Last Updated : July 11, 2023
Details
FilesGeneric Name:
brexucabtagene autoleucel
Project Status:
Complete
Therapeutic Area:
Acute lymphoblastic leukemia
Manufacturer:
Gilead Sciences Canada, Inc.
Brand Name:
Tecartus
Project Line:
Reimbursement Review
Project Number:
PG0304-000
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
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 treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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 | August 10, 2022 |
|---|---|
| Call for patient/clinician input closed | September 30, 2022 |
| Clarification: - Patient input submission received from The Leukemia & Lymphoma Society of Canada. | |
| Submission received | September 15, 2022 |
| Submission accepted | September 29, 2022 |
| Review initiated | October 03, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | December 19, 2022 |
| Deadline for sponsors comments | January 05, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | January 26, 2023 |
| Expert committee meeting (initial) | February 08, 2023 |
| Draft recommendation issued to sponsor | February 22, 2023 |
| Draft recommendation posted for stakeholder feedback | March 02, 2023 |
| End of feedback period | March 16, 2023 |
| Final recommendation issued to sponsor and drug plans | March 29, 2023 |
| Final recommendation posted | April 17, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | April 13, 2023 |
| CADTH review report(s) posted | June 09, 2023 |
Files
Last Updated : July 11, 2023