title: Cost-effectiveness of dabigatran etexilate in the prevention of stroke and systemic embolism in patients with atrial fibrillation in Belgium.
abstract: OBJECTIVE
  To assess the cost-effectiveness of dabigatran etexilate ('dabigatran') vs vitamin K antagonists (VKAs) in the Belgian healthcare setting for the prevention of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (AF).
  
  
  METHODS
  A Markov model was used to calculate the cost-effectiveness of dabigatran vs VKAs in Belgium, whereby warfarin was considered representative for the VKA class. Efficacy and safety data were taken from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial and a network meta-analysis. Local resource use and unit costs were included in the model. Effectiveness was expressed in Quality Adjusted Life-Years (QALYs). The model outcomes were total costs, total QALYs, incremental costs, incremental QALYs and the incremental cost-effectiveness ratio (ICER). The level of International Normalized Ratio (INR) control and the use of other antithrombotic therapies observed in Belgian clinical practice were reflected in two scenario analyses.
  
  
  RESULTS
  In the base case analysis, total costs per patient were €13,333 for dabigatran and €12,454 for warfarin. Total QALYs per patient were 9.51 for dabigatran and 9.19 for warfarin. The corresponding ICER was €2807/QALY. The ICER of dabigatran was €970/QALY vs warfarin with real-world INR control and €5296/QALY vs a mix of warfarin, aspirin, and no treatment. Results were shown to be robust in one-way and probabilistic sensitivity analyses.
  
  
  CONCLUSIONS
  The analysis does not include long-term costs for clinical events, as these data were not available for Belgium. As in any economic model based on data from a randomized clinical trial, several assumptions had to be made when extrapolating results to routine clinical practice in Belgium.
  
  
  CONCLUSIONS
  This analysis suggests that dabigatran, a novel oral anticoagulant, is a cost-effective treatment for the prevention of stroke and SE in patients with non-valvular AF in the Belgian healthcare setting.
authors: SCS Boehringer Ingelheim Comm.V, Brussels, Belgium. hanne.wouters@boehringer-ingelheim.com
authors: Hanne
authors: H
authors: Wouters
authors: Vincent
authors: V
authors: Thijs
authors: Lieven
authors: L
authors: Annemans
mesh_terms: D000328:Adult; D000368:Aged; D001281:Atrial Fibrillation / Q000188:drug therapy*; D001530:Belgium; D001562:Benzimidazoles / Q000191:economics* / Q000627:therapeutic use; D016001:Confidence Intervals; D003362:Cost-Benefit Analysis; D000069604:Dabigatran; D004617:Embolism / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D011725:Pyridines / Q000191:economics* / Q000627:therapeutic use; D019057:Quality-Adjusted Life Years; D020521:Stroke / Q000517:prevention & control*
chemical_list: D001562:Benzimidazoles; D011725:Pyridines; D000069604:Dabigatran