Last Updated : September 10, 2024
Details
FilesGeneric Name:
exagamglogene autotemcel
Project Status:
Active
Therapeutic Area:
Sickle cell disease (SCD)
Manufacturer:
Vertex Pharmaceuticals (Canada) Incorporated
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SG0830-000
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: sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs)
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: • sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs)
- 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.
| Call for patient/clinician input open | 19-Mar-24 |
|---|---|
| Call for patient/clinician input closed | 13-May-24 |
| Submission received | 27-May-24 |
| Submission accepted | 10-Jun-24 |
| Review initiated | 11-Jun-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 29-Aug-24 |
| Deadline for sponsors comments | 10-Sep-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 10-Oct-24 |
| Expert committee meeting (initial) | 23-Oct-24 |
| Draft recommendation issued to sponsor | November 04, 2024 To November 06, 2024 |
| Draft recommendation posted for stakeholder feedback | 14-Nov-24 |
| End of feedback period | 28-Nov-24 |
Files
Last Updated : September 10, 2024