CDA | Evidence Driven
CDA | Evidence Driven

pegcetacoplan

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Generic Name:
pegcetacoplan
Project Status:
Complete
Therapeutic Area:
Paroxysmal nocturnal hemoglobinuria
Manufacturer:
SOBI Canada Inc.
Call for patient/clinician input open:
Brand Name:
Empaveli
Project Line:
Reimbursement Review
Project Number:
SR0748-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
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:
​Indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to, or are intolerant of, a C5 inhibitor.
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 openJuly 28, 2022
Call for patient/clinician input closedSeptember 19, 2022
Clarification:

- Patient input submission received from the Canadian Association of PNH Patients & AAMAC

Submission receivedAugust 26, 2022
Submission acceptedSeptember 12, 2022
Review initiatedSeptember 13, 2022
Draft CADTH review report(s) provided to sponsor for commentNovember 29, 2022
Deadline for sponsors commentsDecember 08, 2022
CADTH review report(s) and responses to comments provided to sponsorJanuary 13, 2023
Expert committee meeting (initial)January 25, 2023
Draft recommendation issued to sponsorFebruary 09, 2023
Draft recommendation posted for stakeholder feedbackFebruary 16, 2023
End of feedback periodMarch 03, 2023
Final recommendation issued to sponsor and drug plansMarch 20, 2023
Final recommendation postedApril 05, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)April 03, 2023
CADTH review report(s) postedMay 18, 2023

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : May 18, 2023