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    Livmarli™

    Drug - Livmarli™ (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

    Questions?

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

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