Last Updated : December 17, 2021
Details
FilesGeneric Name:
azacitidine
Project Status:
Complete
Therapeutic Area:
Acute myeloid leukemia
Manufacturer:
Celgene Inc., a Bristol-Myers Squibb Company
Brand Name:
Onureg
Project Line:
Reimbursement Review
Project Number:
PC0245-000
Tumour Type:
Leukemia
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, and who are not eligible for hematopoietic stem cell transplantation (HSCT).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, and who are not eligible for hematopoietic stem cell transplantation (HSCT).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 Milestones | |
|---|---|
| Call for patient/clinician input open | 29-Jan-21 |
| Call for patient/clinician input closed | 26-Mar-21 |
| Clarification: - Patient input submission received from The Leukemia & Lymphoma Society of Canada | |
| Submission received | 01-Mar-21 |
| Submission accepted | 15-Mar-21 |
| Review initiated | 16-Mar-21 |
| Draft Canada's Drug Agency review report(s) provided to sponsor for comment | 07-Jun-21 |
| Deadline for sponsors comments | 16-Jun-21 |
| Canada's Drug Agency responses on draft review report(s) provided to sponsor | 29-Jul-21 |
| Expert committee meeting (initial) | 11-Aug-21 |
| Draft recommendation posted for stakeholder feedback | 02-Sep-21 |
| End of feedback period | 17-Sep-21 |
| Final recommendation issued to sponsor and drug plans | 01-Oct-21 |
| Final recommendation posted | 20-Oct-21 |
| Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s) | 18-Oct-21 |
| Canada's Drug Agency review report(s) posted | 12-Jan-22 |
Files
Last Updated : December 17, 2021