Abstract

 CADTH recommends that Empaveli should be reimbursed by public drug plans for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to, or are intolerant of, a C5 inhibitor if certain conditions are met.
 Empaveli should only be covered to treat patients with PNH who have met existing reimbursement criteria used by public drug plans for initiating C5 inhibitor treatment (e.g., eculizumab or ravulizumab). While receiving C5 inhibitor treatment, patients should have had persistently low hemoglobin levels, likely due to red blood cell (RBC) destruction occurring outside of blood vessels (known as extravascular hemolysis [EVH]), or intolerable side effects.
 Empaveli should only be reimbursed if prescribed by or in consultation with a hematologist with experience managing PNH. It should not be used with other C5 inhibitors beyond the first 4 weeks of treatment. Also, the cost of Empaveli should be reduced.
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