Elafibranor (Iqirvo)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Iqirvo be reimbursed by public drug plans for the treatment of primary biliary cholangitis (PBC) in adults with an inadequate response to ursodeoxycholic acid (UDCA), or as monotherapy in adults who are unable to tolerate UDCA, if certain conditions are met.
• Iqirvo should only be covered to treat adult patients who have a diagnosis of PBC; who have either not responded adequately to UDCA treatment after taking it for at least a year, with a stable dose maintained for a minimum of 3 months, or who are unable to tolerate UDCA treatment; and who have a total bilirubin level of no higher than 2 times the upper limit of normal (ULN) as well. In addition, patients should have no history or current evidence of other liver diseases. Initial coverage for Iqirvo should not exceed 12 months.
• Iqirvo should only be reimbursed if prescribed by or in consultation with a specialist, such as a gastroenterologist, a hepatologist, or other physicians with expertise in managing PBC, and if the cost of Iqirvo is reduced. For renewal after the initial authorization, Iqirvo should follow the same renewal criteria as obeticholic acid, in accordance with the reimbursement criteria of each public drug plan for treating PBC. For ongoing renewals, physicians must confirm that the patient’s initial response to Iqirvo achieved during the first 12 months has been maintained. Renewal of coverage should be assessed on an annual basis.