Venclexta
Drug - Venclexta™ (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
Approvals
Initial and renewal approval will be for 6 months.
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
