Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation

• DOI: 10.1007/s10198-013-0495-y
• Publication Date: 2013-06-15T06:14:33Z
• Authors: Jörg Ruof; Friedrich Wilhelm...; J.-Matthias Schul...; Charalabos-Markos...
• Keywords: Adverse selection

Since the introduction of German health care reform in January 2011, an early benefit assessment (EBA) is required for all new medicines. Pharmaceutical manufacturers have to submit a dossier evaluation by Institute Quality and Efficiency Health Care (IQWiG). A final decision made Federal Joint Committee (G-BA). The aim this investigation was analyse outcomes 18 months after legislation identify critical areas requiring further discussion development. All EBAs commenced prior June 2012 were included. G-BA website used obtain manufacturers' dossiers, IQWiG assessments, decisions. Four interest analysed: levels additional benefit, appropriate comparative therapy (ACT), patient-relevant endpoints, adverse events. Twenty-seven analysed. stated 50 % EBAs, whereas 63 %, but only identified subgroups 40 patients involved. In 12 ACT suggested differed from comparator phase III trials. reported no benefits on health-related quality life. Discrepancies arose morbidity such as 'progression-free survival' 'sustained virological response'. Categorisation balancing events conducted within various assessments. Considerable variance observed pharmaceutical manufacturers, G-BA. disagreement included selection, definition classification