MEDdesign

Innovative Technologies Help Battle Nation’s Chronic Liver Disease Epidemic

By Jon Gingrich
October 11, 2019


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, Business Analysis, Market Access, MEDdesign

The American Liver Foundation estimates that more than 30% of the U.S. population has some degree of non-alcoholic fatty liver disease (NAFLD), an asymptomatic condition characterized by elevated levels of fat in the liver and the most common type of liver disease in the Western world.^1,2 This can impact other factors of overall health, given the link between NAFLD and diabetes, obesity, insulin resistance and other metabolic risk factors.

NAFLD affects 75 to 100 million adults in the United States and is the leading cause of chronic liver disease worldwide, fueled by the rising epidemic of obesity and metabolic syndrome. Many of these patients are unaware of their condition.³ The growing epidemic of NAFLD and its subtype non-alcoholic steatohepatitis (NASH), a potentially progressive liver disease that can lead to cirrhosis, hepatocellular carcinoma (HCC), liver cancer, liver transplantation and death, is raising alarms around the world.

Given this expanding need for liver assessment, invasive or advanced radiological assessment modalities may be inadequate for assessing patients on a large scale given their significant resource and cost burdens. Now more than ever, the adoption of accurate non-invasive measures of liver health at the point of care is a critical necessity.

Efficient, Non-Invasive Technology

A growing number of healthcare providers have started adopting non-invasive assessment methods that can detect liver diseases, such as NAFLD in the absence of indications or warning signs. There is a non-invasive technology to assess liver health at point of care via transient elastography, a non-imaging modality that quantitatively measures liver stiffness and fat, both of which are critically important components for the diagnosis and monitoring chronic liver diseases, including NAFLD and NASH. FibroScan is a key component of more than 90% of the clinical trial studies now underway and is covered by Medicare, Medicaid and most insurance plans.

The technology produces measurements that can be combined with blood biomarkers to produce scores that are easily interpreted by the healthcare provider. This empowers clinicians with information they can use to refer patients to a specialist or modify care plans in real time, if needed. Wider availability of this easy-to-use technology for diagnosis and monitoring can make a critical difference in the lives of individuals who face chronic liver disease.

The Impact of Obesity

The rise in adult obesity rates in the United States and worldwide has led to more people experiencing liver damage and associated health issues. In fact, obesity rates are increasing across America, with states having rates ranging from 25 to 38% of the adult population. Overall, about 13% of the world’s adult population (11% of men and 15% of women) were obese in 2016, and the worldwide prevalence of obesity nearly tripled between 1975 and 2016.⁴

Obesity can cause severe damage to the body and lead to liver disease, Type 2 diabetes, high blood pressure, sleep apnea and more.⁵ The rising prevalence of Type 2 diabetes and obesity, two of the main causes of NAFLD, will likely increase the demand for liver transplants and deplete the supply of available healthy livers. This amplifies the need for early detection and earlier treatment intervention.⁶

A Look at Vibration-Controlled Transient Elastography

Devices that assess liver stiffness use a patented technique called Vibration-Controlled Transient Elastography (VCTE). VCTE is recognized worldwide as the most extensively studied point-of-care technology for liver stiffness assessment. It has been included in more than 2,000 peer review publications and is the non-invasive reference across most clinical practice guidelines.

In the VCTE assessment, a shear wave is mechanically induced by a tap or vibration on the patient’s side. The shear wave speed is then measured with pulse echo ultrasound. The faster the shear wave travels, the stiffer the liver tissue. The interpretation of the tissue stiffness by VCTE across different etiologies of liver disease has been the subject of guidelines and peer reviewed publications.

To complement the VCTE assessment, FibroScan estimates of the fat content in the liver with a patented technique called Controlled Attenuation parameter (CAP). The pulse echo ultrasound signal used to measure the speed of the shear wave is affected by the amount of fat present in liver tissue. The greater the fat content, the less ultrasound signal returns to the probe. This attenuation of ultrasound signal is measured simultaneously with the assessment of liver stiffness, reducing the examination time. The system also directs the operator through the examination, thus reducing inter-operator variability and allowing for consistency of measurements over time.

With innovative non-invasive technologies, care plans can be adjusted in real time. NAFLD is reversible if caught in the early stages and accompanied by lifestyle changes. What’s more, simple screening and early detection of liver disease can help to prevent more serious conditions, such as end-stage liver disease or liver cancer.

Stakeholders Recognize Urgent Need for Liver Screening

U.S. Military

The U.S. military and Department of Veterans Affairs (VA) are paying increased attention to liver disease and hepatitis C. One study found that the military experienced a 12-fold increase in the number of active military diagnosed with NAFLD and is recognized by the VA as a growing disease that requires immediate action.⁷ They have adopted portable FibroScan models to improve access to non-invasive liver assessment and early detection of chronic liver disease.

Health Plans and Payers

With more health plans and payers shifting from a fee-for-service model to outcome-based care and value-based reimbursement models, technology that supports early detection of NAFLD can support payer programs that promote quality and cost-effective delivery of care. For commercial, Medicare Advantage and Medicaid sectors, it’s become important to align priorities around better individual health, improved outcomes and cost-containment.

Hospitals, Specialists and Healthcare Providers

Hospitals, including Accountable Care Organizations (ACOs), Independent Practice Associations and other models, as well as specialty physician practices, including endocrinologists and gastroenterologists, liver specialists, cardiologists and others, understand the importance of non-invasive screening for liver disease.

As the first line of defense against the advancement of liver disease, more healthcare providers (HCPs) are now integrating more comprehensive liver health assessment into their practices, while also taking a proactive role in educating patients on how liver function affects their health—especially if individuals are obese and might be at risk for liver disease.

HCPs play a critical role in identifying most liver disease by adopting technology that enables them to painlessly provide rapid, consistent results and make the most informed treatment decisions. With scores and data generated by non-invasive technology, they can often rule out the need for an expensive and often painful liver needle biopsy or other invasive, expensive testing.

When liver stiffness and fat measurements are evaluated as part of the overall patient assessment, the HCP can make an immediate determination if a referral to a liver specialist is warranted. This ability to risk stratify and monitor the patients’ liver health can reduce unnecessary and costly specialist referrals and inform earlier intervention, which can potentially impact outcomes.

Patients

The liver stiffness and fat measurements from an examination using non-invasive technology such as FibroScan can serve to improve patient and provider satisfaction. The ability to deliver immediate and actionable information to inform the patient care plan not only reduces the burden of multiple visits and specialist referrals, but also may increase engagement in lifestyle modification programs with the intent to ultimately reverse this life-threatening disease and related comorbidities.

References

1. American Liver Foundation: Liver Disease Statistics; https://liverfoundation.org/liver-disease-statistics/#non-alcoholic-fatty-liver-disease-non-alcoholic-steato-hepatitis; accessed September 13, 2019.
2. Healio; NAFLD: An Emerging Epidemic with No Approved Treatment; Healio Gastroenterology, October 2015; https://www.healio.com/gastroenterology/liver-biliary-disorders/news/print/healio-gastroenterology/%7B0c32daff-f1b3-4b2c-9386-5baad00ac3fd%7D/nafld-an-emerging-epidemic-with-no-approved-treatment; accessed September 13, 2019.
3. Wong, Terrence et al; Diagnostic and Treatment Implications of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis; Gastroenterology and Hepatology; Feb 2019; 15(2): 83–89; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6469262/; accessed September 13, 2019.
4. Centers for Disease Control and Prevention; BRFSS; https://www.cdc.gov/brfss/index.html; accessed September 13, 2019.
5. American Society for Metabolic and Bariatric Surgery; The Impact of Obesity on Your Body and Health; https://asmbs.org/patients/impact-of-obesity; accessed September 13, 2019.
6. Rehm, Jeremy; An invisible liver disease balloons into view; Knowable Magazine; February 19, 2018; https://www.knowablemagazine.org/article/health-disease/2018/invisible-liver-disease-balloons-view; accessed September 13, 2019.
7. Vandiver, John; Nonalcoholic Fatty Liver Disease Way Up Among Service Members; Military.com; Jan 29, 2019; https://www.military.com/daily-news/2019/01/29/nonalcoholic-fatty-liver-disease-way-among-service-members.html; accessed September 13, 2019.