Abemaciclib (Verzenio™)

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

  • In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women 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 women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastic 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

Patients must meet the following criteria for the indication(s) above:

  • Prescribed by an oncologist, AND
  • 18 years or older, AND
  • Chart note documentation is provided, AND
  • Patient has advanced or metastatic HR+ [i.e., estrogen receptor positive {ER+} and/or progestrogen receptor positive {PR+}] disease, AND
  • Patient has HER2-negative breast cancer, AND
  • The patient's breast cancer has progressed during or after endocrine therapy (e.g., anastrozole, exemestane, letrozole, tamoxifen, toremifene, exemestane plus everolimus, fluvestrant IM injection, megestrol acetate, fluoxymesterone, high-dose ethinyl estradiol), AND
  • Patient meets ONE of the following criteria (i, ii, or iii):
    • i) The patient is postmenopausal and Verzenio will be used in combination with fluvestrant IM injection, OR
    • ii) The patient is premenopausal or perimenopausal and meets the following conditions (a and b):
      • a) The patient is receiving ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist (e.g., leuprolid, triptorelin, goserelin); AND
      • b) Verzenio will be used in combination with fluvestrant IM injection; OR
    • iii) Verzenio will be used as monotherapy AND the patient has had prior chemotherapy for treatment of metastatic breast cancer

Dosing:

  • Initial:
    • In combination with fulvestrant or an aromatase inhibitor: 150 mg twice daily
    • Monotherapy: 200 mg twice daily
  • Dosing interruption and/or dose reductions may be required based on individual safety and tolerability

Approval:

  • 1 year

Last review date: November 29, 2018