OBJECTIVES: In 2011, Germany’s new health care reform (AMNOG) came into effect requiring that with market access newly approved products demonstrate their innovation to avoid reference group pricing. The manufacturer has to submit a dossier proving additional benefit versus the appropriate comparator recommended by the G-BA (Joint Federal Committee). On request of the G-BA, IQWiG (Institute for Quality and Efficiency in Health Care) reviews the dossier and performs the benefit assessment. Manufacturers, associations and experts can submit comments and attend a hearing; thereafter the G-BA publishes its final resolution. METHODS: Benefit assessments and G-BA decisions to date were reviewed and analyzed case by case. Differences between IQWiG and G-BA evaluations are outlined and consequences depicted. RESULTS: Up to now 32 dossiers have been submitted, 19 completed the whole process and further 8 will be finally assessed shortly. About half of the products additional therapeutic benefit was granted allowing price negotiations with the statutory health insurance. Not in all cases did the G-BA follow IQWiG’s conclusions as for Eribulin and Pirfenidone (an Orphan drug). The selection of the appropriate comparator treatment was the most controversial issue between G-BA and pharmaceutical companies, followed by questions about evidence for and interpretation of benefit. Thus for Linagliptin no additional benefit against the appropriate comparator is proven according to the G-BA and the manufacturer challenges the process. Other critical methodology issues included the definition of patient-relevant endpoints, use of surrogate endpoints, determination of target patient populations and use of subpopulations. CONCLUSIONS: Although in its second year, AMNOG is still a learning process for all parties involved. Before initiating a dossier it is crucial to investigate possible pitfalls around dossier development. New questions will emerge when it comes to the assessment of drugs already on the market as it is now planned for DPP-4 inhibitors.