Subject: Kisqali Femara Co-Pack 2104-A SGM P2023

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
               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; October 2022.
2. The NCCN Drugs & Biologics Compendium^® © 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed November 10, 2022.

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 18, 2023