Subject: Cometriq 1854-A SGM P2022a

Drug

COMETRIQ  (cabozantinib)

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 Indication
               Treatment of progressive, metastatic medullary thyroid
               cancer (MTC).

          B.  Compendial Uses
               1.  Follicular, Hürthle cell, and papillary thyroid carcinoma
               2.  Non-small cell lung cancer with RET gene arrangements

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

 
      II.  DOCUMENTATION

            Submission of RET gene rearrangement documentation is
            necessary to initiate the prior authorization review for the
            indication of non-small cell lung cancer.

 
    III.  CRITERIA FOR INITIAL APPROVAL

            A.  Follicular, Hurthle Cell, and Papillary Thyroid
                 carcinoma
                 Authorization of 12 months may be granted for treatment
                 of follicular, Hürthle cell, or papillary thyroid carcinoma
                 when all of the following criteria are met:
                 1.  The disease is not amenable to radioactive iodine (RAI)
                      therapy.
                 2.  The disease has progressed after treatment with
                      lenvatinib or sorafenib.

            B.  Medullary Thyroid Carcinoma
                 Authorization of 12 months may be granted for treatment
                 of medullary thyroid carcinoma.

            C.  Non-small cell lung cancer (NSCLC)
                 Authorization of 12 months may be granted for treatment
                 of recurrent, advanced, or metastatic NSCLC with RET gene
                 rearrangements when used 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 listed 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. Cometriq [package insert]. Alameda, CA: Exelixis, Inc.; October 2020.
2. The NCCN Drugs & Biologics Compendium^® © 2022 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed August 4, 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.

February 17, 2023