AMNOG (Germany, 2011)

Germany, federal statute. The Arzneimittelmarktneuordnungsgesetz (AMNOG, the Act on the Reform of the Market for Medicinal Products) was passed in November 2010 and took effect on 1 January 2011, inserting section 35a into Book V of the Social Code (SGB V). Primary text: SGB V section 35a on Gesetze im Internet; the Federal Joint Committee (G-BA) publishes an English overview and every assessment.

How it works: at launch the manufacturer submits a dossier comparing the medicine with an 'appropriate comparator therapy'; the Institute for Quality and Efficiency in Health Care (IQWiG) reviews it within three months and the G-BA decides within six whether the added benefit is major, considerable, minor, non-quantifiable, absent or less than the comparator, by patient subgroup. The manufacturer and the National Association of Statutory Health Insurance Funds then negotiate a reimbursement price, with arbitration if they fail; medicines with no added benefit are priced against the comparator. Orphan medicines are presumed to have added benefit until annual sales pass a threshold, lowered from 50 to 30 million euros by the GKV Financial Stabilisation Act of 2022, which also made the negotiated price apply from the seventh month rather than the thirteenth and added price guardrails for medicines with little added benefit.

Why it matters for oncology and the arguments: cancer medicines are the largest group assessed and often receive the highest added-benefit ratings, and Germany remains the fastest large European market for access. Companies object that IQWiG discounts surrogate endpoints and single-arm data and that subgroup verdicts fragment indications; payers argue that the system prices by evidence and that the German list price still anchors reference pricing across Europe. The EU joint clinical assessments from 2025 draw heavily on AMNOG methods.