CADTH | Evidence Driven
CADTH | Evidence Driven

tisagenlecleucel

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Generic Name:
tisagenlecleucel
Project Status:
Complete
Therapeutic Area:
Relapsed or refractory follicular lymphoma
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Kymriah
Project Line:
Reimbursement Review
Project Number:
PG0306-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Indicated for 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:
Indicated for 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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open21-Nov-22
Call for patient/clinician input closed20-Jan-23
Clarification:

- Patient input submission received from Lymphoma Canada

Submission received01-Feb-23
Submission accepted15-Feb-23
Review initiated16-Feb-23
Draft CADTH review report(s) provided to sponsor for comment05-May-23
Deadline for sponsors comments16-May-23
CADTH review report(s) and responses to comments provided to sponsor29-Jun-23
Expert committee meeting (initial)12-Jul-23
Draft recommendation issued to sponsor25-Jul-23
Draft recommendation posted for stakeholder feedback03-Aug-23
End of feedback period18-Aug-23
Final recommendation issued to sponsor and drug plans01-Sep-23
Final recommendation posted20-Sep-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)18-Sep-23
CADTH review report(s) posted01-Nov-23

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, Ethics, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : November 1, 2023