Author: Jon Gingrich, CEO, Echosens North America
Nonalcoholic fatty liver disease (NAFLD) is an asymptomatic and underdiagnosed disease that affects 37% of U.S. adults and 70% of individuals with Type 2 diabetes. Nonalcoholic steatohepatitis (NASH), the more severe form of NAFLD marked by inflammation and ballooning, can lead to hepatic fibrosis, cirrhosis, and hepatocellular cancer (HCC) if left untreated.
As rates of adult obesity and Type 2 diabetes continue to rise, NAFLD and mortality are expected to increase in the United States and around the world, raising demand for earlier screening and strategies for relieving the financial burden. A U.S. prevalence study estimated that 85.3 million Americans have NAFLD, and 17.3 million have NASH. These conditions contribute billions of dollars to the country’s healthcare costs.
Because liver disease can often be reversed with early diagnosis and intervention, it’s important that more clinicians adopt medical devices known as non-invasive tests (NITs) to help in the management of patients with liver diseases.
High Costs of Liver Disease
Liver damage is linked to over $100 billion in annual direct costs. A recent study among Medicare Advantage plans found that the annual cost of NAFLD was $9,062 for a new diagnosis and $5,363 for long-term management versus $4,111 per matched control. These costs are due to inpatient hospitalization and outpatient appointments, emergency department visits, organ transplantation, medical procedures or new diagnoses, new medications or changes to existing medications, and mortality.
Experts believe that 357 million people will have NASH globally by 2030. Given that NAFLD and NASH are so closely tied to obesity, diabetes, and lifestyle, a preemptive approach to patient engagement is necessary to encourage more positive lifestyle behavioral changes.
Innovative Products for Liver Health
The most promising NIT is a non-invasive solution powered by liver stiffness measurement assessed by vibration-controlled transient elastography (LSM by VCTE™), controlled attenuation parameter (CAP™), and spleen stiffness measurement (SSM by VCTE™). A quick and painless exam is performed in less than 10 minutes to provide immediate results at the point-of-care.
LSM by VCTE offers a complete non-invasive solution for liver disease management to enhance exam efficiency and software designed to 1) improve reliability in the diagnosis and monitoring of steatosis with continuous CAP, 2) extend usage among severely obese patients with deeper assessment of liver fibrosis and steatosis and 3) provide task automation features that enable physicians to dedicate more time to patient care.
It’s important to look for a NIT that also offers scores to easily detect advanced fibrosis and cirrhosis in NAFLD patients, as well as an app that enables users to assess a patient’s liver health, making interpreting results quick and easy at the point-of-care.
Clinicians need an innovative tool like this to expand clinical capabilities in liver health assessment, with the addition of SSM by VCTE, to cost-effectively and non-invasively diagnose, monitor and manage spleen and liver stiffness measurements.
How LSM by VCTE Technology Works
Studies show that detecting and monitoring liver disease using LSM by VCTE is a non-invasive, convenient, and cost-effective way for clinicians to quantify the stiffness of liver tissue and estimate liver fat at the point-of-care.
LSM by VCTE combines standardization, clinical performance, and accessibility for early patient identification and for advanced liver disease patient management, portal hypertension and HCC risk stratification.
This technology enables clinicians to detect and monitor for NAFLD/NASH, alcoholic liver disease (ALD), hepatitis C virus, including post sustained virologic response (PSVR), primary biliary cirrhosis (PBC)/primary sclerosing cholangitis (PSC), and autoimmune hepatitis (AIH) among at-risk populations.
LSM by VCTE Research and Validation
Recognized worldwide as the reference for liver fibrosis and liver steatosis assessment, with more than 3,000+ peer-reviewed publications and 140+ international guidelines, LSM by VCTE can improve the quality of specialist referrals – reducing waste from unnecessary and often invasive testing. This was validated in an independent assessment conducted by Santa Barbara Actuaries Inc. (SBA) and published in the September 2021 issue of the American Journal of Managed Care.
The study found that deploying VCTE/CAP devices to screen and monitor liver stiffness and liver fat in members with diabetes can yield net savings to payers, directly impacting bottom-line performance. While short-term costs increase due to implementation of the testing devices and the identification and management of additional patients with active liver disease, the incremental cost is outweighed by the downstream savings from the avoidance or delay of progression to advanced liver disease. The reduction in unnecessary referrals, biopsies, and imaging further increases cost savings. This tool will also be vital when medications to treat NAFLD become available.
The study also demonstrated that cost savings are increased when expanding access to a broader patient base. High penetration of the VCTE/CAP device in primary care, combined with more intensive behavioral engagement through chronic care management programs, yields the highest returns in both Medicare and commercial settings. One research scenario involved a high device penetration level modeled for a Medicare payer with 100,000 members deploying devices at specialists, where high device penetration corresponded to gradually ramping up device placement to give one-third of members access at their specialists over two years. This produced an estimated five-year cumulative gross savings of $10.1 million and a net savings (subtracting device rental) of $8.8 million. This corresponds to a 5-year 6.5:1 ROI and a net savings of $1.46 PMPM.
Furthermore, the National Institute for Health and Care Excellence (NICE), the United Kingdom’s health technology assessment body providing national guidance and advice to improve health and social care, issued a MedTech Innovation Briefing (MIB) dedicated to utilization of LSM by VCTE non-invasive technology in the primary care setting. Additionally, new guidelines from the European Association for the Study of the Liver (EASL), a professional association for those researching liver disease, outlined an unprecedented level of recommendation for LSM by VCTE. Also, more self-funded employers are beginning to recognize the value of this technology as evidenced by the Action Brief published recently by the Midwest Business Group on Health (MBGH).
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Finding the Right Tool
The most effective LSM by VCTE tools are small and portable, making them easy to use in the office or outpatient setting. Moreover, they can be operated by a trained operator, such as a doctor, nurse, or technician, with results interpreted by the healthcare professional. These tools produce numerous measurements, rather than images, for simplified interpretation and consistency of measurement. This enables clinicians to monitor changes in liver tissue over time and share data with the patient to demonstrate progress or prompt lifestyle changes.
When seeking an SSM by VCTE technology solution, it’s important to find one that offers effective risk stratification of patients with advanced chronic liver disease and portal hypertension. It should also offer embedded ultrasound guidance to ease both liver and spleen targeting.
With a non-invasive SSM, operators can assess and monitor portal hypertension, detect the presence of high-risk varices, determine patient candidacy for evaluation, intervention, treatment, and monitoring of portal hypertension and determine the need for surgery. In fact, SSM by VCTE has the potential to be integrated as a non-invasive marker or management of risk stratification in patients with advanced stages of liver disease.
The LSM by VCTE tool should also offer exceptional ergonomics and high-speed processing, an intuitive user interface, integrated barcode reader and touchscreen with washable keyboard.
Monitoring Behavioral Change
Typically, liver disease advances at a slow pace, giving patients the opportunity to be managed well by primary care physicians. For many patients, diet and exercise can make all the difference. In fact, a 3% reduction in body weight has been associated with reversal of fat in the liver, while a reduction of greater than 7% may resolve NASH in many patients.
Healthcare providers seeking to adopt LSM by VCTE technology to help halt or reverse liver damage among at-risk patients should look for a tool that provides exam results to help monitor lifestyle modification. It should also offer consistent quantitative results to monitor fatty liver disease and provide feedback to patients about their diet and exercise modifications. It’s advantageous to also choose a LSM by VCTE tool that integrates with electronic health records for automatic upload and storage of the exam results to save time, secure data and improve the patient’s follow-up.
A NIT liver exam tool has become increasingly essential for clinicians to help battle a global liver disease epidemic and add value to the practice, enhance patient satisfaction and improve outcomes.
About the Author: With more than 20 years of global medical device and health care sales, marketing and general management experience at AxoGen, Inc., Hologic, Inc., Boston Scientific Corporation and Unilever, N.V, Gingrich now leads the development and execution of the Echosens U.S. strategy for expanding the utilization of FibroScan® technology in the assessment of chronic liver disease. As a member of the broader global executive leadership team, he works to implement the Company’s transformation plan and shape the future of Echosens.
