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非奈利酮联合标准方案治疗射血分数轻度降低型或保留型心力

衰竭的药物经济学评价
Δ

夏茹楠 ，王 旭，陈慧娟，姜梦雨，狄潘潘，赵蒙蒙，刘 丽，梁 海（亳州市人民医院药学部，安徽 亳州
#
＊
236800）

中图分类号 R956 文献标志码 A 文章编号 1001-0408（2025）14-1770-05
DOI 10.6039/j.issn.1001-0408.2025.14.14

摘 要 目的 对非奈利酮联合标准治疗方案（SoC）治疗射血分数轻度降低型心力衰竭（HFmrEF）或射血分数保留型心力衰竭
（HFpEF）的经济性进行评价。方法 基于一项Ⅲ期临床试验，从我国卫生体系角度出发，建立非奈利酮联合SoC方案和SoC方案
治疗HFmrEF/HFpEF的不同心功能状态的Markov模型。以质量调整生命年（QALY）为健康产出指标，以3倍我国2023年人均国
内生产总值作为意愿支付（WTP）阈值，设置模型周期为3个月、模拟时限为10年、贴现率为5%，模拟非奈利酮联合SoC和SoC治
疗HFmrEF/HFpEF各个阶段的动态变化，获得两种治疗方案的长期效果与成本，并进行单因素敏感性分析和概率敏感性分析以检
验结果的稳健性。结果 非奈利酮联合 SoC 方案相比 SoC 方案的增量成本-效果比为 179 504.75 元/QALY，小于本研究设定的
WTP阈值，表明非奈利酮联合SoC方案具有一定的经济性优势。单因素敏感性分析结果显示，NYHA Ⅱ状态的效用值、非奈利酮
的药品价格、贴现率以及两组的住院转移概率对结果的影响较大，但未影响模型的稳健性。概率敏感性分析也验证了模型的稳健
性。结论 在本研究设定的WTP阈值下，非奈利酮联合SoC治疗HFmrEF/HFpEF相较于SoC更具有经济性。
关键词 非奈利酮；射血分数轻度降低型心力衰竭；射血分数保留型心力衰竭；Markov模型；成本-效用分析

Pharmacoeconomic evaluation of finerenone combined with standard regimen in the treatment of heart
failure with preserved or mildly reduced ejection fraction
XIA Runan，WANG Xu，CHEN Huijuan，JIANG Mengyu，DI Panpan，ZHAO Mengmeng，LIU Li，LIANG Hai
（Dept. of Pharmacy， People’s Hospital of Bozhou， Anhui Bozhou 236800， China）

ABSTRACT OBJECTIVE To evaluate the cost-effectiveness of finerenone combined with standard of care （SoC） in the
treatment of heart failure with mildly reduced ejection fraction （HFmrEF） or preserved ejection fraction （HFpEF）. METHODS
Based on a phase Ⅲ clinical trial， a Markov model was constructed from the perspective of China’s healthcare system to compare
the treatment outcomes of finerenone combined with SoC regimen versus SoC regimen alone in the treatment of different cardiac
functional statuses of HFmrEF/HFpEF. Using quality-adjusted life year （QALY） as the health output index， 3 times China’s per
capita GDP in 2023 as the willingness-to-pay （WTP） threshold， a simulation was conducted with a 3-month cycle length and a 10-
year time horizon， incorporating an annual discount rate of 5%. The dynamic changes across various stages of HFmrEF/HFpEF
treated with finerenone combined with SoC versus SoC alone were simulated to evaluate the long-term effectiveness and costs of the
two treatment strategies. Additionally， one-way sensitivity analysis and probabilistic sensitivity analysis were performed， to test the
robustness of the results. RESULTS The incremental cost-effectiveness ratio （ICER） of the finerenone combined with SoC regimen
versus SoC regimen alone was 179 504.75 yuan/QALY， which was below the WTP threshold set in this study， indicating that the
finerenone combined with SoC regimen possessed certain economic advantages. The results of one-way sensitivity analysis showed
that the utility value of NYHA Ⅱ status， the drug price of finerenone， the discount rate， and the probability of hospital transfer for
both groups had a great influence on ICER， but did not affect the robustness of the model. The probabilistic sensitivity analysis also
confirmed the robustness of the model. CONCLUSIONS Under the WTP threshold set in this study， finerenone combined with
SoC is cost-effective in the treatment of HFmrEF/HFpEF， compared with the SoC regimen.
KEYWORDS finerenone； HFmrEF； HFpEF； Markov model； cost-utility analysis

Δ 基金项目 安徽省重点研究与开发计划项目（No.2022e07020066）； 心力衰竭（heart failure，HF）是各种心脏疾病的严重
安徽医科大学校科研基金立项资助项目（No.2023xkj202） 表现或晚期阶段，以呼吸困难、疲乏和液体潴留等为主
＊第一作者 主管药师，硕士。研究方向：药物经济学。E-mail： [1―2]
要临床表现，具有较高的患病率和死亡率 。目前，全
xiarunan312@163.com
球HF患病人数约为3 700万例 ，我国HF患病人数约为
[3]
# 通信作者 副主任药师，硕士生导师，硕士。研究方向：药物经济
[4]
学。E-mail：lianghai_ay@163.com 890 万例 ，其中射血分数轻度降低型心力衰竭（heart
· 1770 · China Pharmacy 2025 Vol. 36 No. 14 中国药房 2025年第36卷第14期