skip to content
Primary navigation


DrugKisqali® (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


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

back to top