Livmarli (maralixibat) — CareFirst (Caremark)

Initial criteria

• Member has a confirmed molecular diagnosis of PFIC (e.g., ATP8B1, ABCB11, ABCB4, TJP2, or MYO5B gene variants)
• Member has evidence of cholestasis (e.g., elevated serum bile acid level)
• Member does not have any other concomitant liver disease (e.g., biliary atresia, liver cancer, alternate non-PFIC related etiology of cholestasis)
• Member has not received a liver transplant
• Member is age ≥ 12 months
• Member does not have PFIC type 2 with variants in the ABCB11 gene resulting in non-functional or complete absence of bile salt export pump (BSEP) protein
• Medication must be prescribed by or in consultation with a hepatologist or gastroenterologist
• Medication will not be used concomitantly with any other ileal bile acid transporter (IBAT) inhibitor (e.g., Bylvay)

Reauthorization criteria

• Member is experiencing benefit from therapy (e.g., improvement in pruritus)

Approval duration

Initial: 6 months; Reauthorization: 12 months