Last Updated : April 23, 2025
Details
FilesGeneric Name:
blinatumomab
Project Status:
Active
Therapeutic Area:
B-cell precursor acute lymphoblastic leukemia
Manufacturer:
Amgen Canada Inc.
Call for patient/clinician input open:
Brand Name:
Blincyto
Project Line:
Reimbursement Review
Project Number:
PC0365-000
Call for patient/clinician input closed:
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult and pediatric patients with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia in the consolidation phase of multiphase chemotherapy in the frontline setting.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult and pediatric patients with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia in the consolidation phase of multiphase chemotherapy in the frontline setting.
- 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 | 06-Sep-24 |
---|---|
Call for patient/clinician input closed | 25-Nov-24 |
Submission received | 18-Oct-24 |
Submission accepted | 01-Nov-24 |
Review initiated | 04-Nov-24 |
Draft CADTH review report(s) provided to sponsor for comment | 31-Jan-25 |
Deadline for sponsors comments | 07-Feb-25 |
CDA-AMC review report(s) and responses to comments provided to sponsor | 28-Feb-25 |
Expert committee meeting (initial) | 12-Mar-25 |
Draft recommendation issued to sponsor | 25-Mar-25 |
Draft recommendation posted for stakeholder feedback | 03-Apr-25 |
End of feedback period | 17-Apr-25 |
Final recommendation issued to sponsor and drug plans | 01-May-25 |
Final recommendation posted | - |
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 15-May-25 |
CDA-AMC review report(s) posted | - |
Files
Last Updated : April 23, 2025