Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

exagamglogene autotemcel

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Generic Name:
exagamglogene autotemcel
Project Status:
Active
Therapeutic Area:
Transfusion-dependent β-thalassemia
Manufacturer:
Vertex Pharmaceuticals (Canada) Incorporated
Call for patient/clinician input open:
Brand Name:
Casgevy
Project Line:
Reimbursement Review
Project Number:
SG0831-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Casgevy (exagamglogene autotemcel) is an autologous genome edited hematopoietic stem cell-based therapy indicated for the treatment of patients 12 years of age and older with: transfusion-dependent -thalassemia (TDT)
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Casgevy (exagamglogene autotemcel) is an autologous genome edited hematopoietic stem cell-based therapy indicated for the treatment of patients 12 years of age and older with: • transfusion-dependent β-thalassemia (TDT)
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 open19-Mar-24
Call for patient/clinician input closed13-May-24
Submission received27-May-24
Submission accepted10-Jun-24
Review initiated11-Jun-24
Draft CADTH review report(s) provided to sponsor for comment06-Sep-24
Deadline for sponsors comments17-Sep-24
CADTH review report(s) and responses to comments provided to sponsor10-Oct-24
Expert committee meeting (initial)23-Oct-24
Draft recommendation issued to sponsor04-Nov-24
Draft recommendation posted for stakeholder feedback14-Nov-24
End of feedback period28-Nov-24
Final recommendation issued to sponsor and drug plans11-Dec-24
Final recommendation posted06-Jan-25
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)02-Jan-25
CADTH review report(s) posted-

Files

Recommendation and Reasons View PDF
Patient and Clinician Group Input View PDF
Last Updated : February 3, 2025