Subject: Tukysa SGM 3782-A P2025

Drug

TUKYSA  (tucatinib)

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 Indications¹

• Tukysa is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
• Tukysa is indicated in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

Compendial Uses^2-5

• Breast Cancer – recurrent unresectable disease
• Breast Cancer – no response to preoperative systemic therapy
• Colorectal Cancer – BRAF wild-type disease
• HER2-positive Biliary Tract Cancers – gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma

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:

• Documentation of human epidermal growth factor receptor 2 (HER2) status, where applicable
• Documentation of RAS mutation status, where applicable
• Documentation of BRAF mutation status, where applicable

Coverage Criteria

Breast Cancer^1,2

Authorization of 12 months may be granted for treatment of HER2-positive breast cancer in combination with trastuzumab and capecitabine when any of the following criteria are met:

• As subsequent therapy for members with no response to preoperative systemic therapy, recurrent unresectable, advanced unresectable, or metastatic disease including limited or extensive brain metastases; or
• As initial therapy for members with small asymptomatic brain metastases

Colorectal Cancer^1-4

Authorization of 12 months may be granted for treatment of unresectable, advanced, inoperable, or metastatic colorectal cancer, including appendiceal adenocarcinoma and anal adenocarcinoma, when all of the following criteria are met:

• The member has HER2-positive disease
• The disease is negative (wild-type) for RAS (KRAS and NRAS) and BRAF mutations
• The requested medication will be used in combination with trastuzumab
• Intensive therapy is not appropriate or the member has experienced disease progression

Biliary Tract Cancers^2,5

Authorization of 12 months may be granted for subsequent treatment of locally advanced, unresectable, resected gross residual (R2) or metastatic HER2-positive biliary tract cancers (including gallbladder cancer, intrahepatic and extrahepatic cholangiocarcinoma) when used in combination with trastuzumab.

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. Tukysa [package insert]. Bothell, WA: Seagen, Inc.; January 2023.
2. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed November 6, 2024.
3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer. Version 5.2024. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Accessed November 6, 2024.
4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Anal Carcinoma. Version 1.2024. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf. Accessed November 6, 2024.
5. Lexicomp [database online]. Hudson, OH: Lexi-Comp, Inc.; https://online.lexi.com/lco/action/home [available with subscription]. Accessed November 12, 2024.

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