From Prescription to
Refill, Access
Support Is Available
for Every Step of
CHOLBAM® (cholic
acid) Treatment
Getting Patients Started
Mirum Access Plus Support Program
If you’d like to prescribe CHOLBAM for your patient, download the Patient Enrollment Form and Patient Authorization Form. Once you have filled out the forms fax them to Mirum Access Plus at 1-855-282-4884.
Mirum Access Plus is available to help you, your office, and your patient not only get started with CHOLBAM after you’ve prescribed it, but also to provide support throughout treatment.
Read on to learn about the details of Mirum Access Plus support available to you and your patients.
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.
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.
Insurance Coverage and Access Support
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.
Financial Support for Patients
Mirum Access Plus Savings Program: Eligible patients with commercial or private insurance may pay as little as $0 out of pocket per fill for CHOLBAM.*
Mirum Patient Assistance Program (PAP): Provides CHOLBAM at no cost for up to 1 calendar year for patients without insurance coverage, with eligibility reviewed each year.†
as little as $0 out of
pocket per fill for CHOLBAM*
Single-Source Specialty Pharmacy
Mirum Access Plus is a single-source specialty pharmacy that will ship CHOLBAM directly to patients, provide 24/7 access to pharmacists, and proactively manage refills.
* 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 Your Patient’s Treatment Journey
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 their medical condition.
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).
If your patients choose to enroll, 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 CHOLBAM, 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. They will also encourage communication between patients and their physicians.
Mirum Is Your Partner in Patient-Centric Care
Mirum has a driven and focused team whose mission is to create transformative, life-changing medicine for patients with rare diseases. We have a strong understanding of the significant impact rare diseases have on quality of life for patients and caregivers. With 140+ industry veterans, scientists, and thought-leaders, Mirum is backed by significant expertise in rare diseases and pharmaceutical development. We aim to always provide dedicated leadership and safe, effective treatments that you, your patients, and their caregivers can rely on.
Discover MirumINDICATION
CHOLBAM® (cholic acid) is a bile acid indicated for- Treatment of bile acid synthesis disorders due to single enzyme defects.
- Adjunctive treatment of peroxisomal disorders, including Zellweger spectrum disorders, in patients who exhibit manifestations of liver disease, steatorrhea, or complications from decreased fat-soluble vitamin absorption.
LIMITATIONS OF USE
The safety and effectiveness of CHOLBAM on extrahepatic manifestations of bile acid synthesis disorders due to single enzyme defects or peroxisomal disorders, including Zellweger spectrum disorders, have not been established.IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS – Exacerbation of liver impairment
- Monitor liver function and discontinue CHOLBAM in patients who develop worsening of liver function while on treatment.
- Concurrent elevations of serum gamma glutamyltransferase (GGT) and alanine aminotransferase (ALT) may indicate CHOLBAM overdose.
- Discontinue treatment with CHOLBAM at any time if there are clinical or laboratory indicators of worsening liver function or cholestasis.
ADVERSE REACTIONS
- The most common adverse reactions (≥1%) are diarrhea, reflux esophagitis, malaise, jaundice, skin lesion, nausea, abdominal pain, intestinal polyp, urinary tract infection, and peripheral neuropathy.
DRUG INTERACTIONS
- Inhibitors of Bile Acid Transporters: Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. Concomitant medications that inhibit canalicular membrane bile acid transporters such as the BSEP may exacerbate accumulation of conjugated bile salts in the liver and result in clinical symptoms. If concomitant use is deemed necessary, monitoring of serum transaminases and bilirubin is recommended.
- Bile Acid Binding Resins: Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the efficacy of CHOLBAM. Take CHOLBAM at least 1 hour before or 4 to 6 hours (or at as great an interval as possible) after a bile acid binding resin.
- Aluminum-Based Antacids: Aluminum-based antacids have been shown to adsorb bile acids in vitro and can reduce the bioavailability of CHOLBAM. Take CHOLBAM at least 1 hour before or 4 to 6 hours (or at as great an interval as possible) after an aluminum-based antacid.
PREGNANCY
No studies in pregnant women or animal reproduction studies have been conducted with CHOLBAM.LACTATION
Endogenous cholic acid is present in human milk. Clinical lactation studies have not been conducted to assess the presence of CHOLBAM in human milk, the effects of CHOLBAM on the breastfed infant, or the effects of CHOLBAM on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CHOLBAM and any potential adverse effects on the breastfed infant from CHOLBAM or from the underlying maternal condition.GERIATRIC USE
It is not known if elderly patients respond differently from younger patients.HEPATIC IMPAIRMENT
- Discontinue treatment with CHOLBAM if liver function does not improve within 3 months of the start of treatment.
- Discontinue treatment with CHOLBAM at any time if there are clinical or laboratory indicators of worsening liver function or cholestasis. Continue to monitor laboratory parameters of liver function and consider restarting at a lower dose when the parameters return to baseline.