A Real-World Experience With Resmetirom: Tolerability and Access

Area of Science:

• Hepatology
• Pharmacology
• Clinical Medicine

Background:

• Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease.
• Resmetirom is the first FDA-approved treatment for MASH.
• Evaluating resmetirom's tolerability and access is crucial for patient care.

Purpose of the Study:

• Assess resmetirom tolerability in MASH patients over 3 months.
• Identify factors affecting medication access, including insurance and dispensing.
• Analyze treatment outcomes and adverse events.

Main Methods:

• Retrospective chart review of 113 MASH patients treated with resmetirom for at least 3 months.
• Data collected on tolerability, adverse effects, liver enzymes, insurance coverage, and dispensing delays.
• Analysis of patient outcomes and medication adherence.

Main Results:

• Resmetirom showed good tolerability with low discontinuation rates (8.8%).
• Common side effects included nausea, vomiting, and diarrhea (12.4% each).
• Liver enzymes (AST, ALT, ALP) showed a decrease after 3 months of treatment.
• 24.1% of patients required insurance appeals, with 93.4% ultimately approved.
• Average delay in prescription fill post-approval was 12.5 days.

Conclusions:

• Resmetirom is a safe and well-tolerated MASH treatment in the short term.
• Insurance approval is generally achievable, but appeals and dispensing delays are common.
• Invasive fibrosis testing may be required for insurance approval, impacting timely access.