title: Health benefit assessment of pharmaceuticals: An international comparison of decisions from Germany, England, Scotland and Australia.
abstract: BACKGROUND
  Little is known on the performance of the newly introduced health benefit assessment process, AMNOG, in Germany compared to other health technology assessment agencies.
  
  
  OBJECTIVE
  We analysed whether decisions of the German Federal Joint Committee (FJC) deviate from decisions of the UK National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the Australian Pharmaceutical Benefits Advisory Committee (PBAC).
  
  
  METHODS
  We analysed decisions made for comparable patient subgroups by the four agencies between 2011 and 2014. First, decisions were compared (a) by their final outcome, i.e. whether a health benefit was identified, and (b) by the agencies' judgement on comparative effectiveness. Subsequently, we partially explored reasons for differences between HTA agencies.
  
  
  RESULTS
  From the 192 FJC decisions, we identified 55 that overlapped with NICE, 166 with SMC and 119 with PBAC. FJC agreed with NICE in 40% in final outcome (Cohen's Kappa=-0.13). Similar results were obtained for FJC and SMC (47.6%, kappa=0.03) and FJC and PBAC (48.7%, kappa=0.07). Agreement increased when comparing judgements based on comparative effectiveness only. However, the FJC's final decision was positive only in 43.6%, 39.2% and 44.5% of the patient subgroups, as opposed to 74.5% (NICE), 68.7% (SMC), and 68.9% (PBAC), respectively.
  
  
  CONCLUSIONS
  We show that the FJC - an agency relatively new in structurally assessing the health benefit of pharmaceuticals - deviates considerably in decisions compared to other HTA agencies. Our study also reveals that the FJC tends to appraise stricter than NICE.
authors.affiliation: Hamburg Center for Health Economics, University of Hamburg, Hamburg, Germany; Columbia Business School, Columbia University, New York, USA.
authors.forename: Katharina Elisabeth
authors.initials: KE
authors.lastname: Fischer
authors.affiliation: Hamburg Center for Health Economics, University of Hamburg, Hamburg, Germany; Ludwig-Maximilians-University Munich, Munich, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Heisser
authors.affiliation: Hamburg Center for Health Economics, University of Hamburg, Hamburg, Germany. Electronic address: Tom.Stargardt@wiso.uni-hamburg.de.
authors.forename: Tom
authors.initials: T
authors.lastname: Stargardt
mesh_terms: D001315:Australia; D057186:Comparative Effectiveness Research; D003659:Decision Making, Organizational; D004345:Drug Industry; D005060:Europe; D006077:Government Agencies / Q000458:organization & administration*; D006292:Health Priorities; D006801:Humans; D019458:Insurance Coverage / Q000191:economics / Q000458:organization & administration; D007391:International Cooperation; D010043:Outcome and Process Assessment, Health Care; D013673:Technology Assessment, Biomedical / Q000379:methods / Q000458:organization & administration*
keywords: Decision making; Early Benefit Assessment; Priority setting; Reimbursement of pharmaceuticals