世界卫生组织《基本药物标准清单》中胰岛素制剂的变化对我国药品目录修订的启示

Enlightenment of changes in insulin preparations in the WHO essential model list on the revision of China’s drug catalogue

目的了解《国家基本药物目录2018年版》(NEML-2018)、《国家基本医疗保险、工伤保险和生育保险药品目录》(NRML-2021)与世界卫生组织(WHO)《基本药物标准清单2021》(WHO-EML-2021)目录中胰岛素制剂收录变化和品种差异,结合目录中胰岛素的变动情况,探讨WHO-EML-2021对NEML-2018及NRML-2021制订的启示。方法比较各目录中胰岛素制剂收录的数量、品种、规格的异同,就目录变化和存在的问题进行分析。结果我国NEML-2018及NRML-2021胰岛素制剂在收录品种和遴选方法方面较WHOEML-2021有差异。收录品种方面,WHO-EML-2021收录了短效和中效的人胰岛素及3种超长效胰岛素类似物,NEML-2018收录了人源及动物源的短效、中效、长效胰岛素、预混胰岛素及1种超长效胰岛素类似物(甘精胰岛素)。NRML-2021则较为全面,覆盖了我国上市的所有类型胰岛素制剂。结论NEML-2018、NRML-2021与WHO-EML-2021在药物遴选和品种收录方面仍存在一定的差距,可借鉴WHO-EML及遴选程序,加强循证评价和药物经济学分析,不断完善胰岛素制剂的遴选。

Objective To understand the differences of insulin preparations between WHO essential model list(NEML-2018),National essential medicines list(NRML-2021)and National reimbursement medicines list(WHO-EML-2021),combined with the changes of insulin preparations in the lists to discuss the enlightenment on the revision of NEML and NRML.Methods The similarities and differences in the quantities,varieties and specifications of insulin preparations in the NEML and NRML of China and the WHO-EML were compared and then the characteristics and problems were analyzed.Results There were some differences among NEML-2018,NRML-2021 and WHO-EML-2021 in medicine selection and variety collection.For the varieties in the lists,WHO-EML has included short-acting,intermediate-acting human insulin and all the three ultralong-acting insulin analogs.The NEML included the short,intermediate,long-acting insulin(human and animal origin)and 1ultra-long-acting insulin analog(insulin glargine).The NRML-2021 has covered all types of insulin preparations.Conclusion Compared to WHO-EML-2021,some disadvantages were still existing in NEML-2018 and NRML-2021,including medicine selection and variety collection.Taking WHO-EML as reference,evidence-based evaluation and pharmacoeconomic analysis should be considered in the future revision of insulin preparations.