Gemeinsamer Bundesausschuss / IQWiG

The Gemeinsamer Bundesausschuss is the self-governing body of insurers, physicians and hospitals that determines the benefits covered by Germany's statutory health insurance, and the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen in Cologne is the independent institute it commissions to assess evidence. Under the AMNOG early benefit assessment since 2011, every new drug is judged for added benefit against the appropriate comparator within a year of launch, and the rating (from major added benefit to none) drives the price negotiated with the insurers' association. IQWiG's demanding view of surrogate endpoints, single-arm trials and quality-of-life data has shaped how companies design oncology trials for Europe, and G-BA decisions also govern screening programmes and quality requirements for cancer centres.