OH Epic Formulary restricted to:

Indications

1. Treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH), restricted to Hematology Service Line
2. Treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS), restricted to Hematology Service Line
3. Treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive
4. Treatment of neuromyelitis optica spectrum disorder (NMOSD) seropositive for aquaporin-4 (AQP4) IgG antibodies

Additional restrictions for use in gMG:

• Service Line: Neurology
• Formulary Location: Outpatient
• Service location: Outpatient Infusion, Home Infusion
• Patient Population: Adult weighing at least 40 kg
• Prior Authorization Required: Yes
  • Used as switch therapy:
    • Patient is currently receiving treatment with Soliris and has shown a beneficial disease response and absence of unacceptable toxicity while on therapy
  • Used for complement inhibitor treatment-naïve patient (all will apply, unless specified):
    • • 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 ≥ 6
      • Prescriber is enrolled in Ultomiris REMS program
      • Patient is vaccinated against meningococcal infections at least 2 weeks prior to administering the first dose of Ultomiris, unless the risks of delaying therapy outweigh the risk of developing a meningococcal infection
      • Trial and failure, contraindications or intolerance to at least one (1) immunosuppressive therapy (e.g., corticosteroids, methotrexate, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, or tacrolimus)

Additional restrictions for use in NMOSD:

• Service Line: Neurology
• Formulary Location: Outpatient
• Service location: Outpatient Infusion, Home Infusion
• Patient Population: Adult weighing at least 40 kg
• Prior Authorization Required: Yes
• Restriction/Criteria of use:
  • Used for complement inhibitor treatment-naïve patient (all will apply, unless specified):
    • Diagnosis of NMOSD with a positive serological test for anti-aquaporin-4 (AQP4) antibodies
    • Prescriber is enrolled in Ultomiris REMS program
    • Patient is vaccinated against meningococcal infections at least 2 weeks prior to administering the first dose of Ultomiris, unless the risks of delaying therapy outweigh the risk of developing a meningococcal infection
    • Trial and failure, contraindications or intolerance to at least one (1) immunosuppressive therapy (e.g., corticosteroids, methotrexate, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, or tacrolimus)

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