title: Relative efficacy and effectiveness assessment of new pharmaceuticals in three EU member states: current practices and outcome agreement between Belgium, the Netherlands and France.
abstract: OBJECTIVE
  Relative efficacy and effectiveness assessment (REA) of a pharmaceutical product is critical in reimbursement decisions. The Pharmaceutical Forum (2005-2008) asked European Union (EU) member states (MS) to strengthen the methodological quality and rigor of REA and identify any scope for common approaches. Here, we have compared REA practices and results within three EU MS with similar reimbursement procedures for the period 2007-2010 to describe the actual situation.
  
  
  METHODS
  Assessment procedures and reports from the Belgian, Dutch and French Agency websites were retrieved and corresponding products matched. The REA-outcome was coded as added therapeutic value (ATV) yes or no. The strength of agreement between the three MS was estimated and analyzed in relation to some explanatory variables.
  
  
  RESULTS
  Of the 144 Belgian, 122 Dutch and 236 French assessment reports retrieved, ATV was granted in 35, 39 and 23 % of cases, respectively, with 72 matches between the three MS. In all MS the results of at least one randomized trial were available in >90 % of reports. Between two MS significant agreement was achieved in ≥ 72 % of cases; this was 54 % between the three MS. Differences in ATV existed for treatments in severe chronic diseases. Assessment procedures were poorly documented in Belgium and France.
  
  
  CONCLUSIONS
  Our findings reveal that the three similar EU MS under study agree on the REA-outcome of only half of the new drugs. Differences in applied methodology (e.g. inferences from study results, handling of uncertainty) between MS may exist. We suggest that a joint REA approach would benefit from a common understanding and application of the scientific assessment process using shared guidelines.
authors.affiliation: Department of Clinical Pharmacology and Pharmacotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090, Brussels, Belgium, philippe.smart@gmail.com.
authors.forename: P B
authors.initials: PB
authors.lastname: Van Wilder
authors.forename: V V
authors.initials: VV
authors.lastname: Bormans
authors.forename: A G
authors.initials: AG
authors.lastname: Dupont
mesh_terms: D001530:Belgium; D004358:Drug Therapy / Q000592:standards*; D005062:European Union; D005602:France; D006801:Humans; D009426:Netherlands; D000091402:Prohibitins; D012051:Reimbursement Mechanisms; D016896:Treatment Outcome