Subject: Augtyro 6256-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. Treatment of adult patients with locally advanced or metastatic ROS1-positive non-small
cell lung cancer (NSCLC)
2. Treatment of adult and pediatric patients 12 years of age and older with solid tumors
that:
a. Have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion
b. Are locally advanced or metastatic or where surgical resection is likely to result in
severe morbidity, and
c. Have progressed following treatment or have no satisfactory alternative therapy
B. Compendial Uses
NSCLC, recurrent, advanced or metastatic NTRK1/2/3 gene fusion-positive or ROS1
rearrangement-positive tumors
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:
NTRK gene fusion status or ROS1 status (where applicable).
III. CRITERIA FOR INITIAL APPROVAL
A. Non-Small Cell Lung Cancer
Authorization of 12 months may be granted for treatment of recurrent, advanced, or
metastatic ROS1-positive non-small cell lung cancer.
B. Solid tumors with NTRK gene fusion
Authorization of 12 months may be granted for treatment of members 12 years of age and
older with solid tumors that have an NTRK gene fusion, as demonstrated by laboratory
testing (e.g., next-generation sequencing [NGS] or fluorescence in situ hybridization
[FISH]).
IV. CONTINUATION OF THERAPY
A. ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
Authorization of 12 months may be granted for continued treatment of ROS1-positive non-
small cell lung cancer (NSCLC) in members requesting reauthorization when there is no
evidence of unacceptable toxicity while on the current regimen.
B. Solid tumors with NTRK gene fusion
Authorization of 12 months may be granted for continued treatment of solid tumors that
have an NTRK gene fusion 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:
- Augtyro [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; June 2024.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed July 8, 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 01, 2024
