Subject: Rozlytrek 3165-A SGM P2022

Drug

ROZLYTREK  (entrectinib)

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.

            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.

           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.

 
     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:

1. Rozlytrek [package insert]. South San Francisco, CA: Genentech, Inc. November 2021.
2. The NCCN Drugs & Biologics Compendium^® © 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed June 30, 2022.

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.

December 29, 2022