Product Details

Enspryng

Satralizumab
120 mg/mL
Solution for Subcutaneous Injection
Single-Use 120-mg Pre-Filled Syringe (Preservative-Free)

DIN/PIN/NPN

02499681

Manufacturer

Hoffmann-La Roche Limited

Formulary Listing Date

2023-02-03  

Unit Price

9450.0000

Amount MOH Pays

9450.0000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AC19

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Ocular Treatments

Satralizumab

  • Brand(s): Enspryng
  • Dosage Form/Strength: 120 mg/mL Prefilled Syringe
  • Effective date: February 3, 2023

Initiation Criteria:

For the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in patients meeting the following criteria

  1. Patient is 12 years of age or older; AND 

  1. NMOSD diagnosis meets international diagnostic criteria; AND 

  1. Patient is seropositive for the aquaporin-4 (AQP-4) antibody; AND 

  1. The patient must have had at least ONE relapse of NMOSD in the previous 12 months despite an adequate trial of rituximab for NMOSD (Note that if the patient is not appropriate for rituximab, an adequate trial of another preventative treatment such as azathioprine or mycophenolate must have been used); AND 

  1. Patients must have an Expanded Disability Status Scale (EDSS) score of 6.5 points or less; AND 

  1. The prescriber is a neurologist with expertise in the diagnosis and treatment of NMOSD. 

Notes: 

  1. Satralizumab should not be initiated during a NMOSD relapse episode. 

  1. Patients should be evaluated every 6 months. 

  1. Satralizumab may be used alone or in combination with an immunosuppressant therapy. 

  1. Case-by-case consideration will be provided for patients with EDSS score higher than 6.5 and higher than 8.0 (i.e., per the discontinuation criteria).

Exclusion Criteria:

  • Satralizumab will not be funded in combination with other biologics for NMOSD. 

  • Satriluzumab will not be funded as acute treatment of an NMOSD relapse.

Renewal Criteria:

Renewal of satralizumab should be provided for those who continue to benefit from preventative treatment and who do not meet the discontinuation criteria.

At the time of renewal, the number of relapses in the prior 12 months on treatment and a recent EDSS score must be provided.

Discontinuation criteria:

Reimbursement should be discontinued for patients with an EDSS of 8 or higher.

Approved dose:

120 mg by subcutaneous injection at weeks 0, 2, and 4 for the first 3 administrations, followed by a maintenance dose of 120 mg every 4 weeks.

Approval duration: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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