CurrentNeighborhood Health Plan of Rhode IslandPolicy 1865-A

Lenvima (lenvatinib) coverage

Defines medical necessity and prior authorization criteria for lenvatinib (Lenvima) for approved FDA indications and certain compendial uses for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLenvima (lenvatinib) coverage

Policy CodePolicy 1865-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation including tumor MMR status when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

ListedFDA indications summarized

Yescompendial uses included

Coverage and Medical Necessity Criteria

Thyroid carcinoma

Covered when ANY of the following are met; authorization of 12 months may be granted.

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Renal cell carcinoma (RCC)

Covered when ANY of the following combination therapy criteria are met; authorization of 12 months may be granted.

RCC — lenvatinib + everolimus: Requested drug will be used in combination with everolimus and either: the disease histology is predominantly clear cell and the member has used prior therapy, OR the disease histology is non-clear cell.

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

Hepatocellular carcinoma (HCC)

Covered as single agent when ALL of the following are met; authorization of 12 months may be granted.

HCC single-agent criteria: Member has unresectable disease and is not a transplant candidate; Member has extrahepatic/metastatic disease and is ineligible for resection, transplant, or locoregional therapy.

Endometrial carcinoma

Covered in combination with pembrolizumab when ANY of the following are met; authorization of 12 months may be granted.

Endometrial carcinoma — pMMR: Member has advanced or recurrent endometrial carcinoma that is mismatch repair proficient (pMMR).

Documentation of MMR status by an FDA-approved test is required where applicable.

Endometrial carcinoma — dMMR progressed after platinum: Member has advanced endometrial carcinoma that is mismatch repair deficient (dMMR) and has progressed following prior platinum-based chemotherapy.

Documentation of MMR status by an FDA-approved test is required where applicable.

Compendial and other covered uses

Authorization of 12 months may be granted for listed compendial uses when criteria for those indications are met.

Compendial — thyroid subtypes: Anaplastic, medullary, follicular, oncocytic/Hürthle cell, or papillary thyroid carcinoma as listed under compendial uses.

Compendial — HCC: Hepatocellular carcinoma (HCC) as listed under compendial uses.

Compendial — relapsed RCC: Relapsed renal cell carcinoma as a compendial use.

Compendial — recurrent endometrial carcinoma: Recurrent endometrial carcinoma as a compendial use.

Compendial — thymic carcinoma: Thymic carcinoma treated with lenvatinib as a single agent.

Compendial — cutaneous melanoma: Metastatic or unresectable cutaneous melanoma that has progressed following anti-PD-1/PD-L1 therapy, when used in combination with pembrolizumab.

Regimen	Indication / Setting	Coverage status
Lenvatinib + pembrolizumab	First-line treatment of advanced renal cell carcinoma (RCC); also for advanced endometrial carcinoma when used with pembrolizumab and criteria for MMR status are met	Covered
Lenvatinib + everolimus	Treatment of advanced RCC following one prior anti-angiogenic therapy, or when disease histology is non–clear cell	Covered
Lenvatinib (single-agent)	First-line treatment of unresectable hepatocellular carcinoma (HCC); also used for differentiated thyroid cancers (radioactive iodine‑refractory DTC) and selected compendial single‑agent indications per policy	Covered
Lenvatinib + pembrolizumab	Advanced or recurrent endometrial carcinoma: when mismatch repair proficient (pMMR) OR mismatch repair deficient (dMMR) after progression on prior platinum‑based chemotherapy	Covered
Lenvatinib + pembrolizumab	Metastatic or unresectable cutaneous melanoma that progressed after anti‑PD‑1/PD‑L1 therapy (compendial use)	Covered

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lenvima (lenvatinib). Approval is generally granted for up to 12 months when the member meets the indication-specific criteria in the coverage section.

Prior authorization required for all indications listed in the policy
Typical approval duration: up to 12 months, when criteria are met

Documentation Required

Documentation Requirements for MMR/MSI Status

Submit documentation of the member’s tumor mismatch repair (MMR) status (laboratory report) when the requested indication requires determination of MMR or MSI status. Lack of documentation of tumor MMR/MSI status where applicable may result in inability to approve the prior authorization.

Provide an FDA‑approved test result for MMR/MSI when treating endometrial carcinoma or other indications requiring MMR/MSI status
Attach lab report to the prior authorization request

Prior Authorization

Required Prior Therapies for Medullary Thyroid Carcinoma

For medullary thyroid carcinoma indications, prior authorization will require documentation that the member has experienced disease progression on vandetanib (Caprelsa) or cabozantinib (Cometriq), or documentation that those therapies are unavailable or medically inappropriate for the member.

If available, include prior treatment records showing progression on vandetanib or cabozantinib
If those agents are unavailable or inappropriate, include documentation explaining contraindication, intolerance, or access issue

Specified Lines of Therapy

first-line

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

second-line

Second-line RCC after anti-angiogenic therapy: Lenvatinib in combination with everolimus for treatment of advanced renal cell carcinoma following one prior anti-angiogenic therapy.

Biomarker and Diagnostic Requirements

MMR / MSI — pMMR or dMMR (inv-16)

RequirementTumor MMR status must be documented as either pMMR or dMMR as determined by an FDA-approved test.

When requiredDocumentation of MMR status is applicable for endometrial carcinoma when used in combination with pembrolizumab and other indications referencing MMR.

Acceptable evidenceSubmit laboratory report confirming mismatch repair (MMR) tumor status from an FDA-approved test.

Consequences of missing documentationLack of documentation of tumor MMR status where applicable may lead to inability to approve prior authorization.

Mismatch repair (MMR) status — inv-13

DefinitionMismatch repair (MMR) tumor status must be determined as proficient (pMMR) or deficient (dMMR) by an FDA-approved test.

Documentation requiredSubmit laboratory report confirming MMR tumor status from an FDA-approved test when applicable; documentation is required for endometrial carcinoma criteria.

Clinical useMMR status informs eligibility for lenvatinib plus pembrolizumab in endometrial carcinoma (pMMR or dMMR with prior platinum-based chemotherapy as specified).

Source guidancePolicy references FDA-indicated requirement that endometrial carcinoma be classified as pMMR (or not MSI-H) by an FDA-approved test.

Background and Drug Information

Lenvatinib (Lenvima) is an oral multikinase inhibitor used in oncology for multiple tumor types. It is approved in FDA-labeled regimens and is also listed for selected compendial uses such as various thyroid carcinoma subtypes, hepatocellular carcinoma, and as part of combination regimens in renal cell and endometrial cancers. The policy authorizes therapy for approved indications and certain compendial uses when criteria are met, generally with prior authorization for up to 12 months.