Ravulizumab (Ultomiris)

Abstract

Canada’s Drug Agency (CDA-AMC) recommends that Ultomiris be reimbursed by public drug plans for the treatment of adults with generalized myasthenia gravis (gMG) if certain conditions are met. Ultomiris should only be covered to treat those who meet the Myasthenia Gravis Foundation of America (MGFA) classification (which categorizes clinical features by increasing severity) of II (i.e., mild weakness affecting body muscles and may also include weakness in the eye muscles) to IV (i.e., severe weakness affecting body muscles and may also include weakness in the eye muscles), test positive for anti–acetylcholine receptor (AChR) antibodies, and have a Myasthenia Gravis Activities of Daily Living (MG-ADL) score (which estimates patients’ ability to perform activities of daily living) of at least 6 (scores range from 0 to 24, with higher scores indicating more impairment). Ultomiris should only be covered to treat patients if their symptoms persist despite a stable dose of standard of care acetylcholinesterase inhibitors (AChEIs), corticosteroids (CSs), and/or nonsteroidal immunosuppressants (NSISTs). Ultomiris should only be covered to treat those who have received prior vaccination against meningococcal infections. Ultomiris should not be reimbursed when given during a gMG exacerbation (i.e., a moment when the patient experiences weakness in some or all muscles, without needing assistance to breath) or crisis (i.e., a moment when respiratory muscles are too weak, limiting air flow in and out of lungs, and as a result the patient is unable to breathe), or within 12 months of thymectomy (i.e., surgical removal of thymus gland). Ultomiris should only be reimbursed if prescribed by or in consultation with a neurologist with expertise in managing patients with gMG and the cost of Ultomiris is reduced. Ultomiris should not be used concomitantly with rituximab, efgartigimod alfa, or complement inhibitors, such as eculizumab.