Subject: Tukysa 3782-A SGM P2022
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
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.
B. Compendial Uses
Breast Cancer – recurrent unresectable disease
All other indications are considered
experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of human epidermal growth factor receptor 2
(HER2) status is necessary to initiate the prior authorization
review.
III. CRITERIA FOR INITIAL APPROVAL
Breast Cancer
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:
1. As subsequent therapy for recurrent unresectable, advanced
unresectable, or metastatic disease including limited or
extensive brain metastases; or
2. As initial therapy for members with small asymptomatic
brain metastases
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:
- Tukysa [package insert]. Bothell, WA: Seagen, Inc; April 2020.
- 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
