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DrugVenclexta™ (venetoclax) [AbbVie Inc.]

September 2019

Therapeutic area - Oncology

Approval criteria

  • Documentation of diagnosis from patient’s medical records must be provided at time of request AND
  • Must have one of the following diagnoses:
    • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) AND
      • Patient is 18 years or older AND
      • Venclexta™ is used:
        • As monotherapy OR
        • In combination with obinutuzumab OR
        • In combination with rituximab OR
    • Acute myeloid leukemia (AML) AND
      • Patient is 75 years or older OR has comorbidities that preclude the use of intensive induction chemotherapy AND
      • Venclexta™ is used as induction chemotherapy in combination with one of the following:
        • Azacitidine OR
        • Decitabine OR
        • Low-dose cytarabine

Quantity limits

  • For CLL/SLL:
    • Maximum 400 mg per day
    • 10 mg tablets: 14 tablets per 7 days
    • 50 mg tablets: 7 tablets per 7 days
    • 100 mg tablets: 120 tablets per 30 days
    • Starter Pack: 42 tablets per 28 days
    • Wallet: 14 tablets per 7 days (10 mg tablets) or 7 tablets per 7 days (50 mg tablets)
  • For ALL
    • In combination with azacitidine OR decitabine: 400 mg per day
    • In combination with low-dose cytarabine: 600 mg per day

Renewal criteria

  • Documentation must be supplied at time of request showing patient has no disease progression or unacceptable toxicity. Disease progression is defined as any of the following:
    • Appearance of any new lesion, such as enlarged lymph nodes (>1.5 cm), splenomegaly, hepatomegaly, or other organ infiltrates OR an increase by 50% or more in greatest determined diameter of any previous site
    • An increase in the previously noted enlargement of the liver or spleen by 50% or more or the de novo appearance of hepatomegaly or splenomegaly
    • An increase in the number of blood lymphocytes by 50% or more with at least 5000 B lymphocytes per microliter
    • Transformation to a more aggressive histology (e.g., Richter syndrome) established by lymph node biopsy
    • Progression of any cytopenia (unrelated to autoimmune cytopenia), as documented by a decrease of Hb levels by more than 2g/dL or to less than 10g/dL OR by a decrease of platelet count by more than 50% or to less than 100,000/microliter which occurs at least 3 months after treatment


Initial and renewal approval will be for 6 months.


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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