Subject: Lenvima 1865-A SGM P2022
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
1. Lenvima is indicated for the treatment of patients with locally recurrent or metastatic, progressive,
radioactive iodine-refractory differentiated thyroid cancer (DTC).
2. Lenvima is indicated in combination with everolimus, for the treatment of patients with advanced
renal cell carcinoma (RCC) following one prior anti-angiogenic therapy.
3. Lenvima is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
4. Lenvima is indicated in combination with pembrolizumab, for the treatment of patients with advanced
endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR),
who have disease progression following prior systemic therapy in any setting and are not candidates for curative
surgery or radiation.
5. Lenvima is indicated in combination with pembrolizumab for the first line treatment of patients with
advanced renal cell carcinoma.
B. Compendial Uses
1. Medullary, follicular, Hurthle cell, or papillary thyroid carcinoma
2. HCC: inoperable by performance status or comorbidity, local disease, metastatic disease or extensive liver
tumor burden
3. Relapsed RCC
4. Recurrent endometrial carcinoma
5. Thymic carcinoma
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review for endometrial carcinoma:
Documentation of laboratory report confirming MSI-H or mismatch repair deficient (dMMR) tumor status.
III. CRITERIA FOR INITIAL APPROVAL
A. Thyroid carcinoma
Authorization of 12 months may be granted for treatment of thyroid carcinoma when any of the following
criteria are met:
1. Member has follicular, Hürthle cell, or papillary thyroid carcinoma not amenable to radioactive iodine
therapy (RAI).
2. Member has medullary thyroid carcinoma and has progressed on vandetanib (Caprelsa) or cabozantinib
(Cometriq) OR these therapies are inappropriate
B. Renal Cell Carcinoma
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.
1. Lenvima will be used in combination with everolimus (Afinitor) and either of the following is met:
i. The disease histology is predominantly clear cell and the member has used prior therapy OR
ii. The disease histology is non-clear cell
2. Lenvima will be used in combination with pembrolizumab (Keytruda).
C. Hepatocellular Carcinoma
Authorization of 12 months may be grantd for treatment of hepatocellular carcinoma when any of the
following criteria are met:
1. Member has unresectable disease or inoperable by performance status or comorbidity
2. Member has local disease
3. Member has metastatic disease or extensive liver tumor burden
D. Endometrial Carcinoma
Authorization of 12 months may be granted for treatment of endometrial carcinoma when used in
combination with pembrolizumab for advanced, metastatic or recurrent endometrial carcinoma that is
not MSI-H or dMMR when the member has disease progression following prior systemic therapy and is
not a candidate for curative surgery or radiation.
E. Thymic Carcinoma
Authorization of 12 months may be granted for treatment of thymic carcinoma 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:
- Lenvima [package insert]. Woodcliff Lake, NJ: Eisai Inc.; August 2021.
- The NCCN Drugs & Biologics Compendium 2021 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed November 8, 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
