CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lenvima (lenvatinib)

Defines clinical indications, documentation and prior authorization criteria for coverage of lenvatinib (Lenvima) for FDA-approved and select compendial uses (thyroid carcinoma, renal cell carcinoma, hepatocellular carcinoma, endometrial carcinoma, thymic carcinoma, cutaneous melanoma) and continuity/reauthorization rules for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLenvima (lenvatinib)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation, including laboratory report confirming mismatch repair (MMR) tumor status when applicable; authorizations may be granted for 12 months if criteria are met.

POLICY UPDATE CHANGES

No material clinical/coverage changes

6Covered Indications Listed

12 monthsAuthorization Duration (typical)

Coverage Summary & Indications

Lenvima (lenvatinib) is a multi-kinase inhibitor with FDA approvals across several malignancies and additional compendial uses referenced from NCCN and other compendia. This policy summarizes coverage and prior authorization criteria based on the Lenvima package insert (Nov 2022) and the NCCN Drugs & Biologics Compendium 2023 and defines indications, documentation, and prior authorization scope for Neighborhood Health Plan of Rhode Island members.

FDA-Approved Indications - Specific

Covered when ALL of the following are met for the specific FDA-approved indication:

FDA-Approved Indications (any of the following)

Lenvima in combination with pembrolizumab for first-line treatment of adult patients with advanced renal cell carcinoma
Lenvima for treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC)
Lenvima in combination with everolimus for treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy
Lenvima in combination with pembrolizumab for treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
Lenvima for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)

Initial Therapy Criteria (by Indication)

Thyroid Carcinoma - Authorization Criteria

Authorization of 12 months may be granted for treatment of thyroid carcinoma when ANY of the following are met:

ANY of the following

Member has follicular, oncocytic/Hurthle cell, or papillary thyroid carcinoma not amenable to radioactive iodine therapy (RAI)
Member has medullary thyroid carcinoma and has progressed on vandetanib (Caprelsa) or cabozantinib (Cometriq) OR these therapies are inappropriate
Member has locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC) (FDA indication)

Renal Cell Carcinoma - Authorization Criteria

Authorization of 12 months may be granted for treatment of advanced, relapsed or stage IV renal cell carcinoma when used in the following settings:

ANY of the following

When used with everolimus (Afinitor)
- Requested drug will be used in combination with everolimus (Afinitor)
- Disease histology is predominantly clear cell AND the member has used prior therapy
When used with pembrolizumab (Keytruda)
- Requested drug will be used in combination with pembrolizumab (Keytruda)
- Disease histology is non-clear cell
Lenvima in combination with pembrolizumab for first-line treatment of advanced RCC (FDA indication)

Hepatocellular Carcinoma (HCC) - Authorization Criteria

Authorization of 12 months may be granted for treatment of hepatocellular carcinoma as a single agent when ANY of the following are met:

ANY of the following

Member has unresectable disease and is not a transplant candidate
Member has local disease, inoperable by performance status, comorbidity, or with minimal or uncertain extrahepatic disease
Member has metastatic disease or extensive liver tumor burden
Lenvima for first-line treatment of unresectable HCC (FDA indication)

Endometrial Carcinoma - Authorization Criteria

Authorization of 12 months may be granted for treatment of advanced, metastatic or recurrent endometrial carcinoma when used in combination with pembrolizumab (Keytruda) when either of the following are met:

ANY of the following

The disease is mismatch repair proficient (pMMR)
The disease is mismatch repair deficient (dMMR) and has progressed following prior platinum-based chemotherapy
Lenvima in combination with pembrolizumab for advanced endometrial carcinoma that is pMMR or not MSI-H after progression on prior systemic therapy and not candidates for curative therapy (FDA indication)

Thymic Carcinoma - Authorization Criteria

Authorization of 12 months may be granted when criteria met:

ALL of the following

Indication is thymic carcinoma (compendial use)
Lenvima used as a single agent

Cutaneous Melanoma - Authorization Criteria

Authorization of 12 months may be granted when criteria met:

ALL of the following

Metastatic or unresectable cutaneous melanoma that has progressed following treatment with an anti-PD-1/PD-L1-based therapy
Lenvima used in combination with pembrolizumab

Continuation / Reauthorization Criteria

Continuation of Therapy / Reauthorization

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization when ALL of the following are met:

ALL of the following

Current indication is listed in the policy (Section III)
There is no evidence of unacceptable toxicity while on the current regimen
There is no evidence of disease progression while on the current regimen

Authorization duration (typical): 12 months. Reauthorization may be granted for an additional 12 months when continuation criteria are met (no unacceptable toxicity and no evidence of disease progression).

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required

Submission of documentation is necessary to initiate the prior authorization review. Authorization may be granted for up to 12 months if the approval criteria are met.

Documentation Required

MMR status documentation

Provider must submit a laboratory report confirming mismatch repair (MMR) tumor status when applicable (for example, pMMR/dMMR determinations in endometrial carcinoma).

Providers must submit indication-specific documentation to support the request (for example, prior therapy history for renal cell carcinoma and documentation of prior anti-PD-1/PD-L1 therapy for cutaneous melanoma, and laboratory reports confirming mismatch repair (MMR) tumor status for endometrial carcinoma when applicable).

Background

Lenvima is a multi-kinase inhibitor with FDA-approved indications including treatment of radioactive iodine‑refractory differentiated thyroid cancer, first-line unresectable hepatocellular carcinoma, and several renal cell carcinoma and endometrial carcinoma indications (including combinations with pembrolizumab or everolimus); it also has compendial uses such as medullary and other thyroid carcinomas, relapsed RCC, thymic carcinoma, and cutaneous melanoma as referenced in NCCN and other compendia.

Policy ScopeDefines clinical indications, documentation and prior authorization criteria for coverage of lenvatinib (Lenvima) for FDA-approved and select compendial uses (thyroid carcinoma, renal cell carcinoma, hepatocellular carcinoma, endometrial carcinoma, thymic carcinoma, cutaneous melanoma) and continuity/reauthorization rules for Neighborhood Health Plan of Rhode Island members.

Coverage StanceCovered with criteria

OpenPayer

Lenvima (lenvatinib)

Coverage Summary & Indications

Initial Therapy Criteria (by Indication)

Continuation / Reauthorization Criteria

Prior Authorization & Documentation Requirements

Applicable Codes

Clinical Evidence & References

Background

Revision History