这也意味着，在"反内卷"的集采新原则下，中国药品采购机制正经历一场兼顾效率与临床需求 的深度改革。 记者丨季媛媛 编辑丨包芳鸣 药品集采进入第十一批， 政策规则正从"唯低价"向"质量优先"悄然转身， 一场兼顾效率与临 床需求的改革新试验正在展开。 8月6日，全国医疗机构正式启动第十一批国家组织药品集中采购需求量填报工作。根据国家医 保局披露的信息，本次集采共涉及55个品种，梳理报量工作特点不难看出，一方面，与以往不 同， 此次集采报量首次允许医疗机构按厂牌报量， 改变了以往只能按药品通用名报量的规 则；另一方面， 设置了80%的报量红线， 要求医疗机构报量不得低于两年平均用量的80%。 此外，对于存在临床需求明显减少、业务调整等因素导致预期用量显著减少的， 医疗机构可 作出书面说明后按实际需求报量。 此次报量工作也明确需要与基本药物、儿童用药等政策保 持衔接，对于基本药物规格，报量系统中专门作出标注，如该规格未通过质量和疗效一致性评 价，医疗机构可自行确定折算比例，并在报量时作出说明。对于儿童适宜品规，如未通过一致 性评价，医疗机构认为难以替代、报量无法折算的，可根据实际需要报量并作出说明。 国家医保局在填报 ...

Group 1 - The core announcement is about the initiation of the 11th batch of national organized drug procurement, allowing companies to submit information for drug selection from July 16 to July 31, 2023 [1] - A total of 55 drug varieties have been included in this procurement, covering commonly used clinical medications such as anti-tumor, diabetes, cardiovascular, and respiratory drugs [2][3] - The procurement process will exclude innovative drugs and focus on mature products that have been on the market for years and have multiple manufacturers [1][2] Group 2 - 68 drugs that met the evaluation criteria were not included in this procurement, with reasons including insufficient competitive landscape and low projected procurement amounts [3] - Notably, five drugs were excluded due to high patent infringement risks, including Novartis' sacubitril/valsartan, which has seen significant sales growth in recent years [3][4] - The procurement rules are expected to be optimized, focusing on maintaining clinical stability, ensuring quality, and preventing irrational competition among companies [5][6] Group 3 - The selection criteria for this batch of procurement have been made transparent, combining previous rules with new policy requirements [6] - Quality requirements have been strengthened, with a new mandate for bidders to have at least two years of production experience for similar formulations [6][7] - The pricing mechanism has been adjusted to discourage irrational low-price competition, with a focus on rational pricing based on cost and quality [7]