Venetoclax


( Last Updated : April 28, 2021)
Generic Name:
venetoclax
Project Status:
Active
Therapeutic Area:
Acute myeloid leukemia
Manufacturer:
AbbVie Corporation
Brand Name:
Venclexta
Project Line:
Reimbursement Review
Project Number:
PC0238-000

Details


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.
  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 openDecember 03, 2020
Call for patient/clinician input closedJanuary 29, 2021
Clarification:

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

Submission receivedJanuary 08, 2021
Submission acceptedFebruary 05, 2021
Clarification:

- Submission was not accepted for review on 22 Jan 21

Review initiatedFebruary 08, 2021
Draft CADTH review report(s) provided to sponsor for commentApril 27, 2021
Deadline for sponsors commentsMay 06, 2021
CADTH responses on draft review report(s) provided to sponsorMay 31, 2021
Expert committee meeting (initial)June 10, 2021
Draft recommendation issued to sponsorJune 24, 2021
Draft recommendation posted for stakeholder feedbackJuly 08, 2021
End of feedback periodJuly 22, 2021
Final recommendation issued to sponsor and drug plansAugust 04, 2021
Final recommendation posted
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)
CADTH review report(s) posted