Efgartigimod Alfa Injection (Vyvgart SC)

Canada’s Drug Agency (CDA-AMC) recommends that Vyvgart SC be reimbursed by public drug plans as monotherapy for adult patients with active chronic inflammatory demyelinating polyneuropathy (CIDP), if certain conditions are met. Vyvgart SC should only be covered for adults with CIDP confirmed by electrodiagnostic testing, or for adults with possible CIDP based on clinical features and at least 2 supportive criteria consistent with current guidelines. Supportive criteria may include objective response to treatment, imaging, cerebrospinal fluid analysis, or nerve biopsy. Vyvgart SC should not be covered for adults with a history of myelopathy, evidence of central demyelination, another disease that better explains symptoms, polyneuropathy of other causes, pure sensory CIDP as per clinician judgment, or anti-MAG peripheral neuropathy. Vyvgart SC should be prescribed by, or in consultation with, a neurologist or neuromuscular specialist. After the first 6 months of treatment, Vyvgart SC will only be covered if there is clinical stability in symptoms using at least 1 approved assessment tool and if the total cost of Vyvgart SC does not exceed the total cost of Ig treatment. Treatment can continue if the patient’s condition remains stable after those 6 months, and it should be reviewed every 12 months thereafter. Important budget impact considerations must be addressed for health systems to be able to adopt Vyvgart SC.