Guest: Anja Pownell

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

Introduction

The German Federal Joint Committee (G-BA), responsible for assessing the additional benefits of healthcare interventions, theoretically, has a relatively new tool at its disposal to make more informed decisions. Since 2020, G-BA has had the authority to request real-world evidence (RWE) data collection for certain products, providing a valuable addition to the traditional clinical trial data used in benefit assessments.

Real-World Evidence Data Collection requested by the G-BA

Some drugs, such as those with conditional approval, those authorized under exceptional circumstances, or orphan drugs, receive regulatory approval under special statuses. These approvals aim to make these treatments available to patients quickly, often leading to a lack of mature or sufficient data for conventional benefit assessments.

In these cases, the G-BA can request that manufacturers collect RWE on their use in routine clinical practice, a process known as “Anwendungsbegleitende Datenerhebung.” The G-BA can request this data collection from the manufacturer immediately upon market entry of a new drug or at a later time point. This data collection ensures better, more relevant information becomes available as patients receive the product in daily German clinical practice.

After several years, the G-BA re-evaluates the drug, incorporating the collected RWE alongside data from clinical trials. This comprehensive evaluation is intended to help the G-BA make more informed decisions regarding the additional benefit. Currently, RWE collection is underway for only two products, highlighting the novelty of this approach:

– Zolgensma in spinal muscle atrophy, final data expected by 2027.

– Tecartus in relapsed/refractory mantle cell lymphoma, final data expected in 2028.

The need and feasibility of RWE collection are being assessed for another 8 products.

Thus, it is too early to fully understand the role RWE will play in G-BA’s decision-making. These first re-assessments after RWE collection in 2027 or 2028 will undoubtedly provide valuable insights into how the G-BA will deal with the non-comparative RWE.

The Future of RWE in G-BA’s Decision-Making

As we move forward, it will be interesting to see how the utilization of RWE in benefit assessments evolves and expands, offering more insights and maintaining a high level of transparency in the decision-making process within the German healthcare system.

[Source: G-BA – Anwendungsbegleitende Datenerhebung] (https://www.g-ba.de/themen/arzneimittel/arzneimittel-richtlinie-anlagen/anwendungsbegleitende-datenerhebung/)