A new retrospective observational study analyzing US healthcare claims data has revealed a significant shift toward noninvasive testing (NIT) for diagnosing metabolic dysfunction-associated steatohepatitis (MASH), marking a departure from traditional liver biopsy-based diagnosis.
The research, led by Novo Nordisk's evidence generation manager Semiu Gbadamosi, MD, PhD, examined diagnostic patterns in 18,396 patients newly diagnosed with MASH between October 2016 and March 2023. The findings demonstrate a clear preference for combining various noninvasive diagnostic methods over invasive procedures.
Diagnostic Patterns and Testing Approaches
The study revealed that only 10% of patients underwent liver biopsy prior to MASH diagnosis, with these procedures occurring approximately 3.3 months before final diagnosis. Instead, healthcare providers relied heavily on a combination of routine laboratory tests, composite liver function tests, and imaging procedures.
Ultrasound emerged as the most frequently utilized imaging method, employed in 62% of cases approximately 12.7 months before diagnosis. The most common diagnostic pathway, observed in 45.8% of cases, combined common laboratory tests, additional laboratory tests, composite liver function tests, and imaging, without liver biopsy.
Patient Demographics and Comorbidity Profile
The study population showed a slight female predominance (53.8%) and primarily consisted of patients aged 45 years or older (73.3%). Commercial health insurance covered 89% of the cohort. Notably, patients demonstrated a substantial comorbidity burden, with a mean Charlson Comorbidity Index score of 2.4.
Metabolic comorbidities were particularly prevalent:
- Hyperlipidemia: 65.8%
- Hypertension: 62%
- Obesity: 58%
- Diabetes: 39.8%
Evolving Healthcare Provider Involvement
The research highlighted interesting trends in provider involvement for MASH diagnosis:
- Primary care physicians: 49% of diagnoses
- Gastroenterologists: 26% of diagnoses
- Endocrinology/metabolism specialists: 1.8% of diagnoses
A notable shift occurred during the study period, with primary care physician diagnoses decreasing from 50% to 47%, while endocrinology specialist involvement increased from 1% to 2%.
Clinical Implications and Future Outlook
The findings come at a critical time, as MASLD (Metabolic dysfunction-associated steatotic liver disease) is projected to affect 41.4% of US adults by 2050, potentially becoming the leading indication for liver transplantation. The study's results suggest a growing acceptance of noninvasive diagnostic approaches, which could facilitate earlier detection and monitoring of MASH.
"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," noted Dr. Gbadamosi and colleagues.
The research underscores the evolution of MASH diagnosis in clinical practice, highlighting the potential for improved diagnostic strategies that balance accuracy with patient comfort and healthcare resource utilization.
