OH Epic Formulary,

available via therapy plan, restricted to:

• Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive OR chronic inflammatory demyelinating polyneuropathy (CIDP) indication 
• Service Line: Neurology
• Formulary Location: Outpatient
• Service location: Outpatient Infusion, Home Infusion
• Patient Population: Adult
• Prior Authorization Required: Yes
• Restriction/Criteria of Use (all will apply, unless specified):
  • treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive OR chronic inflammatory demyelinating polyneuropathy (CIDP) indication 
    • Diagnosis of generalized MG with a positive serological test for anti-AChR antibodies
    • Patient has a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of class II, III, or IV disease at the start of therapy
    • Patient has Myasthenia Gravis-Activities of Daily Living (MG-ADL) score ≥ 5
    • Must not be used with other biologic therapies for myasthenia gravis or immunoglobulin therapy
    • Trial and failure, contraindications or intolerance to at least one (1) immunosuppressive therapy (e.g., corticosteroids, methotrexate, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, or tacrolimus) 
    • Six month trial and failure of eculizumab or ravulizumab
  • For chronic inflammatory demyelinating polyneuropathy (CIDP) indication:
    • Diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP)
    • CIDP Disease Activity Status (CDAS) score ≥2 at the start of therapy
    • Inflammatory Neuropathy Cause and Treatment (INCAT) score ≥2 at the start of therapy
    • Trial and failure, contraindications or intolerance to intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) 

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