Product Details
Venclexta
Venetoclax10 mg & 50 mg & 100 mg
Tablet (Starter Kit)
DIN/PIN/NPN
02458063
Manufacturer
AbbVie Corporation
Formulary Listing Date
2022-05-06
Unit Price
1833.7200
Amount MOH Pays
1833.7200
Coverage Status
Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
L01XX52
Interchangeable Products
NOLU Clinical Criteria
NOEAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Oncology Drugs | Venetoclax
For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who requires treatment according to the International Workshop on Chronic Lymphoma Leukemia criteria and meeting the following criteria:
Notes:
Renewal Criteria: Renewals for venetoclax in combination with rituximab will be considered until disease progression or development of unacceptable toxicity up to a maximum of two years, whichever comes first. Renewals for venetoclax in combination with Obinutuzumab will not be considered. Exclusion Criteria: (The following situations will not be funded.)
Dosing Regimen of Venetoclax monotherapy: Approved Duration for venetoclax monotherapy Initiation and renewals: 1 year Dosing Regimen for venetoclax and obinutuzumab (VEN-OBI) combination regimen: Venetoclax: Obinutuzumab: Treatment should be given for a total of 12 months as a finite treatment (i.e., six 28-day cycles of obinutuzumab in combination with venetoclax, followed by six additional cycles of single agent venetoclax) Approved Duration for venetoclax (used in a regimen with Obinutuzumab): 1 year Dosing Regimen for venetoclax and rituximab (VEN-RITUX) combination regimen: Venetoclax: Rituximab: The use of rituximab subcutaneous may be considered in patients who are able to tolerate at least one full dose of intravenous infusion of rituximab during the first cycle. If a patient is unable to receive the full IV rituximab dose, continue subsequent cycles with rituximab IV until a full IV dose can be successfully given. Approved Duration for venetoclax (used in a regimen with rituximab): 1 year A total treatment duration of 2 years will be funded from the date of addition of rituximab to the treatment regimen Exclusion Criteria (continued):
Dosing Regimen of Venetoclax monotherapy: Approved Duration for venetoclax monotherapy initiation and renewals: 1 year Dosing Regimen for Venetoclax within a rituximab combination regimen: Dosing Regimen for Rituximab within a venetoclax combination regimen: Approved Duration for venetoclax within a combination regimen with rituximab - Initiation: 1 year Renewal duration for venetoclax within a combination regimen with rituximab: 1 year (total treatment duration funded is a maximum of 2 years from the date of addition of rituximab to the treatment regimen.) Venetoclax
Initial Criteria:
For the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who meet the following criteria:
*Case by case consideration may be provided for ECOG >2 if the worsened performance status is the result of AML.
Renewal Criteria: Notes:
Funded Dose and Duration: Cycle 1: Cycle 2 and onwards: Renewal Duration of initials and renewals: 1 year EAP Drug Request Form: |