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

Cost-utility analysis of enfortumab vedotin combined with pembrolizumab in the first-line treatment ol advancedurothelial carcinoma

LU Qi，HUANG Jinyue， LING Xin， ZHANG Hongxu（Dept. of Pharmacy， Xuzhou Cancer Hospital， Jiangsu Xuzhou ，China）

ABSTRACTOBJECTIVETo evaluate the cost-utlityof enfortumabvedotincombinedwith pembrolizumab（PemEV）versus gemcitabinecombinedwithcisplatinorcarboplatin（GP）inthefirst-linetreatmentof advancedurothelialcarcinoma（aUC）. METHODSFrom the perspective of China's health system，a dynamic Markov model was established based onthe pan-Asian subgroupdatafromtheEV-3O2trial.Thestudytimeframe wassetat2Oyears，withacyclelengthof21daysandadiscountrateof （204 5% .Usingtotal directmedicalcostsandquality-adjustedlifeyears（QALYs）asoutcome measures，the incremental costefectivenessratio（ICER）of thePemEVregimencomparedtotheGPregimen wascalculated.Therobustnessof the model was validatedthroughsensitivityanalysisandscenarioanalysis，andthepricethresholdsforenfortumabvedotinandpembrolizumab were estimatedunderconditions where thePemEVregimen wasmorecost-efectivecomparedtothe GPregimen.RESULTSCostutilty analysis indicatedthatcompared totheGPregimen，PemEVregimencouldgenerateanadditional2.602QALYsinaUC patients，butthetreatmentcostincreasedby3339703.56yuan，withanICERof1283554.39yuan/QALY.Thisfigure significantlyexceededthewilingness-to-pay（WT）threshold（3timesChina’sgrossdomesticproductpercapitain2024， 287247yuan/QALY）.TherateparameteroftheexponentialdistributionfitedtotheoverallsurvivalcurveinthePemEVregimen hadthegreatestimpactonICER，accordingtotheone-waysensitityanalysis.Probabilisticsensivityanalysissuggestedthatthe PemEVregimenhadnochanceofbeingmorecost-effectivethantheGPregimenatthecurent WTPthreshold.Scenarioanalysis revealedthatthePemEVregimenconsistentlylackedcost-utlityadvantageovertheGPregimen，regardless of whetherthestudy modelwaschangedtoaparitioedsurvival model，thestudytimeframe wassetto5，1Oor2Oyears，or thepricesofenfortumab vedotin and/or pembrolizumab were reducedby 60% .The prices of enfortumab vedotin and pembrolizumab should be simultaneously reduced by 78.65% （55.71yuan/mg and 38.26 yuan/mg，respectively）when the PemEV regimen had acost-utility

advantage over the GP regimen.CONCLUSIONS From the perspective of China’s healthcare system，PemEV regimen doesnot demonstrate a cost-utility advantage over GP regimen inthe first-linetreatmentofaUC.

KEYWORDSenfortumab vedotin；pembrolizumab；advanced urothelial carcinoma；cost-utility analysis；pharmacoeconomics

尿路上皮癌是最常见的泌尿系统恶性肿瘤，包括上尿路上皮癌和膀胱尿路上皮癌[。由于其早期症状（如无痛血尿）不具有典型性，易被忽视或误诊为其他泌尿系统疾病，约 11% 的患者在确诊时已进展至晚期[2。对于失去手术机会或已经发生远处转移的尿路上皮癌患者，其5年生存率仅为 10% [3]。针对晚期尿路上皮癌（ad-vancedurothelialcarcinoma，aUC），当前标准一线治疗方案是基于铂类药物的系统化疗，该方案可将患者的中位总生存期（overallsurvival，OS）延长至14个月，但复发和进展的发生率仍很高4，且有 30%～50% 的患者会因不耐受含铂化疗而不得不选用其他疗效较差的替代方案，治疗结果往往欠佳。近年来，抗体偶联药物（antibodydrugconjugates，ADC）与免疫检查点抑制剂的问世，为aUC患者带来了新的治疗希望，其治疗现状有望得以改善。

维恩妥尤单抗是一种完全人源化的ADC，由靶向连接蛋白4的特异性抗体通过药物接头与微管抑制剂连接而成，具有促进恶性尿路上皮细胞凋亡的作用。帕博利珠单抗作为程序性死亡受体1抑制剂，可增强肿瘤特异性抗原T细胞的功能。研究证实，维恩妥尤单抗与帕博利珠单抗联用（简称“PemEV”）能够通过互补的作用机制来协同增强抗肿瘤活性。EV-302研究是一项在多国开展的大型Ⅲ期临床试验，其早期全球队列研究结果显示，与吉西他滨联合顺铂或卡铂（简称“GP”方案相比，PemEV方案用于aUC一线治疗可显著改善患者的长期生存预后[。2024年底，最新披露的该试验泛亚洲亚组的数据更……