Ross Terres Jorge Alfonso, Lozano-Ortega G, Kendall R, Sculpher M J
GlaxoSmithKline, Mississauga, ON, Canada.
GlaxoSmithKline, 2301 Renaissance Boulevard, King of Prussia, PA, 19406, USA.
BMC Cardiovasc Disord. 2015 Dec 29;15:180. doi: 10.1186/s12872-015-0175-1.
Acute coronary syndrome (ACS) refers to a spectrum of life-threatening cardiac diseases usually due to coronary artery plaque rupture, subsequent thrombin generation plaque activation and thrombus formation. To date, no economic analyses have been published about the use of fondaparinux in NSTE-ACS patients in Canada. The purpose of our study is to estimate the lifetime cost-effectiveness of fondaparinux compared to enoxaparin for non-ST-elevation acute coronary syndrome (NSTE-ACS) patients in a Canadian hospital setting.
As an extension of a previous published economic analysis for US patients, an event-based decision analytic model was constructed using clinical and resource use data from OASIS-5, a randomized trial of 20,078 patients from 41 countries. A public payer perspective in the hospital setting was adopted. Resource use data from the trial were valued using Canadian costs. A cost regression model was developed to estimate the mean cost of managing the clinical events over the 180 day period. Annual costs of long-term care for ACS patients were added after 180 days until death. Long-term survival was incorporated using Canadian life tables with further adjustment for additional risks associated with NSTE-ACS. Quality-of-life (utility) decrements from published sources were applied to clinical events. Lifetime costs (2009 CAD$) and quality-adjusted life-years (QALYs), discounted annually at 5 %, were estimated for the typical patient in OASIS-5 (i.e., at mean covariate values).
The trial data showed that fondaparinux is protective against all clinical events observed in the trial. The model showed that: over 180 days, fondaparinux dominates enoxaparin, producing similar estimates of QALYs gained and saving $439; over a patient's lifetime, fondaparinux yields an ICER of $4293/QALY. Based on PSA, the probabilities that fondaparinux dominates enoxaparin (less costly and more effective) and that is cost-effective at a $50,000 threshold were 42 % and 96 %, respectively.
In the Canadian hospital setting, fondaparinux is cost-effective when compared to enoxaparin for the treatment of NSTE-ACS. This result holds both in the immediate post-event period and over the lifetimes of patients.
急性冠状动脉综合征（ACS）是指一系列危及生命的心脏疾病，通常由冠状动脉斑块破裂、随后的凝血酶生成、斑块激活和血栓形成引起。迄今为止，加拿大尚未发表关于磺达肝癸钠用于非ST段抬高型急性冠状动脉综合征（NSTE-ACS）患者的经济学分析。我们研究的目的是评估在加拿大医院环境中，与依诺肝素相比，磺达肝癸钠用于非ST段抬高型急性冠状动脉综合征（NSTE-ACS）患者的终生成本效益。
作为之前已发表的针对美国患者的经济学分析的扩展，使用来自OASIS-5（一项对来自41个国家的20,078名患者进行的随机试验）的临床和资源使用数据构建了一个基于事件的决策分析模型。采用医院环境中的公共支付者视角。试验中的资源使用数据使用加拿大成本进行估值。开发了一个成本回归模型来估计180天期间管理临床事件的平均成本。180天后直至死亡，添加了ACS患者长期护理的年度成本。使用加拿大人寿表纳入长期生存情况，并针对与NSTE-ACS相关的额外风险进行进一步调整。将已发表来源的生活质量（效用）下降应用于临床事件。对OASIS-试验中的典型患者（即平均协变量值）估计了终生成本（2009年加元）和质量调整生命年（QALYs），每年以5%的贴现率进行贴现。
试验数据表明，磺达肝癸钠对试验中观察到的所有临床事件具有保护作用。模型显示：在180天内，磺达肝癸钠优于依诺肝素，获得的QALYs估计相似且节省439加元；在患者的一生中，磺达肝癸钠的增量成本效果比为4293加元/QALY。基于概率敏感性分析，磺达肝癸钠优于依诺肝素（成本更低且更有效）以及在50,000加元阈值下具有成本效益的概率分别为42%和96%。
在加拿大医院环境中，与依诺肝素相比，磺达肝癸钠用于治疗NSTE-ACS具有成本效益。这一结果在事件发生后的即刻期间以及患者的一生中均成立。
