Subject: Gilotrif 1658-A SGM P2024
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® © 2024 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed March 4, 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.
August 18, 2024
