Last Updated : May 20, 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
Performance Metric:
Achieved
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
Submission Complexity:
Standard Review
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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation/Report:
- 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 | September 06, 2024 |
|---|---|
| Call for patient/clinician input closed | November 25, 2024 |
| Submission received | October 18, 2024 |
| Submission accepted | November 01, 2024 |
| Review initiated | November 04, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | January 31, 2025 |
| Deadline for sponsors comments | February 07, 2025 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | February 28, 2025 |
| Expert committee meeting (initial) | March 12, 2025 |
| Draft recommendation issued to sponsor | March 25, 2025 |
| Draft recommendation posted for stakeholder feedback | April 03, 2025 |
| End of feedback period | April 17, 2025 |
| Final recommendation issued to sponsor and drug plans | May 01, 2025 |
| Final recommendation posted | May 20, 2025 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 15, 2025 |
| CDA-AMC review report(s) posted | - |
Files
Last Updated : May 20, 2025