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治疗非小细胞肺癌的国家医保谈判药品支出趋势与代际替代关系分析
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| 篇名： | 治疗非小细胞肺癌的国家医保谈判药品支出趋势与代际替代关系分析 |
| TITLE： | Expenditure trends and intergenerational substitution relationships of national negotiated drugs for non-small cell lung cancer in China |
| 摘要： | 目的 以治疗非小细胞肺癌国家医保谈判药品（下称“NSCLC国谈药品”）为例，分析我国同适应证下药品代际之间的替代效应对该适应证总体医保基金支出的影响。方法从中国医药工业信息中心药物综合数据库中收集2017－2023年7个样本省份二、三级公立医院15种NSCLC国谈药品的销售和使用数据，利用滑动t检验与Mann-Kendall趋势检验评估其销售额和用药频度（DDDs）的变化趋势；以表皮生长因子受体（EGFR）-酪氨酸激酶抑制剂（TKIs）和间变性淋巴瘤激酶（ALK）-TKIs为例分析药品的代际替代特征。结果不同样本地区的NSCLC国谈药品销售额和DDDs突变点略有差异，销售额突变点集中在2019年第一季度至2020年第二季度，DDDs突变点则集中在2021年第一至第二季度。北京、黑龙江、江苏、四川、陕西5个省份的销售额在突变点后不再有显著增长趋势（P＞0.05），而广东和湖北的销售额和DDDs均在突变点之后仍显著上涨（P＜0.05）。2020年起，EGFR-TKIs的销售额增长趋势平缓；2021年后，一、二代药品的销售额和DDDs均呈现下降趋势，三代药品对前代药品的替代作用明显。ALK-TKIs的销售额则一直保持一定增长趋势，其中一代药品的销售额和DDDs逐年下降，二代药品对一代药品的替代作用明显，而三代药品暂未形成替代趋势。结论随着每年国谈药品准入及药品续约，NSCLC国谈药品总体支出进入增长平台期；同适应证药品的代际替代使得同适应证国谈药品基金支出相对稳定。建议医药企业合理布局研发管线，医保部门在续约管理中关注药品的替代效应对该靶点或同一适应证下的实际医保基金总体支出的影响，科学评估续约降价幅度。 |
| ABSTRACT： | OBJECTIVE To analyze the impact of intergenerational substitution effect of the drugs with the same indication on fund expenditures for national medical insurance for this indication in China， taking national medical insurance negotiated drugs for non-small cell lung cancer （hereinafter referred to as “NSCLC national negotiation drugs”） as an example. METHODS The sales amounts of 15 types of NSCLC national negotiated drugs in secondary and tertiary public hospitals across seven sample provinces from 2017 to 2023 were collected from the Pharmaceutical Drug Database of the China National Pharmaceutical Industry Information Center. A sliding t-test and Mann-Kendall trend test were used to evaluate the trends in sales amounts and DDDs. Taking epidermal growth factor receptor（EGFR）-tyrosine kinase inhibitors （TKIs） and anaplastic lymphoma kinase （ALK）-TKIs as examples， the generational substitution characteristics of these drugs were analyzed. RESULTS The change points of sales amounts and DDDs differed slightly across provinces； the change points of sales amount were mostly concentrated between the first quarter of 2019 and the second quarter of 2020， while those for DDDs were primarily concentrated in the first to second quarters of 2021. In five provinces， i.e. Beijing， Heilongjiang， Jiangsu， Sichuan and Shaanxi， sales amounts showed no significant upward trend after the breakpoints （P＞0.05）， whereas in Guangdong and Hubei， both sales amounts and DDDs continued to rise significantly following the breakpoints （P＜0.05）. Since 2020， the growth in sales amounts of EGFR-TKIs had slowed. After 2021， the sales amounts and DDDs of first- and second-generation EGFR-TKIs declined， while third-generation EGFR-TKIs showed clear substitution effects. The sales amounts of ALK-TKIs continuedto grow. However， the sales amounts and DDDs of first-generation ALK-TKIs had declined year by year， with second-generation ALK-TKIs demonstrating a significant substitution effect on first-generation ones， while third-generation ALK-TKIs had not yet shown a clear substitution trend. CONCLUSIONS With the annual access to and renewal of drugs in national medical insurance negotiations， the overall expenditure trend for NSCLC negotiated drugs comes to a plateau. The intergenerational substitution relationships of drugs with the same indication achieve a relative balance in fund expenditures for negotiated drugs with the same indication. It is recommended that pharmaceutical companies carefully consider their research pipelines， and that medical insurance authorities， during the renewal management process， pay attention to the impact of drug substitution effects on the overall actual expenditure of medical insurance funds for that specific target or the same indication， and scientifically evaluate the extent of price reductions during contract renewals. |
| 期刊： | 2025年第36卷第16期 |
| 作者： | 宗舒淇；李伟；肖雨欣；闰浩 |
| AUTHORS： | ZONG Shuqi，LI Wei，XIAO Yuxin，RUN Hao |
| 关键字： | 国家医保谈判药品；非小细胞肺癌；同适应证药品；代际替代；医保基金 |
| KEYWORDS： | national medical insurance negotiated drugs； non-small cell lung cancer； drugs with the same indication； |
| 阅读数： | 3 次 |
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