Zilbrysq — Medical Mutual

Initial criteria

• Patient age ≥ 18 years
• Confirmed anti-acetylcholine receptor antibody-positive generalized myasthenia gravis
• Myasthenia Gravis Foundation of America classification II to IV
• Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6
• Patient received or is currently receiving pyridostigmine OR had inadequate efficacy, a contraindication, or significant intolerance to pyridostigmine
• Patient received or is currently receiving two different immunosuppressant therapies for ≥ 1 year OR had inadequate efficacy, a contraindication, or significant intolerance to two different immunosuppressant therapies (examples include azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus, cyclophosphamide)
• Patient has evidence of unresolved symptoms of generalized myasthenia gravis (e.g., difficulty swallowing, difficulty breathing, functional disability such as double vision, impaired speech, impaired mobility)
• Prescriber is enrolled in the Zilbrysq REMS program
• Patient has completed meningococcal vaccination (serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose
• Medication prescribed by or in consultation with a neurologist

Reauthorization criteria

• Patient age ≥ 18 years
• Patient is continuing to derive benefit from Zilbrysq according to the prescriber (e.g., reductions in exacerbations, improvements in speech, swallowing, mobility, respiratory function)
• Prescriber and patient have been adherent to the REMS program throughout therapy
• Medication prescribed by or in consultation with a neurologist

Approval duration

initial 6 months; reauth 1 year