KISQALI (ribociclib)

KISQALI (ribociclib)

SELF ADMINISTRATION - ORAL

Indication for Prior Authorization:

Kisqali is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

• an aromatase inhibitor as initial endocrine-based therapy
• fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men

Coverage Criteria:

For diagnosis of breast cancer:

• Dose does not exceed maximum amount recommended by the FDA (600 MG once daily); AND
• Prescribed by or in consultation with an oncologist; AND
• Medical records confirm all of the following: 
  • Diagnosis of advanced, recurrent, or metastatic breast cancer
  • Disease is HER2-negative 
  • Disease is HR-positive (i.e., estrogen receptor positive [ER+] and/or progesterone receptor positive [PR+]); AND
• One of the following:
  • Patient is male
  • Patient is postmenopausal female
  • Patient is premenopausal or perimenopausal female and is receiving ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist (e.g., leuprolide, triptorelin, goserelin); AND
• One of the following:
  • Will be used as initial endocrine-based therapy with an aromatase inhibitor (i.e., anastrozole, letrozole, exemestane).
  • Will be used as initial endocrine-based therapy with fulvestrant.
  • Will be used with fulvestrant following disease progression on endocrine therapy.

Coverage Duration:

• One year

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:  

• Avoid concurrent use with strong CYP3A inhibitors. If the strong inhibitor cannot be avoided, reduce the dose.
• Avoid concurrent use with strong CYP3A inducers.
• Kisqali is available as a 200 mg tablet.
• Per NCCN guidelines (v 6.2020), either an aromatase inhibitor or fulvestrant in combination with a CD4/6 inhibitor (i.e., abemaciclib, palbociclib, ribociclib) are preferred regimens (category 1 recommendation) for first line systemic therapy in patients with ER and/or PR positive recurrent or stage IV breast cancer.

Review History:

• 03/13/2017 – Approved by FDA
• 06/12/2017 – New policy review.
• 06/18/2018 – FDA approval expanded.
• 12/31/2020 – Annual review; Format updated; Added new indication to policy.
• 05/17/2022 - Expanded indication to specifically call out male patients; Update criteria format and add scenarios to reflect current FDA indication and NCCN recommendations.

References:

• Kisqali (ribociclib) tablets [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2020.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Breast Cancer, version 6.2020 – September 8, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed December 31, 2020.