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Vyvgart hytrulo — Blue Cross Blue Shield of Alabama

generalized myasthenia gravis (gMG)

Initial criteria

  • Diagnosis of generalized Myasthenia Gravis (gMG) AND ALL of the following:
  • - Positive serological test for anti-AChR antibodies (medical records required)
  • - MGFA clinical classification class of II-IVb
  • - MG-Activities of Daily Living total score ≥ 5
  • AND ONE of the following:
  • - Current medications known to exacerbate myasthenia gravis (e.g., beta blockers, procainamide, quinidine, magnesium, anti-programmed death receptor-1 monoclonal antibodies, hydroxychloroquine, aminoglycosides) have been discontinued
  • OR
  • - Discontinuation of the offending agent is NOT clinically appropriate
  • AND ONE of the following:
  • - Tried and had inadequate response to ≥ 1 conventional agent (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide)
  • OR
  • - Intolerance or hypersensitivity to ≥ 1 conventional agent (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide)
  • OR
  • - FDA labeled contraindication to ALL conventional agents (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide)
  • OR
  • - Required chronic intravenous immunoglobulin (IVIG)
  • OR
  • - Required chronic plasmapheresis/plasma exchange
  • AND patient will NOT use with Rystiggo (rozanolixizumab-noli), Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Ultomiris (ravulizumab-cwvz), or Zilbrysq (zilucoplan) for the requested indication
  • OR Diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) AND ALL of the following:
  • - Disease course is progressive or relapsing and remitting for at least 2 months
  • - Progressive or relapsing motor sensory impairment of more than one limb
  • - Electrodiagnostic findings indicating demyelination with ≥ 1 of the following:
  • • Prolonged distal motor latency in ≥ 2 motor nerves
  • • Reduced motor conduction velocity in ≥ 2 motor nerves
  • • Prolonged F-wave latency in ≥ 2 motor nerves
  • • Absent F-wave in ≥ 2 motor nerves plus one other demyelination criterion in ≥ 1 other nerve
  • • Partial motor conduction block in ≥ 2 motor nerves or in 1 nerve plus one other demyelination criterion
  • • Abnormal temporal dispersion conduction in ≥ 2 motor nerves
  • • Distal CMAP duration increase in ≥ 1 nerve plus one other demyelination criterion in ≥ 1 other nerve
  • AND ONE of the following:
  • - Tried and failed ≥ 3-month trial of ≥ 1 standard of care therapy (corticosteroids, immunoglobulins, plasma exchange)
  • OR
  • - Intolerance or hypersensitivity to ≥ 1 standard of care therapy (corticosteroids, immunoglobulins, plasma exchange)