Abstract
Objective: The aim of this study was to evaluate, from the Spanish National Health System perspective, the cost-effectiveness of rivaroxaban (20 mg/day) versus use of acenocoumarol (5 mg/day) for the treatment of patients with non-valvular atrial fibrillation (NVAF) at moderate to high risk for stroke. Methods: A Markov model was designed and populated with local cost estimates, efficacy and safety of rivaroxaban in stroke prevention in NVAF compared with adjusted-dose warfarin clinical results from the pivotal phase III ROCKET AF trial and utility values obtained from the literature. Warfarin and acenocoumarol were assumed to have therapeutic equivalence. Results: Rivaroxaban treatment was associated with fewer ischemic strokes and systemic embolisms (0.289 vs.0.300 events), intracranial bleeds (0.051 vs.0.067), and myocardial infarctions (0.088 vs.0.102) per patient compared with acenocoumarol. Over a lifetime time horizon, rivaroxaban led to a reduction of 0.041 life-threatening events per patient, and increases of 0.103 life-years and 0.155 quality-adjusted lifeyears (QALYs) versus acenocoumarol treatment. This resulted in an incremental cost-effectiveness ratio of €7045 per QALY and €10 602 per life-year gained. Sensitivity analysis indicated that these results were robust and that rivaroxaban is cost-effective compared with acenocoumarol in 89.4% of cases should a willingness-to-pay threshold of €30 000/QALY gained be considered. Conclusions: The present analysis suggests that rivaroxaban is a cost-effective alternative to acenocoumarol therapy for the prevention of stroke and systemic embolisms in patients with NVAF in the Spanish healthcare setting.
Highlights
Atrial fibrillation (AF) is associated with an increased risk of death, cerebrovascular disease (5 times higher) and systemic embolism.[1]
According to the results generated from the model applied to a cohort of 1000 patients with non-valvular atrial fibrillation (NVAF), with rivaroxaban a number of events would be avoided compared to acenocoumarol: 11 ischemic strokes and systemic embolisms, 16 intracranial bleeds and 14 myocardial infarctions (Table 5)
This difference in costs is mainly due to higher reduction in mortality obtained with rivaroxaban (0.103 life-years gained per patient versus acenocoumarol) and the consequent longer duration of treatment in patients treated with rivaroxaban and its higher acquisition cost
Summary
A Markov model was designed and populated with local cost estimates, efficacy and safety of rivaroxaban in stroke prevention in NVAF compared with adjusted-dose warfarin clinical results from the pivotal phase III ROCKET AF trial and utility values obtained from the literature. The clinical data obtained in the phase III ROCKET AF clinical trial[16] and the Spanish health osts were entered in the model, with the aim of calculating the incremental cost-effectiveness rate (ICER) of rivaroxaban compared to acenocoumarol. Some of the patients in the cohort are moved from one state to another with a given probability called “transition probability”. These transition probabilities are calculated from clinical studies conducted with real patients.[20]
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