Last Updated : June 9, 2023
Details
FilesGeneric Name:
axicabtagene ciloleucel
Project Status:
Complete
Therapeutic Area:
Diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL)
Manufacturer:
Gilead Sciences Canada Inc.
Call for patient/clinician input open:
Brand Name:
Yescarta
Project Line:
Reimbursement Review
Project Number:
PG0293-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Application held awaiting decision by Health Canada
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), who are candidates for autologous stem cell transplant (ASCT)
Submission Type:
Initial
Fee Schedule:
Schedule E
Tumour Type:
Lymphoma
Indications:
For the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
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 | May 11, 2022 |
|---|---|
| Call for patient/clinician input closed | July 04, 2022 |
| Clarification: - Patient input submission received from Lymphoma Canada | |
| Submission received | June 09, 2022 |
| Submission accepted | June 23, 2022 |
| Review initiated | June 24, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | September 16, 2022 |
| Deadline for sponsors comments | September 27, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | October 28, 2022 |
| Expert committee meeting (initial) | November 09, 2022 |
| Draft recommendation issued to sponsor | December 20, 2022 |
| Draft recommendation posted for stakeholder feedback | January 05, 2023 |
| End of feedback period | January 19, 2023 |
| Final recommendation posted | February 22, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 17, 2023 |
| CADTH review report(s) posted | June 09, 2023 |
Files
Last Updated : June 9, 2023