Prospective Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 7, 2017; 23(17): 3163-3173
Published online May 7, 2017. doi: 10.3748/wjg.v23.i17.3163
Cost-effectiveness of enhanced liver fibrosis test to assess liver fibrosis in chronic hepatitis C virus and alcoholic liver disease patients
Marcelo Soto, Laura Sampietro-Colom, Luis Lasalvia, Aurea Mira, Wladimiro Jiménez, Miquel Navasa
Marcelo Soto, Fundació Clínic per a la Recerca Biomèdica, 08036 Barcelona, Spain
Laura Sampietro-Colom, Health Technology Assessment Unit, Hospital Clínic, Barcelona, 08036 Barcelona, Spain
Luis Lasalvia, Siemens Healthcare, Tarrytown, NY 10591, United States
Aurea Mira, Wladimiro Jiménez, Department of Clinical Microbiology, Hospital Clínic, 08036 Barcelona, Spain
Aurea Mira, Wladimiro Jiménez, Department of Biomedicine, University of Barcelona, 08036 Barcelona, Spain
Wladimiro Jiménez, Miquel Navasa, IDIBAPS, CIBERehd, 08036 Barcelona, Spain
Miquel Navasa, Liver Unit, Hospital Clínic, 08036 Barcelona, Spain
Author contributions: Soto M, Sampietro-Colom L, Lasalvia L, Mira A, Jiménez W and Navasa M conceived and designed the study; Soto M, Sampietro-Colom L and Navasa M analyzed the data; Soto M, Sampietro-Colom L, Lasalvia L and Navasa M wrote the paper.
Supported by Siemens. Marcelo Soto received financial support from Plataforma ITEMAS PT13/0006/0009 (FCRB PI043029, partially).
Conflict-of-interest statement: Lasalvia L owns shares of Siemens and is a Siemens employee. Navasa M reports grants from Siemens, during the conduct of the study. Jiménez W reports grants from Siemens, prior the conduct of the study. Siemens has issued patents on ELF.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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/
Correspondence to: Dr. Marcelo Soto, Fundació Clínic per a la Recerca Biomèdica, Roselló 149-153, 08036 Barcelona, Spain. soto@clinic.ub.es
Telephone: +34-93-2271874 Fax: +34-93-2279240
Received: November 4, 2016
Peer-review started: November 21, 2016
First decision: December 28, 2016
Revised: March 3, 2017
Accepted: March 15, 2017
Article in press: March 15, 2017
Published online: May 7, 2017
Processing time: 183 Days and 1.9 Hours
Abstract
AIM

To assess liver fibrosis (LF) in hepatitis C virus (HCV) and alcoholic liver disease (ALD), estimate health outcomes and costs of new noninvasive testing strategies

METHODS

A Markov model was developed to simulate LF progression in HCV and ALD for a cohort of 40-year-old men with abnormal levels of transaminases. Three different testing alternatives were studied: a single liver biopsy; annual Enhanced liver fibrosis (ELF™) followed by liver stiffness measurement (LSM) imaging as a confirmation test if the ELF test is positive; and annual ELF test without LSM. The analysis was performed from the perspective of a university hospital in Spain. Clinical data were obtained from published literature. Costs were sourced from administrative databases of the hospital. Deterministic and probabilistic sensitivity analyses were performed.

RESULTS

In HCV patients, annual sequential ELF test/LSM and annual ELF test alone prevented respectively 12.9 and 13.3 liver fibrosis-related deaths per 100 persons tested, compared to biopsy. The incremental cost-effectiveness ratios (ICERs) were respectively €13400 and €11500 per quality-adjusted life year (QALY). In ALD, fibrosis-related deaths decreased by 11.7 and 22.1 per 100 persons tested respectively with sequential ELF test/LSM and annual ELF test alone. ICERs were €280 and €190 per QALY, respectively.

CONCLUSION

The use of the ELF test with or without a confirmation LSM are cost-effective options compared to a single liver biopsy for testing liver fibrosis in HCV and ALD patients in Spain.

Keywords: Cost-effectiveness analysis; Liver fibrosis; Noninvasive diagnostic assessment; Alcoholic liver disease; Hepatitis C

Core tip: Noninvasive methods to diagnose liver fibrosis have been proposed as an alternative to liver biopsy in patients with abnormal level of transaminases. In a Markov model, sequential testing with enhanced liver fibrosis (ELF) test followed by liver stiffness measurement (LSM) significantly reduce liver-related lifetime morbidity and mortality, compared with biopsy, in hepatitis C virus (HCV) and alcoholic liver disease patients. Noninvasive methods are also associated with an increase in quality-adjusted life years and costs. Overall, they are cost-effective strategies compared with biopsy. ELF test with or without a confirmation LSM may represent a more affordable strategy than the “treat-all” option in HCV patients.