Kisqali®

Drug - Kisqali® (ribociclib) [Novartis]

October 2017

Therapeutic area - Oral Oncology

Initial approval criteria

Patient is > 18 years of age AND
Patient has a diagnosis of advanced or metastatic breast cancer that is
- hormone receptor (HR)-positive AND
- human epidermal growth factor receptor 2 (HER2)-negative AND
Is being used as first-line therapy in combination with an aromatase inhibitor AND
Female patients must be postmenopausal as defined by 1 of the following:
- Prior bilateral oophorectomy
- Age ≥ 60 years
- Age < 60 years and amenorrhea for ≥ 12 months (in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression) and FSH and estradiol levels in the postmenopausal range
Initial approval will be limited to 6 months

Patient continues to meet initial review criteria AND
Tumor response with stabilization of disease or decrease in size of tumor or tumor spread AND
Absence of unacceptable toxicity from the drug at current dosage level (e.g., Grade 3 hypokalemia, Grade 2 QT prolongation, increased ALT/AST)
Renewal approval will be limited to 6 months

MHCP Provider Call Center 651-431-2700 or 800-366-5411