Lenvima® (lenvatinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Coverage Summary

Scope: UnitedHealthcare prior authorization/notification policy specifying clinical coverage criteria, initial authorization and reauthorization rules, pediatric automatic approval, NCCN-recognized indications, and program operational notes for lenvatinib (Lenvima) under commercial plans. Effective date: 2026-05-01. Policy number: 2026 P 1157-14.

Coverage stance: Covered with criteria. High-level covered indications per policy and supporting references include differentiated thyroid cancer (radioactive iodine-refractory or ineligible, locally recurrent/metastatic/progressive/symptomatic), hepatocellular carcinoma (unresectable), advanced renal cell carcinoma (in combination regimens), endometrial carcinoma (in combination with pembrolizumab for specified patients), recurrent adenoid cystic carcinoma, thymic carcinoma, and cutaneous melanoma (used with pembrolizumab for unresectable or metastatic disease).

Initial Therapy Criteria

Differentiated thyroid cancer - Initial Authorization

Lenvima will be approved based on all of the following criteria:

ALL of the following

Diagnosis of differentiated thyroid cancer (DTC)
Disease is locally recurrent, metastatic, progressive, or symptomatic
Disease is radioactive iodine-refractory or ineligible

Authorization will be issued for 12 months.

Advanced renal cell carcinoma (RCC) - Initial Authorization

Lenvima will be approved based on all of the following criteria:

ALL of the following

Diagnosis of advanced renal cell carcinoma
One of the following
- a) Both of the following
  - History of failure, contraindication, or intolerance to prior antiangiogenic therapy (e.g., bevacizumab, pazopanib, sunitinib, sorafenib)
  - Used in combination with Afinitor (everolimus)
- Used in combination with Keytruda (pembrolizumab)

Hepatocellular carcinoma - Initial Authorization

Lenvima will be approved based on the following criterion:

Diagnosis of hepatocellular carcinoma

Authorization will be issued for 12 months.

Endometrial carcinoma - Initial Authorization

Lenvima will be approved based on the following criterion:

Diagnosis of endometrial carcinoma

Authorization will be issued for 12 months.

Recurrent adenoid cystic carcinoma - Initial Authorization

Lenvima will be approved based on the following criterion:

Diagnosis of recurrent adenoid cystic carcinoma

Authorization will be issued for 12 months.

Thymic carcinoma - Initial Authorization

Lenvima will be approved based on the following criterion:

Diagnosis of thymic carcinoma

Authorization will be issued for 12 months.

Cutaneous melanoma - Initial Authorization

Lenvima will be approved based on all of the following criteria:

Diagnosis of cutaneous melanoma

Used in combination with Keytruda (pembrolizumab)

Authorization will be issued for 12 months.

Patients less than 19 years of age

For members under the age of 19 years, the prescription will automatically process without a coverage review. Authorization will be issued for 12 months.

Patient is less than 19 years of age

Authorization will be issued for 12 months.

NCCN Recommended Regimens

The drug has been recognized for treatment of the cancer indication by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

NCCN recognition with Category 1, 2A, or 2B for the indication

Authorization will be issued for 12 months.

Continuation / Reauthorization Criteria

Differentiated thyroid cancer - Reauthorization

Lenvima will be approved based on the following criterion:

Patient does not show evidence of progressive disease while on Lenvima therapy

Authorization will be issued for 12 months.

Advanced renal cell carcinoma (RCC) - Reauthorization

Lenvima will be approved based on the following criteria:

Patient does not show evidence of progressive disease while on Lenvima therapy

Used in combination with Afinitor (everolimus) or Keytruda (pembrolizumab)

Unproven Uses / Exclusions

Exclusions / Unproven uses: The policy limits coverage to NCCN-recognized indications and the FDA/NCCN-aligned indications and criteria. Off-label uses are acknowledged only where recommended by the NCCN Drugs and Biologics Compendium; otherwise use outside those recognized indications would not meet the coverage criteria. The background notes that NCCN recognizes additional off-label uses (for example medullary thyroid carcinoma after progression on vandetanib or cabozantinib) but coverage is driven by NCCN recognition and the policy’s specified criteria.

Applicable Codes

ICD-10 Diagnoses referenced (examples provided in policy text)ICD-10

No codes listed

Provider Actions & Operational Notes

Prior Authorization

Prior authorization required for coverage

Members must meet specified indication-specific clinical criteria for initial authorization. Authorization durations are 12 months. For members under age 19, prescriptions automatically process without coverage review but an authorization will be issued for 12 months.

Documentation Required

Clinical documentation for reauthorization

Reauthorization requires documentation that the patient does not show evidence of progressive disease while on Lenvima therapy. Where applicable, documentation should indicate continuation of the combination agent (e.g., everolimus or pembrolizumab) during reauthorization.

Clinical Evidence & References

Evidence and references: Primary sources cited in the policy are the Lenvima package insert, Eisai Inc.; January 2025, and the NCCN Drugs and Biologics Compendium, accessed January 9, 2026. Background notes specify that NCCN recognizes additional off-label uses and that the policy indications align with FDA labeling and NCCN recommendations.

Background & Definitions

Background: Lenvatinib is an oral kinase inhibitor indicated per FDA labeling and NCCN recommendations for multiple oncology indications including locally recurrent or metastatic, progressive radioactive iodine-refractory differentiated thyroid cancer; advanced renal cell carcinoma (in combination with everolimus after prior anti-angiogenic therapy or with pembrolizumab for first-line advanced RCC); unresectable hepatocellular carcinoma; and in combination with pembrolizumab for certain advanced endometrial carcinoma patients. The NCCN also recommends Lenvima for additional uses such as medullary thyroid carcinoma after progression on vandetanib or cabozantinib, recurrent adenoid cystic carcinoma, metastatic hepatocellular carcinoma, thymic carcinoma, and cutaneous melanoma. Definition: "NCCN-recognized" refers to an indication appearing in the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B.

Revision History

2/2026revisedLatest

Annual review with updates to criteria based on current NCCN recommendations and references (2/2026).

Effective 5/1/2026revised

Policy effective date updated to 2026-05-01; P&T approval history includes reviews from 2015 through 2/2026.

Prior updates 2015-2025 (historic)added

Policy includes approval pathways for multiple indications including differentiated thyroid cancer, RCC (with combinations), hepatocellular carcinoma, endometrial carcinoma, recurrent adenoid cystic carcinoma, thymic carcinoma, and cutaneous melanoma (various prior updates).