CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lenvima (lenvatinib) — Coverage Criteria (oncology)

Defines coverage, prior authorization, and documentation requirements for lenvatinib (Lenvima) for FDA‑approved and compendial oncology indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLenvima (lenvatinib) — Coverage Criteria (oncology)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approvals are typically for 12 months when indication-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 motypical authorization period

FDA + compendiaindications considered covered when criteria met

MMR statusdocumentation required (when applicable)

RCC, EC, melanomamultiple covered indications

Coverage Criteria for Lenvatinib (Lenvima)

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Indication: Member has an FDA‑approved indication or a listed compendial use for lenvatinib

FDA approvals: chunk 1; Compendial uses: chunk 2.

Thyroid carcinoma criteria

Member has follicular, oncocytic/Hürthle cell, or papillary thyroid carcinoma not amenable to radioactive iodine therapy (RAI)
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Member has medullary thyroid carcinoma and has progressed on vandetanib or cabozantinib, or those therapies are inappropriate
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Renal cell carcinoma criteria

Combination with everolimus: Lenvatinib 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
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Combination with pembrolizumab: Lenvatinib will be used in combination with pembrolizumab
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Hepatocellular carcinoma criteria

Member has unresectable disease and is not a transplant candidate
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Member has local disease that is inoperable due to performance status, comorbidity, or with minimal or uncertain extrahepatic disease
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Member has metastatic disease or extensive liver tumor burden
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Endometrial carcinoma criteria: Authorization of 12 months may be granted for advanced, metastatic, or recurrent endometrial carcinoma when used in combination with pembrolizumab and either (1) disease is mismatch repair proficient (pMMR), or (2) disease is mismatch repair deficient (dMMR) and has progressed following prior platinum‑based chemotherapy

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Thymic carcinoma criteria: Authorization of 12 months may be granted when lenvatinib is used as a single agent for thymic carcinoma

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Cutaneous melanoma criteria: Authorization of 12 months may be granted for metastatic or unresectable cutaneous melanoma that has progressed following anti‑PD‑1/PD‑L1 therapy when used in combination with pembrolizumab

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Regimen	Indication / Key criteria	Typical authorization
Lenvatinib + pembrolizumab
First-line advanced renal cell carcinoma; advanced, metastatic, or recurrent endometrial carcinoma (when either pMMR OR dMMR with progression after prior platinum-based chemotherapy); metastatic or unresectable cutaneous melanoma progressed following anti–PD‑1/PD‑L1 therapy
Authorization of 12 months when indication-specific criteria are met

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for use of the requested agent. Typical approvals are for up to 12 months and are contingent on meeting the indication-specific criteria in this policy.

Authorization duration: 12 months (typical)
Approvals contingent on meeting indication-specific criteria in Sections III and IV

Denial Risk

Thyroid carcinoma prior therapy

For medullary thyroid carcinoma, prior progression on vandetanib (Caprelsa) or cabozantinib (Cometriq) is required, or documentation that those therapies are inappropriate for the member.

Documentation Required

Required laboratory documentation

Submit documentation of laboratory report confirming mismatch repair (MMR) tumor status where applicable.

Required when assessing eligibility for endometrial carcinoma therapy (pMMR vs dMMR determinations)
Provide pathology/laboratory report showing MMR or microsatellite instability (MSI) testing results

Denial Risk

Non‑covered indications

Indications not listed in the policy (i.e., not FDA‑approved or compendial uses) are considered experimental/investigational and are not medically necessary.

Biomarker & Definitions

MMR / MSI status — biomarker requirement

Required testDocumentation of laboratory report confirming mismatch repair (MMR) tumor status is required where applicable.

When requiredMMR/MSI status is required for endometrial carcinoma when lenvatinib is used in combination with pembrolizumab.

Accepted resultsReports must indicate mismatch repair proficient (pMMR) or mismatch repair deficient (dMMR)/MSI status as determined by an FDA‑approved test.

Action on dMMRFor dMMR endometrial carcinoma, lenvatinib + pembrolizumab may be authorized when disease has progressed following prior platinum‑based chemotherapy.

Action on pMMRFor pMMR endometrial carcinoma, lenvatinib + pembrolizumab may be authorized per the indication criteria.

Compendial uses — recognized references

Recognized compendiaUses listed in recognized compendia (e.g., NCCN Drugs & Biologics Compendium) are considered in addition to FDA‑approved indications.

Compendial covered usesMedullary, follicular, oncocytic/Hürthle cell, or papillary thyroid carcinoma; HCC; relapsed RCC; recurrent endometrial carcinoma; thymic carcinoma; cutaneous melanoma.

Coverage policy stanceIndications that are FDA‑approved or listed in the compendia are considered covered when all indication‑specific criteria are met.

Non‑compendial usesAll other indications not listed in the FDA‑approved or compendial sections are considered experimental/investigational and not medically necessary.

Line of Therapy Specifications

First-line

First‑line use where specifically indicated per FDA approval and as described below:

Line: First‑line when indicated (for example, lenvatinib in combination with pembrolizumab for first‑line treatment of advanced renal cell carcinoma; lenvatinib for first‑line unresectable hepatocellular carcinoma)

See FDA approvals in chunk 1 and RCC combination details in chunk 6.

Background — Drug Information

Lenvatinib (Lenvima) is a multi‑kinase inhibitor with regulatory approvals and compendial references across several solid tumor types. In this policy, compendial uses include thyroid carcinoma subtypes (medullary, follicular, oncocytic/Hürthle cell, and papillary), hepatocellular carcinoma (HCC), relapsed renal cell carcinoma (RCC), recurrent endometrial carcinoma, thymic carcinoma, and cutaneous melanoma. Coverage is limited to the FDA‑approved and listed compendial indications described in the criteria.