Subject: Gilotrif 1658-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.
A. FDA-Approved Indications
1. EGFR Mutation-Positive, Metastatic Non-Small Cell Lung
Cancer
Gilotrif is indicated for the first-line treatment of patients
with metastatic non-small cell lung cancer (NSCLC)
whose tumors have non-resistant epidermal growth factor
receptor (EGFR) mutations as detected by an FDA-
approved test.
Limitations of Use: Safety and efficacy of Gilotrif were not
established in patients whose tumors have resistant EGFR
mutations.
2. Previously Treated, Metastatic Squamous NSCLC
Gilotrif is indicated for the treatment of patients with
metastatic squamous NSCLC progressing after platinum-
based chemotherapy.
B. Compendial Uses
NSCLC, recurrent, advanced or metastatic sensitizing EGFR
mutation-positive as a single agent or as subsequent therapy
in combination with cetuximab.
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: For NSCLC, EGFR mutation
testing results (where applicable).
III. CRITERIA FOR INITIAL APPROVAL
Non-Small Cell Lung Cancer (NSCLC)
A. Authorization of 12 months may be granted for treatment of
recurrent, advanced or metastatic NSCLC when the member
has sensitizing EGFR mutation-positive disease as a single
agent or in combination with cetuximab.
B. Authorization of 12 months may be granted for treatment of
metastatic squamous NSCLC progressing after platinum-
based chemotherapy.
IV. CONTINUATION OF THERAPY
NSCLC
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for NSCLC
when either of the following criteria are met:
1. There is no evidence of unacceptable toxicity or disease
progression while on the current regimen.
2. Disease is T790M negative and there is no evidence of
unacceptable toxicity.
Place of Service:
Outpatient
The above policy is based on the following references:
- Gilotrif [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; April 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed March 4, 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.
August 18, 2023
