Comprehensive Clinical Evaluation of Drugs for Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Author(s)
Jingyi Zhao, MSc1, Litian Jiang, MS1, Wan Li, MS2, Zili Chen, MS2, Huatang Zeng, Phd1, Mengqing Lu, MS1, Liqun Wu*, MS1, Jianwei Xuan*, Phd2.
1Health Development Research and Data Management Center, Shenzhen, China, 2Health Economic Research Institute, School of Pharmacy, Sun Yat-sen University, Guangzhou, China.
1Health Development Research and Data Management Center, Shenzhen, China, 2Health Economic Research Institute, School of Pharmacy, Sun Yat-sen University, Guangzhou, China.
OBJECTIVES: To establish a methodology for comprehensive clinical evaluation of medication for chronic obstructive pulmonary disease (COPD) disease types, and to explore the decision-making mechanism in support of rational drug use.
METHODS: We first determined the list of medicines to be evaluated. Through extensive literature research and group discussions, a preliminary framework and indicator pool were developed. Expert consultation was conducted using the Delphi method. Consequently, the content of the indicators was determined based on a combination from our indicator selection criteria and feedback from experts. Then, the analytic hierarchy process was employed to assign appropriate weights to each indicator, which were graded with relevant scoring rules. The evaluation focused exclusively on the moderately severe COPD population for value assessment.
RESULTS: The experts involved in the Delphi method were drawn from fields of clinical practice, pharmacy, and health technology assessment, with a response rate of 0.81 and the expert authority coefficient of 0.89. The mean coefficient of variation is 0.17, indicating a relatively high degree of coordination among experts' opinions. Finally, the six first-level indicators and their weight were identified for safety (27%), effectiveness (27%), economy (15%), innovation (6%), appropriateness (16%), and accessibility (9%), as well as 14 second-level indicators. A total of 109 papers were included in our study, of which 62 were cited. Among them, LABA, LAMA, and their combined preparations had more abundant evidence. Referring to the real-world data of COPD patients in Shenzhen, China, the final comprehensive value results of medications for the stable phase showed that the combination regimen was superior to the monotherapy regimen, with the highest scores for LABA/LAMA.
CONCLUSIONS: In this study, we carried out a comprehensive clinical evaluation of drugs for moderate-to-severe stable chronic obstructive pulmonary disease, which can be used to select medicines with higher clinical value through the comprehensive value ranking.
METHODS: We first determined the list of medicines to be evaluated. Through extensive literature research and group discussions, a preliminary framework and indicator pool were developed. Expert consultation was conducted using the Delphi method. Consequently, the content of the indicators was determined based on a combination from our indicator selection criteria and feedback from experts. Then, the analytic hierarchy process was employed to assign appropriate weights to each indicator, which were graded with relevant scoring rules. The evaluation focused exclusively on the moderately severe COPD population for value assessment.
RESULTS: The experts involved in the Delphi method were drawn from fields of clinical practice, pharmacy, and health technology assessment, with a response rate of 0.81 and the expert authority coefficient of 0.89. The mean coefficient of variation is 0.17, indicating a relatively high degree of coordination among experts' opinions. Finally, the six first-level indicators and their weight were identified for safety (27%), effectiveness (27%), economy (15%), innovation (6%), appropriateness (16%), and accessibility (9%), as well as 14 second-level indicators. A total of 109 papers were included in our study, of which 62 were cited. Among them, LABA, LAMA, and their combined preparations had more abundant evidence. Referring to the real-world data of COPD patients in Shenzhen, China, the final comprehensive value results of medications for the stable phase showed that the combination regimen was superior to the monotherapy regimen, with the highest scores for LABA/LAMA.
CONCLUSIONS: In this study, we carried out a comprehensive clinical evaluation of drugs for moderate-to-severe stable chronic obstructive pulmonary disease, which can be used to select medicines with higher clinical value through the comprehensive value ranking.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA87
Topic
Health Technology Assessment
Topic Subcategory
Value Frameworks & Dossier Format
Disease
Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)