etranacogene dezaparvovec

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Generic Name:
etranacogene dezaparvovec
Project Status:
Active
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
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%).
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH 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