Coverage Policies

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If not specified in a QualChoice coverage policy (Benefit Interpretation), QualChoice follows care guidelines published by MCG Health.

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Effective Date: 07/01/2015 Title: Lenvima (Lenvatinib)
Revision Date: 07/01/2021 Document: BI485:00
CPT Code(s): None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Lenvima is used to treat thyroid cancer, advanced renal cell cancer, endometrial cancer, and hepatocellular carcinoma.

2)    Lenvima (lenvatinib) requires prior authorization.

3)    Lenvima is a specialty medication and is available only through two specialty pharmacies, either Accredo or Biologics, Inc.

Medical Statement

Lenvima (lenvatinib) is considered medically necessary for members meeting the following criteria:

1)    Member is 18 years of age or older; AND

2)    Diagnosis of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC); OR

3)    Diagnosis of advanced renal cell cancer (RCC)

a.    Used in combination with everolimus

b.    After progression on one prior anti-angiogenic therapy; OR

4)    Diagnosis of unresectable hepatocellular carcinoma (HCC) as first-line therapy; OR

5)    Diagnosis of Endometrial Cancer;

a.    Prescribed by or in consultation with an oncologist;

b.    Age ≥ 18 years;

c.    Prescribed in combination with Keytruda®; *Prior authorization may be required for Keytruda

d.    Disease is not MSI-H or dMMR (i.e., disease is not indicative of MMR gene mutation or loss of expression);

e.    Disease has progressed following prior systemic therapy (e.g., carboplatin/paclitaxel);

f.     Member is not a candidate for curative surgery or radiation;

g.    Request meets one of the following (a or b):*

h.    a. Dose does not exceed 20 mg (2 capsules) per day;

i.      b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN


As a specialty drug, Lenvima is limited to no more than a 30-day supply per fill through either Accredo or Biologics, Inc.


1)    Lenvima Prescribing Information. Eisai, Inc. Woodcliff Lake, NJ.  July 2020.

2)    Clinical Pharmacology. Accessed online May 16, 2021.

3)    Schlumberger M, Tahara M, Wirth LJ, et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015; 372(7):621-30.

4)    NCCN Drugs and Biologic Compendium. Accessed online 05-16-21.



1)    Effective 04/01/2019: Added coverage criteria for advanced renal cell cancer and unresectable hepatocellular carcinoma.

2)    Effective 07/01/2021: Added coverage criteria for endometrial cancer.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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