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Limited coverage criteria – tocilizumab (for NMOSD)

Last updated on March 24, 2025

 

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Generic name

tocilizumab

Strength & form

80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL, 162 mg/0.9 mL

intravenous infusion vial, pre-filled syringe, autoinjector

Special Authority criteria

Approval period

Initial

For the treatment of neuromyelitis optica spectrum disorder (NMOSD), when a Special Authority request is submitted by a neurologist with expertise in the diagnosis and management of NMOSD, in patients with:

Severe first attack (e.g., marked change in neurological functioning, requiring hospitalization or plasma exchange) or high disability with first attack (e.g., bilateral, or significant visual acuity loss worse than 6/60 or Expanded Disability Status Scale (EDSS) 5 at attack nadir)

OR

The patient must have had treatment failure resulting in at least one moderate to severe relapse of NMOSD within the previous 12 months despite a trial of optimally dosed first-line therapy1, or a documented intolerance or contraindication to a first-line therapy

12 months

Renewal

Patient has maintained an EDSS score of less than 8 points taken within the 3-month period immediately preceding the renewal request

AND

Special Authority request is submitted by a neurologist with expertise in the diagnosis and management of NMOSD

 12 months

Practitioner exemptions

  • None

Special notes

  • 1First line treatment for NMOSD may include azathioprine or rituximab
  • Initial treatment with tocilizumab should be 8 mg/kg every 4 weeks, to a maximum dose of 800 mg
  • Tocilizumab should not be initiated during a NMOSD relapse episode
  • Tocilizumab must not be used in combination with other anti-IL-6, B-cell depletion, or complement inhibitor therapies

Special Authority request form(s)