CurrentUnitedHealthcarePolicy N/A

Lenvima (lenvatinib) — Prior Authorization Criteria

Prior authorization and notification criteria for coverage of Lenvima (lenvatinib) for specified oncologic indications and patient populations under UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerUnitedHealthcare

PolicyLenvima (lenvatinib) — Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization; approvals are typically issued for 12 months when clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical auth duration

Multipleindications covered

1/2A/2BNCCN regimens

No progressionreauthorization req

Coverage Criteria for Lenvima (lenvatinib)

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Covered for patients under 19 years

Pediatric approval: Patient is less than 19 years of age

Authorization issued for 12 months

Differentiated thyroid cancer — Initial Therapy

Initial authorization for differentiated thyroid cancer (DTC)

DTC initial: (1) Diagnosis of differentiated thyroid cancer (DTC) AND (2) Disease is locally recurrent, metastatic, progressive, or symptomatic AND (3) Disease is radioactive iodine-refractory or ineligible

Authorization issued for 12 months

Differentiated thyroid cancer — Reauthorization

Reauthorization for differentiated thyroid cancer

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

Authorization issued for 12 months

Advanced renal cell carcinoma — Initial Therapy

Initial authorization for advanced renal cell carcinoma (RCC)

RCC initial: (1) Diagnosis of advanced renal cell carcinoma AND (2) One of the following: (a) Both: i. History of failure, contraindication, or intolerance to prior antiangiogenic therapy (examples: bevacizumab, pazopanib, sunitinib, sorafenib) AND ii. Used in combination with Afinitor (everolimus); OR (b) Used in combination with Keytruda (pembrolizumab)

Authorization issued for 12 months

Advanced renal cell carcinoma — Reauthorization

Reauthorization for advanced renal cell carcinoma (RCC)

RCC reauth: (1) Patient does not show evidence of progressive disease while on Lenvima therapy AND (2) Used in combination with Afinitor (everolimus) or Keytruda (pembrolizumab)

Authorization issued for 12 months

Hepatocellular carcinoma — Initial Therapy

Initial authorization for hepatocellular carcinoma (HCC)

HCC initial: (1) Diagnosis of hepatocellular carcinoma AND (2) Disease is unresectable or metastatic

Authorization issued for 12 months

Hepatocellular carcinoma — Reauthorization

Reauthorization for hepatocellular carcinoma (HCC)

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

Authorization issued for 12 months

Endometrial carcinoma — Initial and Reauthorization

Initial authorization and reauthorization for endometrial carcinoma

Endometrial initial: (1) Diagnosis of endometrial carcinoma

Authorization issued for 12 months

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

Authorization issued for 12 months

Recurrent adenoid cystic carcinoma — Initial and Reauthorization

Initial authorization and reauthorization for recurrent adenoid cystic carcinoma

Adenoid cystic initial: (1) Diagnosis of recurrent adenoid cystic carcinoma

Authorization issued for 12 months

Adenoid cystic reauth: Patient does not show evidence of progressive disease while on Lenvima therapy

Authorization issued for 12 months

Thymic carcinoma — Initial and Reauthorization

Initial authorization and reauthorization for thymic carcinoma

Thymic initial: (1) Diagnosis of thymic carcinoma AND (2) One of: i. Used as a single agent for those who cannot tolerate first-line combination regimens; OR ii. Used as second-line therapy in unresectable locally advanced disease, solitary metastasis or ipsilateral pleural metastasis, or extrathoracic metastatic disease

Authorization issued for 12 months

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

Authorization issued for 12 months

Initial Therapy — Cutaneous Melanoma (ALL conditions must be met)

Covered when ALL of the following are met for cutaneous melanoma:

Cutaneous Melanoma Initial Authorization: (1) Diagnosis of cutaneous melanoma; AND (2) disease is unresectable OR disease is metastatic; AND (3) used in combination with pembrolizumab (Keytruda).

Authorization issued for 12 months.

Initial Therapy — Single agent / Second-line criteria (ANY of following)

Covered when ANY of the following line-of-therapy criteria apply or as second-line in specified settings:

Single agent or second-line use: (i) Used as a single agent for those who cannot tolerate first-line combination regimens; OR (ii) used as second-line therapy in unresectable locally advanced disease, solitary metastasis or ipsilateral pleural metastasis, or extrathoracic metastatic disease.

Authorization issued for 12 months if no disease progression.

Reauthorization Criteria — general continuation rules

Reauthorization:

Reauthorization for ongoing therapy: (1) Patient does not show evidence of progressive disease while on Lenvima therapy; AND (2) where applicable, continued use in specified combination (e.g., with pembrolizumab or everolimus) as previously authorized.

Authorization will be issued for 12 months.

Per the policy change history, criteria for biliary cancer were removed because that indication is no longer recommended by the NCCN. This modification was implemented in the 2/2025 annual review and is documented in the policy references and change log.

This removal is limited to the biliary cancer criteria; other NCCN-referenced indications and combination-use criteria in the policy remain as specified elsewhere in the document.

Initial Therapy Authorization Nodes

Initial therapy nodes

Initial authorization criteria by indication

DTC initial: Diagnosis of DTC AND locally recurrent, metastatic, progressive, or symptomatic disease AND radioactive iodine-refractory or ineligible

RCC initial: Diagnosis of advanced RCC AND either prior anti-angiogenic therapy failure/contraindication/intolerance and used with everolimus, OR used with pembrolizumab

HCC initial: Diagnosis of hepatocellular carcinoma AND disease is unresectable or metastatic

Endometrial initial: Diagnosis of endometrial carcinoma

Adenoid cystic initial: Diagnosis of recurrent adenoid cystic carcinoma

Thymic initial: Diagnosis of thymic carcinoma AND either single agent if intolerant of first-line combination or as second-line for specified disease states

Initial Therapy — Melanoma specific initial authorization nodes

Initial authorization nodes for melanoma:

Melanoma initial: Diagnosis of cutaneous melanoma; disease unresectable OR metastatic; used in combination with pembrolizumab (Keytruda).

12-month authorization.

Reauthorization / Continuation Criteria

Continuation/Reauthorization — reauthorization across indications

Reauthorization across indications

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

Authorization issued for 12 months

Continuation Therapy — continuation/reauthorization nodes

Continuation/Reauthorization nodes:

Continuation: Patient does not show evidence of progressive disease while on Lenvima therapy; continued combination use (e.g., with pembrolizumab) when applicable.

Authorization issued for 12 months.

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lenvima (lenvatinib). Typical approvals are issued for 12 months. For members under 19 years, the prescription will automatically process without a coverage review. Supply limits may apply. UnitedHealthcare may use prior claim/medication history, diagnosis codes (ICD-10) and claim logic to approve initial or reauthorization requests without additional documentation in some programs.

Typical approval length: 12 months
Members < 19 years: automatic process without coverage review
Automated approvals may be based on prior claims, ICD-10 codes, and claim logic
Supply limits may be enforced

Documentation Required

Initial Authorization — Cutaneous Melanoma

For initial authorization for cutaneous melanoma, provide documentation that supports all of the following:

Diagnosis of cutaneous melanoma
Disease is unresectable OR metastatic
Lenvima is prescribed in combination with Keytruda (pembrolizumab)
Authorization will be issued for 12 months

Step Therapy

Initial Authorization — Other Indications and Step/Sequence Notes

Initial authorization rules for other covered indications (examples) — ensure documentation shows diagnosis and applicable disease/stage details; for advanced renal cell carcinoma, include history of failure, contraindication, or intolerance to prior antiangiogenic therapy when required. For single-agent or second-line uses in certain indications, document intolerance to first-line combination regimens or prior therapy failure as applicable.

Differentiated thyroid cancer: diagnosis, locally recurrent/metastatic/progressive/symptomatic disease, radioactive iodine-refractory or ineligible — 12-month authorization
Advanced renal cell carcinoma: document prior antiangiogenic therapy failure/contraindication/intolerance when required
Hepatocellular carcinoma, endometrial carcinoma, recurrent adenoid cystic carcinoma, thymic carcinoma: provide diagnosis and disease details; many authorizations issued for 12 months
Single-agent use allowed for patients who cannot tolerate first-line combination regimens; second-line use allowed where specified — document prior therapy and intolerance/failure

Denial Risk

Reauthorization and Denial Triggers

Reauthorization will be approved only if the patient does not show evidence of progressive disease while on Lenvima therapy. Reauthorizations are typically issued for 12 months. Denial may occur for progressive disease while on therapy.

Reauthorization criterion: no evidence of progressive disease on therapy
Authorization length on reapproval: 12 months
Progressive disease on therapy may trigger denial of reauthorization

Documentation Required

Documentation Requirements

Required documentation must support the requested indication and include relevant disease status and prior therapies where applicable (e.g., evidence of radioactive iodine-refractory DTC, prior antiangiogenic therapy for RCC, prior intolerance to combination regimens for single-agent allowances).

Diagnosis and clinical details (stage, resectability, metastasis status)
Prior therapy history, failures, contraindications, or intolerances as applicable
Documentation of combination use when required (e.g., pembrolizumab with cutaneous melanoma)

Billing Rule

Automated Approval and Supply Limits

Automated approval and supply limits: UnitedHealthcare may approve initial and reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10), and claim logic. Supply limits may be applied per program.

Automated approvals vary by program and therapeutic class
Supply limits may be enforced

Step Therapy and Sequencing Requirements

Step	Requirement	Examples / Notes
1	Required when Lenvima is used in combination with Afinitor (everolimus) for advanced renal cell carcinoma: history of failure, contraindication, or intolerance to prior anti‑angiogenic therapy is required.	Examples of prior anti‑angiogenic agents: Avastin (bevacizumab), Votrient (pazopanib), Sutent (sunitinib), Nexavar (sorafenib).

Step	Allowance	Conditions
1	Allows single‑agent use of Lenvima when the patient cannot tolerate first‑line combination regimens.	Also allows single‑agent or second‑line use in unresectable locally advanced disease, solitary metastasis or ipsilateral pleural metastasis, or extrathoracic metastatic disease.

Site of Care and Pharmacy Processing

Note

Pharmacy: automated processing and possible supply limits

Pharmacy approvals may be processed using claim history and diagnosis codes; supply limits may be enforced at the pharmacy level.

Approvals/reauthorizations may rely on claim/medication history and ICD‑10 diagnosis codes
Supply limits may be applied in the pharmacy setting

Definitions and Reference Terms

radioactive iodine-refractory

DefinitionRadioactive iodine-refractory: differentiated thyroid cancer that is progressive, metastatic or locally recurrent and no longer responsive to radioactive iodine therapy (i.e., disease described in the policy as 'radioactive iodine-refractory').

Context in policyUsed as a criterion for initial authorization of Lenvima for differentiated thyroid cancer (DTC): patient has locally recurrent or metastatic, progressive, radioactive iodine-refractory disease.

Associated authorization noteWhen criteria are met (including radioactive iodine-refractory status), authorization is typically issued for 12 months.

NCCN Recommended Regimens

DefinitionNCCN Recommended Regimens: regimens recognized in the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B.

Role in policyThe policy recognizes NCCN Recommended Regimens as accepted treatment regimens for covered indications of Lenvima when listed in the NCCN compendium with categories 1, 2A, or 2B.

Implication for coverageUse of regimens listed by NCCN with these categories supports inclusion as an indicated regimen within the policy's coverage criteria.

Background

Lenvima (lenvatinib) is an oral multi-kinase inhibitor used across multiple advanced malignancies. The policy background notes its recognized roles in differentiated thyroid cancer, renal cell carcinoma (including combination regimens), hepatocellular carcinoma, endometrial carcinoma, recurrent adenoid cystic carcinoma, and thymic carcinoma and that certain regimens are identified in the NCCN Drugs & Biologics Compendium.

The policy references combination regimens where applicable (for example, with everolimus or pembrolizumab) and aligns coverage criteria with NCCN-recommended uses and label indications described in the referenced compendium.

Revision History

2025-02criteria_removalLatest

Removed criteria for biliary cancer because it is no longer recommended by NCCN.

2024-02annual_review

Updated thyroid cancer criteria based on label and NCCN; updated hepatobiliary and thymic cancer criteria per NCCN and updated references.

2023-02annual_review

Annual review: updated references and added NCCN recommended use for cutaneous melanoma; added state mandate footnote.

2022-02criteria_update

Updated renal cell cancer reauthorization to include combination use of Afinitor (everolimus) or Keytruda (pembrolizumab).

2021-11annual_review

Updated background and criteria for new approval of use in combination with Keytruda (pembrolizumab) for advanced RCC; removed anaplastic thyroid carcinoma criteria per NCCN.

2020-11annual_review

Updated background and criteria to include NCCN recommended use for recurrent adenoid cystic carcinoma and anaplastic thyroid carcinoma; added concurrent use with everolimus to RCC reauthorization criteria.

2019-11annual_review

Updated background and criteria to include new indication in combination with pembrolizumab for endometrial carcinoma and added general NCCN recommendations for use criteria.

2018-11criteria_update

Updated background and criteria to include new indication for unresectable hepatocellular carcinoma.

2018-07annual_review

Annual review with no change to coverage criteria; updated references.

Policy Summary

PayerUnitedHealthcare

PolicyLenvima (lenvatinib) — Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization; approvals are typically issued for 12 months when clinical criteria are met.

SourceLink

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