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
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input openApril 10, 2024
Call for patient/clinician input closedJune 03, 2024
Submission receivedMay 22, 2024
Submission acceptedJune 05, 2024
Review initiatedJune 06, 2024
Draft CADTH review report(s) provided to sponsor for commentAugust 21, 2024
Deadline for sponsors commentsAugust 30, 2024
CADTH review report(s) and responses to comments provided to sponsorSeptember 26, 2024
Expert committee meeting (initial)October 09, 2024
Draft recommendation issued to sponsorOctober 22, 2024
To
October 24, 2024
Draft recommendation posted for stakeholder feedbackOctober 31, 2024
End of feedback periodNovember 15, 2024

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Last Updated : June 14, 2024