CDA | Evidence Driven
CDA | Evidence Driven

lisocabtagene maraleucel

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Generic Name:
lisocabtagene maraleucel
Project Status:
Active
Therapeutic Area:
Relapsed or refractory large B-cell lymphoma
Manufacturer:
Bristol Myers Squibb Canada
Call for patient/clinician input open:
Brand Name:
Breyanzi
Project Line:
Reimbursement Review
Project Number:
PG0358-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
BREYANZI® (lisocabtagene maraleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for: the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL), and DLBCL arising from follicular lymphoma, who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy, and who are candidates for autologous hematopoietic stem cell transplant (HSCT).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
BREYANZI® (lisocabtagene maraleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for: • the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL), and DLBCL arising from follicular lymphoma, who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy, and who are candidates for autologous hematopoietic stem cell transplant (HSCT). ​
  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 open26-Mar-24
Call for patient/clinician input closed21-May-24
Submission received08-May-24
Submission accepted23-May-24
Review initiated24-May-24
Draft CADTH review report(s) provided to sponsor for comment23-Aug-24
Deadline for sponsors comments04-Sep-24
CADTH review report(s) and responses to comments provided to sponsor26-Sep-24
Expert committee meeting (initial)09-Oct-24
Draft recommendation issued to sponsor24-Oct-24
Draft recommendation posted for stakeholder feedback31-Oct-24
End of feedback period15-Nov-24
Final recommendation issued to sponsor and drug plans27-Nov-24
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)11-Dec-24
CADTH review report(s) posted-

Files

Draft Recommendation and Reasons View PDF
Patient and Clinician Group input View PDF
Last Updated : November 20, 2024