Vol. 5 No. 3 (2025)
Reimbursement Recommendations

Iptacopan (Fabhalta)

decorative image of the issue cover

Published March 31, 2025

Key Messages

  • Canada’s Drug Agency (CDA-AMC) recommends that Fabhalta be reimbursed by public drug plans for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have hemolytic anemia, if certain conditions are met.
  • Fabhalta should only be covered to treat adult patients with a diagnosis of PNH who have persistent anemia (lack of red blood cells [RBCs] to carry oxygen), defined as hemoglobin levels less than 10 g/dL (a measure of how much protein is in RBCs that carry oxygen) despite an adequate trial of C5 inhibitor treatment, or who have intolerable adverse events (AEs) from C5 inhibitor treatment.
  • Fabhalta should only be reimbursed if prescribed by or in consultation with a hematologist with experience managing PNH, and should not be used in combination with other complement inhibitors. The cost of Fabhalta should be negotiated so that Fabhalta does not exceed the drug program cost of treatment with pegcetacoplan for the treatment of adult patients with PNH.