OBJECTIVES: There are three main governmental stakeholders in the German AMNOG process: The IQWiG assesses the AMNOG drug manufacturer’s submission and provides advice on any additional benefit  to the GBA who makes the final decision. Following confirmation of additional benefit, manufacturers start price negotiations with the GKV-Spitzenverband (association of German sickness funds). The aim of this research is to assess the AMNOG-decisions so far. METHODS: All AMNOG decisions up to December 2012 were analyzed in terms of additional benefit decision, reason for additional benefit decision, reimbursed price versus manufacturer set price, and consistency in IQWiG-recommendation and GBA-decision. RESULTS: In total AMNOG decisions of 41 drugs (60 subgroups) were identified. IQWiG recommendations were as follows: 22 cases demonstrated no additional benefit, 2 unquantifiable benefit, 3 slight benefit, 7 significant benefit, and 7 additional benefit due to orphan-drug status. In 6 cases, the GBA upgraded IQWIG’s recommendations. In 3 cases it downgraded it. The following reasons were identified for GBA “additional benefit decisions” (multiple reasons apply for some decisions): No or non-quantifiable additional benefit (18 cases); no reliable clinical data (14 cases; 3 cases no submission), wrong comparator (5 cases); additional benefit in any form (23 cases): mortality advantages (7 cases), orphan drug status (7 cases), morbidity advantages (8 cases), and QoL advantages (3 cases). The negotiated price rebates varied from 4.7% to 70.7% based on manufacturer set price; the rebates show limited correlation to the degree of additional benefit so far. CONCLUSIONS:  Key factors for positive AMNOG decisions are conducting superiority trials on mortality or at least morbidity/QoL against active comparators. If benefits are based on soft end-points, it is crucial to demonstrate these on high quality, preferably German data. Indirect comparisons seem to be challenged as proof of additional benefits.