Last Updated : June 14, 2024
Details
FilesGeneric 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
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:
- 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 | 13-Jul-23 |
|---|---|
| Call for patient/clinician input closed | 01-Sep-23 |
| Clarification: - Patient input submission received from MS Canada and The Sumaira Foundation | |
| Submission received | 29-Aug-23 |
| Submission accepted | 13-Sep-23 |
| Review initiated | 14-Sep-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 30-Nov-23 |
| Deadline for sponsors comments | 11-Dec-23 |
| CADTH review report(s) and responses to comments provided to sponsor | 12-Jan-24 |
| Expert committee meeting (initial) | 24-Jan-24 |
| Draft recommendation issued to sponsor | 07-Feb-24 |
| Draft recommendation posted for stakeholder feedback | 15-Feb-24 |
| End of feedback period | 01-Mar-24 |
| Final recommendation issued to sponsor and drug plans | 13-Mar-24 |
| Final recommendation posted | 02-Apr-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 28-Mar-24 |
| CADTH review report(s) posted | 14-Jun-24 |
Files
Last Updated : June 14, 2024