Analysis of influencing factors on the inclusion of Chinese patent medicines in the national reimbursement drug list
- VernacularTitle:中成药医保准入的影响因素分析
- Author:
Shihuan CAO
1
,
2
,
3
;
Wanxian LIANG
1
,
2
,
3
;
Lining ZHANG
1
,
2
,
3
;
Haijing GUAN
4
;
Xuejing JIN
1
,
2
Author Information
1. School of Traditional Chinese Medicine，Beijing University of Chinese Medicine，Beijing 100029，China
2. Center for Evidence-based Chinese Medicine，Beijing University of Chinese Medicine，Beijing 100029，China
3. International Institute of Evidence-based Chinese Medicine，Beijing University of Chinese Medicine，Beijing 100029，China
4. Dept. of Pharmacy，Beijing Tiantan Hospital，Capital Medical University，Beijing 100070，China
- Publication Type:Journal Article
- Keywords:
Chinese patent medicines;
national reimbursement drug list;
influencing factors
- From:
China Pharmacy
2024;35(22):2709-2715
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To analyze the factors affecting the inclusion of Chinese patent medicines in China’s National reimbursement drug list （NRDL）， and assist these medicines in fully reflecting their actual value in the reimbursement admission process. METHODS From the official website of the China’s National Healthcare Security Administration， the application materials of Chinese patent medicines outside the list that passed the formal review from 2021 to 2023 were obtained， including basic information on the medicines， safety， efficacy， innovation and heritage information， and supplemented with references from the pharmacopeia and the Yaozhi Database. Economic information and enterprise information were obtained through websites such as the Yaozhi Database. Univariate analysis， multivariate Logistic regression analysis and stepwise regression analysis were conducted on the initial application information and admission outcomes of the medicines. Sensitivity analysis was also performed on medicines that applied multiple times in different years as independent samples. RESULTS & CONCLUSIONS There were 27 Chinese patent medicines that passed the formal review from 2021 to 2023， involving 37 applications. The univariate analysis results showed that medicines with descriptions of traditional Chinese medicine （TCM） syndrome types， clear adjustment information for medication plans for specific population groups， short time to market in the indications of the package insert， registered as Class 1 to 6 following or class Ⅰ innovative TCM/class Ⅲ ancient classic prescription compound TCM registered， and those produced by enterprises listed in the “Top 100 Chinese Pharmaceutical Industry Enterprises” list for the current year were more likely to be included in the NRDL （P＜0.05）. The results of the multivariate Logistic regression analysis were not statistically significant， but the stepwise regression results indicated good consistency with the univariate analysis. The results of the sensitivity analysis were consistent with the trend of basic analysis. It is recommended that Chinese patent medicine enterprises further clarify the description of product instructions， expand innovation capabilities， inherit and develop ancient classic prescriptions， and promptly complete clinical trial evidence.
