Observational Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Nov 7, 2020; 26(41): 6455-6474
Published online Nov 7, 2020. doi: 10.3748/wjg.v26.i41.6455
Real-world cost-effectiveness associated with infliximab maintenance therapy for moderate to severe Crohn’s disease in China
Ji-Hao Shi, Liang Luo, Xiao-Li Chen, Yi-Peng Pan, Zhou Zhang, Hao Fang, Ying Chen, Wen-Dong Chen, Qian Cao
Ji-Hao Shi, Liang Luo, Xiao-Li Chen, Yi-Peng Pan, Zhou Zhang, Hao Fang, Qian Cao, Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou 310016, Zhejiang Province, China
Ying Chen, Department of Project, Changsha Normin Health Technology Ltd, Changsha 410013, Hunan Province, China
Wen-Dong Chen, Department of HEOR, Normin Health Consulting Ltd, Toronto L5R 0E9, Ontario, Canada
Qian Cao, Inflammatory Bowel Disease Center, Sir Run Run Shaw Hospital, Hangzhou 310016, Zhejiang Province, China
Author contributions: Cao Q and Chen WD formulated the research idea; Shi JH, Chen Y, Chen WD, and Cao Q developed the study protocol; Shi JH, Wang Y, Pan YP, Zhang Z, and Fang H conducted the patient identification, data extraction, and patient telephone survey; Chen Y and Chen WD conducted the data analysis; Shi JH, Chen WD, and Cao Q developed the manuscript; All authors have critically reviewed the manuscript and approved this manuscript submission.
Supported by Zhejiang Medical and Health Science and Technology Project, No. 2020KY608; and Natural Science Foundation of Zhejiang Province, No. LQ19H030013.
Institutional review board statement: The study was reviewed and approved by the Sir Run Run Shaw Hospital Institutional Review Board.
Conflict-of-interest statement: Chen Y and Chen WD are employed by a consulting firm that receives industry funds to conduct health economics and outcome research. Other authors have none to declare. 
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at caoq@zju.edu.cn. 
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Qian Cao, MD, PhD, Professor, Department of Gastroenterology, Sir Run Run Shaw Hospital, No. 3 Qingchun E Road, Xin Cheng Shang Quan, Jianggan District, Hangzhou 310016, Zhejiang Province, China. caoq@zju.edu.cn
Received: July 2, 2020
Peer-review started: July 2, 2020
First decision: July 28, 2020
Revised: August 5, 2020
Accepted: September 18, 2020
Article in press: September 18, 2020
Published online: November 7, 2020
ARTICLE HIGHLIGHTS
Research background

Infliximab was the first approved biologic treatment for moderate to severe Crohn’s disease (MS-CD) in China. Even though infliximab was proven to be clinically more effective and safer than conventional treatments, Chinese MS-CD patients still had limited access to infliximab due to lack of reimbursement for their infliximab treatment. 

Research motivation

The conventional treatments could not meet the medical needs of Chinese MS-CD patients. However, the patients could not afford regular infliximab-contained maintenance treatment (IMT) without reimbursement support. Reimbursement decision makers needed evidence to support the reimbursement coverage of infliximab used as maintenance therapy for MS-CD. 

Research objectives

This study was designed to leverage the real-world evidence from a clinical cohort of patients with MS-CD in a Chinese tertiary care hospital and existing literature evidence to assess the cost-effectiveness of IMT relative to conventional maintenance therapy (CMT) in Chinese MS-CD patients.

Research methods

This study conducted a retrospective cohort study to compare IMT vs CMT for disease remission, quality of life, health resource utilizations, and direct medical costs in MS-CD patients who were followed up over one year in a Chinese inflammatory bowel disease treatment center. The generated evidence from the retrospective cohort study were further used to construct a decision analytic model to assess the cost-effectiveness of IMT relative to CMT in Chinese MS-CD patients.

Research results

The retrospective data analysis in this study observed significantly better clinical outcomes, including disease remission rate, CD-related complications, and quality of life, and less utilization of health resources associated with IMT. The base case cost-effectiveness analysis estimated that IMT was associated with attractive incremental cost-effectiveness ratio per gained quality-adjusted life year, which was less than one gross domestic products per capita in China. Probabilistic sensitivity analysis confirmed the attractive cost-effectiveness of IMT relative to CMT in Chinese MS-CD patients under the recommended cost-effectiveness threshold. 

Research conclusions

IMT was confirmed to be superior to CMT in Chinese real-world MS-CD patients. With the overall uncertainty associated with clinical effectiveness, quality of life, and direct medical costs associated with IMT and CMT in Chinese MS-CD patients, the cost-effectiveness of IMT relative to CMT was attractive from the perspective of Chinese health care payers. 

Research perspectives

This study only followed up a relatively small cohort with MS-CD patients from a single treatment center. The generalizability associated with generated evidence in this study needs confirmation by future studies with large sample size of patients enrolled from more treatment centers. Additionally, this study followed up MS-CD patients for only 1 year. Future studies are needed to follow up patients longer to assess the impact of IMT on long-term clinical outcomes, which should include survival outcomes and CD-related to surgery and complications.