Subject: Ibrance 1726-A SGM P2023

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 adult patients with
               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,
                    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.  The requested medication is used in combination with an
                    aromatase inhibitor (e.g., anastrozole, exemestane,
                    letrozole).
               2.  The requested medication 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.; December 2022.
2. Ibrance tablets [package insert]. New York, NY: Pfizer Inc.; December 2022.
3. The NCCN Drugs & Biologics Compendium^® © 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed November 1, 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