Subject: Rozlytrek SGM 3165-A P2024_R

Drug

ROZLYTREK  (entrectinib)

Policy:

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

Solid Tumors

Rozlytrek is indicated for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that:

• have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation,
• are metastatic or where surgical resection is likely to result in severe morbidity, and
• have progressed following treatment or have no satisfactory alternative therapy.

Non-Small Cell Lung Cancer

Rozlytrek is indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

Compendial Uses

• Non-small cell lung cancer
• Cutaneous melanoma

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review: NTRK gene fusion status or ROS1 status (where applicable).

Coverage Criteria

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]).

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-rearrangement positive NSCLC as a single agent.

Cutaneous Melanoma

Authorization of 12 months may be granted for treatment of metastatic or unresectable NTRK gene fusion-positive or ROS1-gene fusion positive cutaneous melanoma as second-line or subsequent therapy as a single agent for disease progression, intolerance, and/or projected risk of progression with BRAF-targeted therapy.

Continuation of Therapy

ROS1-Rearrangement Positive NSCLC

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for ROS1-rearrangement positive NSCLC when there is no evidence of unacceptable toxicity while on the current regimen.

All Other Indications

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication in the coverage criteria section 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:

1. Rozlytrek [package insert]. South San Francisco, CA: Genentech USA, Inc. January 2024.
2. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed July 1, 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.

January 01, 2025