中国药业2024，Vol.33Issue(11)：1-7,7.DOI:10.3969/j.issn.1006-4931.2024.11.001
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
Differences Among Indications,Medical Limited Insurance Payment Scopes and Guideline Recommendations of Novel Hematological Antineoplastic Drugs
摘要
Abstract
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.关键词
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Key words
hematological malignancy/novel antineoplastic drugs/indications/CSCO Guidelines/medical limited insurance payment scope分类
医药卫生引用本文复制引用
胡晓静..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[J].中国药业,2024,33(11):1-7,7.基金项目
上海市2021年度"科技创新行动计划"软科学重点项目[21692104200]. （）
