Last Updated : June 15, 2021
Details
FilesGeneric 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
Biosimilar:
No
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:
- 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 |
| CADTH review report(s) and responses to comments 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 | June 15, 2021 |
Files
Last Updated : June 15, 2021