Guides AMNOG
Des guides de référence sur les éléments clés de la procédure allemande AMNOG d'évaluation du bénéfice. Ces guides sont proposés en anglais.
Guides AMNOG sur la procédure et le dossier (en anglais)
AMNOG dossier: structure, modules and requirements
The AMNOG dossier is the central evidence submission for the early benefit assessment of new medicines in Germany. Pharmaceutical companies submit the benefit dossier to Germany’s Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA). It contains the information and evidence required to assess the medical benefit and additional benefit compared with the appropriate comparator therapy.
AMNOG process: from early benefit assessment to reimbursement negotiation
The AMNOG process describes the pathway from submission of the AMNOG dossier through the early benefit assessment to the negotiation of the reimbursement amount for new medicines in Germany. It includes dossier submission, the benefit assessment, the commenting procedure, the oral hearing, the G-BA decision on additional benefit and the subsequent reimbursement negotiation.