CDA | Evidence Driven
CDA | Evidence Driven

inebilizumab

Details

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Generic Name:
inebilizumab
Project Status:
Complete
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
Performance Metric:
Achieved
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:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open07-Jul-23
Call for patient/clinician input closed01-Sep-23
Clarification:

- Patient input submission received from MS Canada and The Sumaira Foundation

Submission received18-Aug-23
Submission accepted01-Sep-23
Review initiated05-Sep-23
Draft CADTH review report(s) provided to sponsor for comment21-Nov-23
Deadline for sponsors comments30-Nov-23
CADTH review report(s) and responses to comments provided to sponsor12-Jan-24
Expert committee meeting (initial)24-Jan-24
Draft recommendation issued to sponsor06-Feb-24
Draft recommendation posted for stakeholder feedback15-Feb-24
End of feedback period01-Mar-24
Final recommendation issued to sponsor and drug plans13-Mar-24
Final recommendation posted02-Apr-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)28-Mar-24
CADTH review report(s) posted23-Jul-24

Files

Recommendation and Reasons View PDF
Patient and Clinician Group input View PDF
Clinical and Pharmacoeconomic Combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : July 23, 2024