CADTH | Evidence Driven
CADTH | Evidence Driven

ciltacabtagene autoleucel

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Generic Name:
ciltacabtagene autoleucel
Project Status:
Complete
Therapeutic Area:
Relapsed or refractory multiple myeloma
Manufacturer:
Janssen Inc.
Brand Name:
Carvykti
Project Line:
Reimbursement Review
Project Number:
PG0302-000
Tumour Type:
Myeloma
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The treatment of adult patients with multiple myeloma, whohave received at least three prior lines of therapy, including aproteasome inhibitor, an immunomodulatory agent and ananti-CD38 antibody, and who are refractory to their lasttreatment.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
The treatment of adult patients with multiple myeloma, whohave received at least three prior lines of therapy, including aproteasome inhibitor, an immunomodulatory agent and ananti-CD38 antibody, and who are refractory to their lasttreatment.
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 open25-Aug-22
Call for patient/clinician input closed17-Oct-22
Clarification:

- Patient input submission received from Myeloma Canada

Submission received23-Sep-22
Submission accepted07-Oct-22
Review initiated11-Oct-22
Draft CADTH review report(s) provided to sponsor for comment22-Dec-22
Deadline for sponsors comments10-Jan-23
CADTH review report(s) and responses to comments provided to sponsor24-Feb-23
Expert committee meeting (initial)08-Mar-23
Draft recommendation issued to sponsor21-Mar-23
Draft recommendation posted for stakeholder feedback30-Mar-23
End of feedback period14-Apr-23
Final recommendation issued to sponsor and drug plans01-May-23
Final recommendation posted17-May-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)15-May-23
CADTH review report(s) posted02-Aug-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 : August 2, 2023