skip to content
Primary navigation

Venclexta

DrugVenclexta™ (venetoclax) [AbbVie Inc.]

January 2018

Therapeutic area - Oncology

Approval criteria

  • Patient is 18 years of age or older AND
  • Must have a diagnosis of chronic lymphocytic leukemia with 17p deletion, as detected by an FDA approved test AND
  • Must have received at least one prior therapy
  • Documentation of diagnosis from patient’s medical records must be provided at time of request

Quantity limits

  • 10 mg tablets: 68 tablets per 34 days
  • 50 mg tablets: 34 tablets per 34 days
  • 100 mg tablets: 136 tablets per 34 days
  • Starter Pack: 42 tablets per 28 days
  • Dose Hold Pack: 14 tablets per 7 days (10 mg tablets) or 7 tablets per 7 days (50 mg tablets)

Renewal criteria

  • Documentation must be supplied at time of request showing patient has no disease progression characterized by the absence of at least one 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.

Background information

Venclexta is FDA-approved under accelerated approval based on overall response rate. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Questions?

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

back to top