Issue8-Breast Cancer ScreeningThe hidden price tag: Unveiling underdiagnosed and costly Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Metabolic Dysfunction-Associated Steatohepatitis (MASH), a progressive but often underdiagnosed disease, creates heavy clinical and economic burdens, especially in its advanced stages. A recent study by Carelon Research uncovers a high prevalence of comorbidities and underlines the importance of early detection and effective treatment to mitigate its impact.


Enterprise Analytics Core domain(s)
: Cardiometabolic, cost of care


Summary

Background
MASH (formerly known as non-alcoholic steatohepatitis or NASH) is a progressive disease associated with increased risk for many severe liver, kidney, and cardiovascular-related complications. Currently, there is only one FDA-approved treatment available (Rezdiffra, April 2024) for MASH, which continues to be underdiagnosed due to few or no symptoms in its early stages, complexities of obtaining liver biopsies, and uncertainty around the diagnostic reliability of non-invasive testing.

Objectives
Researchers analyzed newly diagnosed MASH, pre-existing MASH, MASH with cirrhosis, and MASH without cirrhosis with the goal of evaluating the impact of disease severity on the burden of MASH.

Methods
This observational, retrospective, claims-based study evaluated patients with ≥ 1 claim diagnosed with MASH, excluding patients with liver-related diagnoses (e.g., other hepatitis-related diseases, alcoholic liver diseases, toxic liver diseases). The study period was over 5 years: from October 1, 2015, to April 30, 2022. Disease severity was assessed via the FIB-4 score, a widely available non-invasive severity marker of liver fibrosis and damage.

Results

  • Among those newly diagnosed with MASH (N=10,205), 10.8% had cirrhosis, and 2,688 had calculated FIB-4 scores (63.3% low, 26.7% indeterminate, and 10.0% high). Also, of 1,671 patients with pre-existing MASH, 16.6% had cirrhosis, and 322 (19.3%) had calculated FIB-4 scores (54.0%, 33.5%, and 12.4% for low, indeterminate, and high, respectively).
  • Hyperlipidemia (65.6%), hypertension (65.2%), obesity (56.4%), type 2 diabetes (T2D, 43.3%), and sleep apnea (26.9%) were the top 5 chronic conditions identified among patients with MASH.
  • Among newly diagnosed MASH patients, 10.6% of patients had liver biopsy, 41.2% had ultrasound, and ≤4% had other MASH-related imaging procedures before diagnosis.
  • During follow-up, prescriptions to manage comorbidities marginally increased for GLP-1 RA (7.0% to 8.7%), SGLT-2is (5.5% to 7.0%), and statins (37.1% to 39.4%) among newly diagnosed MASH patients (all p<0.001).
  • Among patients with cirrhosis at baseline, progression to cirrhosis with complications occurred 87.7% within a mean of 87.6 days.
  • Rates of all-cause, cardiovascular-related, and liver-related hospitalization and medical costs were several-fold higher in patients with elevated MASH disease severity compared to those with low disease severity (Figure 1).


Figure 1. Adjusted post-index hospitalization rates and medical costs among patients with MASH by FIB-4 score



The low FIB-4 reference is depicted by a horizontal, dotted line at y=1. The Y-axis scales are varied. Points are labeled with the corresponding ratio, 95% CI, and P value. High FIB-4 scores (closed circles) and intermediate FIB-4 scores (open circles), which are compared with low FIB-4 scores, are shown.     


Key takeaways

  • Consistent with previous studies, MASH was associated with many components of the metabolic syndrome.
  • Although liver biopsy is the gold standard for definitive diagnosis of MASH, these findings suggest that noninvasive procedures, such as laboratory and radiology testing, are more commonly used in clinical practice.
  • This study demonstrates that there is a significant clinical and economic burden associated with MASH, especially when the condition has progressed to later stages.
  • Early detection and effective treatment for MASH could lessen the risk of liver damage and progression to severe liver disease such as cirrhosis and hepatocellular carcinoma and mitigate some of this burden.

Publications

Articles:
  • Charlton, M., Tonnu-Mihara, I., Teng, C. C., Zhou, Z., et al. (2024). The clinical and economic burdens of metabolic dysfunction-associated steatohepatitis. Journal of Medical Economics, 27(1), 919–930. https://doi.org/10.1080/13696998.2024.2374642.
  • Charlton, M., Tonnu-Mihara, I., Teng, C.C., Zhou, Z., et al. (2024). Evaluating the Burden of Illness of Metabolic Dysfunction-Associated Steatohepatitis in a Large Managed Care Population: The ETHEREAL Study. Accepted by the Journal of Managed Care + Specialty Pharmacy.
Posters:
  • AMCP Nexus Meeting, Orlando, October 2023- “A cohort study assessing diagnostic testing patterns, treatment, and progression in patients diagnosed with nonalcoholic steatohepatitis”
  • Cardiometabolic Health Congress (CMHC), Boston, October 2023 - “Prevalence of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis and Patient Characteristics in a Large Managed Care Population”
  • American Association for the Study of Liver Diseases (AASLD), Boston, November 2023 – “Health Care Resource Utilization and Cost Burden of High Disease Severity in US Adults with Nonalcoholic Steatohepatitis: A Retrospective Cohort Study”


Carelon Research project team:
Chia-Chen (Jenny) Teng, Ivy Tonnu-Mihara*, Vince Willey
*Carelon Research associate at the time of the study.


For more information on a specific study or to connect with the Actionable Insights Committee, contact us at [email protected].

Sponsor: This study was conducted by Carelon Research, Inc., a subsidiary of Elevance Health, and funded by Novo Nordisk. Dissemination and sharing of the newsletter are limited to Elevance Health and its subsidiaries, and the findings and implications included are for Elevance Health and its affiliates’ internal use only.

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