Subject: Kisqali 1639-A SGM P2022
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 Indications
1. Kisqali is indicated in combination with an aromatase
inhibitor 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.
2. Kisqali is indicated in combination with fulvestrant for
the treatment of postmenopausal women or in men with
(HR)-positive, human epidermal growth factor receptor
2 (HER2)-negative advanced or metastatic breast
cancer, as initial endocrine based therapy or following
disease progression on endocrine therapy.
B. Compendial Uses
Breast cancer: 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
treatment of HR-positive, HER2-negative recurrent, advanced,
or metastatic breast cancer when Kisqali is used in combination
with an aromatase inhibitor or fulvestrant.
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:
- Kisqali [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; December 2021.
- 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
