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维恩妥尤单抗联合帕博利珠单抗一线治疗晚期尿路上皮癌的成本-效用分析
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| 篇名： | 维恩妥尤单抗联合帕博利珠单抗一线治疗晚期尿路上皮癌的成本-效用分析 |
| TITLE： | Cost-utility analysis of enfortumab vedotin combined with pembrolizumab in the first-line treatment of advanced urothelial carcinoma |
| 摘要： | 目的 评价维恩妥尤单抗联合帕博利珠单抗（简称“PemEV”）相较于吉西他滨联合顺铂或卡铂（简称“GP”）一线治疗晚期尿路上皮癌（aUC）的经济性。方法从中国卫生体系角度出发，基于EV-302试验泛亚洲亚组数据构建动态Markov模型，设研究时限为20年，循环周期为21d，贴现率为5%。以直接医疗总成本及质量调整生命年（QALYs）为产出指标，计算PemEV方案相较于GP方案的增量成本-效果比（ICER）；通过敏感性分析和情境分析验证模型的稳健性，并测算PemEV方案相较于GP方案更具经济性时维恩妥尤单抗和帕博利珠单抗的价格阈值。结果成本-效用基础分析结果显示，相较于GP方案，PemEV方案可为aUC患者额外带来2.602QALYs，但治疗成本增加了3339703.56元，ICER为1283554.39元/QALY，远超意愿支付（WTP）阈值（3倍我国2024年人均国内生产总值，287247元/QALY）。单因素敏感性分析结果显示，PemEV方案总生存曲线Exponential分布的率参数值对ICER的影响最大。概率敏感性分析结果显示，在当前WTP阈值下，PemEV方案相较于GP方案更具经济性的可能性为0。情境分析结果显示，无论是将研究模型更改为分区生存模型，将研究时限分别设置为5、10、20年，还是将维恩妥尤单抗或（和）帕博利珠单抗的价格下调60%，PemEV方案相较于GP方案始终不具有经济学优势。若要使PemEV方案相较于GP方案更具经济性，维恩妥尤单抗和帕博利珠单抗的价格需同时下调78.65%，即单价分别降至55.71和38.26元/mg。结论基于我国卫生体系角度，PemEV方案相较于GP方案一线治疗aUC不具有经济学优势。 |
| ABSTRACT： | OBJECTIVE To evaluate the cost-utility of enfortumab vedotin combined with pembrolizumab （PemEV） versus gemcitabine combined with cisplatin or carboplatin （GP） in the first-line treatment of advanced urothelial carcinoma （aUC）. METHODS From the perspective of China’s health system， a dynamic Markov model was established based on the pan-Asian subgroup data from the EV-302 trial. The study timeframe was set at 20 years， with a cycle length of 21 days and a discount rate of 5%. Using total direct medical costs and quality-adjusted life years （QALYs） as outcome measures， the incremental cost- effectiveness ratio （ICER） of the PemEV regimen compared to the GP regimen was calculated. The robustness of the model was validated through sensitivity analysis and scenario analysis， and the price thresholds for enfortumab vedotin and pembrolizumab were estimated under conditions where the PemEV regimen was more cost-effective compared to the GP regimen. RESULTS Cost- utility analysis indicated that compared to the GP regimen， PemEV regimen could generate an additional 2.602 QALYs in aUC patients， but the treatment cost increased by 3 339 703.56 yuan， with an ICER of 1 283 554.39 yuan/QALY. This figure significantly exceeded the willingness-to-pay （WTP） threshold （3 times China’s gross domestic product per capita in 2024， 287 247 yuan/QALY）. The rate parameter of the exponential distribution fitted to the overall survival curve in the PemEV regimen had the greatest impact on ICER， according to the one-way sensitivity analysis. Probabilistic sensitivity analysis suggested that the PemEV regimen had no chance of being more cost-effective than the GP regimen at the current WTP threshold. Scenario analysis revealed that the PemEV regimen consistently lacked cost-utility advantage over the GP regimen， regardless of whether the study model was changed to a partitioned survival model， the study timeframe was set to 5， 10 or 20 years， or the prices of enfortumab vedotin and/or pembrolizumab were reduced by 60%. The prices of enfortumab vedotin and pembrolizumab should be simultaneously reduced by 78.65% （55.71 yuan/mg and 38.26 yuan/mg， respectively） when the PemEV regimen had a cost-utility advantage over the GP regimen. CONCLUSIONS From the perspective of China’s healthcare system， PemEV regimen does not demonstrate a cost-utility advantage over GP regimen in the first-line treatment of aUC. |
| 期刊： | 2025年第36卷第20期 |
| 作者： | 鹿琦；黄金岳；凌心；张红旭 |
| AUTHORS： | LU Qi，HUANG Jinyue，LING Xin，ZHANG Hongxu |
| 关键字： | 维恩妥尤单抗；帕博利珠单抗；晚期尿路上皮癌；成本-效用分析；药物经济学 |
| KEYWORDS： | enfortumab vedotin； pembrolizumab； advanced |
| 阅读数： | 1 次 |
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