On 19 September 2025 the Federal Joint Committee (G-BA) issued a press release 'New medicinal products: G-BA defines procedural rules for previous EU assessment', outlining how it will adapt its early benefit assessment (AMNOG) process in response to the new EU-wide Health Technology Assessment (HTA) Regulation. The regulation introduces a system of Joint Clinical Assessments (JCAs), which will provide a single evidence evaluation for new medicines for use across the EU.
The G-BA has now finalised the procedural rules for how these JCAs will be incorporated into the German system. The core principle is that the European JCA report will serve as the scientific basis for the G-BA's subsequent national assessment. As a result, the G-BA will no longer routinely commission its own separate evidence report from the Institute for Quality and Efficiency in Health Care (IQWiG) when a JCA is available, a significant shift designed to reduce duplication of effort.
However, the G-BA maintains its exclusive national authority to determine a drug's "added benefit" (Zusatznutzen), the crucial step that informs price negotiations. Karin Maag, the impartial chair of the G-BA, stated, "The European assessment is the new basis for our work. But the final decision on the added benefit for patients in Germany remains our sovereign task."
Under the new rules, pharmaceutical companies will still be required to submit a dossier to the G-BA. This dossier will be a "leaner" version, building directly on the JCA report but adding specific context for the German healthcare system. Crucially, companies must demonstrate the new drug's value against the specific comparator therapy that is the standard of care in Germany. The G-BA also retains the right to request supplementary analyses from the company if it deems the JCA report insufficient for the German context. The deadline for submitting this national dossier will be one month after the final JCA report is published.
This decision creates a clear, two-stage process for new medicines. Companies must first navigate the EU-level assessment and then successfully translate that evidence for the specific requirements of the German system, ensuring their clinical data aligns with the national standard of care to secure a positive added benefit rating.
Source: Neue Arzneimittel: G-BA legt Verfahrensregeln für vorangehende EU-Bewertung fest
Date: 19 September 2025
