Subject: Cabometyx 2212-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 Indications
Cabometyx is indicated for the treatment of patients with:
1. Advanced renal cell carcinoma (RCC)
2. Advanced renal cell carcinoma (RCC), as a first-line
treatment in combination with nivolumab
3. Hepatocellular carcinoma (HCC) who have been
previously treated with sorafenib
4. Locally advanced or metastatic differentiated thyroid
cancer (DTC) that has progressed following prior VEGFR-
targeted therapy and who are radioactive iodine-
refractory or ineligible (adult and pediatric patients 12
years of age and older)
B. Compendial Uses
1. Relapsed or stage IV renal cell carcinoma
2. Non-small cell lung cancer with RET (rearranged during
transfection) gene rearrangement
3. Hepatocellular carcinoma as subsequent treatment
4. Ewing Sarcoma
5. Osteosarcoma
6. Gastrointestinal Stromal Tumor (GIST)
7. Endometrial carcinoma
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. Renal Cell Carcinoma
Authorization of 12 months may be granted for treatment of
advanced, relapsed, or stage IV renal cell carcinoma
(including brain metastases) when used in either of the
following settings:
1. As a single agent.
2. In combination with nivolumab.
B. Hepatocellular Carcinoma
Authorization of 12 months may be granted as a single agent
for subsequent treatment of hepatocellular carcinoma.
C. Non-small Cell Lung Cancer
Authorization of 12 months may be granted as a single agent
for treatment of recurrent, advanced, or metastatic non-
small cell lung cancer with RET gene rearrangement.
D. Ewing Sarcoma
Authorization of 12 months may be granted for treatment of
Ewing sarcoma as a single agent for subsequent therapy.
E. Osteosarcoma
Authorization of 12 months may be granted for treatment of
osteosarcoma as a single agent for subsequent therapy.
F. Gastrointestinal Stromal Tumor (GIST)
Authorization of 12 months may be granted for treatment of
GIST when all of the following criteria are met:
1. Member has residual, unresectable, recurrent, or
metastatic/tumor rupture disease
2. Member has failed at least four FDA-approved therapies
(e.g., imatininb, sunitinib, regorafenib, ripretinib)
3. The requested medication will be used as a single agent
G. 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. Member has locally advanced or metastatic disease
2. Disease has progressed after VEGFR-targeted therapy
(e.g., lenvatinib and sorafenib)
3. Disease is not amenable to radioactive iodine therapy
(RAI)
4. Member is at least 12 years old
H. Endometrial Carcinoma
Authorization of 12 months may be granted for treatment of
recurrent endometrial carcinoma as a single agent for
subsequent therapy.
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:
- Cabometyx [package insert]. Alameda, CA: Exelixis, Inc.; July 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 3, 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.
November 20, 2023
