Economic evaluation of dabigatran etexilate for the primary prevention of venous tromboembolic events following major orthopedic surgery in the netherlands

OBJECTIVES: Dabigatran etexilate is a new oral direct thrombin inhibitor for prophylaxis of venous thromboembolism (VTE) in patients who have elective surgery for total hip replacement (THR) or total knee replacement (TKR). Among the advantages of dabigatran etexilate over subcutaneous prophylaxis with Low Molecular Weight Heparin (LMWH) are reduced resource uses for (i) teaching patients to self-inject; (ii) home-care visits for subcutaneous administration; and (iii) absence of heparin-induced thrombocytopenia (HIT). Based on the demonstrated non-inferiority, the aim of this study was to conduct a cost-minimization analysis of oral dabigatran etexilate vs subcutaneous low-molecular weight heparin (LMWH) and fondaparinux from the Dutch healthcare perspective. METHODS: A retrospective cohort study was conducted to measure resource use associated with subcutaneous prophylaxis. Results of this study were used in the model to elucidate specific advantages of dabigatran etexilate, next to reduced needs for self-inject teaching and lack of Heparin-Induced Thrombocytopenia. Drug and other resource utilization data were combined with local unit costs. Probabilistic sensitivity analysis was performed to account for uncertainty around relevant parameters included. RESULTS: Home-care visits for subcutaneous administration problems were needed in 9.9% (95% CI=6.4-13.4) and 9.6% (95% CI=5.8-13.4) of THR and TKR patients, respectively. Based on costs for 1000 patients treated with dabigatran etexilate vs LMWHs, per patient cost-savings with dabigatran etexilate were estimated at euro30.68 (95% CI=2.01-65.52) and euro23.19 (95% CI=0.69-48.48) for THR and TKR, respectively. The probability that dabigatran etexilate would be cost-saving was estimated at 98.3% and 97.9% for THR and TKR, respectively. These cost-savings were even higher when including fondaparinux in the analysis, with per patient cost-savings of euro69.87 (43.42-106.10) and euro18.33 (1.63-41.26) for THR and TKR, respectively. Separate calculations for dabigatran etexilate vs nadroparin and dalteparin in THR resulted in probabilities of achieving cost-savings with dabigatran etexilate of 36.2% and 100%, respectively. For TKR these probabilities were estimated at 54.3% and 100%, respectively. CONCLUSIONS: Thromboprophylaxis with dabigatran etexilate is cost-saving in patients undergoing THR and TKR from the Dutch healthcare perspective, compared to subcutaneous LMWHs