Limited coverage criteria – satralizumab

Generic name

satralizumab 

Strength & form

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