Page 61 - 《中国药房》2024年17期

in the national medical insurance system in the treatment of advanced or metastatic non-small cell lung cancer based on real-world
data from the perspective of the national medical insurance payer， to provide a basis for the decision-making of the medical
insurance department. METHODS A budget impact analysis model was constructed to compare the impact of pembrolizumab not
included in medical insurance and included in medical insurance on medical insurance fund expenditure in the next five years （2024-
2028） with 2023 as the baseline year. The target population was the patients with EGFR gene mutation-negative and anaplastic
lymphoma kinase （ALK）-negative locally advanced or metastatic non-small cell lung cancer； estimated cost mainly included the
cost of drugs， the cost of adverse reaction treatment， the cost of examination， the cost of admission and monitoring， etc；
equipment ratio of PEM in 183 hospitals of Guangdong province from 2020 to 2022 was used as the market share. Univariate
sensitivity analysis was used to test the robustness of the basic analysis results. RESULTS When PEM was not included in the
medical insurance， the medical insurance reimbursement amount of the target population from 2024 to 2028 was 4 933 623.5
thousand yuan-5 151 198.3 thousand yuan， respectively. If PEM was included in the medical insurance， the above data were
11 871 972.2 thousand yuan-14 540 571.0 thousand yuan， respectively； the increase in medical insurance reimbursement under the
two scenarios was 6 720 773.9 thousand yuan-9 606 947.5 thousand yuan， respectively. The proportion of medical insurance
reimbursement to the medical insurance expenditure of the year after PEM was included in medical insurance was 0.298 0%，
0.262 1%， 0.228 8%， 0.208 2%， and 0.185 7%， respectively. The increase in medical insurance reimbursement accounted for
1.084 0%， 0.995 7%， 0.888 6%， 0.886 3%， and 0.861 6% of the increase in the expenditure of the medical insurance fund in the
current year， all of which showed a decreasing trend year by year. CONCLUSIONS If PEM is included in medical insurance， due
to its high unit price， the medical expenditure will increase accordingly， which will have a great impact on the medical insurance
fund expenditure. However， when the drug is used in patients with EGFR mutation-negative and ALK-negative locally advanced or
metastatic non-small cell lung cancer， the proportion of the medical insurance reimbursement amount in the current year’s medical
insurance fund expenditure and the proportion of the increase in medical insurance reimbursement in the current year’s increase in
medical insurance fund expenditure are decreasing year by year.
KEYWORDS pembrolizumab； non-small cell lung cancer； budget impact analysis； real-world data； EGFR gene mutation-
negative； anaplastic lymphoma kinase-negative； health insurance

[4]
在我国，肺癌的发病率和病死率均位居恶性肿瘤的 要因素 。
首位，其中非小细胞肺癌（non-small cell lung cancer， 近年来，国家通过“以量换价”策略对创新药物进行
NSCLC）是最常见的类型（占比 80%～85%），且至少 国谈，在保障药企利润和鼓励药物创新的基础上尽可能
[1]
[5]
70% 的 NSCLC 患者在就诊时已为晚期 。对于 EGFR 地降低药品价格，以减轻患者经济负担 。国家将具有
基因突变阴性和间变性淋巴瘤激酶（anaplastic lym‐ 创新性和重大临床价值的药品优先列入医保目录，但针
phoma kinase，ALK）阴性的局部晚期或转移性 NSCLC 对某些发病率不断增高的恶性肿瘤的靶向药物，若将其
患者，程序性死亡受体 1（programmed death-1，PD-1）/程 纳入医保则可能对医保基金的持续运行产生较大影响，
序性死亡受体配体1（programmed death-ligand 1，PD-Ll） 故须通过预算影响分析预估其治疗成本费用，以确定该
抑制剂联合或不联合化疗已经成为其一线标准治疗方 类药物的医保支付价格以及为相关支付政策提供依
[7]
[2]
[6]
案 。帕博利珠单抗（pembrolizumab，PEM）是一种PD-1 据 。PEM 便是其中的代表性药物 。此外，现实世界
抑制剂，其联合放化疗用于晚期或转移性 NSCLC 的临 中我国的医疗卫生政策比较复杂，且药物的实际应用过
床疗效显著，可改善患者的免疫功能，提高患者的生活 程与严格控制条件的临床试验之间存在着较大偏差，故
[3]
质量，且不增加不良反应 。2022 年美国国立综合癌症 有必要基于真实世界数据对PEM纳入医保前后对医保
网络发布的第 5 版 NSCLC 临床实践指南和中国临床肿 基金支出的影响进行讨论。PEM自2018年在我国上市

瘤 学 会（Chinese Society of Clinical Oncology，CSCO） 以来，在治疗晚期或转移性 NSCLC 方面的真实世界研
[8]
2023 年发布的 NSCLC 诊治指南都将 PEM 单药或联合 究数据较少 。本研究将基于真实世界数据，通过预算
化疗方案作为NSCLC的一线疗法。但是在实际临床治 影响分析，预估将PEM作为治疗EGFR基因突变阴性和
疗过程中，该药高昂的价格成为制约患者治疗进程的重 ALK阴性的局部晚期或转移性NSCLC一线用药纳入国

中国药房 2024年第35卷第17期 China Pharmacy 2024 Vol. 35 No. 17 · 2115 ·