Limited coverage drugs – satralizumab

Last updated on September 27, 2024
 

Generic name

satralizumab 

Strength/Form

Solution, in a single-use, pre-filled syringe of 120 mg/mL

 

Special Authority criteria

Approval period

Initial coverage:

For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in patients aged 12 years or older who are anti–aquaporin 4 (AQP4) seropositive, and when requested by a neurologist with expertise in the diagnosis and management of NMOSD, if the following conditions are met:

  1. Patients must have an Expanded Disability Status Scale (EDSS) score of 6.5 points or less taken within the 3-month period immediately preceding satralizumab initiation and one of the following:
    1. The patient must have had treatment failure resulting in at least one relapse of NMOSD within the previous 12 months despite a trial of optimally dosed rituximab OR tocilizumab
      OR
    2. The patient cannot tolerate or has contraindications to both rituximab AND tocilizumab, leading to discontinuation or inability to use rituximab and tocilizumab

12 months

Renewal coverage:

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

AND

When requested by a neurologist with expertise in the diagnosis and management of NMOSD.

12 months

Practitioner exemptions

  • None

Special notes

  • Satralizumab should not be initiated during a NMOSD relapse episode.
  • Satralizumab must not be used in combination with other anti-IL-6, B-cell depletion, or complement inhibitor therapies.

Special Authority requests