azacitidine


( Last Updated : September 20, 2021)
Generic Name:
azacitidine
Project Status:
Active
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

Details


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).
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open29-Jan-21
Call for patient/clinician input closed26-Mar-21
Clarification:

- Patient input submission received from The Leukemia & Lymphoma Society of Canada

Submission received01-Mar-21
Submission accepted15-Mar-21
Review initiated16-Mar-21
Draft CADTH review report(s) provided to sponsor for comment07-Jun-21
Deadline for sponsors comments16-Jun-21
CADTH responses on draft review report(s) provided to sponsor29-Jul-21
Expert committee meeting (initial)11-Aug-21
Draft recommendation posted for stakeholder feedback02-Sep-21
End of feedback period17-Sep-21