Livmarli (maralixibat chloride) — Blue Cross Blue Shield of New Mexico

Preferred products

• cholestyramine
• naltrexone
• rifampicin
• sertraline
• ursodiol

Initial criteria

• Diagnosis of Alagille syndrome with pruritus OR diagnosis of PFIC with pruritus (medical records required) AND no diagnosis of PFIC2 with ABCB11 variants resulting in non-functional or complete absence of BSEP-3
• Patient has tried and had inadequate response to ONE prerequisite agent (Bylvay: cholestyramine; Livmarli: naltrexone, rifampicin, sertraline, ursodiol) OR has intolerance or hypersensitivity to ONE prerequisite agent OR has an FDA labeled contraindication to ALL prerequisite agents
• Patient has another FDA labeled indication for the requested agent and route of administration OR another indication supported in compendia for the requested agent and route of administration
• Patient’s age is within FDA labeling for the requested indication OR there is support for use at the patient’s age for that indication
• If requested agent is Bylvay: INR < 1.4 AND ALT and total bilirubin < 10 × ULN
• If requested agent is Livmarli: patient has NOT had surgical interruption of the enterohepatic circulation of bile acid
• Serum bile acid concentration above the upper limit of normal (ULN)
• Patient has NOT had a liver transplant OR has had a transplant and there is support for post-transplant use
• Prescriber is a specialist in the area of diagnosis (e.g., gastroenterologist, hepatologist) OR has consulted with one
• Patient will NOT use the requested agent in combination with another Ileal Bile Acid Transport (IBAT) inhibitor
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Requested dose within FDA labeled dosing or supported in compendia
• Compendia allowed: AHFS or DrugDex level 1, 2A, or 2B
• Alternative approval: For BCBS NM Fully Insured or NM HIM members, rare disease indication is accepted with no FDA contraindications and supported FDA/compendia indication OR For Ohio Fully Insured or HIM Shop (SG) members, no FDA contraindications and with FDA/compendia support OR two peer-reviewed journal articles supporting safe and effective use

Reauthorization criteria

• Patient previously approved through plan’s Prior Authorization process
• Patient has had clinical benefit with requested agent
• Prescriber is a specialist in patient’s diagnosis area (e.g., gastroenterologist, hepatologist), or has consulted with one
• Patient will NOT use requested agent in combination with another Ileal Bile Acid Transport (IBAT) inhibitor
• Patient does NOT have FDA labeled contraindications to requested agent
• Requested dose within FDA labeled dosing or supported in compendia

Approval duration

12 months (All other plans); 36 months (BCBSOK)