Subject: Kisqali SGM 1639-A P2026

Drug

KISQALI  (ribociclib)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications¹

Kisqali is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.

Kisqali is indicated for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with:

·        An aromatase inhibitor as initial endocrine-based therapy; or

·        Fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.

Compendial Uses²

·        Breast cancer

·        Endometrial carcinoma

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

·        For members requesting initiation of therapy for the treatment of breast cancer: documentation of laboratory results confirming hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status.

·        For members requesting initiation of therapy for the treatment of endometrial carcinoma: documentation of laboratory results confirming estrogen receptor (ER) status.

Coverage Criteria

Breast cancer^1,2

Authorization of 12 months may be granted to members for treatment of HR-positive, HER2-negative recurrent unresectable or metastatic breast cancer when used in combination with an aromatase inhibitor (e.g., anastrozole, letrozole, exemestane) or fulvestrant.

Authorization of 12 months may be granted to members for adjuvant treatment of HR-positive, HER2-negative breast cancer when used in combination with an aromatase inhibitor (e.g., anastrozole, letrozole, exemestane) and either of the following criteria is met:

·        Disease has any lymph node involvement (excluding microscopic nodal involvement).

·        Disease has no nodal involvement and either of the following criteria is met:

o   Tumor size is greater than 5 cm.

o   Tumor size is 2 to 5 cm and the tumor is Grade 2 (and high genomic risk or Ki-67 greater than or equal to 20%) or Grade 3.

Endometrial carcinoma²

Authorization of 12 months may be granted to members for treatment of recurrent or metastatic endometrial carcinoma with ER-positive tumors when used in combination with letrozole.

Authorization of 12 months may be granted to members for adjuvant treatment of stage IV endometrial carcinoma with ER-positive tumors when used in combination with letrozole.

Continuation of Therapy

Adjuvant Breast Cancer Treatment

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for adjuvant treatment of HR-positive, HER2-negative breast cancer until completion of 3 years of treatment or until disease recurrence or unacceptable toxicity while on the current regimen.

Recurrent Unresectable or Metastatic Breast Cancer or Endometrial Carcinoma

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for recurrent unresectable or metastatic breast cancer or endometrial carcinoma when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Kisqali [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; September 2025.

2.     The NCCN Drugs & Biologics Compendium® © 2025 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed November 13, 2025.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

July 14, 2026