我国优先审评药物采购管理研究
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篇名: 我国优先审评药物采购管理研究
TITLE:
摘要: 目的:为完善我国优先审评药物采购管理政策提供参考。方法:从我国优先审评药物采购管理政策出发,梳理截至2017年底已批准上市的优先审评药物,筛选出已明确采购方式的优先审评药物并按照纳入优先审评的理由进行分类,比较不同类别优先审评药物在各省的采购方式,以发现优先审评药物采购管理中存在的不足,并提出相应政策建议。结果与结论:截至2017年底有56个品种被获批为优先审评药物,其中有16种药品通过各省药品采购平台进行交易。上述16种药品中,有13种已明确具体采购方式,包括直接挂网采购、限价挂网采购、竞价采购、议价采购、招标采购、备案采购等6种采购方式,其中直接挂网采购使用频次最高。按照纳入优先审评的理由,上述13种已明确具体采购方式的药品主要分为具有明显临床价值的新药、临床急需药品、儿童用药、首仿药、同步申报药等5类。我国优先审评药物采购管理政策在制度设计、采购方式、管理程序这3个方面存在不足,体现为注册审评政策与采购政策之间没有充分衔接;除临床急需的优先审评药物外,其余类别的优先审评药物采购方式不统一、地区差异性较大;药品采购过程对药物经济学评价的利用度有待提高。建议细化药品采购类别并兼顾注册分类、统一药品采购方式并明确各类优先审评药物采购途径、规范药品采购管理并提高对药物经济学评价的关注度及利用度,以提高我国优先审评药物的可及性。
ABSTRACT: OBJECTIVE: To provide reference for improving the purchase management policy of priority reviewed drugs in China. METHODS: Based on the purchase management policy of priority reviewed drugs in China, priority reviewed drugs approved for market by the end of 2017 were sorted out; the priority reviewed drugs that had been purchased in a clear way were selected and classified according to the reasons for their inclusion in the priority review. The procurement methods of different categories of priority reviewed drugs in different provinces were compared in order to find out the shortcomings of priority reviewed drug procurement management and put forward related suggestions. RESULTS & CONCLUSIONS: By the end of 2017, 56 priority reviewed drugs achieved marketing authorization, 16 of which were purchased through provincial drug procurement platforms. Among the 16 drugs mentioned above, there were 13 priority reviewed drugs of which purchase methods were specific, including direct online purchase, price-limited online purchase, bidding purchase, price-negotiated purchase, bidding purchase and record purchase. And the direct online purchase was used the most frequently. According to the reasons included in the priority review, above 13 drugs with specific purchase methods were divided into 5 categories such as new drugs with obvious clinical value, urgent medical needed drugs, pediatric drugs, first generic drugs, the drugs which had passed investigational new drug application. China’s purchase management policy of priority reviewed drugs still had shortcomings through three aspects, including the system design, purchase method and management procedure. There is no sufficient connection between the registration review policy and the procurement policy. In addition to the clinical badly-needed priority reviewed drugs, the procurement methods of priority reviewed drugs in the remaining categories was not uniform, and the regional difference was large. And the utilization degree of pharmacoeconomic evaluation during the drug purchasing process needed to be improved. It is suggested to make the category of drug purchase more detailed combining with the classification of drug registration, unify the method of drug purchase to make the purchase way of each kind of priority reviewed drugs explicit, standardize the management of drug purchase and improve the attention and utilization of pharmacoeconomic evaluation, so as to improve the accessibility of priority reviewed drugs in China.
期刊: 2019年第30卷第16期
作者: 沈洁,蒋蓉,邵蓉
AUTHORS: SHEN Jie,JIANG Rong,SHAO Rong
关键字: 优先审评药物;集中采购;备案采购;采购方式;管理政策
KEYWORDS: Priority reviewed drug; Centralized drug pur- chase; Record drug purchase; Purchase method; Management policy
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