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

Lei Si, Xiaoying Chen, Menglu Ouyang, Xia Wang, Guofang Chen, Yong-Jun Cao, Guojun Wu, Jinli Zhang, Jingfen Zhang, YuKai Liu, Shihong Zhang, Lili Song, Candice Delcourt, Hisatomi Arima, Lidan Wang, Thomas Lung, Mingshen Chen, Craig S. Anderson, Stephen Jan, ENCHANTED Investigators

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Abstract

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.
Original languageEnglish
Pages (from-to)145-152
Number of pages8
JournalCerebrovascular Diseases
Volume52
Issue number2
Early online date31 Aug 2022
DOIs
Publication statusPublished - 1 Apr 2023

Bibliographical note

Copyright the Author(s) 2022. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • Acute ischemic stroke
  • clinical trial
  • health economics
  • alteplase
  • cost-effectiveness
  • Alteplase
  • Health economics
  • Clinical trial
  • Cost-effectiveness

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