For that purpose, Kantar’s Health division offers a full package of services along the complete AMNOG process, which are also described in this paper.