Hay recursos disponibles en español. Explorar los recursos aquí »
For US HCPs Only
Prescribing Information
  Indication
Important Safety Information
Visit Patient Website
Patient Info + Instructions for Use: English  |  Español
Request an Account Manager
NAVIGATING TOGETHER

From Prescription to Refill, Access Support Is Available for Every Step of LIVMARLI Treatment

Getting Patients Started

Mirum Access Plus Support Program

Mirum Access Plus is available to help you, your office, and your patient not only get started with LIVMARLI after you’ve prescribed it, but also to provide support throughout treatment.

If you’d like to prescribe LIVMARLI for your patient, download the Patient Enrollment Form. Once you have filled out the form and/or have your patient consent for Mirum Access Plus services, fax it to us at 1-855-282-4884.

Refer to this guide on How to Fill Out the Patient Enrollment Form.

You can also digitally prescribe LIVMARLI through your electronic medical records by submitting an eRX straight to EVERSANA Life Science Services, our single-source specialty pharmacy.

Refer to this step-by-step guide for more information on prescribing LIVMARLI.

Ready, Set, Go

Getting Your Patients the Treatment They Need

Support and resources are available through Mirum Access Plus to help you and your office navigate insurance coverage, as well as assist your patients with treatment costs and prescription fulfillment.

Letter of Medical Necessity

By proactively preparing this document, you can help streamline the authorization process and help patients get their prescribed medication as quickly as possible.

Template Letter of Medical Necessity

Tips for Payer Approval

Keep these tips and questions in mind to help with prior authorizations (PA) and appeals for your patients.

Prior Authorization Checklist

Tips for Payer Approval

Tips for Appeals

Financial Support for Patients

Mirum Access Plus Savings Program: Eligible patients with commercial or private insurance may pay as little as $10 out of pocket per fill for LIVMARLI.*

Mirum Patient Assistance Program (PAP): For eligible patients without insurance coverage, Mirum Access Plus Patient Assistance Program provides LIVMARLI to patients at no cost.†

Eligible patients may pay
as little as $10 out of
pocket per fill for LIVMARLI*

Single-Source Specialty Pharmacy

Mirum Access Plus is a single-source specialty pharmacy that will ship LIVMARLI directly to patients, provide 24/7 access to pharmacists, and proactively manage refills.

Single-Source Specialty Pharmacy

Steps to Getting Medication

This resource helps explain to your patients the initial process of receiving LIVMARLI prescription and treatment.

Download: English | Español

*Eligibility restrictions: This program is not available to individuals who use any state or federal government-funded health care program to cover a portion of medication costs, such as Medicare, Medicaid, TRICARE, Department of Defense, or Veterans Administration, or any other state or federal government-funded health care program.

†Subject to program terms and conditions.

By Your Side at Every Turn

A Team Dedicated to Helping Patients

Focus on what matters and leave the rest to our experienced and dedicated team at Mirum Access Plus, who will work with your office staff through the access process and assist your patients at every turn.

Mirum Access Plus Coordinators

Available to your office staff and your patients, Mirum Access Plus Coordinators are experts who specialize in the insurance coverage process and available financial support options.

Experienced Navigators

Navigators will connect with your patients to provide health education and the emotional support needed to address the difficulties of living with progressive familial intrahepatic cholestasis (PFIC).

or

Our goal is to provide information about our program and the medication prior to the patient receiving it, in hopes that they will feel knowledgeable and supported as they begin their journey with LIVMARLI.

—Mirum Access Plus Navigator, EVERSANA

or

—Mirum Access Plus Navigator, EVERSANA

Mirum Access PLUS

Even More to Help Patients Start and Stay on Therapy

In addition to helping your patients get the treatment they need, Mirum Access Plus offers educational resources and tools for patients who sign up for the program, as described in the Mirum Access Plus Brochure (English | Español).

Your Patients Can Easily Enroll in Mirum Access Plus

Speak with your patients about enrolling in the Mirum Access Plus support program through one of the following options.

Visit the Patient Website
or
Download the Patient Consent Form (English | Español) and fax to Mirum Access Plus at (855) 282-4884

Consider providing the Mirum Access Plus Brochure (English | Español) to help familiarize your patients with all that Mirum Access Plus has to offer them.

If your patients choose to enroll in the free enhanced Mirum Access Plus program, they will have access to an even wider range of support services tailored to them:

Personalized support

Navigators can support all patients by answering questions about LIVMARLI, the disease, or the access process. For patients who have provided their consent, navigators can help track treatment goals, develop a support network, and prepare for health care appointments.

Drive adherence

Navigators can help reinforce adherence in consenting patients by introducing and discussing tools to track pruritus. They will also encourage communication between patients and their physicians about pruritus levels and xanthomas.

Convenient interactions

Mirum Access Plus Mobile allows your patients to interact with the program through their mobile devices. Patients can easily provide insurance information, eSign documents to speed up processing, follow the steps to getting their medication with a prescription tracker, and get reminders via text messaging.

If you have any questions about Mirum Access Plus, contact us at 1-855-MRM-4YOU (1-855-676-4968) Monday through Friday, 8:00 AM through 8:00 PM ET.

Improvements in Cholestatic Pruritus

Meaningful improvements in cholestatic pruritus were seen as early as 2 weeks and sustained through 2 years.1-3

See the Efficacy Data

Encourage patients to download the Itch✓ app to help them track symptom patterns over time and generate customized reports to share at appointments.

Check Out the Itch✓ App

Mirum Access Plus assists both you and your patients at every turn, helping you navigate the payer approval process—and beyond—with ease.

Learn More About
Mirum Access Plus

References: 1. LIVMARLI® (maralixibat) oral solution. Prescribing Information. Mirum Pharmaceuticals, Inc. 2. Miethke AG, Moukarzel A, Porta G, et al. Maralixibat in progressive familial intrahepatic cholestasis (MARCH-PFIC): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024;9(7):620-631. doi:10.1016/s2468-1253(24)00080-3 3. Miethke A, Moukarzel A, Porta G, et al. Long-term maintenance of response and improved liver health with maralixibat in patients with progressive familial intrahepatic cholestasis (PFIC): 2-year data from the MARCH-ON study. Presented at: American Association for the Study of Liver Diseases (AASLD) The Liver Meeting: November 10-14, 2023; Boston, MA.

INDICATION

LIVMARLI is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC).

Limitations of Use: LIVMARLI is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump (BSEP) protein.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

LIVMARLI is contraindicated in patients with prior or active hepatic decompensation events (eg, variceal hemorrhage, ascites, or hepatic encephalopathy).

WARNINGS AND PRECAUTIONS

Hepatotoxicity: LIVMARLI treatment is associated with a potential for drug-induced liver injury (DILI).

In the PFIC trial, treatment-emergent hepatic decompensation events and elevations of liver tests or worsening of liver tests occurred. Two patients experienced DILI attributable to LIVMARLI. Two additional patients experienced DILI in the open-label extension portion of the trial. Of these 4 patients, 1 patient required liver transplant and another patient died.

Obtain baseline liver tests and monitor during treatment. Liver-related adverse reactions and physical signs of hepatic decompensation should also be monitored. Dose reduction or treatment interruption may be considered if abnormalities occur in the absence of other causes. Permanently discontinue LIVMARLI if a patient experiences the following: persistent or recurrent liver test abnormalities, clinical hepatitis upon rechallenge, or a hepatic decompensation event.

Gastrointestinal (GI) Adverse Reactions: Diarrhea and abdominal pain were reported as the most common adverse reactions. Monitor for dehydration and treat promptly. Consider reducing the dosage or interrupting LIVMARLI dosing if a patient experiences persistent diarrhea or diarrhea with bloody stool, vomiting, dehydration requiring treatment, or fever.

Fat-Soluble Vitamin (FSV) Deficiency: Patients can have FSV deficiency (vitamins A, D, E, and K) at baseline, and LIVMARLI may adversely affect absorption of FSVs. Treatment-emergent bone fracture events have been observed more frequently with patients treated with LIVMARLI compared with patients treated with placebo. If bone fractures or bleeding occur, consider interrupting LIVMARLI and supplement with FSVs. LIVMARLI can be restarted once FSV deficiency is corrected and maintained at corrected levels.

Risk of Propylene Glycol Toxicity (Pediatric Patients Less Than 5 Years of Age): Total daily intake of propylene glycol should be considered for managing the risk of propylene glycol toxicity. Monitor patients for signs of propylene glycol toxicity. Discontinue LIVMARLI if toxicity is suspected.

ADVERSE REACTIONS

The most common adverse reactions are diarrhea, FSV deficiency, abdominal pain, liver test abnormalities, hematochezia, and bone fractures.

DRUG INTERACTIONS

Administer bile acid binding resins at least 4 hours before or 4 hours after administration of LIVMARLI.
A decrease in the absorption of OATP2B1 substrates (eg, statins) due to OATP2B1 inhibition by LIVMARLI in the GI tract cannot be ruled out. Consider monitoring the drug effects of OATP2B1 substrates as needed.

DOSING INFORMATION

LIVMARLI should be taken twice daily 30 minutes before a meal. The provided oral dosing dispenser must be used to accurately measure the dose. Any remaining LIVMARLI should be discarded 100 days after first opening the bottle.

Collapse icon

References: 1. LIVMARLI® (maralixibat) oral solution. Prescribing Information. Mirum Pharmaceuticals, Inc. 2. Miethke AG, Moukarzel A, Porta G, et al. Maralixibat in progressive familial intrahepatic cholestasis (MARCH-PFIC): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024;9(7):620-631. doi:10.1016/s2468-1253(24)00080-3 3. Miethke A, Moukarzel A, Porta G, et al. Long-term maintenance of response and improved liver health with maralixibat in patients with progressive familial intrahepatic cholestasis (PFIC): 2-year data from the MARCH-ON study. Presented at: American Association for the Study of Liver Diseases (AASLD) The Liver Meeting: November 10-14, 2023; Boston, MA.

INDICATION

LIVMARLI is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC).

Limitations of Use: LIVMARLI is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump (BSEP) protein.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

LIVMARLI is contraindicated in patients with prior or active hepatic decompensation events (eg, variceal hemorrhage, ascites, or hepatic encephalopathy).

WARNINGS AND PRECAUTIONS

Hepatotoxicity: LIVMARLI treatment is associated with a potential for drug-induced liver injury (DILI).

In the PFIC trial, treatment-emergent hepatic decompensation events and elevations of liver tests or worsening of liver tests occurred. Two patients experienced DILI attributable to LIVMARLI. Two additional patients experienced DILI in the open-label extension portion of the trial. Of these 4 patients, 1 patient required liver transplant and another patient died.

Obtain baseline liver tests and monitor during treatment. Liver-related adverse reactions and physical signs of hepatic decompensation should also be monitored. Dose reduction or treatment interruption may be considered if abnormalities occur in the absence of other causes. Permanently discontinue LIVMARLI if a patient experiences the following: persistent or recurrent liver test abnormalities, clinical hepatitis upon rechallenge, or a hepatic decompensation event.

Gastrointestinal (GI) Adverse Reactions: Diarrhea and abdominal pain were reported as the most common adverse reactions. Monitor for dehydration and treat promptly. Consider reducing the dosage or interrupting LIVMARLI dosing if a patient experiences persistent diarrhea or diarrhea with bloody stool, vomiting, dehydration requiring treatment, or fever.

Fat-Soluble Vitamin (FSV) Deficiency: Patients can have FSV deficiency (vitamins A, D, E, and K) at baseline, and LIVMARLI may adversely affect absorption of FSVs. Treatment-emergent bone fracture events have been observed more frequently with patients treated with LIVMARLI compared with patients treated with placebo. If bone fractures or bleeding occur, consider interrupting LIVMARLI and supplement with FSVs. LIVMARLI can be restarted once FSV deficiency is corrected and maintained at corrected levels.

Risk of Propylene Glycol Toxicity (Pediatric Patients Less Than 5 Years of Age): Total daily intake of propylene glycol should be considered for managing the risk of propylene glycol toxicity. Monitor patients for signs of propylene glycol toxicity. Discontinue LIVMARLI if toxicity is suspected.

ADVERSE REACTIONS

The most common adverse reactions are diarrhea, FSV deficiency, abdominal pain, liver test abnormalities, hematochezia, and bone fractures.

DRUG INTERACTIONS

Administer bile acid binding resins at least 4 hours before or 4 hours after administration of LIVMARLI.
A decrease in the absorption of OATP2B1 substrates (eg, statins) due to OATP2B1 inhibition by LIVMARLI in the GI tract cannot be ruled out. Consider monitoring the drug effects of OATP2B1 substrates as needed.

DOSING INFORMATION

LIVMARLI should be taken twice daily 30 minutes before a meal. The provided oral dosing dispenser must be used to accurately measure the dose. Any remaining LIVMARLI should be discarded 100 days after first opening the bottle.