Subject: Rozlytrek 3165-A SGM P2022a
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. Solid tumors
Rozlytrek is indicated for the treatment of adult and
pediatric patients 12 years and older with solid tumors
that:
a. have a neurotrophic tyrosine receptor kinase (NTRK)
gene fusion without a known acquired resistance
mutation,
b. are metastatic or where surgical resection is likely to
result in severe morbidity, and
c. have either progressed following treatment or have no
satisfactory alternative therapy.
2. Non-small cell lung cancer
Rozlytrek is indicated for the treatment of adult patients
with metastatic non-small cell lung cancer (NSCLC)
whose tumors are ROS1-positive.
B. Compendial Use
1. Cutaneous Melanoma
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. Solid tumors
Authorization of 12 months may be granted for treatment of
solid tumors when the tumors have a NTRK gene fusion
without a known acquired resistance mutation, as
demonstrated by laboratory testing (e.g., next-generation
sequencing [NGS] or fluorescence in situ hybridization
[FISH]).
B. Non-small cell lung cancer (NSCLC)
Authorization of 12 months may be granted for treatment of
recurrent, advanced, or metastatic NTRK gene fusion-
positive or ROS1-positive NSCLC as a single agent.
C. Cutaneous Melanoma
Authorization of 12 months may be granted for treatment of
metastatic or unresectable NTRK gene fusion-positive or
ROS1-positive cutaneous melanoma as second-line or
subsequent therapy for disease progression, intolerance,
and/or projected risk of progression with BRAF-targeted
therapy.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication 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:
- Rozlytrek [package insert]. South San Francisco, CA: Genentech, Inc. November 2021.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed January 25, 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.
March 05, 2023
