首页|血液系统新型抗肿瘤药药品说明书适应证、医保限定支付范围和指南推荐的差异分析

血液系统新型抗肿瘤药药品说明书适应证、医保限定支付范围和指南推荐的差异分析

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目的 为血液系统新型抗肿瘤药医保支付和超说明书用药监管提供参考。方法 纳入我国 2000 年至 2021 年批准上市的血液系统新型抗肿瘤药,检索《国家基本医疗保险、工伤保险和生育保险药品目录(2022 年)》(以下简称 2022 年版《国家药品目录》)纳入的血液系统新型抗肿瘤药和 2022 年中国临床肿瘤学会(CSCO)指南中血液系统肿瘤Ⅰ级推荐的新型抗肿瘤药,分析药品说明书适应证、医保限定支付范围和CSCO指南推荐间的差异。结果 2000 年至 2021 年,我国批准上市血液系统新型抗肿瘤药有 33 种。截至2023 年 1 月,共 26 种药品被纳入医保目录,占 78。79%。2022 年版《国家药品目录》中,6 种血液系统新型抗肿瘤药未备注医保限定支付范围;11 种药品医保限定支付范围与药品说明书一致;5 种药品医保限定支付范围大于药品说明书,但限定的疾病种类与药品说明书一致;4 种药品医保限定支付范围小于药品说明书,对适应证范围、有治疗有效证据、医院类别和专科医师处方、医保支付药品数量进行限定。对比药品说明书适应证与CSCO指南推荐,除慢性粒细胞性白血病外,批准的用于治疗其他血液系统肿瘤的药品的适应证与CSCO指南治疗用药推荐间存在差异,可能会出现超说明书用药。结论 部分血液系统新型抗肿瘤药医保限定支付范围仍较严格,CSCO指南推荐的药品使用范围和联合用药方案与药品说明书适应证间存在较大差异。应关注临床超说明书用药及其医保支付等问题,并逐步建立完善的药品循证评价体系。
Differences Among Indications,Medical Limited Insurance Payment Scopes and Guideline Recommendations of Novel Hematological Antineoplastic Drugs
Objective To provide a reference for the medical insurance payment of novel hematological antineoplastic drugs and the supervision of off-label drug use.Methods Novel hematological antineoplastic drugs approved for market by China from 2000 to 2021 were collected.The novel hematological antineoplastic drugs in the 2022 version of the List of Drugs for National Basic Medical Insurance,Industrial Injury Insurance and Maternity Insurance(hereinafter referred to as the 2022 version of the National Medical Insurance Drug List)and the level Ⅰ recommended novel antineoplastic drugs for hematological malignancy in the Chinese Society of Clinical Oncology(CSCO)Guideline were searched to analyze the differences among indications,the medical insurance limited payment scopes and the CSCO Guideline recommendations.Results From 2000 to 2021,33 novel hematological antineoplastic drugs were approved for market in China.By January 2023,a total of 26 drugs(78.79%)were included in the National Medical Insurance Drug List.In the 2022 version of the National Medical Insurance Drug List,the limited payment scopes of six drugs were not noted;those of eleven drugs were consistent with the drug instructions;those of five drugs were more than the drug instructions,but the limited types of diseases were consistent with the drug instructions;those of four drugs were fewer than the drug instructions,including the limitations about the scope of indications,having evidence of effective treatment,type of hospitals and specialist prescription,and the number of drugs paid by medical insurance.Comparing the drug instructions and the recommendations of the CSCO Guideline,there were some differences between the indications of approved drugs for the treatment of hematological malignancies(except for chronic myeloid leukemia)and the treatment drug recommendations in the CSCO Guideline,and off-label drug use might exist during treatment.Conclusion The medical insurance limited payment scopes for some novel hematological antineoplastic drugs are still relatively strict.There are significant differences between the recommended use ranges and combined drug regimens in the CSCO Guideline and the indications in the drug instructions.Attention should be paid to the off-label drug use and their medical insurance payments in clinical practice,and the evidence-based evaluation system should be gradually established.

hematological malignancynovel antineoplastic drugsindicationsCSCO Guidelinesmedical limited insurance payment scope

胡晓静

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上海市卫生和健康发展研究中心·上海市医学科学技术情报研究所,上海 200031

血液系统肿瘤 新型抗肿瘤药 适应证 中国临床肿瘤学会指南 医保限定支付范围

上海市"科技创新行动计划"软科学重点项目(2021)

21692104200

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(11)
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