Odevixibat (Bylvay)

Canada’s Drug Agency (CDA-AMC) recommends that Bylvay be reimbursed by public drug plans for the treatment of cholestatic pruritus in patients aged 12 months and older with Alagille syndrome (ALGS), if certain conditions are met. Bylvay should only be covered to treat patients aged 12 months or older, with a diagnosis of ALGS, who experience significant itch symptoms and have elevated serum bile acid (sBA) levels. Patients must be currently taking or have already tried a systemic medication for itch. Bylvay should only be reimbursed if it is prescribed under the care of a specialist with experience in treating patients with ALGS. The price of Bylvay should be negotiated so that the total treatment cost of Bylvay plus standard of care (SOC) does not exceed the drug program cost of treatment with maralixibat plus SOC. Bylvay should be stopped if the patient receives a liver transplant or biliary diversion surgery.