A regulation that came into effect in Germany in early 2011 now stipulates that the added benefit of most medications containing new active ingredients be assessed as soon as they enter the market. Manufacturers initially set the prices for their new medications, but afterwards prices are based on the results of this assessment, called an “early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG).”
When a medication is launched, the manufacturer is required to submit a dossier to the German Federal Joint Committee (G-BA) for early benefit assessment. This dossier must contain the results of all relevant studies on the new drug.
The Institute for Quality and Efficiency in Health Care (IQWiG, Germany) assesses this dossier on behalf of G-BA. Within three months, IQWiG issues a review evaluating the advantages and disadvantages of the new drug in comparison with an appropriate comparator treatment. G-BA and IQWiG both publish the final review.
You can find these drugs in the following table. An alphabetical list is available here.