CDA | Evidence Driven
CDA | Evidence Driven

axicabtagene ciloleucel

Details

Files
Generic Name:
axicabtagene ciloleucel
Project Status:
Complete
Therapeutic Area:
Relapsed or refractory follicular lymphoma
Manufacturer:
Gilead Sciences Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Yescarta
Project Line:
Reimbursement Review
Project Number:
PG0314-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma (FL) after two or more lines of systemic therapy.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
The treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma (FL) after two or more lines of systemic therapy.
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 open14-Feb-23
Call for patient/clinician input closed11-Apr-23
Clarification:

- Patient input submission received from Lymphoma Canada

Submission received13-Apr-23
Submission accepted27-Apr-23
Review initiated01-May-23
Draft CADTH review report(s) provided to sponsor for comment19-Jul-23
Deadline for sponsors comments28-Jul-23
CADTH review report(s) and responses to comments provided to sponsor31-Aug-23
Expert committee meeting (initial)13-Sep-23
Draft recommendation issued to sponsor26-Sep-23
Draft recommendation posted for stakeholder feedback05-Oct-23
End of feedback period20-Oct-23
Final recommendation issued to sponsor and drug plans02-Nov-23
Final recommendation posted21-Nov-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)17-Nov-23
CADTH review report(s) posted22-Jan-24

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic and Ethics combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : January 22, 2024