azacitidine

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Generic 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:

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:

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

October 20, 2021

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 CADTH review report(s) provided to sponsor for comment	07-Jun-21
Deadline for sponsors comments	16-Jun-21
CADTH 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 CADTH review report(s)	18-Oct-21
CADTH review report(s) posted	12-Jan-22