Subject: Tukysa 3782-A SGM P2023a
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
1. 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.
2. 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.
B. Compendial Uses
1. Breast Cancer – recurrent unresectable disease
2. Breast Cancer – no response to preoperative systemic
therapy
3. Colorectal Cancer – BRAF wild-type disease
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:
A. Documentation of human epidermal growth factor receptor 2
(HER2) status, where applicable
B. Documentation of RAS mutation status, where applicable
C. Documentation of BRAF mutation status, where applicable
III. CRITERIA FOR INITIAL APPROVAL
A. 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 members with no response to
preoperative systemic therapy, 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
B. Colorectal Cancer
Authorization of 12 months may be granted for treatment of
unresectable, advanced, or metastatic colorectal cancer,
including appendiceal adenocarcinoma and anal
adenocarcinoma, when all of the following criteria are met:
1. The member has HER2-positive disease
2. The disease is negative (wild-type) for RAS (KRAS and
NRAS) and BRAF mutations
3. The requested medication will be used in combination
with trastuzumab
4. The member is not appropriate for intensive therapy or
has experienced disease progression
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.; January 2023.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed January 27, 2023.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer. Version 3.2022. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Accessed January 27, 2023.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Anal Carcinoma. Version 1.2023. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf. Accessed January 23, 2023.
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
