Last Updated : June 5, 2024
Details
FilesGeneric Name:
fidanacogene elaparvovec
Project Status:
Complete
Therapeutic Area:
Hemophilia B
Manufacturer:
Pfizer Canada ULC
Call for patient/clinician input open:
Brand Name:
Beqvez
Project Line:
Reimbursement Review
Project Number:
SG0802-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adults (aged 18 years or older) with moderately severe to severe Hemophilia B (congenital Factor IX deficiency) who are negative for neutralizing antibodies to variant AAV serotype Rh74.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Beqvez (fidanacogene elaparvovec) is an adeno-associated viral (AAV) vector-based gene therapy indicated for the treatment of adults (aged 18 years or older) with moderately severe to severe Hemophilia B (congenital Factor IX deficiency) who are negative for neutralizing antibodies to variant AAV serotype Rh74
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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.
| Call for patient/clinician input open | June 20, 2023 |
|---|---|
| Call for patient/clinician input closed | August 14, 2023 |
| Clarification: - Patient input submission received from Canadian Hemophilia Society (CHS) | |
| Submission received | August 01, 2023 |
| Submission accepted | August 16, 2023 |
| Review initiated | August 17, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | November 02, 2023 |
| Deadline for sponsors comments | November 14, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | December 08, 2023 |
| Expert committee meeting (initial) | December 20, 2023 |
| Draft recommendation issued to sponsor | January 11, 2024 |
| Draft recommendation posted for stakeholder feedback | January 18, 2024 |
| End of feedback period | February 02, 2024 |
| Final recommendation posted | March 06, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 04, 2024 |
| CADTH review report(s) posted | June 05, 2024 |
Files
Last Updated : June 5, 2024