CDA | Evidence Driven
CDA | Evidence Driven

etranacogene dezaparvovec

Details

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Generic Name:
etranacogene dezaparvovec
Project Status:
Complete
Therapeutic Area:
Hemophilia B
Manufacturer:
CSL Behring Canada Inc.
Call for patient/clinician input open:
Brand Name:
Hemgenix
Project Line:
Reimbursement Review
Project Number:
SG0805-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
HEMGENIX (etranacogene dezaparvovec) is indicated for treatment of adults (aged 18 years of age or older) with Hemophilia B (congenital Factor IX deficiency) who require routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
HEMGENIX (etranacogene dezaparvovec) is indicated for treatment of adults (aged 18 years of age or older) with Hemophilia B (congenital Factor IX deficiency) who require routine prophylaxis to prevent or reduce the frequency of bleeding episodes. There is no clinical experience of HEMGENIX use in patientswith mild or moderate Hemophilia B (FIX activity 2%).
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-Aug-23
Call for patient/clinician input closed17-Oct-23
Clarification:

- Patient input submission received from the Canadian Hemophilia Society

Submission received04-Oct-23
Submission accepted19-Oct-23
Review initiated20-Oct-23
Draft CADTH review report(s) provided to sponsor for comment11-Jan-24
Deadline for sponsors comments22-Jan-24
CADTH review report(s) and responses to comments provided to sponsor15-Feb-24
Expert committee meeting (initial)28-Feb-24
Draft recommendation issued to sponsor11-Mar-24
Draft recommendation posted for stakeholder feedback21-Mar-24
End of feedback period08-Apr-24
Final recommendation issued to sponsor and drug plans19-Apr-24
Final recommendation posted08-May-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)06-May-24
CADTH review report(s) posted26-Sep-24

Files

Recommendation and Reason View PDF
Clinical and Pharmacoeconomic Combined Report View PDF
Feedback on Draft Recommendation View PDF
Patient and Clinician Group Input View PDF
Last Updated : September 26, 2024