CDA | Evidence Driven
CDA | Evidence Driven

danicopan

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Generic Name:
danicopan
Project Status:
Active
Therapeutic Area:
Paroxysmal nocturnal hemoglobinuria (PNH)
Manufacturer:
Alexion Pharma GmbH
Call for patient/clinician input open:
Brand Name:
Voydeya
Project Line:
Reimbursement Review
Project Number:
SR0815-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have residual hemolytic anemia due to extravascular hemolysis (EVH).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
As an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have residual hemolytic anemia due to extravascular hemolysis (EVH).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 open22-Feb-24
Call for patient/clinician input closed15-Apr-24
Clarification:

- Patient input submission received from The Canadian Association of PNH Patients & Aplastic Anemia

Submission received04-Apr-24
Submission accepted18-Apr-24
Review initiated19-Apr-24
Draft CADTH review report(s) provided to sponsor for comment11-Jul-24
Deadline for sponsors comments22-Jul-24
CADTH review report(s) and responses to comments provided to sponsor16-Aug-24
Expert committee meeting (initial)28-Aug-24
Draft recommendation issued to sponsor11-Sep-24
Draft recommendation posted for stakeholder feedback19-Sep-24
End of feedback period04-Oct-24
Final recommendation issued to sponsor and drug plans18-Oct-24
Final recommendation posted05-Nov-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)01-Nov-24
CADTH review report(s) posted-

Files

Recommendation and Reasons View PDF
Patient and Clinician Group Input View PDF
Last Updated : November 5, 2024