ULTOMIRIS (ravulizumab)

ULTOMIRIS (ravulizumab)

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
• 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.