the study addresses an important research gap in one of the most common causes of chronic liver disease.

JHEP Reports (the new on-line Journal published by European Association for Study of Liver Disease) has just published the results of a study undertaken by HCD Economics and the University of Chester. ​The study is the Global Assessment of the Impact of NASH (non-alcoholic steatohepatitis) – GAIN study, which was undertaken in 2018. The manuscript was accepted for publication in June 2020 and was published here.

The authors include the study team and other notable experts representing the NASH community including National patient organisations, leading health economists, and experts from the liver disease clinical and research community. The study benefited from the oversight and active review of an expert Steering Committee, which included European and United States representation from the patient community, academia (clinical, health economic and public health faculties) and National liver research institutions. The study was undertaken to address the gap in socioeconomic research in NASH and was conducted to inform the real-world humanistic and socioeconomic burden of NASH in adult patients in Europe and the United States.

3754 patients were enrolled in the study and data was collected to address the primary objective of the impact of NASH on patient’s quality of life and the secondary objective to estimate the total annualised cost of the disease, including all health related items and non-health and indirect costs accruing to patients and their families. . Patient stratification by country and fibrosis stage (to understand early and advanced disease) added granularity to the analyses. Direct medical and non-medical costs were sourced from official country specific data bases, along with a range of complimentary sources including WHO and OECD.

According to the GAIN study, the generic (EQ-5D) and specific (CLDQ-NAFLD) quality of life scores of NASH patients decreased with fibrosis status (early vs advanced) in all countries (with the exception of France). In addition, the NASH-related costs were €2,763, €4,917 and €5,509 per patient for the direct medical, direct non-medical and indirect cost categories respectively. Further analysis to extrapolate NASH medical costs to national burden showed that costs could go from €2.6 billion in France to almost €80 billion in the US (with intermediates estimations for the rest of the 5EU countries), which implies a significant and growing public health concern.   

The paper reports on the study population and basic demographics, including the stratification by severity of disease for each of the six countries (US and 5EU) that participated in the study. Another important finding of the GAIN study revealed that more than 50% of the overall population identified as NASH did not ever receive a biopsy to confirm their disease, with important country specific differences and preferences towards diagnosis procedures.

The authors conclude “this study has successfully furthered our understanding of the cost of NASH in the EU5 and USA and how these costs differ amongst the participating countries.” Ideas for further analysis of the extensive data set now available to the GAIN team include understanding drivers of cost and outcomes and further work to better understand causality of poorer outcomes and higher patient costs.

For more information on the GAIN study and the future plans being developed by HCD Economics for further Real-World evidence (RWE) analysis and RWE collection in NASH, please contact Leo Ruiz, GAIN team leader at HCD Economics