Rozanolixizumab (Rystiggo)

Key Messages

• Canada's Drug Agency (CDA-AMC) recommends that public drug plans reimburse Rystiggo as an add-on therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive and for whom symptoms persist despite conventional therapy with acetylcholinesterase inhibitors (AChEIs), corticosteroids, and/or nonsteroidal immunosuppressive therapies (NSISTs) if certain conditions are met.
• Rystiggo should only be covered to treat patients who have a diagnosis of class II to IV gMG based on the Myasthenia Gravis Foundation of America (MGFA) system, have tested positive for AChR or MuSK antibodies, and have a Myasthenia Gravis Activities of Daily Living (MG-ADL) scale score of at least 3 with at least 3 points for symptoms not related to their eyes. Rystiggo should only be covered to treat patients if their symptoms persist despite a stable dose of conventional therapy with AChEIs, corticosteroids, and/or NSISTs.
• Rystiggo 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 the lungs and, as a result, the patient is unable to breathe), or within 6 months of thymectomy (i.e., surgical removal of the thymus gland). Rystiggo should only be reimbursed if prescribed by or in consultation with a neurologist with expertise in managing patients with gMG, and the total cost of Rystiggo should not exceed the total drug cost with the least costly advanced treatments for gMG. Rystiggo should not be used concomitantly with rituximab, efgartigimod alfa, and/or complement inhibitors such as eculizumab.