AMNOG: Pharmaceutical benefit assessment in Germany
AMNOG, the German Pharmaceutical Market Restructuring Act, has provided a central framework for the assessment and pricing of new medicines in Germany since 2011. For medicines with new active substances, the process assesses whether they provide an added benefit compared with the appropriate comparator therapy. The subsequent decision by the Federal Joint Committee (G-BA) provides an important basis for determining the reimbursement amount.
AMNOG links the early benefit assessment with the subsequent pricing process. For pharmaceutical companies, this creates requirements for evidence planning, dossier preparation, procedural planning and market access.
AMNOG benefit assessment
How does the German AMNOG benefit assessment work? The guide explains the process from dossier submission and IQWiG assessment through the commenting procedure and G-BA decision to the subsequent reimbursement price negotiation.
AMNOG dossier
What are the requirements for the AMNOG dossier? The guide explains the structure, modules and evidence requirements of the German dossier and how EU HTA affects national dossier preparation.
AMNOG Insights
What can current AMNOG procedures and decisions tell us? The insights analyse current benefit assessments, G-BA decisions, methodological developments and regulatory changes relevant to evidence strategy, dossier preparation and market access.
AMNOG Readiness Check
How well prepared is a product for the AMNOG process? The AMNOG Readiness Check structures key questions around evidence, comparator therapy, dossier preparation and procedural readiness.