度伐利尤单抗联合化疗方案一线治疗晚期胆道癌的药物经济学评价-中国药房

度伐利尤单抗联合化疗方案一线治疗晚期胆道癌的药物经济学评价

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篇名：	度伐利尤单抗联合化疗方案一线治疗晚期胆道癌的药物经济学评价
TITLE：	Pharmacoeconomic evaluation of durvalumab combined with chemotherapy as first-line therapy for advanced biliary tract cancer
摘要：	目的从中国卫生体系角度评估度伐利尤单抗联合化疗方案用于晚期胆道癌一线治疗的经济性。方法基于TOPAZ-1临床试验数据，构建包含无进展生存、疾病进展（PD）及死亡三状态的马尔可夫模型，模拟周期为21d，研究时限为10年。观察组患者采用度伐利尤单抗联合吉西他滨+顺铂化疗方案，对照组患者使用安慰剂联合相同化疗方案。评估指标为质量调整生命年（QALY）与增量成本-效果比（ICER），设定意愿支付（WTP）阈值为3倍2024年中国人均国内生产总值（GDP）（287247元/QALY），并开展敏感性分析与情境分析。结果基础分析结果显示，观察组相对于对照组方案的ICER为1166344.46元/QALY，显著高于WTP阈值，不具备经济性。单因素敏感性分析结果表明，PD状态效用值、贴现率、度伐利尤单抗成本及无进展生存状态效用值为影响ICER的主要因素。概率敏感性分析结果显示，在上述WTP阈值下，该方案的可接受概率为0，进一步验证了基础分析结果的稳健性。情境分析中，考虑患者援助计划后，ICER下降至235885.16元/QALY，低于上述WTP阈值，表明该方案在援助机制支持下具备经济性。然而，在以3倍2024年甘肃省（2024年全国GDP最低省份）人均GDP（158475元/QALY）设定的区域WTP阈值下，ICER仍高于WTP阈值，不具备区域经济性。结论在当前价格水平下，度伐利尤单抗联合化疗方案用于晚期胆道癌一线治疗在中国不具备经济性；虽然引入患者援助计划可显著降低ICER，使其在以3倍2024年中国人均GDP作为的WTP阈值下具备经济性，然而在低收入地区，受限于较低的支付能力，该方案仍不具备经济性。
ABSTRACT：	OBJECTIVE To assess the cost-effectiveness of durvalumab combined with chemotherapy as a first-line treatment for advanced biliary tract cancer from the perspective of the Chinese healthcare system. METHODS Using data from the TOPAZ-1 clinical trial， a three-state Markov model comprising progression-free survival （PFS）， progressive disease （PD） and death was developed， with a cycle length of 21 days and a 10-year time horizon. Patients in the observation group received durvalumab in combination with gemcitabine and cisplatin， whereas those in the control group received placebo plus the same chemotherapy regimen. The evaluation indexes were quality-adjusted life year （QALY） and the incremental cost-effectiveness ratio （ICER）. The willingness-to-pay （WTP） threshold was set at three times the 2024 Chinese per capita gross domestic product （GDP）（287 247 yuan/QALY）. The sensitivity analyses， along with scenario analyses， were performed. RESULTS In the base-case analysis， the ICER of observation group compared to control group was 1 166 344.46 yuan/QALY， far exceeding the WTP threshold， indicating that the regimen was not cost-effective. One-way sensitivity analysis identified the PD state utility， discount rate， cost of durvalumab， and PFS state utility as the main drivers of ICER variation. Probabilistic sensitivity analysis showed that， at the above WTP threshold， the probability of the acceeptance of this regimen was 0， further supporting the robustness of the base-case findings. In the scenario analysis， inclusion of a patient assistance program reduced the ICER to 235 885.16 yuan/ QALY， below the above WTP threshold， suggesting cost-effectiveness under this assistance program. However， when applying a regional WTP threshold set at three times the per capita GDP （158 475 yuan/QALY） of Gansu Province （the province with the lowest GDP in China in 2024）， the ICER remained above the threshold， indicating that the regimen was not cost-effective at the regional level. CONCLUSIONS At current pricing， durvalumab plus chemotherapy as a first-line treatment for advanced biliary tract cancer is not cost-effective in China. Although the introduction of a patient assistance program can substantially reduce the ICER and achieve cost-effectiveness at a WTP threshold set at three times the 2024 per capita GDP of China， due to limited affordability in low-income areas， the program remains not cost-effective.
期刊：	2025年第36卷第17期
作者：	霍丽曼；段杨洋；梁平；单彬；孙晓利；冯锐
AUTHORS：	HUO Liman，DUAN Yangyang，LIANG Ping，SHAN Bin，SUN Xiaoli，FENG Rui
关键字：	度伐利尤单抗；化疗；晚期胆道癌；一线治疗；马尔可夫模型；药物经济学；成本-效用分析
KEYWORDS：	durvalumab； chemotherapy； advanced biliary tract cancer； first-line treatment； Markov model； pharmacoeconomics；
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