Page 103 - 2021年15期

·循证药学·

我国已上市PD-1/PD-L1抑制剂经济性评价的系统分析 Δ

马 越 1，2＊ ，朱圣文 ，孙 蕾 ，管 欣 ，陈平钰 ，李洪超 （1.中国药科大学国际医药商学院，南京
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211198；2.中国药科大学药物经济学评价研究中心，南京 211198）
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中图分类号 R956；R979.1 9 文献标志码 A 文章编号 1001-0408（2021）15-1885-09
DOI 10.6039/j.issn.1001-0408.2021.15.16
摘 要 目的：为我国医保目录遴选更具经济性的细胞程序性死亡受体1（PD-1）和细胞程序性死亡配体1（PD-L1）抑制剂并提高
相应经济学评价质量提供参考。方法：计算机检索中国知网、维普网、万方数据库、PubMed、Web of Science、Ovid Embase等数据
库，收集我国已上市PD-1/PD-L1抑制剂的经济性评价的研究，检索时限为建库至2020年10月。利用CHEERS质量评价表评估纳
入文献的质量，系统分析纳入文献的方法学特征以及经济性评价结果。结果：共纳入14篇文献，所有文献均基于模型，且文献总
体质量为中等偏高。但纳入文献仍存在一定不足，主要表现为模型设定或选取参数的原因报告不充分，以及临床效果数据和效用
值不确定性较大等。纳入文献仅涉及我国已上市的8个PD-1/PD-L1抑制剂中的3个；在与化疗或靶向治疗等方案比较时，有9篇
（占64.29％）结果显示含有PD-1/PD-L1抑制剂的治疗方案不具经济性。结论：我国已上市的国产PD-1/PD-L1抑制剂经济性证据
缺乏，进口PD-1/PD-L1抑制剂价格较高导致经济性较差，且已有经济性评价在方法学应用和参数选择方面存在不足。制药企业
应填补数据空白和调整产品定价策略，研究者应提高研究规范性，医保决策部门应提高对于经济性证据质量的判断，共同促使更
具经济性的PD-1/PD-L1抑制剂纳入国家医保目录。
关键词 PD-1/PD-L1抑制剂；药物经济学；系统分析

Systematic Analysis of Economic Evaluation of Listed PD-1/PD-L1 Inhibitors in China
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MA Yue ，ZHU Shengwen ，SUN Lei ，GUAN Xin ，CHEN Pingyu ，LI Hongchao （1. College of
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International Pharmaceutical Business，China Pharmaceutical University，Nanjing 211198，China；2. Center for
Pharmacoeconomics Evaluation and Research，China Pharmaceutical University，Nanjing 211198，China）
ABSTRACT OBJECTIVE：To provide reference for the selection of more economical programmed death-1（PD-1）/programmed
death-ligand 1（PD-L1）inhibitors for National Medical Insurance List and the quality improvement of related economic evaluation.
METHODS：Retrieved from CNKI，VIP，Wanfang database，PubMed，Web of Science and Ovid Embase，economic evaluation
studies including listed PD-1/PD-L1 inhibitors of China were collected during the inception to Oct. 2020. CHEERS checklist was
used to evaluate the quality of the included literatures，and the methodological characteristics and economic evaluation results of the
included studies were analyzed systematically. RESULTS：A total of 14 literatures were included，all of which were model-based
and with moderate or high quality. However，there were still some deficiencies in the included literatures，mainly manifesting as
the insufficient reports on the reasons for setting or selecting model parameters，as well as the great uncertainty of clinical effect
data and utility value. Only 3 of the 8 PD-1/PD-L1 inhibitors listed in China were involved in the included literatures. Compared
with chemotherapy or targeted therapy plan，9 literatures（64.29％）showed that the therapy plan containing PD-1/PD-L1 inhibitors
was not cost-effective. CONCLUSIONS：The economic evidence of domestic PD-1/PD-L1 inhibitors is lacking，the higher price of
imported PD-1/PD-L1 inhibitors lead to poor economic performance. The existing economic evaluations has some shortcomings in
methodological application and parameter selection. Pharmaceutical enterprises should fill in the data gaps and adjust the pricing
strategy，researchers should improve the standardization of research，and medical insurance decision-making departments should
improve the judgment on the quality of economic evidences，so as to promote more economical drugs to be included in the
National Medical Insurance List.
KEYWORDS PD-1/PD-L1 inhibitors；Pharmacoeconomics；Systematic analysis

恶性肿瘤是对人类健康威胁较大的疾病之一，也是
Δ 基金项目：中国博士后科学基金（No.2020M681784）；江苏省高
[1]
校哲学社会科学研究一般项目（No.2020SJA0070） 造成我国患病人群过早死亡的首要原因 。据《2018 中
＊硕士研究生。研究方向：药物经济学。E-mail：cpumayue@163.
国肿瘤登记年报》统计，我国 2015 年新发恶性肿瘤患者
com
达 92.3 万例，全国发病率已从 2011 年的每 10 万人口
# 通信作者：讲师，博士。研究方向：药物经济学。E-mail：li-
hongchao@cpu.edu.cn 250.28例上升至2015年的每10万人口287.6例，并且肺

中国药房 2021年第32卷第15期 China Pharmacy 2021 Vol. 32 No. 15 ·1885 ·