Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
J Am Coll Cardiol. 2015 Feb 10;65(5):465-76. doi: 10.1016/j.jacc.2014.11.034.
Based on results of the PLATO (Platelet Inhibition and Patient Outcomes) trial comparing ticagrelor with clopidogrel therapy, the U.S. Food and Drug Administration approved ticagrelor in 2011 for reducing thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) with the proviso that it be taken with low-dose aspirin.
This study sought to assess the cost and cost effectiveness of ticagrelor therapy relative to clopidogrel in treating ACS patients from the perspective of the U.S. health care system.
We estimated within-trial resource use and costs using U.S. low-dose aspirin patients in PLATO (n = 547). Quality-adjusted life expectancy was estimated using the total PLATO population (n = 18,624), combined with baseline risk and long-term survival data from an external ACS patient cohort. Study drugs were valued at current costs. Cost effectiveness was assessed, as was the sensitivity of results to sampling and methodological uncertainties.
One year of ticagrelor therapy, relative to that of generic clopidogrel, cost $29,665/quality-adjusted life-year gained, with 99% of bootstrap estimates falling under a $100,000 willingness-to-pay threshold. Results were robust to extensive sensitivity analyses, including variations in clopidogrel cost, exclusion of costs in extended years of life, and a recalibrated estimate of survival reflecting a lower underlying mortality risk in the United States.
For PLATO-eligible ACS patients, a U.S. perspective comparison of the current standard of dual antiplatelet therapy of aspirin with clopidogrel versus aspirin plus ticagrelor showed that the ticagrelor regimen increased life expectancy at an incremental cost well within accepted benchmarks of good value for money. (A Comparison of Ticagrelor [AZD6140] and Clopidogrel in Patients With Acute Coronary Syndrome [PLATO]; NCT00391872).
基于 PLATO（血小板抑制和患者预后）试验比较替格瑞洛与氯吡格雷治疗的结果，美国食品和药物管理局于 2011 年批准替格瑞洛用于减少急性冠脉综合征（ACS）患者的血栓心血管事件，前提是与低剂量阿司匹林一起使用。
本研究旨在从美国医疗保健系统的角度评估替格瑞洛治疗 ACS 患者的成本和成本效益相对于氯吡格雷。
我们使用 PLATO 中的美国低剂量阿司匹林患者（n = 547）估算了试验内的资源利用和成本。使用来自外部 ACS 患者队列的基线风险和长期生存数据，结合 PLATO 总人群（n = 18624）估算了质量调整后的预期寿命。研究药物按当前成本计价。评估了成本效益，以及结果对抽样和方法学不确定性的敏感性。
与通用氯吡格雷相比，替格瑞洛治疗一年的成本为 29665 美元/质量调整生命年，99%的 bootstrap 估计值低于 100000 美元的支付意愿阈值。结果对广泛的敏感性分析具有稳健性，包括氯吡格雷成本的变化、延长生命年限的成本排除以及反映美国基础死亡率较低的生存估计的重新校准。
对于 PLATO 合格的 ACS 患者，从美国角度对当前双重抗血小板治疗标准（阿司匹林加氯吡格雷）与阿司匹林加替格瑞洛进行比较，结果表明替格瑞洛方案以可接受的物有所值基准内的增量成本增加了预期寿命。（替格瑞洛[AZD6140]与氯吡格雷在急性冠脉综合征患者中的比较[PLATO]；NCT00391872）。
