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Vyvgart HytruloMedica

Generalized Myasthenia Gravis

Initial criteria

  • Patient is age ≥ 18 years
  • Patient has confirmed anti-acetylcholine receptor antibody-positive generalized myasthenia gravis
  • Myasthenia Gravis Foundation of America classification is II to IV
  • Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 5
  • Patient meets ONE of the following: (a) Patient received or is currently receiving pyridostigmine; OR (b) Patient 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, or functional disability such as double vision, talking, or impairment of mobility)
  • Treatment cycles are no more frequent than every 50 days from the start of the previous treatment cycle
  • Medication is being prescribed by or in consultation with a neurologist

Reauthorization criteria

  • Patient is age ≥ 18 years
  • According to the prescriber, patient is continuing to derive benefit from Vyvgart Hytrulo (or Vyvgart Intravenous), such as reductions in exacerbations of myasthenia gravis or improvements in speech, swallowing, mobility, and respiratory function
  • Treatment cycles are no more frequent than every 50 days from the start of the previous treatment cycle
  • Medication is being prescribed by or in consultation with a neurologist

Approval duration

initial: 6 months; reauthorization: 1 year