In Germany, the Federal Joint Committee (G-BA) defines the requirements for the scientific evaluation of the benefits, the necessity and the economic efficiency regarding the reimbursement of medicines, following AMNOG (Arzneimittelmarkt-Neuordnungs-Gesetz). The requirements have been recently revised and were entered into force on 17 January 2019. For pharmaceutical companies, this means that the requirements for a reimbursement dossier have now changed. Our aim is to summarise and evaluate the potential impact of these important changes.

We summarized the updated requirements for reimbursement of medicines in Germany, focussing on the structure and contents of Dossiers on benefit assessment (Dossier zur Nutzenbewertung gemäß §35a SGB V).

The revised G-BA requirements offer simplifications regarding the preparation of clinical trial results, such that the effort for companies should be reduced. Simplifications and clarifications have been provided regarding the specification of the presentation of results on single studies, meta-analyses and subgroup analyses, effect modifications, indirect treatment comparisons, and the choice of the appropriate comparator. The instructions for the presentation of adverse events have been improved and criteria for their presentation at the level of SOCs, PTs or SMQs have been better specified.

The updated requirements for reimbursement of medicines in Germany offer clearer instructions to pharmaceutical sponsors on how to develop reimbursement dossiers. Sponsors can potentially reduce the efforts required for the development and presentation of clinical trial results. They also have further opportunities to maximize their chances of a successful submission.