Page 27 - 《中国药房》2026年8期

·药事管理·

医保准入申报中制药企业参照药品的选择策略分析
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王清文 ，安 琴 ，袁小艳 ，韩宇智 ，陈 曦 ，伍红艳 （1.贵州医科大学医药卫生管理学院，贵阳 561113；
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2.贵州医科大学公共卫生与健康学院，贵阳 561113；3.贵州民族大学法学院，贵阳 550025）
中图分类号 R95 文献标志码 A 文章编号 1001-0408（2026）08-0985-06
DOI 10.6039/j.issn.1001-0408.2026.08.03
摘 要 目的 分析医保准入申报中制药企业参照药品的选择情况与理由，为推动企业与医保部门在该环节的沟通共识提供参
考。方法 提取国家医保局2021－2025年公布的通过形式审查的目录外药品申报材料，采用内容分析法系统梳理申报药品和参
照药品的相关信息，重点分析企业选择参照药品的具体情况和理由。结果 共收集到 1 341 份申报药品资料，其中 1 035 个
（77.18%）为阳性对照、306个（22.82%）为空白对照，58个药品（4.33%）以联合用药为参照，5个药品（0.37%）以非药物（或非单纯药
物）治疗方案为参照；在多个企业申报的药品中，50.00%的企业提交的参照药品存在差异。阳性对照药品的选择理由共提炼出4
条基本条件和39条附加条件，空白对照药品则提炼出12条药品相关因素、2条管理因素和1条其他因素。有超过10%的药品未阐
述选择参照药品的理由，选择空白对照的药品中超过44%的申报企业仅给出了1条选择理由。结论 企业在医保准入申报中主要
基于自身利益选择参照药品，其选择依据、理由阐述的充分性和规范性存在不足。建议企业遵循医保部门的原则性要求，结合自
身药品特点充分、规范地说明参照药品选择理由；同时，医保部门可考虑将现有选择理由的开放式阐述形式改为封闭式填答模式，
以突出选择优先级，规范企业申报行为，减少双方沟通分歧。
关键词 医保准入；参照药品；医保目录；制药企业；形式审查

Analysis of comparator selection strategies for pharmaceutical enterprises in the national reimbursement
drug list access application
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WANG Qingwen ，AN Qin ，YUAN Xiaoyan ，HAN Yuzhi ，CHEN Xi ，WU Hongyan（1. School of Medical and
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Health Management，Guizhou Medical University，Guiyang 561113，China；2. School of Public Health，Guizhou
Medical University，Guiyang 561113，China；3. School of Law， Guizhou Minzu University，Guiyang 550025，China）
ABSTRACT OBJECTIVE To analyze the selection and rationales of comparators for pharmaceutical enterprises in their medical
insurance access application， so as to provide a reference for promoting communication and consensus between enterprises and
medical insurance authorities in this process. METHODS The application materials for drugs outside the catalogue that passed
formal review published by the National Healthcare Security Administration from 2021 to 2025 were extracted， and then content
analysis was used to systematically sort out relevant information of the declared drugs and comparators； the specific situations and
rationales of pharmaceutical enterprises’ selection of comparators were analyzed. RESULTS A total of 1 341 declared drug
documents were collected. Data analysis showed that 1 035 （77.18%） were submitted with positive comparators and 306 （22.82%）
used blank comparators； 58 drugs （4.33%） took combination therapy as the reference， and 5 drugs （0.37%） referred to non-
pharmacological （or non-single pharmacological） treatment regimens. Among competitive drugs declared by multiple enterprises，
50.00% of the enterprises submitted different comparators. A total of 4 basic conditions and 39 additional conditions were extracted
as the rationales for selecting positive comparators. For blank comparators， 12 drug-related factors， 2 administrative factors， and 1
other factor were identified. More than 10% of the drugs did not state the rationale for comparator selection， and over 44% of drugs
using blank comparators provided only one justification. CONCLUSIONS Pharmaceutical enterprises mainly select comparators
based on their own interests in the medical insurance access application， and there are deficiencies in the adequacy and
standardization of their selection basis and reasoning. It is recommended that enterprises follow the principled requirements of
medical insurance authorities， and fully and normatively explain the reasons for selecting comparators in combination with the
characteristics of their own products. Meanwhile， it is advisable to change the current open-ended statement form of selection
reasons into a closed-ended answering mode， so as to
Δ 基金项目 国家自然科学基金项目（No.72504066）；贵州省哲学
highlight the priority of selection， standardize the declaration
社会科学规划课题（No.22GZZD10）；贵州医科大学医药经济管理研究
behavior of enterprises， and reduce communication
中心资助课题（No.YG2025-A4）；贵州省医疗保障研究会委托项目
＊第一作者 硕士研究生。研究方向：药物经济学、健康保障、卫生 divergences between the two parties.
事业管理。E-mail：2249934006@qq.com KEYWORDS medical insurance access； comparators； national
# 通信作者 教授，博士生导师，博士。研究方向：生命质量、卫生 reimbursement drug list； pharmaceutical enterprise； formal
事业管理、卫生经济学、药物经济学。E-mail：why_vivian@163.com review

中国药房 2026年第37卷第8期 China Pharmacy 2026 Vol. 37 No. 8 · 985 ·