Last Updated : October 29, 2021
Details
FilesGeneric Name:
daunorubicin and cytarabine
Project Status:
Complete
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
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:
- 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 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 | October 29, 2021 |
Files
Last Updated : October 29, 2021