Non-alcoholic steatohepatitis patients with fibrosis have a higher risk of progression to cirrhosis, end stage liver disease and hepatocellular carcinoma. Therefore, it is critical to resolve NASH in NASH patients with fibrosis before it has a chance to lead to cirrhosis or cancer, and associated life-threatening outcomes
HIGHER CARDIOVASCULAR MORTALITY
NAFLD patients are at higher risk of cardiovascular events. Their atherosclerotic and inflammation markers are higher than those of healthy individuals. In fact, cardiovascular disease is the most common cause of death in NAFLD patients (38% of cases), before non-liver cancer (19%) and liver-related complications (9%).
HIGHER LIVER-RELATED MORTALITY
Liver diseases, including complications due to onset of cirrhosis and liver cancer are the third cause of mortality in NAFLD patients after cardiovascular disease and non-liver cancer. Thus, liver transplantation is commonly indicated for NASH patients with end-stage liver disease. But liver transplant is obviously a complex and risky surgical procedure. Besides, it is not always possible to execute due to the lack of donors. Last, patients who would need to undergo liver transplant may not be eligible because other essential body systems may be affected by a deteriorated liver state.
BURDEN FOR SOCIETIES
Since no effective medication is currently available to treat the disease, NASH is growing as a major economical and societal issue for many countries. In 2017 for instance, the total cost for a liver transplantation in the United States was estimated at US$812,500 per patient (around 681 000€) versus US $740,000 in 2014 and US $577,000 in 2011. In Europe, for Italy, France, Germany and the United Kingdom, the total annual cost of NAFLD* patient care is estimated at 35 billion euros per year and could represent an economic burden estimated at 302 billion euros in ten years.
NASH is also associated with higher risk of cardiovascular disease, and is as such increasing global healthcare expenditures and pressure on health systems. Last, NASH provokes irreversible deterioration of quality of life of individuals, ranging from fatigue to more severe clinical symptoms, impacting working individuals and societies’ productivity.
*NAFLD (from NAFL to severe NASH and end-stage liver diseases)
WHAT ABOUT DRUG THERAPY?
There is still no approved therapy available for patients. This high unmet need has been acknowledged by the scientific community, and by regulatory authorities, who have accepted accelerated clinical trial and approval procedures for NASH. The goal is to provide NASH patients with access to effective therapy as soon as the first drug-candidates can demonstrate a sufficient level of efficacy, safety and tolerability.
In fact, the therapeutic research area for NASH is currently very active. In a similar way it has been done for HIV and hepatitis C, The Liver Forum – an international and transversal organization – provides an independent and neutral venue for ongoing multi-stakeholder dialogue in order to mutualize expertises and provide directions to the field.
It is likely that therapeutic solutions will be made available to NASH patients in the coming few years.
Bentley, T.S. et al, 2017 U.S. organ and tissue transplant cost estimates and discussion. [online] Milliman Research Report, 2017 http://www.milliman.com/uploadedFiles/insight/2017/2017-Transplant-Report.pdf
EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol, 2016. 64(6): p. 1388-402.
Ratziu, V., Novel Pharmacotherapy Options for NASH. Dig Dis Sci, 2016. 61(5): p. 1398-405.
Younossi, Z.M. et al., The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe. Hepatology, 2016. 64(5): p. 1577-1586.