CDA | Evidence Driven
CDA | Evidence Driven

venetoclax

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Generic Name:
venetoclax
Project Status:
Active
Therapeutic Area:
Chronic lymphocytic leukemia (CLL)
Manufacturer:
AbbVie Corporation
Call for patient/clinician input open:
Brand Name:
Venclexta
Project Line:
Reimbursement Review
Project Number:
PC0362-000
Call for patient/clinician input closed:
Tumour Type:
Leukemia
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The AbbVie Corporation requests reimbursement of venetoclax, in combination with obinutuzumab (VenO), for the subgroup of previously untreated CLL patients considered fit and potentially fludarabine-eligible, who were not included in the reimbursement request or recommendation criteria in the previous CDA-AMC review (PC0212-000). Note that based on this request, the reimbursement criteria for VenO would be expanded for the treatment of patients with previously untreated CLL’’, aligned with the Health Canada indication (i.e., irrespective of age or eligibility for fludarabine treatment).
Submission Type:
Reassessment
Fee Schedule:
Schedule A
Indications:
​Venclexta (venetoclax), in combination with obinutuzumab, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
  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 open10-Apr-24
Call for patient/clinician input closed03-Jun-24
Submission received22-May-24
Submission accepted05-Jun-24
Review initiated06-Jun-24
Draft CADTH review report(s) provided to sponsor for comment21-Aug-24
Deadline for sponsors comments30-Aug-24
CADTH review report(s) and responses to comments provided to sponsor26-Sep-24
Draft recommendation issued to sponsor23-Oct-24
Draft recommendation posted for stakeholder feedback31-Oct-24
End of feedback period15-Nov-24
Final recommendation issued to sponsor and drug plans28-Nov-24
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)12-Dec-24
CADTH review report(s) posted-

Files

Draft Recommendation and Reasons View PDF
Patient and Clinician Group input View PDF
Last Updated : November 20, 2024