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在中国接受他汀类药物治疗后低密度脂蛋白胆固醇仍升高的患者中,他伏利单抗的成本效益和价格阈值分析

Cost-Effectiveness and Price Threshold Analysis of Tafolecimab in Chinese Patients with Elevated LDL Cholesterol Despite Statin Therapy.

作者信息

Wan Yuansheng, Liu Jinyu, Zhan Xiaolian, Zhang Yu, You Ruxu

机构信息

Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Avenue, Wuhan, 430022, China.

Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.

出版信息

Am J Cardiovasc Drugs. 2025 Apr 2. doi: 10.1007/s40256-025-00733-0.

Abstract

BACKGROUND

Tafolecimab is a novel PCSK9 inhibitor developed in China. In recently published phase III clinical trials, tafolecimab demonstrated long-term safety and efficacy in Chinese patients with hypercholesterolemia despite statin therapy. However, pharmacoeconomic studies of tafolecimab have yet to be published. This study aimed to explore the maximum cost-effective price of tafolecimab compared with statins alone for Chinese patients with hypercholesterolemia at various willingness-to-pay (WTP) thresholds.

METHODS

A Markov cohort state-transition model was employed to assess the cost-effectiveness of tafolecimab from the perspective of the Chinese healthcare system. The low-density lipoprotein cholesterol (LDL-C) lowering effect of tafolecimab was observed in the CREDIT-4 trial. The baseline and subsequent incidence and transfer probability of cardiovascular events were based on prospective observational data in China and meta-analyses from the Cholesterol Treatment Trialists Study. Cost and utility values were obtained from the China Health Statistics Yearbook, health insurance, and published articles in China. The study also performed subgroup, sensitivity, and scenario analyses.

RESULTS

The annual price thresholds for tafolecimab as an adjunctive therapy to statins were Chinese yuan (CNY) 3304 and CNY 7022 at WTP thresholds of CNY 89,358 and CNY 268,074 per quality-adjusted life year (QALY), respectively. The corresponding annual price thresholds for patients with hypercholesterolemia with acute myocardial infarction were CNY 10,355 and CNY 21,793 per year. Sensitivity analyses showed that the time horizon significantly impacted price thresholds, with a several-fold difference.

CONCLUSIONS

From the perspective of the Chinese healthcare system, the cost-effective annual price threshold for tafolecimab for patients with hypercholesterolemia was CNY 7022, at a threshold of CNY 268,074 per QALY.

摘要

背景

tafolecimab是一种在中国研发的新型前蛋白转化酶枯草溶菌素9(PCSK9)抑制剂。在最近发表的III期临床试验中,tafolecimab在接受他汀类药物治疗的中国高胆固醇血症患者中显示出长期安全性和有效性。然而,tafolecimab的药物经济学研究尚未发表。本研究旨在探讨在中国高胆固醇血症患者中,tafolecimab与单用他汀类药物相比,在不同支付意愿(WTP)阈值下的最大成本效益价格。

方法

采用马尔可夫队列状态转移模型,从中国医疗保健系统的角度评估tafolecimab的成本效益。tafolecimab降低低密度脂蛋白胆固醇(LDL-C)的效果在CREDIT-4试验中观察到。心血管事件的基线及后续发病率和转移概率基于中国的前瞻性观察数据以及胆固醇治疗试验协作组研究的荟萃分析。成本和效用值来自《中国卫生统计年鉴》、医疗保险以及中国发表的文章。该研究还进行了亚组分析、敏感性分析和情景分析。

结果

在每质量调整生命年(QALY)89358元和268074元的WTP阈值下,tafolecimab作为他汀类药物辅助治疗的年度价格阈值分别为3304元和7022元。患有急性心肌梗死的高胆固醇血症患者的相应年度价格阈值分别为每年10355元和21793元。敏感性分析表明,时间范围对价格阈值有显著影响,相差数倍。

结论

从中国医疗保健系统的角度来看,高胆固醇血症患者使用tafolecimab的具有成本效益的年度价格阈值为7022元,每QALY的阈值为268074元。

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