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Frequently Asked Questions
What is Albireo Assist?
Albireo Assist is a treatment support program that is designed to help patients taking Bylvay™ (odevixibat) and their families. Our dedicated Care Coordinators will be here for you as you start treatment, and all along the way. There is no cost to enroll in the program. To learn about all the services Albireo Assist can provide, visit the Support Services page.
How do I enroll in Albireo Assist?
To enroll in Albireo Assist, you must review and sign the Patient Consent Form. In addition, your doctor must complete the Albireo Assist Enrollment Form. Learn more about the process and access the form here.
What forms does my doctor need to fill out to enroll me?
Physicians should complete the 1-page Enrollment Form and then return it to Albireo Assist, along with supporting documentation described on the Enrollment Form, by fax to 866-853-0479. Physicians can get all the details here.
What is a Care Coordinator?
Albireo Assist Care Coordinators are experienced professionals who have training and experience with the healthcare system, with health insurance, and with rare diseases, so they understand the challenges you may be facing.
When you enroll in Albireo Assist, you will be assigned a dedicated Care Coordinator based on where you live, and this person will be your primary contact with the program. They will get to know you and your situation and are committed to helping make the entire treatment process smooth for you.
Who is my Care Coordinator?
That depends on which state you live in, since Care Coordinators are regionally based. After you enroll in Albireo Assist, your assigned Care Coordinator will reach out to you directly with their contact information. You can reach your Care Coordinator by calling their direct number or emailing them, or you can call 855-ALBIREO (855-252-4736), 8am-6pm ET.
Or use the purple Find Your Care Coordinator tool on this page. Just select scroll to select your state.
What if I cannot afford my medication?
Because paying for treatment can sometimes be a challenge, financial assistance programs may be available to you. Once you are enrolled in Albireo Assist, you will be automatically enrolled in the financial assistance programs for which you may be eligible. Your continued eligibility is subject to the satisfaction of the terms and conditions of the financial assistance programs. Your dedicated Care Coordinator can help you understand any programs you might be eligible for.
If I’m not sure my insurance will pay for my medication, can you help?
When you enroll in Albireo Assist, your Care Coordinator will evaluate your insurance benefits, deductibles, and copay or coinsurance, and can help with the paperwork used by insurance companies to determine whether they will cover the cost of a prescribed medicine (known as prior authorization), as well as helping with other insurance requirements. They will report back to you with what they’ve learned, and together you’ll discuss the options available to you.
I work and can’t be on hold with the insurance company all day, can you help?
When it comes to understanding health insurance and the healthcare system, your Care Coordinator is ready to help. They are committed to doing what it takes to understand your insurance coverage and will advocate tirelessly for you.
If I need to be able to explain PFIC to my child’s school nurse, can you help?
Absolutely. It can be difficult to explain a complex medical condition to people over and over again. That’s why we have created a page on this website that is dedicated to explaining PFIC. Visit the About PFIC page here.
When you enroll in Albireo Assist, you will receive wallet cards you can give out or show to someone. These cards have a special QR code that can be scanned with a smartphone to take the person straight to this informative page.
And of course, you can always ask your Care Coordinator to help with this. Call them at their direct number or at 855-ALBIREO (855-252-4736).
If we move to another state, can we get the prescription sent to our new address?
We understand that situations change and we’re here to help navigate those changes so that they don't have an impact on treatment. Moving to another state usually means changing doctors, too. We’re here to help make sure that these changes don’t affect getting the medication.
Your Care Coordinator is here to help with those kinds of logistics, including reaching out to the specialty pharmacy who sends the medication and providing them with your new address.
If you're moving, call 855-ALBIREO (855-252-4736) or contact your Care Coordinator at their direct number or email address.
Enter your state to find your dedicated Albireo Assist Care Coordinator.
- District Of Columbia
- New Hampshire
- New Jersey
- New Mexico
- New York
- North Carolina
- North Dakota
- Rhode Island
- South Carolina
- South Dakota
- West Virginia
Forms & Applications
Complete this Patient Consent Form to enroll in Albireo Assist. Your doctor will also need to complete an Enrollment Form and provide supporting materials for you to sign up.
Complete this Patient Assistance Program application if your Care Coordinator determines you are eligible for the program.
Download this brochure for patients and caregivers for information on Albireo Assist.
Indication and Important Safety Information
Indication and Usage
Bylvay is indicated for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).
Limitations of Use:
- Bylvay may not be effective in PFIC type 2 patients with ABCB11 variants resulting in non-functional or complete absence of bile salt export pump protein (BSEP-3).
Important Safety Information
- Speak with your healthcare provider if you experience: abdominal pain, vomiting, diarrhea, and dehydration as these have been reported with the use of Bylvay. Patients should contact their healthcare provider if they experience new onset or worsening of diarrhea.
- Elevations in liver tests (for example, AST, ALT, TB) have been observed with use of Bylvay. The patient’s health care provider will obtain liver tests before starting Bylvay and periodically during treatment with Bylvay. Patients should report to their healthcare provider any symptoms of liver problems (for example, nausea, vomiting, skin or the whites of eyes turn yellow, dark or brown urine, pain on the right side of the abdomen, loss of appetite).
- Bylvay may impair absorption of fat-soluble vitamins (FSV), which include vitamins A, D, E and K (vitamin K is assessed by measuring INR). The patient’s healthcare provider will obtain serum levels of vitamins A, D, E, and INR (for vitamin K) at baseline and periodically during treatment to assess for worsening of FSV deficiency.
- Do not mix Bylvay with liquids.
- Do not swallow the 200 mcg or 600 mcg capsule(s) containing Oral Pellets whole. These are intended to be opened and the contents mixed into soft food. Take Bylvay in the morning with a meal.
- For patients taking bile acid binding resins, take Bylvay at least 4 hours before or 4 hours after taking a bile acid binding resin.