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
Performance Metric:
Achieved
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 openMarch 19, 2024
Call for patient/clinician input closedMay 13, 2024
Submission receivedMay 27, 2024
Submission acceptedJune 10, 2024
Review initiatedJune 11, 2024
Draft CADTH review report(s) provided to sponsor for commentSeptember 06, 2024
Deadline for sponsors commentsSeptember 17, 2024
CADTH review report(s) and responses to comments provided to sponsorOctober 10, 2024
Expert committee meeting (initial)October 23, 2024
Draft recommendation issued to sponsorNovember 04, 2024
Draft recommendation posted for stakeholder feedbackNovember 14, 2024
End of feedback periodNovember 28, 2024
Final recommendation issued to sponsor and drug plansDecember 11, 2024
Final recommendation postedJanuary 06, 2025
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)January 02, 2025
CADTH review report(s) posted-

Files

Recommendation and Reasons View PDF
Patient and Clinician Group Input View PDF
Last Updated : January 6, 2025