>> When the Medicines Market Reorganization Act (AMNOG) came into force on January 1, 2011, the early benefit assessment of new active ingredients in accordance with Section 35a SGB V was introduced. The dossier submitted by the pharmaceutical company forms the basis for the assessment of the additional benefit. The first drug to have a completed benefit assessment procedure was ticagrelor (Brilique®) with the G-BA decision of December 15, 2011. The platelet aggregation inhibitor for the treatment of coronary artery disease was certified as having considerable additional benefit in patients with unstable angina pectoris (IA) or patients with myocardial infarction without the specific ECG infarction sign of ST-segment elevation (NSTEMI). This patient group represents approximately 73 percent of the total reported patient population for ticagrelor. There was a hint of a non-quantifiable additional benefit for two further restricted patient groups. There was no evidence of an added benefit for three patient groups. In the benefit assessment process of ticagrelor (+ASA), clopidogrel (+ASA) and prasugrel (+ASA), which is characterized in particular by a significant reduction in non-fatal heart attacks (AM-Rl Appendix IV), were selected as appropriate comparator therapies. In the areas of application with an additional benefit, ticagrelor is considered a practice specialty from the first case of treatment in accordance with Section 106 Paragraph 5a SGB V.
In addition, the

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