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DrugLivmarli™ (marlixibat) [Mirum Pharmaceuticals Inc.]

April 2022

Therapeutic area - Bile Salts

Initial approval criteria

  • Patient is ≥ 1 year of age AND
  • Patient is diagnosed with Alagille syndrome AND
  • Patient has evidence of cholestasis, as evidenced by ≥ 1 of the following:
    • Serum bile acid > 3 times upper limit of normal (ULN) for age OR
    • Conjugated bilirubin > 1 mg/dL OR
    • Gamma glutamyl transferase (GGT) > 3 times ULN for age OR
    • Fat soluble vitamin deficiency not otherwise explained OR
    • Intractable pruritus only explained by liver disease AND
  • Patient experiences persistent moderate to severe pruritus AND
  • Patient does NOT have any of the following:
    • Chronic diarrhea requiring ongoing intravenous fluid or nutritional intervention AND
    • Prior hepatic decompensation event AND
    • Significant portal hypertension AND
    • Decompensated cirrhosis AND
    • Another concomitant liver disease AND
  • Maralixibat is prescribed by or in consultation with a specialist (e.g., gastroenterologist, hepatologist, dermatologist) AND
  • Patient has failed an adequate trial, or is intolerant to, or has a contraindication to at least 2 conventional treatment for the symptomatic relief of pruritis (e.g., ursodeoxycholic acid [ursodiol], cholestyramine, rifampin, naloxone, naltrexone, antihistamine)
  • Initial approval is for 6 months

Renewal criteria

  • Patient must continue to meet the above criteria AND
  • Patient has experienced a reduction in serum bile acids from baseline AND
  • Patient must experience improvement in pruritus AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., persistent diarrhea; persistent fat-soluble vitamin deficiency despite vitamin A, D, E, K supplementation; persistent or recurrent worsened liver function tests [alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TB), direct bilirubin (DB)]) AND
  • Patient has NOT developed decompensated cirrhosis AND
  • Patient has NOT developed significant portal hypertension
  • Renewal approval is for 12 months

Quantity limits

  • 28.5 mg/3 mL per day
  • Patient’s weight (in kg) must be submitted at time of request
  • In order to minimize waste, reasonable efforts must be taken to ensure dosing follows weight guidelines presented in FDA-approved label


MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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