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KisqaliMedical Mutual

Breast Cancer in Men

Initial criteria

  • Patient has recurrent, advanced, or metastatic hormone receptor positive (HR+) [i.e., estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+)] disease; AND
  • Patient has human epidermal growth factor receptor 2 (HER2)-negative breast cancer; AND
  • The patient is receiving concomitant therapy with a gonadotropin-releasing hormone (GnRH) agonist (e.g., Lupron [leuprolide], Trelstar [triptorelin], Zoladex [goserelin]) for suppression of testicular steroidogenesis if Kisqali is being used in combination with an aromatase inhibitor; AND
  • One of the following (i, ii, or iii):
  • i. Kisqali will be used as first-line endocrine therapy in combination with anastrozole, exemestane, letrozole, OR fulvestrant; OR
  • ii. Kisqali Femara Co-Pack will be used as first-line endocrine therapy; OR
  • iii. Kisqali will be used as second-line or subsequent endocrine therapy in combination with fulvestrant if a CDK4/6 inhibitor has not been used previously

Reauthorization criteria

  • Prescriber will provide evidence of beneficial response warranting continuation of therapy

Approval duration

initial 6 months; reauth 1 year