Patients & Families

Access to BylvayTM (odevixibat)

Patient Access Philosophy

Our mission is to provide hope for families by delivering innovative and accessible solutions to transform the lives of patients and their families living with rare cholestatic liver diseases. We succeed in our mission only if our products reach the patients who will benefit from them, so we prioritize patient access in everything we do.

Access to Bylvay for PFIC

In our commitment to ensuring that eligible patients can access BylvayTM (odevixibat) in a fully compliant manner, we will work within the relevant regulatory processes for each country to meet our ongoing commitment to patients and to support the PFIC community.

For PFIC patients in the U.S., Bylvay was approved in the U.S. in 2021 and is now available to patients. Albireo has built a customized and company-run patient services program called AlbireoAssist™. To learn more about the program, visit AlbireoAssist.com. If you prefer to send a prescription directly to a specialty pharmacy, Albireo has a limited specialty pharmacy network to choose from:

Accredo, Optum Frontier Therapies and PANTHERx are trademarks of their respective owners.

For PFIC patients outside the U.S., access to Bylvay in certain countries is now available either through country availability or through our Managed Access Program. For patients in Germany, we also offer Albireo Assist Germany, a patient support program for patients and caregivers of children diagnosed with PFIC to accompany Bylvay and optimize outcomes.

As reimbursement is granted in countries outside the U.S., the intent is for patients with PFIC to access Bylvay through their healthcare providers (HCPs). However, country-level timings for reimbursement typically vary significantly depending on local processes so individual patient access to Bylvay in certain countries outside of the U.S. will now be available through our Managed Access Program.

Please see below for who to contact for information regarding individual access via our Managed Access Program or clinical trials.

Due to recent marketing authorization and commercial availability, our Expanded Access Program (EAP) is closed to new PFIC patient enrollments. Patients currently accessing Bylvay via the EAP, or clinical trial, will continue to receive treatment.

Expanded Access Program for Alagille Syndrome

Albireo is studying Bylvay for the treatment of Alagille syndrome (ALGS) in the global Phase 3 pivotal ASSERT study, which is now fully enrolled.

Aligned to the Company’s mission of providing hope for families, Albireo opened an Expanded Access Program (EAP) for patients with ALGS. The program is available in the U.S. and Europe and aims to provide access to Bylvay prior to the product’s planned approval and reimbursement. In the US, access to odevixibat for ALGS patients is on an individual patient basis via the FDA’s single patient IND (sIND) mechanism of expanded access. Timing of availability in Europe will vary due to country-specific regulations and stock availability. This program is available for patients with a clinical diagnosis of ALGS who have no other therapeutic options. For full eligibility criteria and additional information, please contact odevixibat@tannerpharma.com.

If you are a physician who would like to request access to Bylvay for your patient, please send your inquiry to odevixibat@tannerpharma.com.and you will receive a response within one working day with further information.

If you are someone with ALGS or the caregiver of someone with ALGS, and you would like to request EAP access, please share this contact information with your doctor. Your doctor will determine whether you are a good candidate for the program and if so, request access.

Charitable Access Program for Eligible Patients with PFIC & Alagille Syndrome

At Albireo, we offer a charitable access program (CAP) with the intent to provide access to Bylvay for a fixed number of financially needy PFIC patients in underserved countries. This program is available in countries where we are not able to provide Bylvay through clinical studies or commercial pathways. Patients may be eligible for the CAP if they have no ability to access Bylvay through any of our other programs. The availability of Bylvay through this program will vary due to country-specific regulations and stock availability. For more information on the program and country eligibility, please email odevixibat@tannerpharma.com