The Cost of Non-Alcoholic Steatohepatitis (NASH) in Europe and USA: The GAIN Study

Abstract

Background: Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver disorders. The progressive form of NAFLD, non-alcoholic steatohepatitis (NASH), leads to cirrhosis in a proportion of patients and so is associated with a substantial socio-economic burden which, coupled with a steadily rising prevalence, is becoming a growing public health challenge. The Global Assessment of the Impact of NASH (GAIN) study is a socioeconomic, prevalence-based burden of illness study across Europe (France, Germany, Italy, Spain and the United Kingdom) and the United States to determine the socio-economic burden of NASH in the real-world. Methods: GAIN was a retrospective, cross-sectional study in which physicians recruited patients and provided demographic, clinical and economic information via an online survey. Each patient was invited to report quality of life outcomes and information about direct and indirect non-medical costs. Patients diagnosed by liver biopsy were stratified by fibrosis score (F0-F4). Patients diagnosed by serum biomarkers and imaging techniques were stratified into early (F0-F2) or advanced (F3-F4) fibrosis. For analysis purposes in this publication, all patients (whether diagnosed by biopsy or other procedures) were classified into early (F0-F2) or advanced (F3-F4) fibrosis. Per-patient costs were estimated using national unit price data and extrapolated to population level to calculate the economic burden. Findings: Clinical reports for a total of 3,754 patients were received. Of these, 767 patients (20%) provided information on indirect costs and health-related quality of life (HRQoL). Mean EQ-5D (n=749) and CLDQ-NAFLD (n=723) index scores were 0.75 and 4.9 respectively. Both indices decreased with progression of fibrosis stage. For 2018, the mean total annual per patient cost of NASH was estimated at €2,763, €4,917 and €5,509 for the direct medical, direct non-medical and indirect cost categories respectively. National per-patient cost was highest in the US and lowest in France. Costs increased with fibrosis stage and decompensation, driven by hospitalisation and higher co-morbidity. Indirect costs were driven by patient work loss. Interpretation: NASH causes impaired health-related quality of life and is associated with a substantial, and previously under-estimated, socio-economic burden that increases with progression of fibrosis stage. Funding Statement: This study was supported by unrestricted funding from Novo Nordisk A/S and Gilead Sciences, Inc. Declaration of Interests: The authors declare that they have no competing interests. Ethics Approval Statement: All patient participants provided informed consent. The study protocol was approved by the Research Ethics Sub Committee of the Faculty of Health and Social care within the University of Chester. The approval stipulated that the study was to be carried out in correspondence with regional and relevant guidelines.