Last Updated : April 2, 2024
Details
FilesGeneric Name:
inebilizumab
Project Status:
Active
Therapeutic Area:
Neuromyelitis optica spectrum disorders (NMOSD)
Manufacturer:
Horizon Therapeutics Canada
Call for patient/clinician input open:
Brand Name:
Uplizna
Project Line:
Reimbursement Review
Project Number:
SR0793-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As per proposed indication; inebilizumab is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Inebilizumab is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.
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.
| Call for patient/clinician input open | July 07, 2023 |
|---|---|
| Call for patient/clinician input closed | September 01, 2023 |
| Clarification: - Patient input submission received from MS Canada and The Sumaira Foundation | |
| Submission received | August 18, 2023 |
| Submission accepted | September 01, 2023 |
| Review initiated | September 05, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | November 21, 2023 |
| Deadline for sponsors comments | November 30, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | January 12, 2024 |
| Expert committee meeting (initial) | January 24, 2024 |
| Draft recommendation issued to sponsor | February 06, 2024 |
| Draft recommendation posted for stakeholder feedback | February 15, 2024 |
| End of feedback period | March 01, 2024 |
| Final recommendation issued to sponsor and drug plans | March 13, 2024 |
| Final recommendation posted | April 02, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 28, 2024 |
| CADTH review report(s) posted | - |
Files
Last Updated : April 2, 2024