Resmetirom is a once-daily oral drug being investigated for the treatment of NASH with fibrosis. It is a thyroid hormone receptor β agonist that acts by increasing fat metabolism. Madrigal Pharmaceuticals announced the plan to file a new drug application for resmetirom in the second quarter of 2023. OCA, which was also being investigated for the treatment of NASH with fibrosis, was rejected by the FDA in June 2023. Intercept Pharmaceuticals Inc. announced that the FDA issued a complete response letter (CRL) specifying that the drug cannot be approved for the treatment of patients with NASH based on its current data. Given the FDA CRL determination for OCA, this report presents a summary of our findings related to resmetirom only and highlights the key policy recommendations discussed at the Midwest Comparative Effectiveness Public Advisory Council’s (CEPAC) public meeting on April 28, 2023. The full report is available at https://icer.org/wp-content/uploads/2022/10/NASH-Final-Report_ForPublication_053023.pdf.
