Last Updated : November 2, 2021
Details
FilesGeneric Name:
brexucabtagene autoleucel
Project Status:
Complete
Therapeutic Area:
Mantle cell lymphoma
Manufacturer:
Gilead Sciences Canada Inc.
Brand Name:
Tecartus
Project Line:
Reimbursement Review
Project Number:
PG0219-000
Tumour Type:
Lymphoma
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with relapsed or refractory (r/r) mantle cell lymphoma (MCL) who have
received treatment with a Bruton’s tyrosine kinase inhibitor (BTKi).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
For the treatment of adult patients with relapsed or refractory (r/r) mantle cell lymphoma (MCL) who have received treatment with a Bruton’s tyrosine kinase inhibitor (BTKi).
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.
Key Milestones |
|
|---|---|
| Call for patient/clinician input open | November 20, 2020 |
| Call for patient/clinician input closed | January 22, 2021 |
| Clarification:
- Patient input submission received from Lymphoma Canada |
|
| Submission received | December 18, 2020 |
| Submission accepted | January 11, 2021 |
| Review initiated | January 12, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | March 30, 2021 |
| Deadline for sponsors comments | April 09, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | May 03, 2021 |
| Expert committee meeting (initial) | May 14, 2021 |
| Draft recommendation issued to sponsor | June 24, 2021 |
| Clarification:
- pERC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements. |
|
| Draft recommendation posted for stakeholder feedback | July 08, 2021 |
| End of feedback period | July 22, 2021 |
| Final recommendation issued to sponsor and drug plans | August 06, 2021 |
| Final recommendation posted | August 24, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | August 20, 2021 |
| CADTH review report(s) posted | November 2, 2021 |
Files
Last Updated : November 2, 2021