VERZENIO (abemaciclib)

VERZENIO (abemaciclib)

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

Verzenio is a kinase inhibitor 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 and a Ki-67 score ≥ 20% as determined by an FDA approved test.
• In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
• 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
• 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.

Coverage Criteria:

For diagnosis of breast cancer:

• Does does not exceed maximum amount recommended by the FDA (200mg twice daily); AND
• Prescribed by or in consultation with an oncologist; AND
• 18 years or older; AND
• Medical record confirms patient has HER2-negative, HR-positive (i.e., estrogen receptor positive [ER+], and/or progesterone receptor positive [PR+]) breast cancer; AND
• One of the following:
  • Patient is male
  • Patient is postmenopausal female
  • Patient is premenopausal or perimenopausal female and is receiving ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist (e.g., leuprolide, triptorelin, goserelin); AND
• One of the following:
  • Both of the following:
    • Patient has advanced or metastatic disease; AND
    • Will be used as initial endocrine-based therapy with an aromatase inhibitor (i.e., anastrozole, letrozole, exemestane)
  • Both of the following:
    • Patient has high-risk disease as shown by one of the following:
      • Four or more positive lymph nodes
      • One to three positive lymph nodes with one more of the following:
        • Grade 3 disease
        • Tumor size of 5cm or greater
        • Ki-67 score of 20% or greater as determined by an FDA-approved test (i.e., Ki-67 IHC MIB-1 pharmDx [Dako Omnis])
    • Will be used in combination with tamoxifen or an aromatase inhibitor (i.e., anastrozole, letrozole, exemestane)
  • All of the following:
    • Patient has advanced or metastatic disease
    • Will be used in combination with fulvestrant
    • Disease has progressed during or after endocrine therapy (e.g., anastrozole, letrozole, exemestane, tamoxifen)
  • All of the following:
    • Will be used as monotherapy
    • Patient has advanced or metastatic disease
    • Disease has progressed during or after endocrine therapy (e.g., anastrozole, letrozole, exemestane, tamoxifen, fulvestrant)
    • Disease has progressed during or after chemotherapy in the advanced or metastatic disease setting.

Coverage Duration:

• One year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Policy Updates:

• 11/29/2018 -  policy reviewed.
• 05/17/2022 - Updated indications. Reformat criteria. Update criteria language regarding four scenarios based on FDA-approved indications and NCCN guidelines.