多地取消医院用药数量限制,利于创新药落地

文摘   2024-09-04 10:01   北京  

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CN

多地取消医院用药数量限制,利于创新药落地

8月12日,江西省在新发布的《江西省医疗机构药品配备目录管理指南》提出“医疗机构药品目录的品规数应控制在合理范围”,国家医保谈判药品、国家和省组织集中采购中选品种在医院中不受品类限制。自去年以来,全国已有多个地区的卫健委和医保局发布文件,明确取消医疗机构用药数量限制,包括上海、四川、北京和山东济南。广东省发布的医疗机构药品目录管理指南(征求意见稿)也明确提出取消数量限制。


先前,公立医院药品配备目录的数量限制是创新药进院的一大障碍。原卫生部2011年发布的《三级综合医院评审标准实施细则》中规定了不同规模医院的药品品规数,一家三甲医院通常原则上不能配备超过1500种不同品规的药品。这意味着医保目录内的2800种药品也未必能确保进入医院。


医院药品目录的更新,取决于医院药事管理与药物治疗学委员会的决定。这意味着一款新药除了需要经历一个复杂的过程,在通过安全性、有效性和经济性的充分论证之后,还需通过药事会投票,才可以纳入医院药品目录。这导致一些临床急需的新药不得不在经历医院漫长的决策流程过后才能惠及患者。


随着越来越多创新药的上市和医保目录的滚动更新,医疗机构用药总品种数限制已经成为创新药进入医院的阻碍。多地取消这一限制,是扫清了创新药落地的“最后一公里”上的一大障碍。


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EN

Regions Lift Hospital Dug Restrictions, Enhancing Access to Innovative Medicine

On August 12, Jiangxi issued the Guidelines for Provincial Medical Institutions’ Drug and Medical Equipment Catalog Management, recommending more reasonable limits on the number of drugs in medical institutions’ catalogs. Under these guidelines, drugs on the National Reimbursement Drug List (NRDL) and those acquired through volume-based procurement (VBP) are exempt from category restrictions in hospitals’ drug inventories. Since last year, several regions, including Shanghai, Sichuan, Beijing, and Jinan have removed hospital drug inventory restrictions, and Guangdong’s draft guidelines also propose abolishing limits on drug types.


Previously, the limits on the number of drug categories significantly hindered public hospitals’ ability to procure innovative drugs. The former Ministry of Health's 2011 guidelines, Implementing Rules for the Evaluation Criteria for Three Levels of General Hospitals, typically restricted tertiary hospital to 1,500 drug types, while NRDL includes 2800 medicines, meaning that inclusion in NRDL did not ensure a drug's availability in tertiary hospitals.


The revision of a hospital's drug procurement catalog is determined by its pharmacy management and pharmacotherapy committee. Before a new drug can be purchased, it must undergo a complex evaluation of its safety, effectiveness, and value, followed by a vote from the pharmacotherapy committee. Innovative drugs therefore often face lengthy decision-making processes that delay their availability to patients who urgently need them.


As more and more innovative drugs are introduced and NRDL is continuously updated, hospital inventory restrictions have increasingly constrained patients' access to these treatments. The removal of these restrictions in multiple regions has therefore addressed a significant barrier to accessing innovative medicines.


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