Last Updated : April 2, 2024
Details
FilesGeneric Name:
ravulizumab
Project Status:
Active
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 | July 13, 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 29, 2023 |
| Submission accepted | September 13, 2023 |
| Review initiated | September 14, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | November 30, 2023 |
| Deadline for sponsors comments | December 11, 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 07, 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