Last Updated : March 25, 2025
Details
FilesGeneric Name:
danicopan
Project Status:
Complete
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/Report:
- 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 | February 22, 2024 |
|---|---|
| Call for patient/clinician input closed | April 15, 2024 |
| Clarification: - Patient input submission received from The Canadian Association of PNH Patients & Aplastic Anemia | |
| Submission received | April 04, 2024 |
| Submission accepted | April 18, 2024 |
| Review initiated | April 19, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | July 11, 2024 |
| Deadline for sponsors comments | July 22, 2024 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | August 16, 2024 |
| Expert committee meeting (initial) | August 28, 2024 |
| Draft recommendation issued to sponsor | September 11, 2024 |
| Draft recommendation posted for stakeholder feedback | September 19, 2024 |
| End of feedback period | October 04, 2024 |
| Final recommendation issued to sponsor and drug plans | October 18, 2024 |
| Final recommendation posted | November 05, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 01, 2024 |
| CDA-AMC review report(s) posted | March 20, 2025 |
Files
Last Updated : March 25, 2025