Rezdiffra (resmetirom tablets - Madrigal Pharmaceuticals) — Cigna

Initial criteria

• Patient age ≥ 18 years; AND
• Diagnosis of MASH/NASH confirmed by ONE of the following (a or b):
• a) Liver biopsy performed within 3 years preceding treatment with Rezdiffra showing non-alcoholic fatty liver disease activity score ≥ 4 with a score of ≥ 1 in steatosis, ballooning, and lobular inflammation [documentation required]; OR
• b) ONE of the following imaging exams performed within 6 months preceding treatment with Rezdiffra: elastography (e.g., vibration-controlled transient elastography [FibroScan], transient elastography, magnetic resonance elastography, acoustic radiation force impulse imaging, shear wave elastography), computed tomography, or magnetic resonance imaging [documentation required]; AND
• Patient has stage F2 or F3 fibrosis prior to treatment [documentation required]; AND
• According to the prescriber, patient has THREE or more of the following metabolic risk factors managed according to standard of care: central obesity, hypertriglyceridemia, reduced high-density lipoprotein cholesterol, hypertension, elevated fasting plasma glucose indicative of diabetes or pre-diabetes; AND
• Alcohol consumption limit met: female patient < 20 grams/day OR male patient < 30 grams/day; AND
• Medication will be used in combination with appropriate diet and exercise therapy; AND
• Medication prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist.

Reauthorization criteria

• Patient has completed ≥ 1 year of therapy with Rezdiffra AND according to the prescriber, the patient has not had worsening of fibrosis or MASH/NASH; AND
• Patient has not progressed to stage F4 (cirrhosis); AND
• According to the prescriber, metabolic risk factors are managed according to standard of care; AND
• Alcohol consumption limit met: female patient < 20 grams/day OR male patient < 30 grams/day; AND
• Medication will be used in combination with appropriate diet and exercise therapy; AND
• Medication prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist.

Approval duration

1 year