Guest: Anja Pownell

German Market Access – Simplified: https://germanmarketaccesssimplified.com/

Introduction

Since 2020, the German Federal Joint Committee (G-BA) can request real-world evidence (RWE) to enhance its decision-making, as a crucial complement to traditional clinical trial data, for drugs that received regulatory approval under special statuses.

The process of requested RWE collection is meticulous and involves several key steps:

1. Plenum Determination: The G-BA plenum decides whether RWE collection is necessary for a specific drug.
2. Draft Concept Development: Within the next six months, the G-BA or IQWiG develops a draft concept that outlines the data collection’s specifics, including type, duration, extent, key questions, data collection methods, and data evaluation.
3. External Expert Input: The G-BA shares the draft concept with external experts, including the Federal Institute for Drugs and Medical Devices (BfArM), the Paul-Ehrlich-Institute (PEI), medical societies, the Drug Commission of the German Medical Association (AkdÄ), and the manufacturer, for their input.
4. Finalization of the Concept Plan: The G-BA plenum finalizes the concept plan within the next 6 months, ensuring that it covers all aspects of data collection. In some cases, the G-BA may restrict reimbursement to clinicians participating in the data collection, ensuring comprehensive data coverage.
5. Data Collection and Evaluation: The manufacturer is then responsible for conducting the study, which can involve setting up new studies or utilizing existing registries to capture the required data. The manufacturer evaluates the collected data and shares the analyses with G-BA.
6. Periodic Assessments: Every 1.5 years, the G-BA assesses the progress of data collection, evaluating whether the data collection is proceeding as planned, whether the data is sufficient for a benefit re-assessment, and whether any amendments to the concept plan are needed to enhance data meaningfulness.

The Role of IQWiG

With the introduction of the RWE collection requests, in 2020, the Institute for Quality and Efficiency in Health Care (IQWiG) developed criteria and detailed recommendations for manufacturers and registries on how to supplement the trial data with RWE (German: “Versorgungsnahe Daten”), such as registry data. If the RWE is of high quality, the IQWiG and G-BA can use it to determine the additional benefit of an intervention outside of a clinical trial.

According to IQWiG, “manufacturers don’t interpret the detailed requirements on RWE collection how we wish they did. Overall, the problems often were missing key information and differences between patient populations. It was not possible to conduct a meaningful benefit assessment with the data. Manufacturers often did identify the problems themselves but did not draw the necessary consequences.”