OBJECTIVES: Evaluate the cost-effectiveness of dabigatran etexilate compared with enoxaparin for the primary prophylaxis of venous thromboembolism (VTE) after total hip replacement (THR) or total knee replacement (TKR) in Spain.
METHODS: A published cost-effectiveness model was adapted to the perspective of the Spanish National Health Service. Oral dabigatran etexilate 220 mg/day was compared with injectable enoxaparin 40 mg/day. The efficacy and safety of the treatments was determined from two pivotal phase III studies comparing these interventions. The model combined a decision tree for the peri-operative period (acute phase, 10 weeks) with a Markov model for long-term events (chronic phase, 60 years). The treatment patterns, consumption of resources and costs were based on quantitative (databases, patient registries, official statistics) and qualitative (systematic literature review, expert surveys) data sources for Spain. Univariate deterministic and probabilistic sensitivity analyses were performed.
RESULTS: The study results suggest that overall outcomes do not differ significantly between dabigatran etexilate and enoxaparin. Mean Life years were 0.018 and 0.020 higher for dabigatran patients undergoing THR and TKR respectively; mean QALYs were 0.013 and 0.015 higher respectively. Mean overall costs were lower for dabigatran patients by €189 and €53 respectively. In the probabilistic sensitivity analysis, dabigatran etexilate was dominant for most of the one thousand simulations in THR. The probability that dabigatran is cost-effective at a threshold of €30,000/QALY was 99% in THR and 87% in TKR. In the deterministic sensitivity analysis, dabigatran was dominant versus enoxaparin in all scenarios in both THR and TKR.
CONCLUSIONS: From the viewpoint of the Spanish NHS, primary prophylaxis with dabigatran etexilate (220 mg/day orally) has a lower cost than enoxaparin (40 mg/day subcutaneously) after THR and TKR with a comparable efficacy and safety profile.
