Subject: lapatinib-Tykerb SGM 1902-A P2025

Drug

TYKERB  (llapatinib)

Policy:

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.

FDA-approved Indications^1,2

Tykerb is indicated in combination with:

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

Limitations of Use

Patients should have disease progression on trastuzumab prior to initiation of treatment with Tykerb in combination with capecitabine.

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

Compendial Uses^3-5

• Breast cancer
• Central Nervous System (CNS) metastases from breast cancer
• Recurrent epidermal growth factor receptor (EGFR)-positive chordoma
• 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.

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).

Coverage Criteria

Breast cancer^1-3

Authorization of 12 months may be granted for treatment of breast cancer with no response to preoperative systemic therapy or recurrent, advanced, or metastatic HER2-positive breast cancer when any of the following criteria are met:

• The requested medication 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
• The requested medication will be used in combination with capecitabine or trastuzumab.

Central nervous system metastases (CNS) from breast cancer³

Authorization of 12 months may be granted for treatment of brain metastases from HER2-positive breast cancer in combination with capecitabine.

Chordoma³

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

Colorectal Cancer^3-5

Authorization of 12 months may be granted for treatment of colorectal cancer (including appendiceal adenocarcinoma and anal adenocarcinoma) with HER2-amplified and RAS and BRAF wild-type disease in combination with trastuzumab when either of the following are met:

• Member is not appropriate for intensive therapy
• The requested medication will be used as subsequent therapy for progression of advanced or metastatic disease.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section 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; March 2022.
2. Lapatinib [package insert]. Baltimore, MD: Lupin Pharmaceuticals, Inc.; November 2023.
3. The NCCN Drugs & Biologics Compendium © 2024 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 6, 2024.
4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Colon Cancer. Version 5.2024. Accessed November 6, 2024. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf
5. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Anal Carcinoma. Version 1.2024. Accessed November 6, 2024. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf .

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 02, 2025