WHA

Verzenio (abemaciclib)

Indications for Prior Authorization

Verzenio (abemaciclib)
  • For diagnosis of Advanced or Metastatic Breast Cancer
    Indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

  • For diagnosis of Advanced or Metastatic Breast Cancer
    Indicated as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

  • For diagnosis of Advanced or Metastatic Breast Cancer
    Indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer.

  • For diagnosis of Early Breast Cancer
    Indicated in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.

Criteria

Verzenio

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Breast Cancer

  • Diagnosis of breast cancer
Verzenio

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Breast Cancer

  • Patient does not show evidence of progressive disease while on therapy

  • Guideline ID
    GL-149570

  • Formulary
    EHB

  • Effective date
    Aug 1, 2024

  • P&T approval date

P & T Revisions

2024-07-03, 2024-05-20, 2023-06-22, 2023-06-08, 2023-04-26, 2022-05-06, 2021-11-30, 2021-04-12, 2020-04-07

  1. Verzenio Prescribing Information. Lilly USA, LLC. Indianapolis, IN. March 2023.
  • 2024-07-03: Added EHB formulary to guideline. No changes to criteria.
  • 2024-05-20: 2024 UM Annual Review. No criteria changes
  • 2023-06-22: Removed Oncology specialist requirement
  • 2023-06-08: Program update to consolidate under one umbrella Breast Cancer criterion. Removed any criteria related disease classification or combination therapy.
  • 2023-04-26: 2023 UM Annual Review. Updated criteria based on full FDA labeling for expended indications. Updated references
  • 2022-05-06: 2022 Annual Review- Updated criteria to include men in the HR+, HER2-negative advanced/metastatic setting when used in combination with an aromatase inhibitor
  • 2021-11-30: Updated criteria for new indication
  • 2021-04-12: Annual Review: updated background
  • 2020-04-07: Annual Review; updated references & background