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satralizumab

Last Updated: November 13, 2020
Result type: Reports
Project Number: SR0663-000
Product Line: Reimbursement Review

Generic Name: satralizumab

Brand Name: Enspryng

Manufacturer: Hoffmann-La Roche Limited

Therapeutic Area: Neuromyelitis optica spectrum disorder

Indications: ENSPRYNG (satralizumab) is indicated as monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients who are anti-aquaporin 4 (AQP4) seropositive. ENSPRYNG is not intended for acute treatment of an NMOSD relapse.

Manufacturer Requested Reimbursement Criteria1: ENSPRYNG (satralizumab) is indicated as monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients who are anti-aquaporin 4 (AQP4) seropositive. ENSPRYNG is not intended for acute treatment of an NMOSD relapse.

Submission Type: Initial

Project Status: Active

Companion Diagnostics: No

Fee Schedule: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input open September 23, 2020
Call for patient input closed November 12, 2020
Clarification:

- Patient input submission received from Multiple Sclerosis Society of Canada

Submission received October 22, 2020
Submission accepted November 05, 2020
Review initiated November 06, 2020
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for comment January 27, 2021
Deadline for sponsors comments February 05, 2021
CADTH responses on draft review report(s) provided to sponsor March 05, 2021
Expert committee meeting (initial) March 17, 2021
Draft recommendation issued to sponsor March 29, 2021
To
March 31, 2021