Last Updated : October 19, 2021
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
Performance Metric:
Achieved
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.
Key Milestones2 | |
---|---|
Call for patient/clinician input open | 03-Dec-20 |
Call for patient/clinician input closed | 29-Jan-21 |
Clarification: - Patient input submission received from The Leukemia & Lymphoma Society of Canada | |
Submission received | 08-Jan-21 |
Submission accepted | 05-Feb-21 |
Clarification: - Submission was not accepted for review on 22 Jan 21 | |
Review initiated | 08-Feb-21 |
Draft CADTH review report(s) provided to sponsor for comment | 27-Apr-21 |
Deadline for sponsors comments | 06-May-21 |
CADTH responses on draft review report(s) provided to sponsor | 31-May-21 |
Expert committee meeting (initial) | 10-Jun-21 |
Draft recommendation issued to sponsor | 24-Jun-21 |
Draft recommendation posted for stakeholder feedback | 08-Jul-21 |
End of feedback period | 22-Jul-21 |
Final recommendation issued to sponsor and drug plans | 04-Aug-21 |
Final recommendation posted | 20-Aug-21 |
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 18-Aug-21 |
CADTH review report(s) posted | 18-Oct-21 |
Files
Last Updated : October 19, 2021