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azacitidine

Last Updated: June 8, 2021
Result type: Reports
Project Number: PC0245-000
Product Line: Reimbursement Review

Generic Name: azacitidine

Brand Name: Onureg

Manufacturer: Celgene Inc., a Bristol-Myers Squibb Company

Therapeutic Area: Acute myeloid leukemia

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).

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

Tumour Type: Leukemia

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule1: Schedule A

  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 openJanuary 29, 2021
Call for patient/clinician input closedMarch 26, 2021
Clarification:

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

Submission receivedMarch 01, 2021
Submission acceptedMarch 15, 2021
Review initiatedMarch 16, 2021
Draft CADTH review report(s) provided to sponsor for commentJune 07, 2021
Deadline for sponsors commentsJune 16, 2021
CADTH responses on draft review report(s) provided to sponsorJuly 29, 2021
Expert committee meeting (initial)August 11, 2021
Draft recommendation issued to sponsorAugust 23, 2021
To
August 25, 2021
Draft recommendation posted for stakeholder feedback-