Early benefit assessments
Since the year 2011, most medications containing new active ingredients must be assessed as soon as they enter the German market in order to find out whether they have any additional benefits compared to the current standard treatment. The price of the new medication is set by the manufacturer at first, but may be adjusted based on the outcome of the assessment. The law governing this early benefit assessment is called AMNOG (ArzneimittelMarktNeuOrdnungsGesetz) in German, which means “Act on the Reform of the Market for Medicinal Products.”
When a medication is launched, the manufacturer has to submit a collection of documents (a dossier) to the German Federal Joint Committee (G-BA). This dossier must contain the results of all relevant studies on the new medication.
The Institute for Quality and Efficiency in Health Care (IQWiG, Germany) assesses this dossier on behalf of the G-BA. Within three months, IQWiG issues a report evaluating the advantages and disadvantages of the new medication compared to the current standard treatment. G-BA and IQWiG both publish the results of the benefit assessment.
