Real-World Data Suggest Uptake of Noninvasive Testing for MASH Diagnosis

Semiu Gbadamosi, MD, PhD

Credit: Semiu Gbadamosi on LinkedIn

New research is shedding light on the diagnostic pathways leading to metabolic dysfunction–associated steatohepatitis (MASH) diagnosis in real-world clinical settings, suggesting a recent uptake in noninvasive tests (NITs).¹

Leveraging healthcare claims data from the Merative MarketScan Commercial and Medicare databases, the study found liver biopsy was used infrequently to diagnose MASH. Instead, diagnostic pathways relied heavily on a combination of routine laboratory tests, composite liver function tests, and imaging procedures.¹

A common cause of chronic liver disease, metabolic dysfunction–associated steatotic liver disease (MASLD) is projected to become the leading indication for liver transplant in the US. In the absence of effective treatments, the prevalence of MASLD is projected to reach 41.4% in 2050, translating to approximately 122 million US adults.²

“Due to a lack of disease awareness, lack of coordinated care among providers, and because MASH is frequently asymptomatic, MASH is often diagnosed during assessments of other conditions due to abnormal results of blood tests or liver imaging,” Semiu Gbadamosi, MD, PhD, an evidence generation manager for real-world evidence at Novo Nordisk, and colleagues wrote.¹ “Traditionally, diagnosis of MASH has required a liver biopsy, an invasive procedure that can have a substantial cost. However, noninvasive tests to identify MASH are increasingly being used in place of liver biopsy.”

Investigators conducted a retrospective, observational study using US healthcare claims data for adult patients ≥ 18 years of age who were newly diagnosed with MASH between October 2016 and March 2023.¹

A MASH diagnosis was defined as ≥1 primary position inpatient claim or ≥2 nondiagnostic outpatient claims with a diagnosis of MASH based on ICD-10-CM codes. The first qualifying MASH claim served as the index date and patients were required to have ≥12 months of continuous enrollment with medical and pharmacy benefits in the database before the index date.¹

Tests and procedures were categorized as routine laboratory tests, composite liver function tests, imaging procedures, liver biopsy, and additional tests. Investigators also measured clinical characteristics, Charlson Comorbidity Index (CCI), and common MASH-related comorbidities during the baseline period.¹

A total of 18,396 patients were included in the analysis, the majority of whom were female (53.8%), ≥ 45 years of age (73.3%), and had commercial health insurance (89.0%).¹

Investigators noted patients with MASH exhibited a high comorbidity burden with a mean CCI score of 2.4 (Standard deviation [SD], 2.0) in the 12 months before diagnosis. Indicators of metabolic syndrome were common among the cohort, including hyperlipidemia (65.8%), hypertension (62%), obesity (58%), and diabetes (39.8%), but only 5% of patients had a formal diagnosis of metabolic syndrome.¹

The study sample was followed for a mean 42.0 (SD, 21.4) months prior to MASH diagnosis.¹

The mean time from the first liver-related test to MASH diagnosis was 27.1 months. In total, 75% of patients with MASH had all laboratory tests necessary on a single date to calculate FIB-4 and APRI before their MASH diagnosis a mean 23.9 (SD, 19.7) months before diagnosis.¹

Ultrasound was the most common imaging performed prior to MASH diagnosis, occurring among 62% of patients a mean 12.7 (SD, 15.4) months before diagnosis. Of note, just 10% of patients had a liver biopsy performed prior to their MASH diagnosis, occurring a mean 3.3 (SD, 8.2) months before diagnosis.¹

Investigators noted the most common diagnostic test (45.8%) combination included common laboratory tests, additional laboratory tests, composite liver function tests, and imaging, but not liver biopsy. The second most common pathway (10.7%) included only common laboratory tests, composite liver function tests, and imaging. All diagnostic testing modalities, including liver biopsy, were part of the diagnostic pathway in 8% of cases.¹

Further analysis revealed 49% of patients were diagnosed by a primary care physician (PCP), 26% by a gastroenterologist, and 1.8% by an endocrinology/metabolism specialist. Of note, during the study period, the percentage of MASH diagnoses made by a PCP decreased from 50% in 2016 to 47% in 2022, whereas diagnoses by an endocrinology and/or metabolism specialist increased from 1% to 2%.¹

“Overall, this study provides a current, real-world understanding of the types and combinations of diagnostic tests, common comorbidities, and comorbidity-related treatments experienced in the period before MASH diagnosis,” investigators concluded.¹ “Our findings also add to the growing body of evidence that noninvasive methods are being used more often than liver biopsies for the diagnosis of MASH.”

References

1. ^{Gbadamosi SO, Evans KA, Brady BL, Hoovler A. Noninvasive tests and diagnostic pathways to MASH diagnosis in the United States: a retrospective observational study. J Med Econ. doi:10.1080/13696998.2025.2468582}
2. ^{Brooks A. MASLD Prevalence Projected to Exceed 40% by 2050, Increasing Health System Burden. HCPLive. January 18, 2025. Accessed February 21, 2025. https://www.hcplive.com/view/masld-prevalence-projected-exceed-40-by-2050-increasing-health-system-burden}