Subject: Nerlynx 2178-A SGM P2023
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.
FDA-Approved Indications
1. Nerlynx is indicated as a single agent for the extended
adjuvant treatment of adult patients with early-stage human
epidermal growth factor receptor 2 (HER2)-positive breast
cancer, to follow adjuvant trastuzumab-based therapy.
2. Nerlynx is indicated in combination with capecitabine, for the
treatment of adult patients with advanced or metastatic
HER2-positive breast cancer who have received two or more
prior anti-HER2 based regimens in the metastatic setting.
Compendial Uses
1. HER2-positive breast cancer in combination with capecitabine
2. Brain metastases from HER2-positive breast cancer in
combination with capecitabine
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
A. Authorization of up to 12 months total may be granted for
treatment of early stage HER2-positive breast cancer when
the requested medication will be initiated after completing
adjuvant trastuzumab-based therapy when used as a single
agent.
B. Authorization of 12 months may be granted for treatment of
breast cancer with no response to preoperative systemic
therapy or recurrent, advanced or metastatic (including brain
metastases) HER2-positive breast cancer in combination with
capecitabine.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication outlined in section III when there is no evidence of
unacceptable toxicity or disease progression while on the current
regimen. Adjuvant treatment of early-stage breast cancer will be
approved for a total of 12 months of therapy.
Place of Service:
Outpatient
The above policy is based on the following references:
- Nerlynx [package insert]. Los Angeles, CA: Puma Biotechnology, Inc.; March 2022.
- Chan A, Delaloge S, Holmes FA, et al. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016; 17(3):367-77.
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
