Memory Aging and Cognition Centre, Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Blk MD3, 16 Medical Drive, #04-01, Singapore, 117600, Singapore.
Singapore Clinical Research Institute, Consortium for Clinical Research and Innovation Singapore, 23 Rochester Park, Singapore, 139234, Singapore.
BMC Health Serv Res. 2024 Sep 27;24(1):1127. doi: 10.1186/s12913-024-11618-4.
Despite progress in stroke therapy (e.g., revascularisation interventions by thrombolysis and/or thrombectomy, organised stroke care), many stroke survivors will have impairment of neurological function. We aimed to compare the cost-effectiveness of an oral natural formulation, MLC601, versus placebo in functional recovery among subjects receiving standard of care after an ischemic stroke of intermediate severity assessed with NIH Stroke Scale at baseline (b-NIHSS 8-14).
A Markov cohort model with a 2-year time horizon was developed to simulate patients from a published randomised placebo-controlled clinical trial of MLC601 in their post-stroke functional recovery assessed by modified Rankin Score (mRS), from a health system perspective. Transition probabilities were derived from a multi-centre clinical trial in South East Asia. As cost and utility data were not collected in the trial, therefore we extracted them from the published literature. The main outcomes were incremental cost, incremental quality-adjusted life-year (QALY) gained, and incremental cost-effectiveness ratio (ICER). Besides base-case and sensitivity analyses, we performed subgroup analyses to explore the heterogeneity of patients with poor-prognosis factors (b-NIHSS 10-14, stroke onset to treatment time > 48 h, rehabilitation during first 3 month). All costs are expressed in 2022 Euro and USD, with an annual discount rate of 3% applied to costs and QALYs.
Base-case analysis showed that MLC601 was cost-effective compared with placebo, with €5,080 saved and 0.45 QALY gained, resulting in an ICER of -€11,352.50 per QALY gained. Similarly, results from subgroup analyses indicated that the use of MLC601 was a dominant strategy in all subgroups with poor-prognosis factors. Sensitivity analyses revealed the results were robust.
Compared with placebo on top of standard stroke care, MLC601 was cost-effective in post-stroke functional recovery over two years. Due to the lack of cost and utility data from the study population, the results might not be generalizable to other settings. Further studies with country-specific data are needed to confirm the results of this study.
URL http://www.
gov . Unique identifier NCT00554723 November 7, 2007.
尽管在中风治疗方面取得了进展（例如，溶栓和/或血栓切除术的血管再通干预、组织化的中风护理），但许多中风幸存者的神经功能仍会受损。我们旨在比较口服天然配方 MLC601 与安慰剂在接受标准护理后的功能恢复方面的成本效益，这些患者在基线时接受 NIH 中风量表评估的中度严重程度的缺血性中风（b-NIHSS 8-14）。
从东南亚一项多中心临床试验中得出转移概率。由于在试验中没有收集成本和效用数据，因此我们从已发表的文献中提取了这些数据。主要结果是增量成本、增量质量调整生命年（QALY）和增量成本效益比（ICER）。除了基本情况和敏感性分析外，我们还进行了亚组分析，以探索预后不良因素（b-NIHSS 10-14、发病至治疗时间>48 小时、前 3 个月康复）患者的异质性。所有成本均以 2022 年欧元和美元表示，并对成本和 QALY 应用 3%的年度贴现率。
基本情况分析表明，与安慰剂相比，MLC601 具有成本效益，节省了 5080 欧元，获得了 0.45 个 QALY，导致每获得 1 个 QALY 的成本效益比为-11352.50 欧元。同样，亚组分析的结果表明，在所有预后不良因素的亚组中，使用 MLC601 都是一种主导策略。敏感性分析表明结果具有稳健性。
与标准中风护理相比，在中风后两年内，MLC601 在功能恢复方面具有成本效益。由于缺乏来自研究人群的成本和效用数据，因此结果可能不适用于其他环境。需要进行具有国家特定数据的进一步研究来证实本研究的结果。
