Subject: Lenvima SGM 1865-A P2025

Drug

LENVIMA  (lenvatinib)

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 Indications¹

• Lenvima is indicated for the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
• Lenvima is indicated in combination with pembrolizumab for the first line treatment of adult patients with advanced renal cell carcinoma (RCC).
• Lenvima is indicated in combination with everolimus, for the treatment of adult patients with advanced RCC following one prior anti-angiogenic therapy.
• Lenvima is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
• Lenvima is indicated in combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Compendial Uses²

• Anaplastic, medullary, follicular, oncocytic/Hurthle cell, or papillary thyroid carcinoma
• HCC
• Relapsed RCC
• Recurrent endometrial carcinoma
• Thymic carcinoma
• Cutaneous melanoma

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

Documentation

Submission of the following information is necessary to initiate the prior authorization review: Documentation of laboratory report confirming mismatch repair (MMR) tumor status, where applicable.

Coverage Criteria

Thyroid carcinoma^1-3

Authorization of 12 months may be granted for treatment of thyroid carcinoma when any of the following criteria are met:

• Member has follicular or papillary thyroid carcinoma not amenable to radioactive iodine therapy (RAI).
• Member has oncocytic/Hürthle cell thyroid carcinoma.
• Member has medullary thyroid carcinoma and has progressed on vandetanib (Caprelsa) or cabozantinib (Cometriq) OR these therapies are unavailable or inappropriate.
• Member has stage IVC anaplastic thyroid carcinoma and the requested medication will be used in combination with pembrolizumab (Keytruda).

Renal Cell Carcinoma^1,2

Authorization of 12 months may be granted for treatment of advanced, relapsed, or stage IV renal cell carcinoma when used in any of the following settings:

• The requested drug will be used in combination with everolimus (Afinitor) and either of the following is met:
  • The disease histology is predominantly clear cell and the member has used prior therapy.
  • The disease histology is non-clear cell.
• The requested drug will be used in combination with pembrolizumab (Keytruda) when either of the following are met:
  • The disease histology is non-clear cell.
  • The disease histology is predominantly clear cell and either of the following are met:
    • The requested medication will be used as first line therapy.
    • The requested medication will be used as subsequent therapy and member is immuno-oncology therapy naive.

Authorization of 12 months may be granted for subsequent treatment of relapsed or stage IV renal cell carcinoma as a single agent when the disease histology is predominantly clear cell.

Hepatocellular Carcinoma^1,2

Authorization of 12 months may be granted for treatment of hepatocellular carcinoma as a single agent when either of the following criteria are met:

• The requested medication will be used as first line therapy and either of the following are met:
  • Member has unresectable disease and is not a transplant candidate.
  • Member has extrahepatic/metastatic disease and is ineligible for resection, transplant, or locoregional therapy.
• The requested medication will be used as subsequent therapy.

Endometrial Carcinoma^1,2,4

Authorization of 12 months may be granted for treatment of endometrial carcinoma when any of the following are met:

• The member has advanced or recurrent disease that is mismatch repair proficient (pMMR) and the requested medication will be used in combination with pembrolizumab (Keytruda).
• The member has advanced disease that is mismatch repair deficient (dMMR) and has progressed following prior platinum-based chemotherapy when the requested medication will be used in combination with pembrolizumab (Keytruda).
• The member has recurrent disease and the requested medication will be used as single agent subsequent therapy.

Thymic Carcinoma²

Authorization of 12 months may be granted for treatment of thymic carcinoma when used as a single agent.

Cutaneous Melanoma²

Authorization of 12 months may be granted for treatment of metastatic or unresectable cutaneous melanoma that has progressed following treatment with an anti-PD-1/PD-L1-based therapy, in combination with pembrolizumab.

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. For follicular, oncocytic/Hürthle cell, and papillary thyroid carcinoma, if disease progression occurs with single agent Lenvima therapy, pembrolizumab (Keytruda) can be added to the regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Lenvima [package insert]. Nutley, NJ: Eisai Inc.; January 2025.
2. The NCCN Drugs & Biologics Compendium 2025 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed August 13, 2025.
3. National Comprehensive Cancer Network (NCCN) Guidelines: Thyroid Carcinoma V1.2025. National Comprehensive Cancer Network, Inc. https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf. Accessed August 1, 2025.
4. Micromedex Solutions [database online]. Ann Arbor, MI: Merative. www.micromedexsolutions.com [available with subscription]. Accessed August 13, 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