OBJECTIVES: The IQWiG as the methodologically meticulous critic and the G-BA as the final decision-maker carry out a benefit assessment for new drugs after market entry in Germany (§ 35a SGB V). If a medicinal product is not granted an added benefit, its annual treatment costs must not exceed those of a comparator, which could substantially jeopardize the business case for Germany, and thereby for all European countries. This analysis aims to identify if, and why, the G-BA has overruled a no-added-benefit proposal by the IQWiG in the past.

METHODS: Using our SKC database, all benefit assessments initially proposing no added benefit by IQWiG and subsequently being granted any added benefit by G-BA were identified (until June 2020). The respective rationale was manually extracted out of the dossier assessment, resolution, the hearing protocols and the main reasons (“Tragende Gründe”). The SKC database is based on publicly available data, combining IQWiG/G-BA assessments with GKV-SV price negotiation outcomes (LAUER-TAXE®).

RESULTS: IQWiG was involved in 402 of 514 procedures until June 2020. Within 301 procedures with no added benefit in ≥ 1 subpopulation, the G-BA followed in 230 cases (79,4 %). In 38 cases, the manufacturer re-submitted data, which changed the IQWiG’s position in 16 cases. In the remaining 55 initial assessments, the IQWiG’s main reasons were incorrect comparator (53 %), slicing of population (15 %) and inadequate study population (9 %). The G-BA overruled the IQWiG’s decision and was mainly convinced by clinical experts (78 %) in the hearing procedure and/or the therapeutic need in the indication (67 %).

CONCLUSIONS: Despite still having high quality standards, the G-BA listens to clinical experts and considers e.g. the therapeutic need in the indication. In the AMNOG process, a link of clinical evidence to actual therapeutic need in the current care context is therefore essential.