Subject: Cometriq 1854-A SGM P2022

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]. South San Francisco, CA: Exelixis; October 2020.
2. The NCCN Drugs & Biologics Compendium^® © 2021 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed November 4, 2021.    

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.

May 16, 2022