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Rezdiffra (resmetirom) — Highmark

metabolic dysfunction-associated steatohepatitis (MASH), also known as nonalcoholic steatohepatitis (NASH)

Initial criteria

  • age ≥ 18 years
  • prescribed by a gastroenterologist or hepatologist
  • diagnosis of MASH (ICD-10: K75.81) documented by one of the following: (1) liver biopsy performed within the previous 3 years OR (2) noninvasive tests (NIT) with imaging (e.g., transient elastography, vibration-controlled transient elastography [Fibroscan], or magnetic resonance elastography) performed within the past 6 months
  • documentation of stage F2 or F3 fibrosis, as confirmed by liver biopsy or NIT
  • documentation of at least one cardiometabolic risk factor:
  • – BMI ≥ 25 kg/m2 or ethnicity adjusted equivalent OR waist circumference ≥ 94 cm for males or ≥ 80 cm for females or ethnicity adjusted equivalent
  • – fasting serum glucose ≥ 100 mg/dL OR 2-hour post-prandial serum glucose ≥ 140 mg/dL OR HbA1c ≥ 5.7% OR diagnosis of type 2 diabetes OR receiving treatment for type 2 diabetes
  • – plasma triglycerides ≥ 150 mg/dL OR receiving lipid lowering treatment
  • – plasma HDL ≤ 40 mg/dL for males OR ≤ 50 mg/dL for females OR receiving lipid lowering treatment
  • – blood pressure ≥ 130/85 mmHg OR receiving treatment for hypertension
  • prescriber documents lifestyle interventions including weight loss (if indicated), dietary changes, and exercise
  • prescriber documents member is receiving standard of care pharmacologic treatment to manage comorbid diseases (e.g., cardiovascular disease, dyslipidemia, diabetes, hypertension)
  • prescriber documents no evidence of cirrhosis, hepatic decompensation, or hepatocellular carcinoma
  • prescriber documents alcohol consumption ≤ 20 g/day for females or ≤ 30 g/day for males
  • if request is for Wegovy, medication will NOT be used in combination with any GLP-1 receptor agonist or GLP-1 receptor agonist combination (e.g., with insulin, GIP RA)

Reauthorization criteria

  • prescribed by a gastroenterologist or hepatologist
  • member has experienced improvement or stabilization of fibrosis, as documented by NIT
  • member has not progressed to stage F4 fibrosis, as documented by NIT
  • prescriber documents continued lifestyle interventions including weight loss (if indicated), dietary changes, and exercise