Subject: lapatinib-Tykerb 1902-A SGM P2022

Drug

TYKERB  (lapatinib)

lapatinib

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
                 Tykerb is indicated in combination with:
                 1.  Capecitabine for the treatment of patients with
                      advanced or metastatic breast cancer whose tumors
                      overexpress human epidermal growth factor receptor 2
                      (HER2) and who have received prior therapy including
                      an anthracycline, a taxane, and trastuzumab
                 2.  Letrozole for the treatment of postmenopausal women
                      with hormone receptor (HR)-positive metastatic breast
                      cancer that overexpresses the HER2 receptor for whom
                      hormonal therapy is indicated

            B.  Compendial Uses
                 1.  Recurrent or metastatic HER2-positive breast cancer in
                      combination with trastuzumab
                 2.  Recurrent or stage IV hormone receptor-positive, HER2-
                      positive breast cancer in combination with aromatase
                      inhibition in postmenopausal women,
                 3.  Central Nervous System (CNS) metastases from breast
                      cancer
                 4.  Recurrent epidermal growth factor receptor (EGFR)-
                      positive chordoma
                 5.  HER2-amplified and RAS and BRAF wild-type colorectal
                      cancer in combination with trastuzumab

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

 
     II.  DOCUMENTATION

           Submission of the following information is necessary to initiate
           the prior authorization review: Hormone receptor status, HER2
           status, RAS and BRAF mutation status, EGFR mutation testing
           results (where applicable).

 
    III.  CRITERIA FOR INITIAL APPROVAL

            A.  Breast cancer
                 Authorization of 12 months may be granted for treatment
                 of recurrent, advanced, or metastatic HER2-positive breast
                 cancer when any of the following criteria are met:
                 1.  Tykerb is used in combination with an aromatase
                      inhibitor (e.g., letrozole, anastrozole, or exemestane)
                      either with or without trastuzumab for the treatment of
                      hormone receptor-positive disease; or
                 2.  Tykerb will be used in combination with capecitabine or
                      trastuzumab.

            B.  Central nervous system metastases (CNS) from
                  breast cancer
                 Authorization of 12 months may be granted for treatment
                 of brain metastases from HER2-positive breast cancer in
                 combination with capecitabine.

            C.  Chordoma
                 Authorization of 12 months may be granted for treatment
                 of EGFR-positive recurrent chordoma, as a single agent.

            D.  Colorectal Cancer
                 Authorization of 12 months may be granted for treatment
                 of colorectal cancer with HER2-amplified and RAS and BRAF
                 wild-type disease in combination with trastuzumab when
                 either of the following are met:
                 1.  Member is not appropriate for intensive therapy
                 2.  Tykerb will be used as subsequent therapy for
                      progression of advanced or metastatic disease.

 
    IV.  CONTINUATION OF THERAPY

           Authorization of 12 months may be granted for continued
           treatment in members requesting reauthorization for an
           indication listed 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. Tykerb [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; February 2021.
2. The NCCN Drugs & Biologics Compendium 2021 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed December 6, 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