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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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| 篇名： | 医保准入申报中制药企业参照药品的选择策略分析 |
| TITLE： | Analysis of comparator selection strategies for pharmaceutical enterprises in the national reimbursement drug list access application |
| 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1341份申报药品资料，其中1035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。 |
| 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 highlight the priority of selection， standardize the declaration behavior of enterprises， and reduce communication divergences between the two parties. |
| 期刊： | 2026年第37卷第08期 |
| 作者： | 王清文；安琴；袁小艳；韩宇智；陈曦；伍红艳 |
| AUTHORS： | WANG Qingwen，AN Qin，YUAN Xiaoyan，HAN Yuzhi，CHEN Xi，WU Hongyan |
| 关键字： | 医保准入；参照药品；医保目录；制药企业；形式审查 |
| KEYWORDS： | medical insurance access； comparators； national |
| 阅读数： | 4 次 |
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