Zilbrysq (zilucoplan subcutaneous injection – UCB) — Cigna

Initial criteria

• Patient age ≥ 18 years; AND
• Patient has confirmed anti-acetylcholine receptor antibody-positive generalized myasthenia gravis; AND
• Patient meets BOTH of the following: (a) Myasthenia Gravis Foundation of America classification II to IV; AND (b) Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6; AND
• Patient meets ONE of the following: (a) Patient received or is currently receiving pyridostigmine; OR (b) Patient had inadequate efficacy, a contraindication, or significant intolerance to pyridostigmine; AND
• Patient meets ONE of the following: (a) Patient received or is currently receiving two different immunosuppressant therapies for ≥ 1 year; OR (b) Patient had inadequate efficacy, a contraindication, or significant intolerance to two different immunosuppressant therapies; AND
• Patient has evidence of unresolved symptoms of generalized myasthenia gravis (e.g., difficulty swallowing, difficulty breathing, or functional disability such as double vision, talking, impairment of mobility); AND
• Medication is prescribed by or in consultation with a neurologist.

Reauthorization criteria

• Patient age ≥ 18 years; AND
• According to the prescriber, patient is continuing to derive benefit from Zilbrysq (e.g., reductions in exacerbations of myasthenia gravis; improvements in speech, swallowing, mobility, and respiratory function); AND
• Medication is prescribed by or in consultation with a neurologist.

Approval duration

Initial: 6 months; Reauthorization: 1 year