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 ultra-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.
In planning for our first potential commercial product approval, we worked to determine the price of our medicines for ultra-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 PFIC community.
Bylvay is approved by the FDA in the U.S. for the treatment of pruritus in patients with all forms of PFIC. Therefore, patients with PFIC in the U.S. may be able to access Bylvay through their healthcare providers (HCPs) as well as our ongoing PEDFIC2 clinical study.
To help patients with access to Bylvay, Albireo has built a customized and company-run U.S. patient services program called AlbireoAssist™. This program, developed with input from patient advocates, offers the highest level of support while ensuring clarity, transparency and ease of implementation. To learn more about the program, and how patients outside the U.S. can get information, visit albireoassist.com.
Bylvay received European Marketing authorization for the treatment of all subtypes of PFIC. Therefore, as reimbursement is granted in each EU country, patients with PFIC may be able to access Bylvay through their healthcare providers (HCPs). Country-level timings for reimbursement typically vary significantly depending on local processes.
Access to Bylvay in certain countries will now be available via a Managed Access Program outside of the U.S., as well as the ongoing PEDFIC2 clinical study.
Albireo’s Expanded Access Program (EAP) is closed to new patient enrollment. Patients currently accessing Bylvay via the EAP, or clinical trial, will continue to receive treatment.