国家医保目录内外抗肿瘤类创新药物临床效果比较

目的 分析我国肿瘤领域药物近年上市数量及其适应证的基本情况，比较该领域内国家医保目录内外创新药物在临床效果表现上的差异。方法 收集整理2017年1月1日—2020年8月31日间我国创新药物市场中上市的肿瘤领域创新药物清单，分析各年度上市数量、种类、适应证的变化情况；检索Pubmed和Web of Science数据库中2017年至调研时影响因子较高的英文期刊，搜集发表的以安慰剂为对照的系统综述类文章；提取研究药物临床主要结果的合并效应量指标，采用Bucher法间接比较医保目录内外药物的合并效应量。结果 2017年1月1日—2020年8月31日肿瘤领域国内市场共上市52个创新药物，数量呈现明显增长态势，涵盖非小细胞肺癌、乳腺癌、黑色素瘤等19个具体适应证。共检索到38个创新药物临床结果的合并效应量，其中医保目录内的有23个，医保目录外的有15个。间接比较结果显示医保目录内的盐酸安罗替尼胶囊、巴瑞替尼等在无进展生存期（progression-freesurvival,PFS）上的效果与该领域的目录外药物相比较差，且差异具有统计学意义（P<0.05）。结论 肿瘤领域内创新药物竞争激烈，...

Comparison of clinical effects of anti-tumor innovative drugs inside and outside the Chinese national medical insurance catalogue

Objective To analyze the basic situation of the number of drugs on the market and indications in the field of cancer in recent years， and to compare the differences in clinical effects of innovative drugs inside and outside the Chinese medical insurance catalogue in this field. Methods We collected and sorted out the list of innovative drugs in the field of cancer in China's innovative drug market from Jan 1， 2017 to Aug 31， 2020， and analyzed the changes in the number， types and indications of drugs on the market in each year. We searched Pubmed and Web of Science databases for English journals with high impact factors from 2017 to the time of research， and collected published systematic review articles with placebo as the control， then extracted the combined effect index of the main clinical results of research drugs， and indirectly compared the combined effect of drugs inside and outside the medical insurance catalogue by Bucher method. Results From Jan 1， 2017 to Aug 31， 2020， 52 innovative drugs were listed in the cancer field， showing a significant growth trend， covering 19 specific indications， including non-small cell lung cancer， breast cancer and melanoma. The combined effects of 38 innovative drugs’ clinical results were retrieved， including 23 in the medical insurance catalogue and 15 outside the medical insurance catalogue. The indirect comparison results showed that the effects of arotinib hydrochloride capsule and baretinib in the medical insurance catalogue on PFS were worse than those of drugs outside the catalogue in this field， and the difference was statistically significant （P<0.05）. Conclusion The competition of innovative drugs in the field of cancer is fierce. There are some drugs in the current medical insurance catalogue whose clinical effects are worse than those outside the catalogue. Dynamic and comparative analysis should be made for the adjustment of the catalogue.