国家医保谈判抗肿瘤药品支付限定条件的循证医学证据变迁

Evidence-based medical evidence change of the payment limitation of antitumor drugs in national medical-insurance negotiation

目的研究国家医保谈判(简称"国谈")抗肿瘤药品医保支付限定条件和对应的中国临床肿瘤学会(CSCO)历年肿瘤诊疗指南推荐意见变迁情况,以期为国谈工作提供参考。方法整理汇总各年度国谈抗肿瘤药品目录,检索国谈抗肿瘤药品医保支付限定条件提及肿瘤类型对应的CSCO诊疗指南,定量分析国谈抗肿瘤药品医保支付限定条件与CSCO诊疗指南的证据衍变。结果与结论在纳入分析的46个协议期内抗肿瘤药品品种中,医保支付限定条件发生改变的有7个,医保支付限定条件、药品说明书和CSCO诊疗指南推荐意见之间存在差异的有13个,不同年度CSCO诊疗指南推荐意见/证据强度/推荐等级存在变化的有28个,各癌种CSCO诊疗指南推荐药品品种数有较大差异。国谈抗肿瘤药品医保支付限定条件逐渐扩大,对应的临床诊疗指南推荐意见、证据强度及推荐等级不断提升,但多数药品的医保支付限定条件仅限于药品说明书适应证、包括食管癌和鼻咽癌在内的部分癌种治疗药物缺乏。

OBJECTIVE To study the changes in medical-insurance payment limitations of antitumor drugs in national medicalinsurance negotiation(hereinafter referred to as“national negotiation”)and recommendations of diagnosis and treatment guidelines corresponding to tumor issued by Chinese Society of Clinical Oncology(CSCO),so as to provide reference for the performance of national negotiation. METHODS The annual list of antitumor drugs in national negotiation were summarized;CSCO diagnosis and treatment guidelines were searched according to the tumor types restricted by the medical-insurance payment limitations of antitumor drugs in national negotiation;the evidence evolution of the payment limitations of medical insurance for antitumor drugs and CSCO diagnosis and treatment guidelines were analyzed quantitatively. RESULTS & CONCLUSIONS Finally,46 antitumor drugs in the agreement period were included;seven of their payment limitations of medical insurance had changed;and there were differences among the payment limitation of medical insurance,drug labels and recommendations of CSCO diagnosis and treatment guidelines for 13 varieties;the recommendations,strength of evidence,recommendation level of CSCO diagnosis and treatment guidelines were changing for 28 varieties antitumor drugs in different years;the number of antitumor drugs recommended by CSCO diagnosis and treatment guidelines differed significantly among different cancer varieties. The medical insurance payment limitations of antitumor drugs in national negotiation have been gradually expanded,and the corresponding recommendations,strength of evidence, recommendation level in guidelines have been constantly improved. However, the payment limitation of medical insurance for most drugs are limited to the indications of drug labels and drugs for some cancers are scarce,such as esophageal cancer and nasopharyngeal carcinoma.