Subject: Specialty Quantity Limit Livmarli 5006-H P2024a

Drug

LIVMARLI  (maralixibat)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

Covered Quantities

Medication	Standard Limit
Livmarli (maralixibat) 9.5 mg/mL oral solution	90 mL (3 bottles) per 30 days
Livmarli (maralixibat) 19 mg/mL oral solution	60 mL (2 bottles) per 30 days
Livmarli (maralixibat) 10 mg tablets	60 per 30 days
Livmarli (maralixibat) 15 mg tablets	60 per 30 days
Livmarli (maralixibat) 20 mg tablets	60 per 30 days
Livmarli (maralixibat) 30 mg tablets	30 per 30 days

FDA-recommended Dosing

Alagille Syndrome (ALGS) – 9.5 mg/mL oral solution or tablets

380 mcg/kg once daily

Start dosing at 190 mcg/kg once daily. After one week, increase to 380 mcg/kg once daily, as tolerated. The maximum daily dose should not exceed 28.5 mg (3 mL) per day for oral solution and 30 mg per day for tablets.

Progressive Familial Intrahepatic Cholestasis (PFIC) – 19 mg/mL oral solution or tablets

570 mcg/kg twice daily

Start dosing at 285 mcg/kg once daily. Dosing should be increased to 285 mcg/kg twice daily, 428 mcg/kg twice daily, and then to 570 mcg/kg twice daily, as tolerated. The maximum daily dose should not exceed 38 mg (2 mL) per day for oral solution and 40 mg per day for tablets.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Livmarli [package insert]. Foster City, CA: Mirum Pharmaceuticals, Inc.; April 2025.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 07, 2025