CADTH | Evidence Driven
CADTH | Evidence Driven

fidanacogene elaparvovec

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Generic Name:
fidanacogene elaparvovec
Project Status:
Active
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
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:
  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 open20-Jun-23
Call for patient/clinician input closed14-Aug-23
Clarification:

- Patient input submission received from Canadian Hemophilia Society (CHS)

Submission received01-Aug-23
Submission accepted16-Aug-23
Review initiated17-Aug-23
Draft CADTH review report(s) provided to sponsor for comment02-Nov-23
Deadline for sponsors comments14-Nov-23
CADTH review report(s) and responses to comments provided to sponsor08-Dec-23
Expert committee meeting (initial)20-Dec-23
Draft recommendation issued to sponsor11-Jan-24
Draft recommendation posted for stakeholder feedback18-Jan-24
End of feedback period02-Feb-24
Final recommendation posted06-Mar-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)04-Mar-24
CADTH review report(s) posted-

Files

Recommendation and Reasons View PDF
Last Updated : March 6, 2024