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泰国大肝切除患者术前肝功能的吲哚菁绿试验的经济评估与预算影响分析

Economic Evaluation and Budget Impact Analysis of Indocyanine Green Test for Preoperative Liver Function in Patients with Major Hepatectomy in Thailand.

作者信息

Permsuwan Unchalee, Sriuttha Pajaree, Tovikkai Chutwichai, Chotirosniramit Anon, Thepbunchonchai Asara, Junrungsee Sunhawit, Lapisatepun Worakitti, Chaiyabutr Kittipong, Srisuk Tharatip, Dilokthornsakul Piyameth

机构信息

Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.

Center for Medical and Health Technology Assessment (CM-HTA), Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.

出版信息

Adv Ther. 2025 Aug 22. doi: 10.1007/s12325-025-03341-1.

Abstract

INTRODUCTION

Post-hepatectomy liver failure (PHLF) remains a significant cause of morbidity and mortality following liver resections. Indocyanine green (ICG) clearance testing provides quantitative liver function assessment to improve perioperative risk stratification. However, its cost poses a concern in resource-limited settings like Thailand. This study aimed to evaluate the cost-utility and budget impact of adding ICG testing to standard diagnosis compared to standard diagnosis alone in patients undergoing first major hepatectomy.

METHODS

A hybrid model combining a decision tree and Markov model was developed from a societal perspective over a lifetime horizon. Clinical data and cancer treatment costs were derived from 400 real-world patients admitted to four university hospitals. PHLF costs were sourced from the National Health Security Office and utility values were directly collected from patients admitted for major hepatectomy. Primary outcomes included total costs, life years, quality-adjusted life years (QALYs), and the incremental cost-effectiveness ratio (ICER). A 3% annual discount rate was applied. A variety of sensitivity analyses were conducted to test parameter uncertainty. A 5-year budget impact analysis was also performed from a payer's perspective, calculating the net budget impact (NBI) between both strategies.

RESULTS

Compared to standard diagnosis alone, adding ICG testing increased costs by 3600 Thai baht (THB) [102 US dollars ($)] and gained 0.001 QALYs, yielding an ICER of 2,763,973 THB/QALY ($78,321). The probability of cost-effectiveness at the ceiling threshold of 160,000 THB/QALY ($4,534) was 6.3%. The ICER would fall below this threshold if PHLF risk exceeded 10.1% or if ICG test cost decreased by at least 88%. The 5-year NBI was 39.5 million THB ($1.1 million), reduced by 47.3% with dose-sharing.

CONCLUSION

Although not cost-effective at current thresholds, ICG reduces PHLF-related costs and maintains an acceptable NBI per year.

摘要

引言

肝切除术后肝衰竭(PHLF)仍是肝切除术后发病和死亡的重要原因。吲哚菁绿(ICG)清除试验可提供定量肝功能评估,以改善围手术期风险分层。然而,在泰国等资源有限的地区,其成本令人担忧。本研究旨在评估在接受首次大肝切除术的患者中,与单纯标准诊断相比,增加ICG检测的成本效益和预算影响。

方法

从社会角度出发,在终身范围内开发了一种结合决策树和马尔可夫模型的混合模型。临床数据和癌症治疗成本来自四家大学医院收治的400例真实世界患者。PHLF成本来自国家卫生安全办公室,效用值直接从接受大肝切除术的患者中收集。主要结局包括总成本、生命年、质量调整生命年(QALY)和增量成本效益比(ICER)。采用3%的年贴现率。进行了各种敏感性分析以测试参数不确定性。还从支付方的角度进行了为期5年的预算影响分析,计算了两种策略之间的净预算影响(NBI)。

结果

与单纯标准诊断相比,增加ICG检测使成本增加了3600泰铢(102美元),获得了0.001个QALY,ICER为2763973泰铢/QALY(78321美元)。在160000泰铢/QALY(4534美元)的上限阈值下具有成本效益的概率为6.3%。如果PHLF风险超过10.1%或ICG检测成本至少降低88%,ICER将低于该阈值。5年NBI为3950万泰铢(110万美元),通过剂量分摊可降低47.3%。

结论

尽管在当前阈值下不具有成本效益,但ICG可降低与PHLF相关的成本,并保持每年可接受的NBI。

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