United BioSource Corporation, Bethesda, MD 20814, USA.
Thromb Haemost. 2012 Oct;108(4):672-82. doi: 10.1160/TH12-06-0388. Epub 2012 Aug 17.
Canadian patients with atrial fibrillation (AF) in whom anticoagulation is appropriate have two new choices for anticoagulation for prevention of stroke and systemic embolism--dabigatran etexilate (dabigatran) and rivaroxaban. Based on the RE-LY and ROCKET AF trial results, we investigated the cost-effectiveness of dabigatran (twice daily dosing of 150 mg or 110 mg based on patient age) versus rivaroxaban from a Canadian payer perspective. A formal indirect treatment comparison (ITC) of dabigatran versus rivaroxaban was performed, using dabigatran clinical event rates from RE-LY for the safety-on-treatment population, adjusted to the ROCKET AF population. A previously described Markov model was modified to simulate anticoagulation treatment using ITC results as inputs. Model outputs included total costs, event rates, and quality-adjusted life-years (QALYs). The ITC found when compared to rivaroxaban, dabigatran had a lower risk of intracranial haemorrhage (ICH) (relative risk [RR] = 0.38; 95% confidence interval [CI] 0.21 - 0.67) and stroke (RR = 0.62; 95%CI 0.45-0.87). Over a lifetime horizon, the model found dabigatran-treated patients experienced fewer ICHs (0.33 dabigatran vs. 0.71 rivaroxaban) and ischaemic strokes (3.40 vs. 3.96) per 100 patient-years, and accrued more QALYs (6.17 vs. 6.01). Dabigatran-treated patients had lower acute care and long-term follow-up costs per patient ($52,314 vs. $53,638) which more than offset differences in drug costs ($7,299 vs. $6,128). In probabilistic analysis, dabigatran had high probability of being the most cost-effective therapy at common thresholds of willingness-to-pay (93% at a $20,000/QALY threshold). This study found dabigatran is economically dominant versus rivaroxaban for prevention of stroke and systemic embolism among Canadian AF patients.
加拿大心房颤动 (AF) 患者，若适合抗凝治疗，那么有两种新的抗凝药物可供选择，用于预防中风和全身性栓塞——达比加群酯 (dabigatran) 和利伐沙班。基于 RE-LY 和 ROCKET AF 试验结果，我们从加拿大支付者的角度调查了达比加群（基于患者年龄，每日两次给药 150 毫克或 110 毫克）与利伐沙班的成本效益。使用 RE-LY 试验中达比加群的临床事件率，对治疗中的安全性人群进行了正式的间接治疗比较 (ITC)，并根据 ROCKET AF 人群进行了调整。对先前描述的 Markov 模型进行了修改，以使用 ITC 结果作为输入来模拟抗凝治疗。模型输出包括总成本、事件发生率和质量调整生命年 (QALY)。ITC 发现，与利伐沙班相比，达比加群的颅内出血 (ICH) 风险较低（相对风险 [RR] = 0.38；95%置信区间 [CI] 0.21-0.67）和中风（RR = 0.62；95%CI 0.45-0.87）。在终身范围内，该模型发现达比加群治疗的患者每 100 名患者年发生 ICH 更少（0.33 例达比加群 vs. 0.71 例利伐沙班）和缺血性中风（3.40 例 vs. 3.96 例），并获得更多的 QALY（6.17 例 vs. 6.01 例）。达比加群治疗的患者每例急性护理和长期随访的费用较低（52314 美元 vs. 53638 美元），这超过了药物成本的差异（7299 美元 vs. 6128 美元）。在概率分析中，达比加群在常见的意愿支付阈值（20000 美元/QALY 阈值时为 93%）上具有成为最具成本效益治疗的高概率。这项研究发现，对于加拿大 AF 患者，预防中风和全身性栓塞，达比加群在经济上优于利伐沙班。
