Subject: Cometriq 1854-A SGM P2023
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, oncocytic, 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, Oncocytic/Hurthle Cell, and Papillary
Thyroid carcinoma
Authorization of 12 months may be granted for treatment of
follicular, oncocytic/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 as a single agent
for treatment of recurrent, advanced, or metastatic NSCLC
with RET gene rearrangements when the member has not
experienced disease progression on therapy with a RET
rearrangement positive-targeted regimen.
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:
- Cometriq [package insert]. Alameda, CA: Exelixis, Inc.; October 2020.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed August 17, 2023.
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 06, 2024