Last Updated : January 10, 2025
Details
FilesGeneric Name:
iptacopan
Project Status:
Active
Therapeutic Area:
paroxysmal nocturnal hemoglobinuria (PNH)
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Fabhalta
Project Line:
Reimbursement Review
Project Number:
SR0851-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The treatment of adult patients with PNH who have an inadequate response to, or are intolerant of, a C5 inhibitor.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Monotherapy in the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have hemolytic anemia.
- 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 | 04-Jul-24 |
|---|---|
| Call for patient/clinician input closed | 23-Aug-24 |
| Submission received | 15-Aug-24 |
| Submission accepted | 29-Aug-24 |
| Review initiated | 30-Aug-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 28-Nov-24 |
| Deadline for sponsors comments | 09-Dec-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 10-Jan-25 |
| Expert committee meeting (initial) | 22-Jan-25 |
| Draft recommendation issued to sponsor | February 04, 2025 To February 06, 2025 |
| Draft recommendation posted for stakeholder feedback | 13-Feb-25 |
| End of feedback period | 28-Feb-25 |
Files
Last Updated : January 10, 2025