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satralizumab

Last Updated: April 23, 2021
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

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

Date Recommendation Issued: April 21, 2021

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 February 02, 2021
Deadline for sponsors comments February 11, 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 30, 2021
End of embargo period April 14, 2021
Final recommendation issued to sponsor and drug plans April 21, 2021
Final recommendation posted April 23, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) May 05, 2021
CADTH review report(s) posted -