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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
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| 篇名： | 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 |
| TITLE： | Pharmacoeconomic evaluation of finerenone combined with standard regimen in the treatment of heart failure with preserved or mildly reduced ejection fraction |
| 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179504.75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，NYHAⅡ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。 |
| 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. |
| 期刊： | 2025年第36卷第14期 |
| 作者： | 夏茹楠；王旭；陈慧娟；姜梦雨；狄潘潘；赵蒙蒙；刘丽；梁海 |
| AUTHORS： | XIA Runan， WANG Xu，CHEN Huijuan，JIANG Mengyu，DI Panpan，ZHAO Mengmeng，LIU Li，LIANG Hai |
| 关键字： | 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 |
| KEYWORDS： | finerenone； HFmrEF； HFpEF； Markov model； cost-utility analysis |
| 阅读数： | 7 次 |
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