Limited coverage criteria – tocilizumab for neuromyelitis optica spectrum disorder

 

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Biosimilar transition initiative

PharmaCare is changing coverage of tocilizumab for neuromyelitis optica spectrum disorder (NMOSD). To maintain PharmaCare coverage, patients currently covered for the originator tocilizumab biologic product, Actemra^®, must, in consultation with their prescriber, switch to the approved biosimilar product, Tyenne^®.

Prescribers can request a list of their patients who are receiving PharmaCare coverage for Actemra, so they can contact them to start the switch to Tyenne.

• HLTH 5839 – Tocilizumab patient list request (PDF, 968KB)

May 27, 2025

All new Special Authority (SA) requests, including renewals, for tocilizumab will only be approved for Tyenne.

May 27, 2025 to November 27, 2025

During the six-month transition period, patients with PharmaCare coverage for the originator tocilizumab (Actemra) who wish to maintain their coverage must transition to the biosimilar tocilizumab (Tyenne). A new SA request is not required until the next scheduled renewal date (if applicable). To maintain patients' coverage, prescribers must write a new prescription for their patients on Actemra, indicating the transition to Tyenne.

November 28, 2025

Actemra is no longer an eligible PharmaCare benefit and only Tyenne is authorized for continued coverage.

SA requests for patients who are unable to transition to Tyenne will be considered on an exceptional case-by-case basis.

Generic name	tocilizumab
Strength & form	80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL intravenous infusion vial 162 mg/0.9 mL pre-filled syringe, autoinjector pen

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	1 year
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	1 year

Practitioner exemptions

• None

Special notes

• ¹First line treatment for NMOSD may include azathioprine or rituximab
• Treatment with tocilizumab should be 8 mg/kg IV every 4 weeks (to a maximum dose of 800 mg) or 162 mg subcutaneously every 1 to 2 weeks
• PharmaCare covers a maximum of 28 days' supply per fill for the IV formulation, and up to 56 days' supply for the SC formulary when dosed at 14-day intervals. Coverage is limited to 800 mg every 4 weeks for the IV formulation or 162 mg once weekly for the SC formulation
• Tocilizumab should not be initiated during an 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)

• Log in to eForms
• HLTH 5851 – Rituximab / Tocilizumab for Neuromyelitis Optica Spectrum Disorder (PDF, 710KB)