Subject: Ibrance 1726-A SGM P2022

Drug

IBRANCE  (palbociclib)

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
                 Ibrance is indicated for the treatment of hormone receptor
                 (HR)-positive, human epidermal growth factor receptor 2
                 (HER2)-negative advanced or metastatic breast cancer in
                 combination with:
                 1.  an aromatase inhibitor as initial endocrine based
                      therapy in postmenopausal women or in men, or
                 2.  fulvestrant in patients with disease progression following
                      endocrine therapy.

            B.  Compendial Uses
                 1.  Breast cancer: Therapy for recurrent HR-positive, HER2-
                      negative disease
                 2.  Soft tissue sarcoma: Single-agent therapy for
                      unresectable well-differentiated/dedifferentiated
                      liposarcoma of the retroperitoneum.

            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, where applicable.

 
    III.  CRITERIA FOR INITIAL APPROVAL

            A.  Breast cancer
                 Authorization of 12 months may be granted for treatment
                 of HR-positive, HER2-negative recurrent, advanced, or
                 metastatic breast cancer when one of the following criteria
                 is met:
                 1.  Ibrance is used in combination with an aromatase
                      inhibitor (e.g., anastrozole, exemestane, letrozole).
                 2.  Ibrance is used in combination with fulvestrant.

            B.  Soft tissue sarcoma
                 Authorization of 12 months may be granted for treatment
                 of unresectable well-differentiated/dedifferentiated
                 liposarcoma of the retroperitoneum when used as a single
                 agent.

 
     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. Ibrance capsules [package insert]. New York, NY: Pfizer Inc.; September 2019.
2. Ibrance tablets [package insert]. New York, NY: Pfizer Inc.; November 2019.
3. The NCCN Drugs & Biologics Compendium © 2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed November 24, 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