venetoclax


( Last Updated : October 14, 2021)
Generic Name:
venetoclax
Project Status:
Complete
Therapeutic Area:
Acute myeloid leukemia
Manufacturer:
AbbVie Corporation
Brand Name:
Venclexta
Project Line:
Reimbursement Review
Project Number:
PC0239-000
Tumour Type:
Leukemia
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
In combination with low-dose cytarabine 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:
In combination with azacitidine or low-dose cytarabine is indicated 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.
Recommendation Type:
Do not reimburse
Final Recommendation:
  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 open17-Dec-20
Call for patient/clinician input closed12-Feb-21
Clarification:

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

Submission received22-Jan-21
Submission accepted05-Feb-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 plans05-Aug-21
Final recommendation posted23-Aug-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)11-Aug-21
CADTH review report(s) posted14-Oct-21