+
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.
For our first commercial product approval in 2021, we worked to determine the price of our medicines for rare diseases based on their value and impact on patients, families, caregivers, providers, payors and society. As such, we are guided by the following principles:
In our commitment to ensuring that eligible patients can access Bylvay® (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 Cholestatic Liver disease (CLD) community.
For PFIC patients in the U.S., Albireo has built a customized and company-run patient services program called AlbireoAssist®. To learn more about the program, visit AlbireoAssist.com.
For PFIC patients outside the U.S., access to Bylvay in certain countries is now available 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.
Albireo is studying Bylvay for the treatment of Alagille syndrome (ALGS) in the global open-extension study. The global Phase 3 pivotal ASSERT study is completed.
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., UK, Europe and certain other participating countries, and 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.
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