Cost-Effectiveness of Low-Dose Compared to Standard-Dose Alteplase for Acute Ischemic Stroke in China: A Within-Trial Economic Evaluation of the ENCHANTED Study
Cost-Effectiveness of Low-Dose Compared to Standard-Dose Alteplase for Acute Ischemic Stroke in China: A Within-Trial Economic Evaluation of the ENCHANTED Study
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DOI：
10.1159/000525869
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发表时间：
2022-08
影响因子：
2.9
通讯作者：
L. Si;Xiaoying Chen;Menglu Ouyang;Xia Wang;Guofang Chen;Yong-jun Cao;Guojun Wu;Jinli Zhang;Jingfen Zhang;Yukai Liu;Shihong Zhang;L. Song;C. Delcourt;H. Arima;Lidan Wang;T. Lung;Mingsheng Chen;C. Anderson;Stephen Jan
中科院分区：
文献类型：
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作者：
L. Si;Xiaoying Chen;Menglu Ouyang;Xia Wang;Guofang Chen;Yong-jun Cao;Guojun Wu;Jinli Zhang;Jingfen Zhang;Yukai Liu;Shihong Zhang;L. Song;C. Delcourt;H. Arima;Lidan Wang;T. Lung;Mingsheng Chen;C. Anderson;Stephen Jan
导论：高血压和溶栓脑卒中强化控制研究（ENCHANTED）表明，在急性缺血性脑卒中（AIS）中，低剂量阿替普酶是安全的，但并不明显优于标准剂量阿替普酶。鉴于该药的巨大成本，我们进行了成本效益分析，以确定在中国低剂量相对于标准剂量阿替普酶具有成本效益的可能性。方法：对具有可用健康成本数据的中国ENCHANTED参与者进行成本-效果和成本-效用分析，其中分别以90天死亡或残疾（修正Rankin量表评分2-6）和质量调整生命年（QALYs）作为结果测量指标。在进行非劣效性试验的同时，根据保健付款人的观点，遵守了卫生经济评估的标准准则。对于基本案例分析，成本和有效性的等效边际分别设定为691美元和- 0.025质量年。采用概率敏感性分析评价低剂量阿替普酶非劣效性的概率。结果：虽然低剂量组阿替普酶的平均成本较低（1569美元，标准剂量组2154美元），但由于低剂量组住院费用较高，总成本较标准剂量组高56美元（95%置信区间[CI]: - 1000 - 1113）。在低剂量组和标准剂量组中，每1000名患者分别有462例（95% CI: 415-509）和410例（95% CI: 363-457）死亡或残疾。与标准剂量组相比，低剂量组的QALYs略低（0.008,95% CI: - 0.016-0.001）。与标准剂量组相比，低剂量组在成本-效果上发现有88%的可能性是不劣的。结论：该健康经济评估与ENCHANTED表明，与使用标准剂量相比，使用低剂量阿替普酶不能节省总体医疗成本，也不能导致中国AIS患者管理中QALYs的增加。从经济角度来看，在AIS中放弃标准治疗溶栓几乎没有什么正当理由。
Introduction: The Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) showed that a low-dose alteplase was safe but not clearly non-inferior to standard-dose alteplase in acute ischemic stroke (AIS). Given the significant cost of this medicine, we undertook a cost-effectiveness analysis to determine the probability that low-dose is cost-effective relative to standard-dose alteplase in China. Methods: For ENCHANTED participants in China with available health cost data, cost-effectiveness and cost-utility analyses were undertaken in which death or disability (modified Rankin scale scores 2–6) at 90 days and quality-adjusted life-years (QALYs) were used as outcome measures, respectively. There was adherence to standard guidelines for health economic evaluations alongside non-inferiority trials and according to a health-care payer’s perspective. The equivalence margin for cost and effectiveness was set at USD 691 and −0.025 QALYs, respectively, for the base-case analysis. Probabilistic sensitivity analyses were used to evaluate the probability of low-dose alteplase being non-inferior. Results: While the mean cost of alteplase was lower in the low-dose group (USD 1,569 vs. USD 2,154 in the standard-dose group), the total cost was USD 56 (95% confidence interval [CI]: −1,000–1,113) higher compared to the standard-dose group due to higher hospitalization costs in the low-dose group. There were 462 (95% CI: 415–509) and 410 (95% CI: 363–457) patients with death or disability per 1,000 patients in the low-dose and standard-dose groups, respectively. The low-dose group had marginally lower (0.008, 95% CI: −0.016–0.001) QALYs compared to their standard-dose counterparts. The low-dose group was found to have an 88% probability of being non-inferior based on cost-effectiveness versus the standard-dose group. Conclusions: This health economic evaluation alongside the ENCHANTED indicates that the use of low-dose alteplase does not save overall healthcare costs nor lead to a gain in QALYs in the management of Chinese patients with AIS compared to the use of standard dose. There is little justification on economic grounds to shift from standard-of-care thrombolysis in AIS.