skip to content
Primary navigation

Rezdiffra™

Drug - Rezdiffra™ (resmetirom) [Madrigal Pharmaceuticals Inc.]

January 2025

Therapeutic area - NASH/MASH

Initial approval criteria

  • Age ≥ 18 years; AND
  • Diagnosis of noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (medical records required) AND ALL of the following:
    • The patient has stage F2 or F3 fibrosis; AND
    • ONE of the following:
      • The patient is ≤ 65 years of age and has a Fibrosis Index Based on 4 Factors (FIB-4) score > 1.3; OR
      • The patient is > 65 years of age and has a FIB-4 score > 2; AND
    • The patient has ONE of the following:
    • A liver biopsy within the past 2 years; OR
    • At least TWO of the following:
      • Vibration-controlled transient elastography (VCTE, e.g., Fibroscan) score > 8.1
      • Enhanced liver fibrosis (ELF) score > 7.7
      • Magnetic resonance elastography (MRE) score > 2.6; AND
  • The patient is being monitored and/or treated for any comorbid conditions (e.g., cardiovascular disease, diabetes, dyslipidemia, hypertension); AND
  • BOTH of the following:
    • The patient is currently on a weight loss regimen of a low calorie diet, increased physical activity, and behavioral modifications; AND
    • The patient will continue the weight loss regimen in combination with the requested agent; AND
  • Patient does NOT have any of the following:
    • Decompensated cirrhosis; AND
    • Moderate to severe hepatic impairment (Child-Pugh Class B or C); AND
    • Any other liver disease (e.g., Wilson’s disease, hepatocellular carcinoma, viral hepatitis); AND
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hepatologist, gastroenterologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis.

Renewal criteria

  • Patient must continue to meet the above criteria; AND
  • Patient must have disease improvement as evidenced by NASH resolution or improvement in liver fibrosis; AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., hepatotoxicity, gallbladder-related adverse reactions [e.g., cholelithiasis, acute cholecystitis, obstructive pancreatitis], statin-related adverse reactions [e.g., elevation of liver tests, myopathy, rhabdomyolysis] when given concurrently with a statin).

Quantity limits

  • 30 tablets/30 days. Max dose 100 mg daily.

Background

Rezdiffra is a thyroid hormone receptor-beta (THR-beta) agonist indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of NASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Avoid use of Rezdiffra in patients with decompensated cirrhosis.

Questions

Provider Call Center (844) 575-7887

back to top