satralizumab


( Last Updated : June 15, 2021)
Generic Name:
satralizumab
Project Status:
Complete
Therapeutic Area:
Neuromyelitis optica spectrum disorder
Manufacturer:
Hoffmann-La Roche Limited
Call for patient/clinician input open:
Brand Name:
Enspryng
Project Line:
Reimbursement Review
Project Number:
SR0663-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC

Details


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
Fee Schedule:
Schedule A
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.
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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
CADTH review report(s) and responses to comments 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 postedApril 23, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)May 05, 2021
CADTH review report(s) postedJune 15, 2021