axicabtagene ciloleucel

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Generic 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:
  1. 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 Milestones2
Call for patient/clinician input openMay 11, 2022
Call for patient/clinician input closedJuly 04, 2022
Clarification:

- Patient input submission received from Lymphoma Canada

Submission receivedJune 09, 2022
Submission acceptedJune 23, 2022
Review initiatedJune 24, 2022
Draft CADTH review report(s) provided to sponsor for commentSeptember 16, 2022
Deadline for sponsors commentsSeptember 27, 2022
CADTH review report(s) and responses to comments provided to sponsorOctober 28, 2022
Expert committee meeting (initial)November 09, 2022
Draft recommendation issued to sponsorDecember 20, 2022
Draft recommendation posted for stakeholder feedbackJanuary 05, 2023
End of feedback periodJanuary 19, 2023
Final recommendation postedFebruary 22, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 17, 2023
CADTH review report(s) postedJune 09, 2023