CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lenvima (lenvatinib) — coverage criteria

Defines medical necessity and prior authorization criteria for lenvatinib (Lenvima) across FDA-approved and select compendial oncology indications for plan members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLenvima (lenvatinib) — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization required; authorizations up to 12 months may be granted when indication-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization duration

5+FDA-approved indications listed

6Compendial uses enumerated

Documentation requiredMMR requirement

Coverage Criteria for Lenvima (lenvatinib)

Thyroid carcinoma (initial therapy)

Thyroid carcinoma - general: Member has follicular, oncocytic/Hürthle cell, or papillary thyroid carcinoma not amenable to radioactive iodine therapy (RAI).

See policy thyroid carcinoma criteria.

Thyroid carcinoma - medullary: Member has medullary thyroid carcinoma and has progressed on vandetanib or cabozantinib OR these therapies are inappropriate.

Prior therapy requirement for medullary thyroid carcinoma.

Thyroid carcinoma - anaplastic: Member has stage IVC anaplastic thyroid carcinoma and the requested drug will be used in combination with pembrolizumab.

Combination use required for anaplastic thyroid carcinoma.

Renal cell carcinoma

Covered when ANY of the following RCC settings are met (authorization up to 12 months):

RCC with everolimus: Requested drug will be used in combination with everolimus and either (i) disease histology is predominantly clear cell and the member has used prior therapy OR (ii) disease histology is non-clear cell.

Indication-specific combination and histology criteria.

RCC with pembrolizumab: Requested drug will be used in combination with pembrolizumab.

First-line combination option with pembrolizumab.

Hepatocellular carcinoma

Covered when ALL of the following are met for hepatocellular carcinoma (authorization up to 12 months):

HCC unresectable: Member has unresectable disease and is not a transplant candidate.

Single-agent use for unresectable HCC.

HCC local disease: Member has local disease inoperable by performance status, comorbidity, or with minimal or uncertain extrahepatic disease.

Inoperable local disease qualifies for single-agent therapy.

HCC metastatic: Member has metastatic disease or extensive liver tumor burden.

Extensive or metastatic liver involvement qualifies for single-agent therapy.

Endometrial carcinoma (with pembrolizumab)

Covered when ANY of the following are met for endometrial carcinoma (authorization up to 12 months):

Endometrial carcinoma pMMR: The disease is mismatch repair proficient (pMMR).

MMR status must be determined by an FDA-approved test; submit laboratory report when applicable.

Endometrial carcinoma dMMR progression: The disease is mismatch repair deficient (dMMR) and has progressed following prior platinum-based chemotherapy.

Documentation of prior platinum-based chemotherapy and MMR test results required.

Thymic carcinoma

Covered when the following are met for thymic carcinoma:

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

Single-agent use; authorization up to 12 months.

Cutaneous melanoma

Covered when the following are met for cutaneous melanoma:

Cutaneous melanoma: Authorization may be granted for metastatic or unresectable cutaneous melanoma that has progressed following anti-PD-1/PD-L1-based therapy, when used in combination with pembrolizumab.

Combination with pembrolizumab required; prior anti-PD-1/PD-L1 therapy progression documented.

All indications for lenvatinib (Lenvima) that are not listed in the policy’s FDA-approved indications or compendial uses are considered experimental/investigational and not medically necessary.

Indications that are not included in the policy’s enumerated FDA-approved indications or the listed compendial uses (for example, those not in the Compendial Uses list) are not medically necessary and will not be covered.

Covered Regimens and Combinations

Regimen	Indications / Line of therapy	Authorization duration	Coverage status
Lenvima (lenvatinib) in combination with pembrolizumab (Keytruda)
First-line treatment of advanced renal cell carcinoma; advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or specified endometrial settings; metastatic or unresectable cutaneous melanoma that progressed after anti-PD-1/PD-L1 therapy (melanoma use in combination with pembrolizumab)
Authorizations of up to 12 months may be granted
Covered

Regimen	Indications / Line of therapy	Authorization duration	Coverage status
Lenvima (lenvatinib) in combination with everolimus (Afinitor)
Treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy (for predominantly clear cell histology with prior therapy) or for non–clear cell histology
Authorizations of up to 12 months may be granted
Covered

Regimen	Indications / Line of therapy	Authorization duration	Coverage status
Lenvima (lenvatinib) as a single agent
Unresectable hepatocellular carcinoma (HCC) — including unresectable disease not a transplant candidate, inoperable local disease, or metastatic/extensive liver tumor burden; thymic carcinoma (single-agent use)
Authorizations of up to 12 months may be granted
Covered

Provider Actions, Documentation & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorizations of up to 12 months may be granted when indication‑specific criteria are met (see clinical criteria sections for thyroid carcinoma, renal cell carcinoma, hepatocellular carcinoma, endometrial carcinoma, thymic carcinoma, and cutaneous melanoma).

Prior authorization required
Authorizations up to 12 months may be granted when criteria are met

Documentation Required

MMR Documentation

Submit documentation of laboratory report confirming tumor mismatch repair (MMR) status when applicable (e.g., for endometrial carcinoma and other indications where MMR status affects coverage).

Laboratory report confirming MMR tumor status must be provided when applicable

Denial Risk

Non‑Covered Indications

Indications not listed among FDA‑approved or compendial uses are considered experimental/investigational and are not medically necessary.

Non‑covered: all indications that are not FDA‑approved or supported by compendia (see Compendial Uses list for covered indications)

Biomarker & Test Requirements

inv-16: MMR (mismatch repair)

Required documentationLaboratory report confirming mismatch repair (MMR) tumor status must be submitted when applicable.

DefinitionspMMR = proficient mismatch repair; dMMR = deficient mismatch repair as determined by an FDA‑approved test.

Use in endometrial carcinomaMMR status is required to determine eligibility for combination therapy with pembrolizumab in advanced, metastatic, or recurrent endometrial carcinoma.

When to testMMR testing is applicable when considering lenvatinib plus pembrolizumab for endometrial carcinoma or other indications specifying MMR status.

Definitions

inv-14: pMMR / dMMR

pMMR (proficient MMR)Disease is mismatch repair proficient (pMMR) as determined by an FDA‑approved test; eligible for lenvatinib plus pembrolizumab in advanced endometrial carcinoma.

dMMR (deficient MMR)Disease is mismatch repair deficient (dMMR); coverage with lenvatinib plus pembrolizumab requires prior platinum‑based chemotherapy and progression.

Test standardMMR status must be determined by an FDA‑approved test (equivalently, MSI status may be used per FDA wording).

Line of Therapy

first-line | second-line

First-line: Lenvima in combination with pembrolizumab for first-line treatment of advanced renal cell carcinoma.

Authorization up to 12 months for first-line advanced RCC with pembrolizumab.

Second-line: Lenvima in combination with everolimus for treatment of advanced RCC following one prior anti-angiogenic therapy.

Use with everolimus appropriate for subsequent-line therapy or non-clear cell histology.

Background

The compendial uses list includes: anaplastic, medullary, follicular, oncocytic/Hürthle cell, or papillary thyroid carcinoma; hepatocellular carcinoma (HCC); relapsed renal cell carcinoma (RCC); recurrent endometrial carcinoma; thymic carcinoma; and cutaneous melanoma. Any use outside these compendial indications (and outside FDA-approved indications) is considered experimental/investigational and not medically necessary.