Analysis of comparator selection strategies for pharmaceutical enterprises in the national reimbursement drug list access application
- VernacularTitle:医保准入申报中制药企业参照药品的选择策略分析
- Author:
Qingwen WANG
1
;
Qin AN
2
;
Xiaoyan YUAN
2
;
Yuzhi HAN
2
;
Xi CHEN
3
;
Hongyan WU
1
Author Information
1. School of Medical and 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
- Publication Type:Journal Article
- Keywords:
medical insurance access;
comparators;
national
- From:
China Pharmacy
2026;37(8):985-990
- CountryChina
- Language:Chinese
-
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.
