CDA | Evidence Driven
CDA | Evidence Driven

iptacopan

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Generic Name:
iptacopan
Project Status:
Active
Therapeutic Area:
paroxysmal nocturnal hemoglobinuria (PNH)
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBD
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 paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to, or are intolerant of, a C5 inhibitor
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
The treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)
  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 open04-Jul-24
Call for patient/clinician input closed23-Aug-24
Submission received15-Aug-24
Submission accepted29-Aug-24
Review initiated30-Aug-24
Draft CADTH review report(s) provided to sponsor for comment28-Nov-24
Deadline for sponsors comments09-Dec-24
CADTH review report(s) and responses to comments provided to sponsor10-Jan-25
Expert committee meeting (initial)22-Jan-25
Draft recommendation issued to sponsorFebruary 04, 2025
To
February 06, 2025
Draft recommendation posted for stakeholder feedback13-Feb-25
End of feedback period28-Feb-25

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Patient and Clinician Group input View PDF
Last Updated : October 21, 2024