venetoclax

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Generic Name:

venetoclax

Project Status:

Complete

Therapeutic Area:

Acute myeloid leukemia

Manufacturer:

AbbVie Corporation

Brand Name:

Venclexta

Project Line:

Reimbursement Review

Project Number:

PC0238-000

Tumour Type:

Leukemia

NOC Status at Filing:

Post NOC

Biosimilar:

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.

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

August 20, 2021

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 open	03-Dec-20
Call for patient/clinician input closed	29-Jan-21
Clarification: - Patient input submission received from The Leukemia & Lymphoma Society of Canada
Submission received	08-Jan-21
Submission accepted	05-Feb-21
Clarification: - Submission was not accepted for review on 22 Jan 21
Review initiated	08-Feb-21
Draft CADTH review report(s) provided to sponsor for comment	27-Apr-21
Deadline for sponsors comments	06-May-21
CADTH responses on draft review report(s) provided to sponsor	31-May-21
Expert committee meeting (initial)	10-Jun-21
Draft recommendation issued to sponsor	24-Jun-21
Draft recommendation posted for stakeholder feedback	08-Jul-21
End of feedback period	22-Jul-21
Final recommendation issued to sponsor and drug plans	04-Aug-21
Final recommendation posted	20-Aug-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	18-Aug-21
CADTH review report(s) posted	18-Oct-21