Last Updated : March 28, 2025
Details
FilesGeneric Name:
venetoclax
Project Status:
Complete
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).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation/Report:
- 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 | April 10, 2024 |
|---|---|
| Call for patient/clinician input closed | June 03, 2024 |
| Submission received | May 22, 2024 |
| Submission accepted | June 05, 2024 |
| Review initiated | June 06, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | August 21, 2024 |
| Deadline for sponsors comments | August 30, 2024 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | September 26, 2024 |
| Draft recommendation issued to sponsor | October 23, 2024 |
| Draft recommendation posted for stakeholder feedback | October 31, 2024 |
| End of feedback period | November 15, 2024 |
| Final recommendation issued to sponsor and drug plans | November 28, 2024 |
| Final recommendation posted | December 16, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | December 12, 2024 |
| CDA-AMC review report(s) posted | March 27, 2025 |
Files
Last Updated : March 28, 2025