Chevalier Julie, Delaitre Olivier, Hammès Florence, de Pouvourville Gérard
Chair of Health Systems, ESSEC Business School, Cergy-Pontoise, France.
Boehringer Ingelheim France, Paris, France.
Arch Cardiovasc Dis. 2014 Jun-Jul;107(6-7):381-90. doi: 10.1016/j.acvd.2014.04.009. Epub 2014 Jun 24.
Atrial fibrillation is the main cause of stroke, but the risk can be reduced, usually with vitamin K antagonists (VKAs) such as warfarin. The RE-LY atrial fibrillation study demonstrated that the rates of stroke and systemic embolism with dabigatran (an oral direct thrombin inhibitor) were similar to or lower than those with warfarin.
To estimate the cost-effectiveness, from a French payer perspective, of dabigatran (150 or 110mg bid for patients<or≥80 years, respectively) versus warfarin.
Cost-effectiveness was modeled using a Markov model in a cohort of 10,000 patients with atrial fibrillation followed over their lifetime. Events accounted for included ischemic stroke, systemic embolism, transient ischemic attack, hemorrhage, myocardial infarction and death. The model patient population matched the RE-LY patients. Dabigatran was compared with "trial-like" warfarin and "real-world" prescribing. Risks of clinical events were obtained from RE-LY. Event and follow-up costs were based on the French national tariff or published literature. Clinical events, QALYs, total costs and incremental cost-effectiveness ratios (ICERs) were calculated.
The ICERs of dabigatran compared with "trial-like" warfarin and "real-world" prescribing were €15,838/QALY and €7473/QALY, respectively. Deterministic and probabilistic sensitivity analyses showed these to be robust to uncertainty and variability in the model parameters. The ICER for dabigatran was below €24,000/QALY or €36,000/QALY in 71% or 92%, respectively, of the simulations when compared with "trial-like" warfarin and 100% and 100%, respectively, when compared with "real-world" prescribing.
This study suggests that the use of dabigatran in French atrial fibrillation patients is cost-effective, according to usually accepted thresholds.
心房颤动是中风的主要原因,但通常使用维生素K拮抗剂(VKA)如华法林可降低风险。RE-LY心房颤动研究表明,达比加群(一种口服直接凝血酶抑制剂)导致的中风和全身性栓塞发生率与华法林相似或更低。
从法国医保支付方的角度评估达比加群(分别用于年龄<80岁或≥80岁患者,每日两次,每次150毫克或110毫克)与华法林相比的成本效益。
采用马尔可夫模型对10000名心房颤动患者进行终生随访,模拟成本效益。纳入的事件包括缺血性中风、全身性栓塞、短暂性脑缺血发作、出血、心肌梗死和死亡。模型中的患者群体与RE-LY研究中的患者相匹配。将达比加群与“试验样”华法林及“真实世界”处方进行比较。临床事件风险来自RE-LY研究。事件及随访成本基于法国国家收费标准或已发表文献。计算临床事件数、质量调整生命年(QALY)、总成本及增量成本效益比(ICER)。
与“试验样”华法林及“真实世界”处方相比,达比加群的ICER分别为每QALY 15838欧元和每QALY 7473欧元。确定性和概率性敏感性分析表明,这些结果对模型参数的不确定性和变异性具有稳健性。与“试验样”华法林相比,在71%或92%的模拟中,达比加群的ICER分别低于每QALY 24000欧元或每QALY 36000欧元;与“真实世界”处方相比,这两个比例分别为100%和100%。
本研究表明,按照通常认可的阈值,在法国心房颤动患者中使用达比加群具有成本效益。