Mirum Access Plus Support Program

Getting Patients Started

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
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.

Get Your Patients Started Today

Download the Patient Enrollment Form

Descargar la Versión en Español

Ready, Set, Go

Getting Your Patients the Treatment They Need

~94% of patients are approved by their insurance and 98% of patients pay $10 or less per fill.*^†

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.

Insurance Coverage and Access Support

LIVMARLI is covered by 100% of insurance plans as of 1/1/2023.^‡

Throughout the payer approval process, Mirum Access Plus works closely with you, your patients, and the insurance plan to help ensure patients get the treatment they need. Consider the following resources to help your patients access LIVMARLI:

Template Letter of Medical Necessity

How to Fill Out the 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): Provides LIVMARLI at no cost for up to 1 calendar year for patients without insurance coverage, with eligibility reviewed each year.^||

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.

Steps to Getting Medication

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

Download: English | Español

*Data from 1/1/2022 to 12/31/2023.

^†Patients enrolled in the Mirum Patient Assistance Program are included in those paying $10 or less per fill.

^‡Top 65 commercial and Medicaid plans.

^§Eligibility restrictions: This program is not available to individuals who use any state or federal government-funded healthcare 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 healthcare program.

^||Subject to program terms and conditions.

By Your Side at Every Turn

A Team Dedicated to Alagille Syndrome

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 Alagille syndrome.

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

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.

Early Improvements in Cholestatic Pruritus With Long-Term Impact

Significant improvements in cholestatic pruritus from baseline were seen at the very first assessment.¹ For those who were treated with LIVMARLI in 3 long-term clinical trials (N=76) as part of a post hoc analysis, 93% of patients remained transplant free 6 years after starting LIVMARLI.^2,3*

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

Always
Safety First!

LIVMARLI has a well-characterized safety and tolerability profile for cholestatic pruritus in patients with Alagille syndrome.^4,5

See the Safety Profile

*Transplant-free survival was defined as time to liver transplant or death.²

References: 1. Gonzales E, Hardikar W, Stormon M, et al. Efficacy and safety of maralixibat treatment in patients with Alagille syndrome and cholestatic pruritus (ICONIC): a randomised phase 2 study. Lancet. 2021;398(10311):1581-1592. doi:10.1016/S0140-6736(21)01256-3 2. Sokol RJ, Gonzales EM, Kamath BM, et al. Predictors of 6-year event-free survival in Alagille syndrome patients treated with maralixibat, an ileal bile acid transporter inhibitor. Hepatology. 2023;78(6):1698-1710. doi:10.1097/HEP.0000000000000502 3. Data on file. REF-00342. Mirum Pharmaceuticals, Inc. 4. Raman RK, Garner W, Vig P, Tucker E. An integrated analysis of long-term clinical safety in maralixibat-treated participants with Alagille syndrome. Poster presented at: European Association for the Study of the Liver (EASL): International Liver Congress; June 23-26, 2021. 5. LIVMARLI^® (maralixibat) oral solution. Prescribing Information. Mirum Pharmaceuticals, Inc.

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. In the Alagille syndrome trial, treatment-emergent elevations of liver tests or worsening of liver tests occurred.

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. For persistent or recurrent liver test abnormalities, consider treatment discontinuation. 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 treatment if a patient experiences persistent diarrhea or has 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 occurs, 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): LIVMARLI oral solution contains propylene glycol. 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, abdominal pain, vomiting, FSV deficiency, liver test abnormalities, and bone fractures.

DRUG INTERACTIONS

Administer LIVMARLI at least 4 hours before or 4 hours after administration of bile acid binding resins.

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 30 minutes before a meal. Refer to the dosing by weight guidelines in the full Prescribing Information for complete details on dosing for the oral solution and tablet formulations. The provided oral solution dosing dispenser must be used to accurately measure the dose. Any remaining LIVMARLI oral solution should be discarded 100 days after first opening the bottle. LIVMARLI tablets can be used in patients weighing ≥25 kg who can swallow tablets.

Please see full Prescribing Information for LIVMARLI.