ravulizumab

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Generic Name:
ravulizumab
Project Status:
Complete
Therapeutic Area:
Neuromyelitis optica spectrum disorder (NMOSD)
Manufacturer:
Alexion Pharma GmbH
Brand Name:
Ultomiris
Project Line:
Reimbursement Review
Project Number:
SR0785-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with anti-aquaporin 4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with anti-aquaporin 4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).
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 open13-Jul-23
Call for patient/clinician input closed01-Sep-23
Clarification:

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

Submission received29-Aug-23
Submission accepted13-Sep-23
Review initiated14-Sep-23
Draft CADTH review report(s) provided to sponsor for comment30-Nov-23
Deadline for sponsors comments11-Dec-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 sponsor07-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) posted14-Jun-24