ABSTRACT
Federal Institute for Pharmaceuticals and Medical Devices (Bundesinstitut Fur Arzneimittel Und Medizinprodukte, Bfarm) BfArM holds responsibility for licensing of new pharmaceuticals and medical devices in Germany. Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) G-BA is the most important self-governing body, responsible for all German reimbursement decision making and guidelines, including reference pricing groups. G-BA has been evaluating added benefits for pharmaceuticals as part of the AMNOG (Arzneimittelmarkt-Neuordnungsgesetz) process for prescription drug price negotiations. AMNOG is a federal price control system based on the assessment of the benefit of newly authorized pharmaceuticals in comparison with existing treatment alternatives. Reimbursement of pharmaceuticals is controlled by the Federal Joint Committee and several other committees on behalf of the Federal Ministry of Health. Reimbursement decisions are officially not linked to price, but rather to the offered value. In Germany the term "price referencing" is used, since formally it is not used to set price, but rather to establish reimbursement limits.
