venetoclax

Details

Files

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

Biosimilar:

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:

August 23, 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	17-Dec-20
Call for patient/clinician input closed	12-Feb-21
Clarification: - Patient input submission received from The Leukemia & Lymphoma Society of Canada
Submission received	22-Jan-21
Submission accepted	05-Feb-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	05-Aug-21
Final recommendation posted	23-Aug-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	11-Aug-21
CADTH review report(s) posted	14-Oct-21