Last Updated : February 27, 2025
Details
FilesGeneric Name:
crovalimab
Project Status:
Active
Therapeutic Area:
paroxysmal nocturnal hemoglobinuria (PNH)
Manufacturer:
Hoffmann-La Roche Limited
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0858-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Crovalimab is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Crovalimab is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).
- 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.
| Call for patient/clinician input open | August 19, 2024 |
|---|---|
| Call for patient/clinician input closed | October 15, 2024 |
| Submission received | October 01, 2024 |
| Submission accepted | October 16, 2024 |
| Review initiated | October 17, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | January 08, 2025 |
| Deadline for sponsors comments | January 17, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | February 13, 2025 |
| Expert committee meeting (initial) | February 26, 2025 |
| Draft recommendation issued to sponsor | - |
| Draft recommendation posted for stakeholder feedback | - |
| End of feedback period | - |
Files
Last Updated : February 27, 2025