Page 70 - 《中国药房》2025年20期

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
Δ

＊
#
鹿 琦 ，黄金岳，凌 心，张红旭（徐州市肿瘤医院药剂科，江苏 徐州 221005）
中图分类号 R956；R979.1 文献标志码 A 文章编号 1001-0408（2025）20-2548-07
DOI 10.6039/j.issn.1001-0408.2025.20.11

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21 d，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 2.602 QALYs，但治疗成本增加了 3 339 703.56 元，ICER 为 1 283 554.39 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，287 247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。
关键词 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

Cost-utility analysis of enfortumab vedotin combined with pembrolizumab in the first-line treatment of
advanced urothelial carcinoma
LU Qi，HUANG Jinyue，LING Xin，ZHANG Hongxu（Dept. of Pharmacy， Xuzhou Cancer Hospital， Jiangsu
Xuzhou 221005， China）

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
Δ 基金项目 徐州市卫生健康委药学科研项目（No.XWYXKY- perspective of China’s healthcare system， PemEV regimen
202305） does not demonstrate a cost-utility advantage over GP regimen
＊第一作者 主管药师，硕士。研究方向：临床药学、药物经济学。
in the first-line treatment of aUC.
E-mail：lcyslq@163.com
# 通信作者 主任药师，硕士。研究方向：临床药学、抗肿瘤药物合 KEYWORDS enfortumab vedotin； pembrolizumab； advanced
理应用。E-mail：wastlx@163.com urothelial carcinoma； cost-utility analysis； pharmacoeconomics

· 2548 · China Pharmacy 2025 Vol. 36 No. 20 中国药房 2025年第36卷第20期