Product Details

Venclexta

Venetoclax
50 mg
Tablet


DIN/PIN/NPN

02458047

Manufacturer

AbbVie Corporation

Formulary Listing Date

2022-05-06  

Unit Price

35.4000

Amount MOH Pays

35.4000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01XX52

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Venetoclax

  • Brand(s): Venclexta
  • Dosage Form/Strength: 10 mg, 50 mg, 100 mg, tablet; Starter Pk (10mg/50mg/100mg)
  • Updated May 6, 2022

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:

  1. Patient has good performance status with ECOG equal to or less than 2; AND

  1. Venetoclax is being used in one of the following situations:
    i) Venetoclax will be used in combination with obinutuzumab as first line therapy in a patient with previously untreated CLL or SLL and who is deemed to be unfit for a fludarabine-based regimen (Note 1);
    OR
    ii)     Venetoclax will be used in the relapsed refractory setting in combination with rituximab as second or subsequent line of therapy in a patient who has experienced treatment failure or unacceptable toxicities to ONE or more of the following regimens:
    a) a fludarabine-based regimen
    b) a Bruton’s Tyrosine Kinase (BTK) inhibitor (i.e. acalabrutinib or ibrutinib) OR a combination therapy with idelalisib and rituximab
    c) relapsed after a progression-free remission of more than 6 months in duration following chlorambucil-obinutuzumab in first line or a rituximab-based chemoimmunotherapy regimen in first or subsequent lines
    d) relapsed after a progression-free remission of more than 12 months following a combination regimen of venetoclax and obinutuzumab used as first line;
    OR
    iii)     Venetoclax will be used as monotherapy in the relapsed refractory setting as second or subsequent line of therapy in a patient who has experienced treatment failure or unacceptable toxicities to at least one prior line of therapy which may include:
    a) a fludarabine-based regimen or a rituximab-based chemoimmunotherapy regimen
    b) a Bruton’s Tyrosine Kinase (BTK) inhibitor (i.e. acalabrutinib or ibrutinib) or a combination therapy with idelalisib and rituximab
    c) chlorambucil-obinutuzumab in first line
    d) relapsed after a progression-free remission of more than 12 months following a combination regimen of venetoclax and obinutuzumab used as first line or a venetoclax and rituximab combination used in second or subsequent lines.

Notes:

  1. A patient who is deemed to be unfit for a fludarabine-based regimen may be indicated by a Cumulative Illness Rating Scale (CIRS) score greater than 6 OR creatine clearance (CrCl) that is less than 70 mL per minute.

  1. Provincially funded chemotherapy and immunotherapy combination regimens for CLL can be considered based on the patient’s fitness/frailty and tolerability to targeted options. Patients must have met the provincial funding criteria for the prior lines of therapy. (For example, a patient using a BTK inhibitor as first line must have high risk cytogenic markers in accordance with the published EAP reimbursement criteria.)

    Refer to a list of funded chemoimmunotherapy regimens on the Ontario Health - Cancer Care Ontario (OH-CCO) website at https://www.cancercareontario.ca/en/search?nav- search=CLL&sort_by=search_api_relevance&=Apply 

  1. Retreatment with venetoclax in combination with rituximab therapy may be considered at the time of relapse for patients who were able to tolerate and complete 12 months of venetoclax and obinutuzumab and/or 24 months of a combination venetoclax and rituximab regimen and who have demonstrated a progression-free remission of at least 12 months in duration after stopping therapy.

  1. Patients with severe intolerances to treatments required in prior lines of therapy will be considered case-by-case. Please provide details of the grade of toxicity experienced and/or clinical details to justify the contraindication to treatment options.

  1. Venetoclax as monotherapy or as combination therapy with rituximab will not be funded in fifth line or beyond, except case-by-case consideration will be provided for a venetoclax and rituximab combination therapy if the request meets the retreatment criteria in Note 3.

Renewal Criteria:
Renewals for venetoclax monotherapy will be considered until disease progression or development of unacceptable toxicity.

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.)

  1. Patients who have experienced disease progression while on venetoclax. 

  1. Retreatment with venetoclax in a combination with obinutuzumab for relapsed disease. 

  1. Patient who has experienced a relapse of CLL or SLL within 6 months of stopping/completing a rituximab-containing regimen or an obinutuzumab-containing regimen for CLL will not be reimbursed for a venetoclax combination regimen with rituximab in a subsequent line. 

  1. Patient who has had an allogenic stem cell transplant in the 12 months preceding the request for EAP coverage for venetoclax as monotherapy or as combination therapy with rituximab. 

  1. Patients with active or uncontrolled autoimmune cytopenias. 

  1. Patients with a history of central nervous system (CNS) lymphoma, CNS leukemia, CNS prolymphocytic leukemia, or Richter syndrome will not be reimbursed for venetoclax in combination with obinutuzumab. 

Dosing Regimen of Venetoclax monotherapy:
Using the venetoclax (Venclexta) “starter pack” for the ramp up phase, dose at 20 mg once daily for 7 days, followed by 50 mg once daily for 7 days, followed by 100 mg once daily for 7 days, followed by 200 mg once daily for 7 days, followed by 400 mg once daily until disease progression or unacceptable toxicity. 

Approved Duration for venetoclax monotherapy Initiation and renewals: 1 year 

Dosing Regimen for venetoclax and obinutuzumab (VEN-OBI) combination regimen:

Venetoclax:
Using the venetoclax (Venclexta) “starter pack” for the ramp up phase starting on day 22 of Cycle 1, dose at 20 mg once daily for 7 days (week 1), 50 mg once daily for 7 days (week 2), 100mg once daily for 7 days (week 3), followed by 200 mg once daily for 7 days (week 4), followed by 400mg once daily until disease progression or unacceptable toxicity up to a maximum of 12 Cycles (i.e., 48 weeks) whichever comes first.

Obinutuzumab:
Cycle 1 - 100 mg Intravenously (IV) on Day 1 followed by 900 mg on day 2 (or 1000 mg on day 1), followed by 1000 mg IV on days 8 and 15, in combination with venetoclax.
Cycle 2 to 6 - 1000 mg IV on day 1 in combination with venetoclax

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:
Using the venetoclax (Venclexta) “starter pack” for the ramp up phase, dose at 20 mg once daily for 7 days (week 1), 50mg once daily for 7 days (week 2), 100 mg once daily for 7 days (week 3), followed by 200mg once daily for 7 days (week 4), followed by 400 mg once daily until disease progression or unacceptable toxicity up to a maximum of two years (24 months from Cycle 1 Day 2 of rituximab) whichever comes first. 

Rituximab:
Cycle 1 - 375 mg/metre2 Intravenously (IV) on Day 1 (to be initiated after the patient has completed 5 weeks of ramp-up schedule with venetoclax and having received the 400 mg dose of venetoclax for 7 days)
Cycle 2 to 6 – 500 mg/m2 IV on Day 1, for a total of 6 infusions of 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):

  • Patients who are NOT CD20 antibody sensitive (i.e. an individual who has experienced a relapse of CLL within 12 months of stopping/completing a rituximab-containing regimen or an obinutuzumab-containing regimen for CLL) will not be reimbursed for a venetoclax combination regimen with rituximab.
  • Patient who has had an allogenic stem cell transplant in the 12 months preceding the request for EAP coverage for venetoclax as monotherapy or as combination therapy with rituximab.
  • Patients with active or uncontrolled autoimmune cytopenias.

Dosing Regimen of Venetoclax monotherapy:
Using the venetoclax (Venclexta) “starter pack” for the ramp up phase, dose at 20 mg once daily for 7 days, followed by 50mg once daily for 7 days, followed by 100mg once daily for 7 days, followed by 200mg once daily for 7 days, followed by 400mg once daily until disease progression or unacceptable toxicity.

Approved Duration for venetoclax monotherapy initiation and renewals: 1 year

Dosing Regimen for Venetoclax within a rituximab combination regimen:
Using the venetoclax (Venclexta) “starter pack” for the ramp up phase, dose at 20mg once daily for 7 days (week 1), 50mg once daily for 7 days (week 2), 100mg once daily for 7 days (week 3), followed by 200mg once daily for 7 days (week 4), followed by 400mg once daily until disease progression or unacceptable toxicity up to a maximum of two years (24 months from Cycle 1 Day 2 of rituximab) whichever comes first.

Dosing Regimen for Rituximab within a venetoclax combination regimen:
375 mg/metre2 Intravenously1 on Day 1 of Cycle 1 (to be initiated after the patient has completed 5 weeks of ramp-up schedule with venetoclax and having received the 400 mg dose of venetoclax for 7 days), followed by 500mg/m2 on Day 1 of Cycles 2 to 6, for a total of 6 infusions1 of rituximab. Approved

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

  • Brand(s): Venclexta
  • Dosage Form/Strength: 50 mg, 100 mg tablet
  • Effective: August 19, 2022
Initial Criteria:

For the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who meet the following criteria:

  1. Venetoclax is used in combination with azacitidine; AND

  1. Patient has not received prior treatment with venetoclax, a hypomethylating agent (e.g., azacitidine), and/or chemotherapy for myelodysplastic syndrome (MDS); AND

  1. Patient is considered to be ineliglble for standard intensive induction chemotherapy for AML as a result of one of the following circumstances:
    i) Patient is 75 years of age or older and has an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2*
    OR
    ii)     Patient is 18 to 74 years of age with at least ONE of the following comorbidities below:
    a) ECOG performance status of 2 to 3
    b) History of congestive heart failure requiring treatment
    c) Ejection fraction less than or equal to 50%
    d) Chronic stable angina
    e) Diffusing capacity of the lungs for carbon monoxide (DLCO) levels less than or equal to 65%
    f) Forced Expiry Volume in 1 second (FEV1) less than or equal to 65%
    g) Creatinine clearance between 30 mL/min to less than 45 mL/min
    h) Moderate hepatic impairment with total bilirubin greater than 1.5 to less than or the same as 3 times the Upper limit of normal (ULN)

*Case by case consideration may be provided for ECOG >2 if the worsened performance status is the result of AML.

  1. Prescribed by clinicians with expertise in the diagnosis, treatment, and management of patients with AML.

Renewal Criteria:
Renewals of funding of venetoclax in combination with azacitidine will be considered for patients who continue to derive clinical benefit and do not have documented disease progression or unacceptable toxicities from treatment.

Notes:

  1. Patients without unacceptable toxicity, are recommended to be treated for a minimum of 6 cycles.

  1. If a patient stops treatment with the azacitidine component as a result of toxicities or intolerances (i.e. reasons other than disease progression), venetoclax should also be discontinued.

Funded Dose and Duration:

Cycle 1:
Azacitidine 75 mg/m2 subcutaneously (SC) once daily for 6 or 7 doses (starting on day 1) in combination with oral venetoclax 100 mg once daily on day 1, 200 mg once daily on day 2, then 400 mg once daily on days 3 to 28.

Cycle 2 and onwards:
Azacitidine 75 mg/m2 SC once daily for 6 or 7 doses (starting on day 1) in combination with oral venetoclax 400 mg once daily on days 1 to 28
[repeated every 28 days; 1 cycle = every 28 days]

Renewal Duration of initials and renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

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