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·药物经济学·
帕博利珠单抗联合化疗方案一线治疗晚期或不可切除胆道恶性
肿瘤的成本-效用分析 Δ
＊
丁 樱 ，王旋辉，宫春博（山东中医药大学药学院，济南 250300）
#
中图分类号 R956；R735.8 文献标志码 A 文章编号 1001-0408（2023）23-2891-05
DOI 10.6039/j.issn.1001-0408.2023.23.13
摘 要 目的 从我国卫生体系角度出发，评价帕博利珠单抗联合化疗方案对比安慰剂联合化疗方案一线治疗晚期或不可切除胆
道恶性肿瘤（BTC）的经济性。方法 根据 KEYNOTE-966 试验数据构建分区生存模型，模拟周期为 21 d，模拟时限为患者终生。
以质量调整生命年（QALY）为产出指标，采用成本-效用分析法评价上述两种方案的经济性。通过单因素敏感性分析和概率敏感
性分析验证基础分析结果，并探讨有赠药方案情境下的经济性。结果 基础分析结果显示，帕博利珠单抗组的成本与效果均高于
安慰剂组，增量成本-效果比（ICER）为3 909 359.78元/QALY，高于以3倍我国2022年人均国内生产总值（GDP）即257 094元作为
的意愿支付（WTP）阈值，证明没有经济性。单因素敏感性分析结果显示，效用贴现率、无进展生存状态效用值、成本贴现率、帕博
利珠单抗成本等对 ICER 的影响较大。概率敏感性分析验证了基础分析结果的稳健性，并得出当 WTP 阈值大于 1 500 000
元/QALY时，帕博利珠单抗组方案开始具有经济性。情境分析结果表明，当考虑针对低收入人群的帕博利珠单抗慈善赠药方案
时，虽然治疗成本大幅下降，但仍不具有经济性。结论 在以3倍我国2022年人均GDP作为WTP阈值时，相比于安慰剂联合化疗
方案，帕博利珠单抗联合化疗方案治疗晚期或不可切除BTC不具有经济性。
关键词 帕博利珠单抗；分区生存模型；胆道恶性肿瘤；成本-效用分析；药物经济学评价
Cost-utility analysis of pembrolizumab combined with chemotherapy in the first-line treatment of advanced
or unresectable biliary tract carcinoma
DING Ying，WANG Xuanhui，GONG Chunbo（School of Pharmacy， Shandong University of Traditional Chinese
Medicine， Jinan 250300， China）
ABSTRACT OBJECTIVE To evaluate the cost-effectiveness of pembrolizumab combined with chemotherapy versus placebo
combined with chemotherapy in the first-line treatment of advanced or unresectable biliary tract carcinoma （BTC） from the
perspective of China’s health system. METHODS A partitioned survival model was constructed based on the KEYNOTE-966 study
data. The simulation period was 21 days， and the simulation time was the patient’s whole life. Using quality-adjusted life year
（QALY） as the output indicator， the cost-utility analysis method was used to evaluate the cost-effectiveness of the two schemes
mentioned above. Univariate and probabilistic sensitivity analyses were performed to verify the results of the basic analysis， and to
explore the cost-effectiveness under the scenario of drug donation scheme. RESULTS The basic analysis showed that both the cost
and effectiveness of the pembrolizumab group were higher than those of the placebo group， and the incremental cost-effectiveness
ratio （ICER） was 3 909 359.78 yuan/QALY， which was higher than the willingness-to-pay （WTP） threshold of 3 times 2022 gross
domestic product （GDP） per capita （257 094 yuan）， indicating no cost-effectiveness. The results of univariate sensitivity analysis
showed that the utility discount rate， the utility value of progression-free survival （PFS） status， the cost discount rate， and the cost
of pembrolizumab had a great influence on ICER. Probabilistic sensitivity analysis verified the robustness of the results of basic
analysis， and concluded that when the WTP threshold was greater than 1 500 000 yuan/QALY， the pembrolizumab group became
cost-effective. The results of the scenario analysis showed that
Δ 基金项目 山 东 省 研 究 生 教 育 质 量 提 升 计 划 项 目（No. considering the drug donation scheme of pembrolizumab for
SDYKC21053）；山东中医药大学青年科研创新团队（社会科学类）项 low-income people， although its treatment cost was
目（No.校字〔2020〕54号） significantly reduced， it was still not cost-effective.
＊第一作者 硕士研究生。研究方向：药事管理、卫生经济。
CONCLUSIONS At the WTP threshold of 3 times China’s
E-mail：3477229348@qq.com
# 通信作者 副教授，硕士生导师，博士。研究方向：药事管理、健 GDP per capita in 2022， pembrolizumab combined with
康经济学与医疗保障。E-mail：gongchunbo168@163.com chemotherapy is not cost-effective compared with placebo
中国药房 2023年第34卷第23期 China Pharmacy 2023 Vol. 34 No. 23 · 2891 ·
