Limited coverage criteria – satralizumab

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

Special Authority criteria

Approval period

Initial:

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:

• 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:

• 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

• 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:

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