Last Updated : June 10, 2024
Details
FilesGeneric 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:
TBC
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:
Exagamglogene autotemcel (exa-cel) is an autologous genome edited hematopoietic stem cell-based therapy indicated for the treatment of patients aged 12 years and older with: transfusion-dependent beta-thalassemia (TDT)
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Exagamglogene autotemcel (exa-cel) is an autologous genome edited hematopoietic stem cell-based therapy indicated for the treatment of patients aged 12 years and older with: • transfusion-dependent beta-thalassemia (TDT)
- 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.
| Call for patient/clinician input open | March 19, 2024 |
|---|---|
| Call for patient/clinician input closed | May 13, 2024 |
| Submission received | May 27, 2024 |
| Submission accepted | June 10, 2024 |
| Review initiated | June 11, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | September 06, 2024 |
| Deadline for sponsors comments | September 17, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | October 10, 2024 |
| Expert committee meeting (initial) | October 23, 2024 |
| Draft recommendation issued to sponsor | November 04, 2024 To November 06, 2024 |
| Draft recommendation posted for stakeholder feedback | November 14, 2024 |
| End of feedback period | November 28, 2024 |
Files
Last Updated : June 10, 2024