Last Updated : August 23, 2023
Details
Generic Name:
etranacogene dezaparvovec
Project Status:
Pending
Therapeutic Area:
Hemophilia B
Manufacturer:
CSL Behring Canada Inc.
Call for patient/clinician input open:
Brand Name:
Hemgenix
Project Line:
Reimbursement Review
Call for patient/clinician input closed:
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Hemgenix (etranacogene dezaparvovec) is an adeno-associated virus (AAV) vector-based gene therapy indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) and with a preexisting neutralizing AAV5 antibody titer below 1:900 to reduce the frequency of bleeding episodes and the need for Factor IX replacement therapy who: currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
Submission Type:
Initial
Fee Schedule:
Pending
Indications:
Hemgenix (etranacogene dezaparvovec) is an adeno-associated virus (AAV) vector-based gene therapy indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) and with a preexisting neutralizing AAV5 antibody titer below 1:900 to reduce the frequency of bleeding episodes and the need for Factor IX replacement therapy who: currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
Anticipated Date:
- 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.
Last Updated : August 23, 2023