Last Updated : April 19, 2024
Details
FilesGeneric 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%).
- 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.
| Call for patient/clinician input open | August 22, 2023 |
|---|---|
| Call for patient/clinician input closed | October 17, 2023 |
| Clarification: - Patient input submission received from the Canadian Hemophilia Society | |
| Submission received | October 04, 2023 |
| Submission accepted | October 19, 2023 |
| Review initiated | October 20, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | January 11, 2024 |
| Deadline for sponsors comments | January 22, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | February 15, 2024 |
| Expert committee meeting (initial) | February 28, 2024 |
| Draft recommendation issued to sponsor | March 11, 2024 |
| Draft recommendation posted for stakeholder feedback | March 21, 2024 |
| End of feedback period | April 08, 2024 |
| Final recommendation issued to sponsor and drug plans | April 19, 2024 |
| Final recommendation posted | - |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 06, 2024 |
| CADTH review report(s) posted | - |
Files
Last Updated : April 19, 2024