Early Prescribing Patterns of a New Liver Therapy Reveal Gaps in Diagnosis and Access
A large-scale national analysis of early prescribing patterns for resmetirom, the first FDA-approved therapy for noncirrhotic MASH with moderate-to-advanced fibrosis, reveals significant underutilization and potential diagnostic miscoding. The retrospective cohort study, published in Liver International, examined data from 44 healthcare organizations and over 19,000 eligible patients. It found that only 5.4% of treatment-eligible patients received the new therapy. Treated patients were more likely to be Asian or Hispanic and had a higher metabolic burden, including greater use of GLP-1 receptor agonists, statins, and other medications. The study highlights critical challenges in the real-world application of novel therapeutics, including disparities in access and the need for accurate diagnostic coding in metabolic liver disease pathology.
Study Significance: For pathologists and clinicians, this study underscores the gap between biomarker-driven drug approval and real-world diagnostic implementation. It suggests that tissue morphology and biopsy analysis for MASH may not be consistently translating into treatment eligibility in clinical practice. The findings call for refined diagnostic pathways and laboratory quality control to ensure patients with confirmed fibrosis stages can access targeted therapies, directly impacting tumor staging and therapeutic decision-making in metabolic liver disease.
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