Last Updated : January 29, 2025
Details
FilesGeneric Name:
venetoclax
Project Status:
Complete
Therapeutic Area:
Acute myeloid leukemia
Manufacturer:
AbbVie Corporation
Brand Name:
Venclexta
Project Line:
Reimbursement Review
Project Number:
PC0238-000
Tumour Type:
Leukemia
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Venclexta is indicated, in combination with a hypomethylating agent or in combination with low-dose cytarabine, in adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.
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.
| Call for patient/clinician input open | December 03, 2020 |
|---|---|
| Call for patient/clinician input closed | January 29, 2021 |
| Clarification: - Patient input submission received from The Leukemia & Lymphoma Society of Canada | |
| Submission received | January 08, 2021 |
| Submission accepted | February 05, 2021 |
| Clarification: - Submission was not accepted for review on 22 Jan 21 | |
| Review initiated | February 08, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | April 27, 2021 |
| Deadline for sponsors comments | May 06, 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 04, 2021 |
| Final recommendation posted | August 20, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | August 18, 2021 |
| CADTH review report(s) posted | October 18, 2021 |
Files
Last Updated : January 29, 2025