注射剂区域带量采购的模式研究和政策建议 点击下载
| 论文标题： | 注射剂区域带量采购的模式研究和政策建议 |
| 英文标题： | |
| 中文摘要： | 目的：研究国内注射剂区域带量采购模式，设计完善且有效的注射剂带量采购方案，为政府部门提供决策依据。方法：检索截至2021年2月8日时所有省份/省际联盟开展注射剂带量采购的官方文件，采用内容分析法对注射剂带量采购种类、注射剂分组方式、产品中选方式等信息进行梳理和对比，结合已有信息提出注射剂带量采购模式完善的建议和完善后的注射剂带量采购模式框架。结果与结论：截至2021年2月8日，共有13个省份/省际联盟开展了注射剂带量采购，涉及的注射剂品种以抗菌药和质子泵抑制剂为主，多采用综合评审制进行评价。综合评审制涉及注射剂的价格、质量以及企业信誉等方面，能够将除价格外的多种因素纳入评审范围。但综合评审制尚处于初步应用阶段，各省份/省际联盟综合评审制内容有所差异，细节有待完善，尚未形成统一规范，未来需细化产品质量检验方式。笔者在现有基础上，构建并完善了包括药品疗效、安全性、经济性等指标在内的综合评审制框架。建议应进一步推动药品临床综合评价，并将更多真实世界数据应用于产品评审，以进一步降低药价，促进医药行业健康发展。 |
| 英文摘要： | OBJECTIVE：To study the mode of regional volume-based proc urement of injection ，design complete and effective volume-based procurement plan of injection ，and to provide decision-making basis for government departments. METHODS ：The official documents of all provinces/provincial-level alliances that carried out injection volume-based procurement were retrieved as of Feb. 8th，2021. Content analysis method was used to sort out and compare volume-based procurement types ，grouping methods ， product selection methods and other information of injection. Combined with the existing information ，the suggestions were put forward for improving volume-based procurement mode and the improved volume-based procurement mode framework. RESULTS & CONCLUSIONS ：By Feb. 8th，2021，a total of 13 provinces/provincial-level alliances have launched volume-based procurement of injections ，mainly involving antibiotics and proton pump inhibitors ；a comprehensive evaluation system was used for evaluation for many provinces/provincial-level alliances. Comprehensive evaluation system involves the price and quality of injection ，and enterprise credit ，etc.，and include a variety of factors other than price into evaluation scope. But the comprehensive evaluation system is still in its preliminary application stage ，and has differences in each province/provincial-level. Its details need to be perfected and it has not yet formed a unified standard. In the future，the way of product quality inspection needs to be refined. On the existing basis ，it has been constructed and improved that comprehensive evaluation system framework include efficacy ，safety，economy and other indicators. It is suggested to promote the comprehensive clinical evaluation of com drugs and apply more re al world data for product review ，so as to further reduce drug price，and promote the hea lthy development of the pharmaceutical industry. |
| 期刊： | 2021年第32卷第15期 |
| 作者： | 张梦然，田磊 |
| 英文作者： | ZHANG Mengran ，TIAN Lei |
| 关键字： | 注射剂；区域带量采购；模式；综合评审制 |
| KEYWORDS： | Injection；Regional volume-based procurement ；Mode；Comprehensive evaluation system |
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