Kisqali — Medical Mutual

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 meets ONE of the following criteria (i, ii, iii, or iv):
• i. The patient is postmenopausal and Kisqali will be used as first-line endocrine therapy in combination with anastrozole, exemestane, letrozole, OR fulvestrant; OR
• ii. The patient is postmenopausal and Kisqali Femara Co-Pack will be used as first-line endocrine therapy; OR
• iii. The patient is postmenopausal and 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; OR
• iv. The patient is premenopausal or perimenopausal and meets the following conditions (a and b):
• a. The patient is receiving ovarian suppression/ablation with a gonadotropin-releasing hormone (GnRH) agonist (e.g., Lupron [leuprolide], Trelstar [triptorelin], Zoladex [goserelin]), surgical bilateral oophorectomy, or ovarian irradiation; AND
• b. 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