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我国《临床急需境外新药名单》纳入品种及优化策略研究
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| 篇名： | 我国《临床急需境外新药名单》纳入品种及优化策略研究 |
| TITLE： | Study on the varieties included in the List of Overseas New Drugs Urgently Needed in Clinic in China and the optimization strategy |
| 摘要： | 目的 对我国《临床急需境外新药名单》的纳入品种及优化策略进行研究，以更好地满足患者用药需求。方法对我国《临床急需境外新药名单》的发布过程、临床急需境外新药的品种特点与属性、《临床急需境外新药名单》落实过程中存在的问题等进行分析，并就如何优化完善《临床急需境外新药名单》提出对策建议。结果与结论《临床急需境外新药名单》的发布过程大致可分为孕育阶段、准备阶段和实施阶段。3批临床急需境外新药的治疗领域相对集中于内分泌和代谢病、肿瘤、皮肤疾病，纳入的73个品种中已经有50个品种获批上市，26个品种被纳入医保，4个品种被纳入《鼓励仿制药品目录》。当前我国临床急需境外新药还存在短缺监测制度有待建立健全、与医保的联动减弱、鼓励仿制力度不足等问题。应当加强临床急需境外新药短缺监测的部门协同联动，建立以临床价值为导向的医保支付体系，完善鼓励仿制临床急需境外新药的配套激励机制。 |
| ABSTRACT： | OBJECTIVE To study the variety included in the List of Overseas New Drugs Urgently Needed in Clinic in China and optimization strategy， in order to better meet the needs of patients. METHODS The release process of List of Overseas New Drugs Urgently Needed in Clinic， the characteristics and attributes of the new drugs urgently needed abroad， and the problems in the implementation process were all analyzed to put forward some suggestions for optimizing the List of Overseas New Drugs Urgently Needed in Clinic. RESULTS & CONCLUSIONS The release process of the List of Overseas New Drugs Urgently Needed in Clinic was roughly divided into incubation stage， preparation stage and implementation stage. The treatment fields of 3 batches of overseas new drugs urgently needed in clinic were relatively concentrated on endocrine and metabolic diseases，tumor and skin diseases. Of included 73 varieties， 50 varieties have been approved for market，and 26 varieties have been included in the medical insurance， 4 varieties were included in the Catalogue of Encouraged Generic Drugs. At present， there are still some problems in our country， such as the shortage monitoring system needs to be established and improved； the linkage with medical insurance is weakened； the encouragement of generic drugs is insufficient. It is necessary to strengthen the cooperation of monitored departments in the shortage of new overseas drugs，establish a medical insurance payment system oriented by clinical value， and improve the incentive mechanism to encourage the imitation of overseas new drugs urgently needed in clinic. |
| 期刊： | 2023年第34卷第01期 |
| 作者： | 蒋丰；田侃 |
| AUTHORS： | JIANG Feng，TIAN Kan |
| 关键字： | 临床急需境外新药名单；品种；优化策略 |
| KEYWORDS： | List of Overseas New Drugs Urgently Needed in Clinic； variety； optimization strategy |
| 阅读数： | 785 次 |
| 本月下载数： | 11 次 |
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