Subject: Cometriq SGM 1854-A P2025

Drug

COMETRIQ  (cabozantinib)

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 Indication¹

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

Compendial Uses²

• Follicular and papillary thyroid carcinoma
• Oncocytic/Hurthle Cell thyroid carcinoma
• Non-small cell lung cancer with RET gene arrangements

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

Documentation

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

Coverage Criteria

Follicular and Papillary Thyroid Carcinoma²

Authorization of 12 months may be granted for treatment of follicular or papillary thyroid carcinoma when all of the following criteria are met:

• The disease is not amenable to radioactive iodine (RAI) therapy.
• The disease has progressed after treatment with lenvatinib or sorafenib.

Oncocytic/Hurthle Cell Thyroid Carcinoma²

Authorization of 12 months may be granted for treatment of oncocytic/Hürthle cell thyroid carcinoma when the disease has progressed after treatment with lenvatinib or sorafenib.

Medullary Thyroid Carcinoma^1,2

Authorization of 12 months may be granted for treatment of medullary thyroid carcinoma.

Non-Small Cell Lung Cancer (NSCLC)²

Authorization of 12 months may be granted as a single agent for treatment of recurrent, advanced, or metastatic NSCLC with RET gene rearrangements as subsequent therapy following progression on first-line pralsetinib (Gavreto) or selpercatinib (Retevmo).

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed 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. Cometriq [package insert]. Alameda, CA: Exelixis, Inc.; August 2023.
2. The NCCN Drugs & Biologics Compendium® © 2025 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed August 8, 2025.

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 20, 2026