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
Renewal criteria
- 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
Quantity limits
- 200 mg tablets: 63 tablets per 28 days
- Kisqali/Femara Co-Pack: 1 pack per 28-day supply
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411