Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Department of Sleep Medical Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Cardiovasc Drugs Ther. 2021 Aug;35(4):775-785. doi: 10.1007/s10557-020-07079-6. Epub 2020 Oct 22.
Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are an indispensable lipid-lowering treatment option, but their cost-effectiveness has been questioned. This study aimed to perform a health economic evaluation of evolocumab versus placebo in patients with myocardial infarction (MI) in China.
A Markov cohort state-transition model was developed in decision analysis software to estimate the incremental cost-effectiveness ratio (ICER), defined as cost per quality-adjusted life-year (QALY) saved. The simulation subjects could undergo non-fatal MI and/or stroke, or vascular or non-vascular death event. We integrated the Chinese population-specific demographics and event rates with the risk reduction of evolocumab based on the FOURIER trial and/or lowering of low-density lipoprotein cholesterol (LDL-C). Age-related change, event costs and utilities were included from published sources.
At its current list price [33,748 Chinese yuan (CNY) annually per person], the ICER for evolocumab therapy was 927,713 CNY per QALY gained when integrating the FOURIER trial with absolute reduction of LDL-C. The probability of cost-effectiveness of evolocumab versus placebo was 1.96%, with a generally accepted threshold of 212,676 CNY per QALY gained. A reduction in acquisition price by approximately 70% (to less than 10,255 CNY annually) was needed to be cost-effective. Alternative scenario analyses of therapeutic benefit showed that the ICER for evolocumab in MI patients with uncontrolled familial hypercholesterolemia (FH) was 187,736 CNY per QALY gained.
Evolocumab in patients with MI was not cost-effective based on the price in 2019 in China; however, treatment with evolocumab was more favorable in MI patients with FH.
前蛋白转化酶枯草溶菌素/糜蛋白酶 9(PCSK9)抑制剂是一种不可或缺的降脂治疗选择,但它们的成本效益一直受到质疑。本研究旨在对中国心肌梗死(MI)患者使用依洛尤单抗与安慰剂进行卫生经济学评价。
采用决策分析软件中的 Markov 队列状态转移模型来估计增量成本效益比(ICER),定义为每节省一个质量调整生命年(QALY)的成本。模拟对象可能经历非致死性 MI 和/或中风,或血管或非血管死亡事件。我们将中国特定的人口统计学和事件发生率与 FOURIER 试验中依洛尤单抗的风险降低率以及降低低密度脂蛋白胆固醇(LDL-C)相结合。年龄相关变化、事件成本和效用均来自已发表的资料。
按照目前的定价[每人每年 33748 元人民币(CNY)],当将 FOURIER 试验与 LDL-C 绝对降低相结合时,依洛尤单抗治疗的 ICER 为每获得一个 QALY 需花费 927713 CNY。依洛尤单抗与安慰剂相比,其成本效益的概率为 1.96%,而普遍接受的阈值为每获得一个 QALY 需花费 212676 CNY。需要将药价降低约 70%(每年低于 10255 CNY)才能具有成本效益。治疗效果的替代情景分析表明,在未控制家族性高胆固醇血症(FH)的 MI 患者中,依洛尤单抗的 ICER 为每获得一个 QALY 需花费 187736 CNY。
按照 2019 年中国的价格,MI 患者使用依洛尤单抗并不具有成本效益;然而,在 FH 的 MI 患者中,依洛尤单抗的治疗效果更有利。