CADTH is committed to supporting Canada’s health care decision-makers through this challenging and uncertain time.
For evidence, tools, and resources related to COVID-19, visit our COVID-19 Evidence Portal.

 

Begin main content

satralizumab

Last Updated: December 22, 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

NOC Status at Filing: Post NOC

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 openSeptember 23, 2020
Call for patient input closedNovember 12, 2020
Clarification:

- Patient input submission received from Multiple Sclerosis Society of Canada

Submission receivedOctober 22, 2020
Submission acceptedNovember 05, 2020
Review initiatedNovember 06, 2020
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for commentFebruary 02, 2021
Deadline for sponsors commentsFebruary 11, 2021
CADTH responses on draft review report(s) provided to sponsorMarch 05, 2021
Expert committee meeting (initial)March 17, 2021
Draft recommendation issued to sponsorMarch 30, 2021
End of embargo periodApril 14, 2021
Final recommendation issued to sponsor and drug plansApril 21, 2021
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)-
CADTH review report(s) posted-