The AMNOG procedure
Does the new drug have an added benefit versus standard treatment? This is the question to be investigated. To prove the drug’s added benefit, the pharmaceutical company prepares a dossier. Immediately after approval of the new drug, the company sends this dossier to the , which forwards it to IQWiG for scientific assessment. IQWiG prepares a so-called dossier assessment. Using this assessment, the then makes a decision on the added benefit, which serves as the basis for setting the price of the new drug.