By Scott Howell, D.O., MPH&TM, CPE
Traditionally a disease that primarily attracted the focused attention of hepatologists, nonalcoholic fatty liver disease (NAFLD), an asymptomatic condition characterized by elevated levels of fat in the liver, has recently raised alarms across a spectrum of health care providers and payers. This broader interest level is largely the result of the identification of a more advanced form among patients with the cohort of obesity and Type 2 diabetes (T2D). The combination has an additive consequence whereby liver disease makes diabetes management even more challenging.
Today, the sheer number of individuals with NAFLD reflects the rising trend of obesity in the United States, as NAFLD is now the most common form of chronic liver disease. Addressing the significant economic and medical burden of NAFLD requires strategies for early detection and intervention, as well as ongoing assessment of liver health for those at risk for progressive liver disease.
Liver Disease Epidemic Dwarfs Hepatitis C Crisis
To put the severity of this health crisis into perspective, let’s compare it to the hepatitis C virus (HCV) crisis:
- HCV affects 3.5 million Americans and is curable with safe and effective treatments.
- About 100 million Americans have NAFLD, and, as the disease advances, it affects as many as seven million more who develop advancing liver disease a related condition called non-alcoholic steatohepatitis with advancing fibrosis or cirrhosis (fibrotic-NASH).
Despite this differential, HCV has received considerably greater attention as a communicable disease.
The costs of HCV are expected to reach $9.5 billion by 2020, driven entirely by the costs associated by end-stage liver disease – decompensated cirrhosis, liver cancer and liver transplant. By comparison, the estimated cost of NAFLD is $103 billion in the United States and expected to increase along with the rates of diabetes and obesity.
Currently, NAFLD is the number two indication for liver transplantation behind HCV and will likely replace HCV in the coming years. NAFLD tends to be diagnosed at an older age and due to its silent course with an ever increasing prevalence due to metabolic syndrome. Cirrhosis can be the first presentation in 38% – 45% of cases presentations. The overall prevalence of HCV is expected to decline to one million, with compensated cirrhotics declining from 600,000 to 400,000 during this same period.
Current Diagnostic Challenge
Healthcare Providers (HCPs) often rely upon abnormal liver enzymes to guide specialist referrals, which alone are a poor diagnostic of liver NAFLD or NASH.
The American Journal of Gastroenterology considers normal health ALT (alanine aminotransferase) to range from 29 to 33 IU/U for males and 19 to 25 IU/I for females – in many cases 50% lower than the cut-off levels reported in standard lab reports. Serum ALT can be normal in up to nearly 60% of NAFLD patients with NASH.Serum ALT can be increased in up to 53% of NAFLD patients without NASH.Therefore, serum ALT level alone is notpredictive of NASH or fibrosis level because normal ALT cannot rule out progression or NASH, and increased ALT cannot predict NASH.
Here’s the good news: while outward signs of advancing liver disease are often associated with liver cirrhosis or liver cancer, if detected early, therapeutic interventions and lifestyle modifications can alter the course of NAFLD, improve prognosis and reduce costs.
While drugs designed to address liver disease are in the pipeline for 2020, for now, early detection is critical and can help to prevent more serious conditions such as end-stage liver disease or liver cancer.
Non-Invasive Liver Examinations Are Available
Current innovative non-invasive examination methods can quickly provide a quantitative assessment of liver stiffness and fat (steatosis) at the point of care, as part of an overall patient assessment. Quantitative scores can be used to efficiently rule out the need for further assessment, like an invasive procedure of liver biopsy, saving time and resources for people who do not require additional assessment for NASH.
For example, FibroScan is the most widely studied non-imaging tool for quantitative liver assessment in point of care in the world, with over 2,000 peer-reviewed research publications. This examination yields rapid results and can mitigate downstream costs of care which impacts budgeting and allocation of resources. For commercial plan benefits, budget planning is critical for NAFLD/NASH therapeutic launches and under fee-for-service care, FibroScan is reimbursed under liver elastography (CPT 91200).
Over 1,000 FibroScan systems have been placed in the United States, with the expectation that this technology could eventually become an important component of HCP protocols in the doctor’s office, diagnostic facility or other healthcare setting as a routine part of patient/member management.
Scott Howell, D.O., MPH&TM, CPE, is Advisor to Echosens.