title: Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation.
abstract: OBJECTIVE
  Since the introduction of the German health care reform in January 2011, an early benefit assessment (EBA) is required for all new medicines. Pharmaceutical manufacturers have to submit a benefit dossier for evaluation by the Institute for Quality and Efficiency in Health Care (IQWiG). A final decision is made by the Federal Joint Committee (G-BA). The aim of this investigation was to analyse the outcomes 18 months after introduction of the new legislation and to identify critical areas requiring further discussion and development.
  
  
  METHODS
  All EBAs commenced prior to June 2012 were included. The G-BA website was used to obtain manufacturers' benefit dossiers, IQWiG assessments, and G-BA decisions. Four areas of interest were analysed: levels of additional benefit, appropriate comparative therapy (ACT), patient-relevant endpoints, and adverse events.
  
  
  RESULTS
  Twenty-seven EBAs were analysed. IQWiG stated a benefit in 50% of EBAs, whereas G-BA stated a benefit in 63%, but only in 50% of identified subgroups and 40% of patients involved. In 12 EBAs, the ACT suggested by G-BA differed from the comparator used in phase III trials. The G-BA reported no benefits on health-related quality of life. Discrepancies arose in morbidity outcomes such as 'progression-free survival' and 'sustained virological response'. Categorisation and balancing of adverse events was conducted within various assessments.
  
  
  CONCLUSIONS
  Considerable variance was observed in the levels of additional benefit reported by pharmaceutical manufacturers, IQWiG and G-BA. The areas of disagreement included ACT selection, definition of subgroups and patient-relevant endpoints, and classification and balancing of adverse events.
authors.affiliation: Roche Pharma AG, Emil-Barrell-Str. 1, 79639, Grenzach-Wyhlen, Germany, joerg.ruof@roche.com.
authors.forename: Jörg
authors.initials: J
authors.lastname: Ruof
authors.forename: Friedrich Wilhelm
authors.initials: FW
authors.lastname: Schwartz
authors.forename: J-Matthias
authors.initials: JM
authors.lastname: Schulenburg
authors.forename: Charalabos-Markos
authors.initials: CM
authors.lastname: Dintsios
mesh_terms: D003659:Decision Making, Organizational; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D016527:Drug Costs / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D005858:Germany; D018166:Health Care Reform / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D006801:Humans; D016896:Treatment Outcome