背景:第一个证明房颤/扑动(AF/AFL)患者心血管住院率降低的抗心律失常药物是安慰剂对照的决奈达隆,双盲,平行分组试验评估决奈达隆400mgbid预防房颤/房扑患者心血管住院或任何原因死亡的疗效(ATHENA试验)。在美国尚未报道决奈达隆在该患者人群中的潜在成本效益。本研究从美国医疗保健支付者的角度评估决奈达隆的成本效益。
结果:ATHENA患者数据应用于患者级别的健康状态转换模型。健康状态转变的概率来自ATHENA和已发布的数据。当试验数据不可用时,模型中使用的相关成本(2010年的值)是从公布的来源获得的。基本情况模型假设患者接受决奈达隆治疗持续ATHENA(平均21个月),并随访一生。成本效益,从付款人的角度来看,使用蒙特卡洛微观模拟(100万虚构患者)确定。决奈达隆加上标准护理提供了0.13个生命年(LYG),和0.11质量调整寿命年(QALYs),仅标准护理就超过了标准护理;成本/质量为19,520美元,成本/LYG为16,930美元。与风险较低的患者相比,卒中风险较高的患者(充血性心力衰竭,高血压病史,年龄≥75岁,糖尿病,既往卒中或短暂性脑缺血发作史(CHADS(2))评分3-6分对0分)的成本/QALY较低($9580-$16,000分对$26,450).在假设使用终生决奈达隆治疗的情况下,成本/质量最高,没有心血管死亡率的益处,在标准治疗中没有与AF/AFL复发相关的费用,当5%的折扣与0%的折扣相比。
结论:通过推断大的结果,多中心,随机临床试验(雅典娜),该模型表明决奈达隆是美国批准的适应症(阵发性/持续性AF/AFL)的一种经济有效的治疗选择.
BACKGROUND: The first antiarrhythmic drug to demonstrate a reduced rate of cardiovascular hospitalization in atrial fibrillation/flutter (AF/AFL) patients was dronedarone in a placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter (
ATHENA trial). The potential cost-effectiveness of dronedarone in this patient population has not been reported in a US context. This study assesses the cost-effectiveness of dronedarone from a US health care payers\' perspective.
RESULTS: ATHENA patient data were applied to a patient-level health state transition model. Probabilities of health state transitions were derived from
ATHENA and published data. Associated costs used in the model (2010 values) were obtained from published sources when trial data were not available. The base-case model assumed that patients were treated with dronedarone for the duration of
ATHENA (mean 21 months) and were followed over a lifetime. Cost-effectiveness, from the payers\' perspective, was determined using a Monte Carlo microsimulation (1 million fictitious patients). Dronedarone plus standard care provided 0.13 life years gained (LYG), and 0.11 quality-adjusted life years (QALYs), over standard care alone; cost/QALY was $19,520 and cost/LYG was $16,930. Compared to lower risk patients, patients at higher risk of stroke (Congestive heart failure, history of Hypertension, Age ≥ 75 years, Diabetes mellitus, and past history of Stroke or transient ischemic attack (CHADS(2)) scores 3-6 versus 0) had a lower cost/QALY ($9580-$16,000 versus $26,450). Cost/QALY was highest in scenarios assuming lifetime dronedarone therapy, no cardiovascular mortality benefit, no cost associated with AF/AFL recurrence on standard care, and when discounting of 5% was compared with 0%.
CONCLUSIONS: By extrapolating the results of a large, multicenter, randomized clinical trial (
ATHENA), this model suggests that dronedarone is a cost-effective treatment option for approved indications (paroxysmal/persistent AF/AFL) in the US.