Reynolds Matthew R, Nilsson Jonas, Akerborg Orjan, Jhaveri Mehul, Lindgren Peter
Beth Israel Deaconess Medical Center, VA Boston Healthcare System, Boston, MA, USA;
Clinicoecon Outcomes Res. 2013;5:19-28. doi: 10.2147/CEOR.S36019. Epub 2013 Jan 8.
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.
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%.
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.
在一项安慰剂对照、双盲、平行组试验（评估400毫克每日两次决奈达隆预防心房颤动/心房扑动（AF/AFL）患者心血管住院或任何原因死亡的疗效试验（ATHENA试验））中，首个被证明能降低心房颤动/心房扑动（AF/AFL）患者心血管住院率的抗心律失常药物是决奈达隆。在美国背景下，尚未有关于决奈达隆在该患者群体中潜在成本效益的报道。本研究从美国医疗保健支付方的角度评估决奈达隆的成本效益。
将ATHENA患者数据应用于患者水平的健康状态转换模型。健康状态转换的概率源自ATHENA及已发表的数据。当无法获取试验数据时，模型中使用的相关成本（2010年数值）从已发表的资料中获取。基础病例模型假设患者在ATHENA试验期间（平均21个月）接受决奈达隆治疗，并随访终生。从支付方角度，使用蒙特卡洛微观模拟（100万虚拟患者）确定成本效益。与单纯标准治疗相比，决奈达隆加标准治疗可多获得0.13个生命年（LYG）和0.11个质量调整生命年（QALY）；成本/ QALY为19,520美元，成本/ LYG为16,930美元。与低风险患者相比，中风风险较高的患者（充血性心力衰竭、高血压病史、年龄≥75岁、糖尿病以及中风或短暂性脑缺血发作病史（CHADS(2)）评分3 - 6分与0分）的成本/ QALY较低（9580 - 16,000美元与26,450美元）。在假设终生使用决奈达隆治疗、无心血管死亡获益、标准治疗下无AF/AFL复发相关成本以及5%贴现率与0%贴现率相比的情况下，成本/ QALY最高。
通过推断一项大型、多中心、随机临床试验（ATHENA）的结果，该模型表明决奈达隆在美国对于已获批适应症（阵发性/持续性AF/AFL）是一种具有成本效益的治疗选择。
