daunorubicin and cytarabine


( Last Updated : August 24, 2021)
Generic Name:
daunorubicin and cytarabine
Project Status:
Active
Therapeutic Area:
Acute myeloid leukemia
Manufacturer:
Jazz Pharmaceuticals Canada Inc.
Brand Name:
Vyxeos
Project Line:
Reimbursement Review
Project Number:
PC0237-000
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of adults with newly diagnosed therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adults with newly diagnosed therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 open December 17, 2020
Call for patient/clinician input closed February 12, 2021
Clarification:

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

Submission received January 22, 2021
Submission accepted February 05, 2021
Review initiated February 08, 2021
Draft CADTH review report(s) provided to sponsor for comment April 23, 2021
Deadline for sponsors comments May 04, 2021
CADTH responses on draft review report(s) provided to sponsor May 31, 2021
Expert committee meeting (initial) June 10, 2021
Draft recommendation issued to sponsor June 24, 2021
Draft recommendation posted for stakeholder feedback July 08, 2021
End of feedback period July 22, 2021
Final recommendation issued to sponsor and drug plans August 6, 2021
Final recommendation posted August 24, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) August 23, 2021
CADTH review report(s) posted