Rystiggo (rozanolixizumab-noli) — Medica

Initial criteria

• age ≥ 18 years
• Patient has confirmed anti-acetylcholine receptor antibody-positive generalized myasthenia gravis OR confirmed anti-muscle-specific tyrosine kinase antibody-positive generalized myasthenia gravis
• Myasthenia Gravis Foundation of America class II to IV AND Myasthenia Gravis Activities of Daily Living (MG-ADL) total score ≥ 3 for non-ocular symptoms
• Patient received or is currently receiving pyridostigmine OR has had inadequate efficacy, a contraindication, or significant intolerance to pyridostigmine
• Patient has evidence of unresolved symptoms of generalized myasthenia gravis (e.g., difficulty swallowing, difficulty breathing, functional disability such as double vision, talking impairment, impairment of mobility)
• Treatment cycles are no more frequent than every 63 days from the start of the previous treatment cycle
• Medication is prescribed by or in consultation with a neurologist

Reauthorization criteria

• age ≥ 18 years
• According to the prescriber, patient is continuing to derive benefit from Rystiggo (e.g., reductions in exacerbations of myasthenia gravis, improvements in speech, swallowing, mobility, or respiratory function)
• Treatment cycles are no more frequent than every 63 days from the start of the previous treatment cycle
• Medication is prescribed by or in consultation with a neurologist

Approval duration

initial 6 months; reauthorization 1 year