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
Abstract
BACKGROUND

Infliximab was the first approved biologic treatment for moderate to severe Crohn’s disease (MS-CD) in China. However, the cost-effectiveness of infliximab maintenance therapy (IMT) for MS-CD relative to conventional maintenance therapy remained unclarified. 

AIM

To assess the cost-effectiveness of IMT for MS-CD in Chinese patients from the perspective of Chinese public insurance payer.

METHODS

A cohort of MS-CD patients managed in a Chinese tertiary care hospital was created to compare IMT with conventional maintenance therapy (CMT) for clinical outcomes and direct medical costs over a 1-year observation time using conventional regression analyses. A decision-analytic model with the generated evidence was constructed to assess the cost-effectiveness of IMT relative to CMT using reimbursed medical costs. 

RESULTS

Based on the included 389 patients, IMT was associated with significantly higher disease remission chance [odds ratio: 4.060, P = 0.003], lower risk of developing new complications (odds ratio: 0.527, P = 0.010), higher utility value for quality of life (coefficient 0.822, P = 0.008), and lower total hospital costs related to disease management (coefficient -0.378, P = 0.008) than CMT. Base-case cost-effectiveness analysis estimated that IMT could cost Chinese health insurance payers ¥55260 to gain one quality-adjusted life year (QALY). The cost-effectiveness of IMT was mainly driven by the estimate of quality of life, treatment efficacy of maintenance therapy, mortality risk associated with active disease, and unit price of infliximab. The probability that IMT was cost-effective at a willingness-to-pay threshold of three times gross domestic product [2018 Chinese gross domestic product per capita (GDPPC)] was 86.4%. 

CONCLUSION

IMT significantly improved real-world health outcomes and cost the Chinese public health insurance payers less than one GDPPC to gain one QALY in Chinese MS-CD patients. 

Keywords: Infliximab, Crohn’s disease, Maintenance therapy, Cost-effectiveness, Outcomes, Direct medical costs

Core Tip: Infliximab maintenance therapy significantly reduced disease severity, improved quality of life, and reduced outpatient clinic visits and hospitalization related to active disease in Chinese patients with moderate to severe Crohn’s disease. Even though the drug acquisition costs of infliximab could not be fully offset by the saved medical costs, the cost-effectiveness of infliximab maintenance therapy was highly attractive from the perspective of Chinese health care payers.