Ravulizumab (Ultomiris™)

OFFICE ADMINISTRATION

Indications for Prior Authorization:
  • Indicated in adults for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
The following criteria must be met for coverage:
  • Patient is of 18 years of age or older, AND
  • Patient has a diagnosis of PNH as confirmed by peripheral blood flow cytometry results showing the absence or deficiency of GPI-anchored proteins on at least 2 cell lineages, AND
  • Medication is prescribed by or in consultation with a hematologist, AND
  • Patient does not have unresolved Neisseria Meningitidis infection.
Dosing:
  • Loading dose and maintenance doses are all administrated by intravenous infusion
  • ≥ 40 kg to < 60 kg:
    • Loading Dose: 2,400 mg
    • Maintenance Dose: 3,000 mg once every 8 weeks (starting 2 weeks after loading dose)
  • ≥ 60 kg to < 100 kg :
    • Loading Dose: 2,700 mg
    • Maintenance Dose: 3,300 mg once every 8 weeks (starting 2 weeks after loading dose)
  • ≥ 100 kg:
    • Loading Dose: 3,000 mg
    • Maintenance Dose: 3,600 mg once every 8 weeks (starting 2 weeks after loading dose)
Approval:
  • Initial: 6 months
  • Renewal: 1 year if the patient continues to derive benefit as confirmed by chart note documentation.

Last review date: August 12, 2019