brexucabtagene autoleucel


( Last Updated : October 3, 2022)
Generic Name:
brexucabtagene autoleucel
Project Status:
Active
Therapeutic Area:
Acute lymphoblastic leukemia
Manufacturer:
Gilead Sciences Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Tecartus
Project Line:
Reimbursement Review
Project Number:
PG0304-000
Call for patient/clinician input closed:
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
The indication filed for review with Health Canada is: -for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
The indication filed for review with Health Canada is: -for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
  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 open10-Aug-22
Call for patient/clinician input closed30-Sep-22
Clarification:

- Patient input submission received from The Leukemia & Lymphoma Society of Canada.

Submission received15-Sep-22
Submission accepted29-Sep-22
Review initiated03-Oct-22
Draft CADTH review report(s) provided to sponsor for comment15-Dec-22
Deadline for sponsors comments03-Jan-23
CADTH review report(s) and responses to comments provided to sponsor27-Jan-23
Expert committee meeting (initial)08-Feb-23
Draft recommendation issued to sponsorFebruary 21, 2023
To
February 23, 2023
Draft recommendation posted for stakeholder feedback02-Mar-23
End of feedback period16-Mar-23