Corrected T1 (cT1) is the most appropriate diagnosis and monitoring tool for widespread adoption of resmetirom treatment in the United States.

Abstract

Objective: The US Food and Drug Administration (FDA) recently approved the first treatment for metabolic dysfunction-associated steatohepatitis (MASH), resmetirom, without clarifying the most effective strategy for diagnosing or monitoring response to therapy. Current standards-of-care (SoC) for Veterans Health Administration (VHA) and Medicare patients largely rely on vibration-controlled transient elastography (VCTE) and/or liver biopsy. Multiparametric MRI corrected T1 (cT1) is a cost-effective, noninvasive liver disease assessment (NILDA) tool in MASH. We evaluated the budgetary impact of pathways using cT1 versus SoC (liver biopsy or VCTE) to assign suspected MASH patients to resmetirom and for those assigned treatment, monitor response.

Methods: A model of the VHA and Medicare populations was used to derive a budget impact comparing cT1, VCTE and liver biopsy. Clinical and cost data were taken from publicly available sources and used to estimate the number of patients prescribed resmetirom, the identification of those benefiting from therapy, the budgetary impact of each diagnosis and monitoring strategy and the cost of medication prescribed.

Results: For the VHA, cT1 resulted in the lowest per-patient costs ($7,022 (cT1) vs $7,268 (liver biopsy) vs $28,509 (VCTE)), with results remaining consistent across scenario analyses. In the Medicare population, cT1 also resulted in the lowest per-patient costs ($11,866 (cT1) vs $15,488 (biopsy) vs $27,539 (VCTE)) and these results also remained consistent across scenario analyses.

Conclusion: The use of cT1 to assign and monitor resmetirom treatment improves treatment allocation and reduces health system cost vs VCTE and liver biopsy.