Subject: Kisqali Femara Co-Pack 2104-A SGM P2022

Drug

KISQALI FEMARA CO-PACK  (ribociclib tablets; letrozole tablets)

Policy:

       I.  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.

            A.  FDA-Approved Indication
                 The Kisqali Femara Co-Pack is indicated as initial endocrine-
                 based therapy for the treatment of adult patients with
                 hormone receptor (HR)-positive, human epidermal growth
                 factor receptor 2 (HER2)-negative advanced or metastatic
                 breast cancer.

            B.  Compendial Uses
                 Breast cancer: Therapy for recurrent HR-positive, HER2-
                 negative disease

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

 
     II.  DOCUMENTATION

           Submission of hormone receptor (HR) and human epidermal
           growth factor receptor 2 (HER2) status is necessary to initiate
           the prior authorization review.

 
    III.  CRITERIA FOR INITIAL APPROVAL

            Breast cancer
            Authorization of 12 months may be granted to members for
            the treatment of HR-positive, HER2-negative recurrent,
            advanced or metastatic breast cancer.

 
     IV.  CONTINUATION OF THERAPY

            Authorization of 12 months may be granted for continued
            treatment in members requesting reauthorization for an
            indication outlined in section III 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 Femara Co-Pack [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; December 2021.
2. The NCCN Drugs & Biologics Compendium^® © 2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed December 1, 2021.

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.

June 26, 2022