Abstract
BACKGROUND AND AIMS: Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease often leading to cirrhosis. Resmetirom is the first Food and Drug Administration-approved treatment for MASH. The aim of this study was to evaluate the tolerability of resmetirom for the treatment of MASH fibrosis and factors affecting access, including insurance coverage and dispensing delays for patients that received at least 3 months of therapy. METHODS: A retrospective chart review conducted at a large tertiary hospital for all (113) MASH patients prescribed resmetirom between April 2024 to September 2024 and who were treated for at least 3 months to assess their tolerability and any obstacles medication access. RESULTS: Resmetirom was prescribed for 137 patients, of whom 113 (85.5%) completed at least 3 months of treatment and met the inclusion criteria. Pertinent adverse effects were nausea and vomiting (12.4%) and diarrhea (12.4%). The mean baseline aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase values were 40.15 international units per liter (IU/L), 49.96 IU/L, and 83.04 IU/L, respectively. At 3 months of treatment, mean aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase values decreased to 36.15 IU/L, 45.38 IU/L, and 81.33 IU/L, respectively. Regarding insurance coverage for all patients prescribed resmetirom, 33 patients (24.1%) required an appeal, with 93.4% (128) ultimately receiving insurance approval. Average delay in prescription fill after insurance approval was 12.5 days. Resmetirom discontinuation incurred among 10 (8.8%) patients. CONCLUSION: Resmetirom is a safe medication with good tolerability in regard to the side effect profile for the first 3 months. Most patients were able to gain insurance approval but delays in dispensing and insurance requirements of invasive fibrosis testing to obtain approval were observed.