CDA | Evidence Driven
CDA | Evidence Driven

venetoclax

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Generic 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:
  1. 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 open03-Dec-20
Call for patient/clinician input closed29-Jan-21
Clarification:

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

Submission received08-Jan-21
Submission accepted05-Feb-21
Clarification:

- Submission was not accepted for review on 22 Jan 21

Review initiated08-Feb-21
Draft CADTH review report(s) provided to sponsor for comment27-Apr-21
Deadline for sponsors comments06-May-21
CADTH responses on draft review report(s) provided to sponsor31-May-21
Expert committee meeting (initial)10-Jun-21
Draft recommendation issued to sponsor24-Jun-21
Draft recommendation posted for stakeholder feedback08-Jul-21
End of feedback period22-Jul-21
Final recommendation issued to sponsor and drug plans04-Aug-21
Final recommendation posted20-Aug-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)18-Aug-21
CADTH review report(s) posted18-Oct-21

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Patient Group Input Submissions View PDF
Clinician Input View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : October 19, 2021