Centene lenvatinib Coverage & Prior Auth Policy Update

Coverage Criteria

Initial Approval - Differentiated Thyroid Cancer (DTC)

Covered when ALL of the following are met

DTC initial criteria: 1. Diagnosis of differentiated thyroid cancer (papillary, follicular, or oncocytic/ Hurthle cell carcinoma). 2. Prescribed by or in consultation with an oncologist. 3. Age > 18 years. 4. Disease is radioactive iodine‑refractory and recurrent, metastatic, or progressive. 5. Prescribed as monotherapy. 6. For brand Lenvima requests, member must use generic lenvatinib if available unless contraindicated or clinically significant adverse effects are experienced. 7. Request meets one of the following: a) Dose does not exceed both: i) 24 mg per day; and ii) 3 capsules per day; OR b) Dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA‑approved or recommended by NCCN; Hurthle clarified as oncocytic (see document history).

Initial Approval - Medullary or Anaplastic Thyroid Carcinoma (off-label)

Covered when ALL of the following are met

MTC/ATC criteria: 1. Diagnosis of medullary thyroid carcinoma (MTC) that is recurrent, progressive, or metastatic OR anaplastic thyroid carcinoma (ATC) that is metastatic. 2. Prescribed by or in consultation with an oncologist. 3. Age >= 18 years. 4. For MTC: failure of Cometriq (cabozantinib) or Caprelsa (vandetanib) unless contraindicated or not tolerated (prior authorization for these agents may be required). 5. For ATC: prescribed in combination with pembrolizumab (Keytruda). 6. For brand Lenvima requests, member must use generic lenvatinib if available unless contraindicated or clinically significant adverse effects are experienced. 7. Request meets one of the following: a) Dose does not exceed both: i) 24 mg per day; and ii) 3 capsules per day; OR b) Dose is within the FDA maximum limit for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA‑approved or recommended by NCCN; ATC off‑label criteria included per NCCN when applicable (see history).

Initial Approval - Renal Cell Carcinoma (RCC)

Covered when ALL of the following are met

RCC criteria: 1. Diagnosis of advanced renal cell carcinoma (relapsed, metastatic, or stage IV). 2. Prescribed by or in consultation with an oncologist. 3. Age >= 18 years. 4. Lenvatinib is prescribed in one of the following ways: a) in combination with pembrolizumab (Keytruda); b) in combination with everolimus (Afinitor/everolimus); or c) as subsequent therapy if histology is clear cell. 5. For brand Lenvima requests, member must use generic lenvatinib if available unless contraindicated or clinically significant adverse effects are experienced. 6. Request meets dosing limits depending on regimen: if with Keytruda: dose does not exceed both 20 mg per day and 2 capsules per day; if with everolimus: dose does not exceed both 18 mg per day and 2 (or up to 3 per regimen limits) capsules per day. 7. Alternatively, dose supported by practice guidelines or peer‑reviewed literature is acceptable (prescriber must submit supporting evidence).

Prior authorization may be required for Keytruda and everolimus; prescribed regimen must be FDA‑approved or recommended by NCCN; after 2 years of combination therapy, lenvatinib may be continued as single agent per dosing guidance (see continuation criteria).

Initial Approval - Hepatocellular Carcinoma (HCC)

Covered when ALL of the following are met

HCC criteria: 1. Diagnosis of hepatocellular carcinoma (HCC). 2. Prescribed by or in consultation with an oncologist. 3. Age >= 18 years. 4. Prescribed as single agent. 5. For brand Lenvima requests, member must use generic lenvatinib if available unless contraindicated or clinically significant adverse effects are experienced. 6. Dosing based on actual body weight: a) For body weight >= 60 kg: dose does not exceed both 12 mg per day and 3 capsules per day; b) For body weight < 60 kg: dose does not exceed both 8 mg per day and 2 capsules per day. 7. Alternatively, dose supported by practice guidelines or peer‑reviewed literature is acceptable (prescriber must submit supporting evidence).

Prescribed regimen must be FDA‑approved or recommended by NCCN; weight‑based dosing threshold applies (>=60 kg vs <60 kg).

Initial Approval - Endometrial Carcinoma (in combination with pembrolizumab)

Covered when ALL of the following are met

Endometrial carcinoma criteria: 1. Prescribed by or in consultation with an oncologist. 2. Age >= 18 years. 3. Disease is pMMR (not MSI‑H). 4. Prescribed in combination with pembrolizumab (Keytruda). 5. Disease has progressed following platinum‑based systemic therapy. 6. Member is not a candidate for curative surgery or radiation. 7. For brand Lenvima requests, member must use generic lenvatinib if available unless contraindicated or clinically significant adverse effects are experienced. 8. Dose does not exceed 20 mg per day and 2 capsules per day, or dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Prior authorization may be required for Keytruda; EC requires pMMR/non‑MSI‑H status per FDA/NCCN guidance.

Initial Approval - Thymic Carcinoma (off-label)

Covered when ALL of the following are met

Thymic carcinoma criteria: 1. Diagnosis of thymic carcinoma. 2. Prescribed by or in consultation with an oncologist. 3. Age >= 18 years. 4. Prescribed as single agent and as subsequent therapy. 5. For brand Lenvima requests, member must use generic lenvatinib if available unless contraindicated or clinically significant adverse effects are experienced. 6. Request meets one of the following: a) Dose does not exceed both: i) 24 mg per day; and ii) 3 capsules per day; OR b) Dose is within the FDA maximum limit for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Off‑label use allowed per NCCN category 2A for thymic carcinoma (document history).

Initial Approval - Cutaneous Melanoma (off-label, with pembrolizumab)

Covered when ALL of the following are met

Cutaneous melanoma criteria: 1. Diagnosis of cutaneous melanoma that is metastatic or unresectable. 2. Prescribed by or in consultation with an oncologist. 3. Age >= 18 years. 4. Disease has progressed following anti‑PD‑1/PD‑L1 therapy (e.g., pembrolizumab). 5. Prescribed in combination with pembrolizumab (Keytruda). 6. For brand Lenvima requests, member must use generic lenvatinib if available unless contraindicated or clinically significant adverse effects are experienced. 7. Dose does not exceed 20 mg per day and 2 capsules per day, or dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Prior authorization may be required for Keytruda; off‑label use included per NCCN category 2A (document history).

Continued Therapy

Covered when ALL of the following are met

Continued therapy criteria: 1. Member is currently receiving Lenvima via the Centene benefit or documentation supports member has received Lenvima for at least 30 days for a covered indication. 2. Member is responding positively to therapy. 3. For brand Lenvima requests, member must use generic lenvatinib if available unless contraindicated or clinically significant adverse effects are experienced. 4. If request is for a dose increase, the new dose must meet one of the following indication‑specific maxima or be supported by guidelines/literature with submitted evidence: a) DTC, MTC, ATC, TC: new dose does not exceed both 24 mg per day and 3 capsules per day; b) RCC in combination with everolimus: new dose does not exceed both 18 mg per day and 3 capsules per day; c) HCC: new dose does not exceed either 12 mg per day (if actual body weight >= 60 kg and <=3 capsules) or 8 mg per day (if actual body weight < 60 kg and <=2 capsules); d) RCC with pembrolizumab, endometrial carcinoma, or cutaneous melanoma: new dose does not exceed both 20 mg per day and 2 capsules per day. 5. New dose increases for off‑label uses must be supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

After completing 2 years of combination therapy with pembrolizumab, lenvatinib may be continued as single agent until disease progression or unacceptable toxicity (RCC context).

Indication-level coverage notes

Document history and indication-level clarifications (not exhaustive criteria):

Commercial approval duration: Approved for 12 months or duration of request, whichever is less.

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Dosing by indication: DTC: 24 mg/day; HCC: 12 mg PO QD if actual body weight >= 60 kg or 8 mg PO QD if actual body weight < 60 kg; RCC (with pembrolizumab): 20 mg PO QD; After 2 years of combination therapy with pembrolizumab, lenvatinib may be continued as single agent until disease progression or unacceptable toxicity.

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DTC specific: Hurthle (Hurthle) cell carcinoma clarified as oncocytic carcinoma and requires prescription as monotherapy.

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Off-label NCCN-based uses:

Other diagnoses or indications not explicitly covered within the indication-specific criteria are governed by the applicable formulary/no-coverage and non‑formulary policies for the member's line of business. Follow CP.CPA.190 for Commercial, HIM.PA.33 for Health Insurance Marketplace, and CP PMN.255 for Medicaid when the drug is on the formulary/PDL; if the drug is not on the formulary/PDL, follow the corresponding non‑formulary policies (CP.CPA.190 or HIM.PA.103 for marketplace and CP PMN.16 for Medicaid) as referenced in policy.

Requests for non‑FDA approved indications that are not addressed in this policy are excluded from coverage unless there is sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

If a requested use is not listed among the authorized diagnoses/indications and does not meet the criteria in this policy, route the request through the applicable off‑label or non‑formulary pathway per line‑of‑business policy. This includes reviewing recent label changes (within the prior 6 months) and applying the referenced policies (off‑label and non‑formulary/no‑coverage) to determine coverage.

Use of lenvatinib for non‑FDA approved indications without sufficient supporting documentation as required by the off‑label use policies may be determined to be not medically necessary. Providers should submit evidence of efficacy and safety per the referenced off‑label policies to support coverage consideration.

Dosing, Weight Thresholds, and Codes

Body weight dosing threshold for HCC

HCC weight-based dosing threshold>= 60 kg versus < 60 kg (use different maintenance doses)

Weight >= 60 kg12 mg per day (<= 3 capsules/day)

Weight < 60 kg8 mg per day (<= 2 capsules/day)

Maximum daily dose (varies by indication)

DTC / Thymic carcinoma maximum24 mg per day (<= 3 capsules/day)

RCC with pembrolizumab (Keytruda)20 mg per day (<= 2 capsules/day)

RCC with everolimus (Afinitor)

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Failure to submit required documentation may result in denial.

Prior authorization is required for Lenvima requests.
Required documentation includes office notes, pathology reports, imaging, and lab results demonstrating the member meets the specific criteria for the requested indication.

Note

Approval Duration

Commercial approvals are authorized for 12 months or the duration of the request, whichever is less. Medicaid/HIM approvals are authorized for 6 months where specified.

Commercial: 12 months or duration of request, whichever is less.
Medicaid/HIM: 6 months (where applicable per indication).
Prescribed regimen must be FDA-approved or recommended by NCCN; off-label or non-standard regimens require supporting evidence.

Initial Therapy Requirements

Initial authorization requirements by indication

Initial therapy nodes: See indication‑specific initial approval criteria sets: DTC, MTC/ATC, RCC, HCC, EC, thymic carcinoma, and cutaneous melanoma. Each requires oncology prescribing/consultation, age >= 18, brand‑to‑generic preference, indication‑specific dosing limits or supporting evidence, and prescribed regimen must be FDA‑approved or recommended by NCCN; prior authorization may be required for combination or prior agents (e.g., Keytruda, Afinitor/everolimus, Cometriq, Caprelsa).

Refer to each indication's criteria for exact dosing and prior agent requirements.

Initial/subsequent therapy notes

Initial/subsequent therapy language simplified in history

Subsequent therapy requirement: For RCC and thymic carcinoma (TC), criteria were simplified to require use as subsequent therapy or failure of prior NCCN‑recommended agents; document history reflects simplification of step/subsequent therapy language.

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Continuation Criteria

Continued Therapy

Criteria for continuing Lenvima therapy

Continuation nodes: 1. Member currently receiving Lenvima via Centene or has documentation of >=30 days treatment for a covered indication. 2. Member is responding positively to therapy. 3. For brand Lenvima requests, member must use generic lenvatinib if available unless contraindicated or clinically significant adverse effects are experienced. 4. Dose increases must not exceed indication‑specific maxima (see dosing table): DTC/MTC/ATC/TC: <=24 mg/day and <=3 capsules/day; RCC with everolimus: <=18 mg/day and appropriate capsule limit; HCC: weight‑based limits (12 mg or 8 mg) and capsule limits; RCC with pembrolizumab, EC, cutaneous melanoma: <=20 mg/day and <=2 capsules/day. 5. New dose increases for off‑label uses must be supported by practice guidelines or peer‑reviewed literature (prescriber must submit evidence).

After 2 years of combination therapy with pembrolizumab, lenvatinib may be continued as single agent until progression or unacceptable toxicity for RCC combination cases.

RCC continuation

Continuation after combination therapy in RCC

Post-combination continuation:

Step Therapy and Prior Treatments

Requirement	Policy detail
Prior agent/failure required for some thyroid indications
Medullary thyroid carcinoma (MTC): failure of Cometriq (cabozantinib) or Caprelsa (vandetanib) is required unless contraindicated or intolerant; prior authorization may be required for Cometriq and Caprelsa.
Anaplastic thyroid carcinoma (ATC): when covered as off-label, must be prescribed in combination with pembrolizumab (Keytruda) per policy.
Renal cell carcinoma (RCC) sequences: for clear cell RCC, lenvatinib may be used as subsequent therapy; policy allows lenvatinib in combination with pembrolizumab (Keytruda) or with everolimus (Afinitor) with specified dose limits; prior authorization may be required for Keytruda and Afinitor.
Dose and regimen support requirement
Prescribed regimen must be FDA‑approved or recommended by NCCN; alternative/off‑label dosing requires supporting practice guidelines or peer‑reviewed literature submitted by prescriber.

Requirement	Policy detail
Use as subsequent therapy (simplified historical language)
For RCC and thymic carcinoma (TC), criteria were simplified historically to require lenvatinib use as subsequent therapy or after failure/intolerance of prior NCCN‑recommended agents; documentation of prior therapy or intolerance should be provided as applicable.

Background

Lenvatinib is a multi‑kinase inhibitor indicated across several advanced malignancies. The policy addresses FDA‑approved uses such as differentiated thyroid cancer (radioactive iodine‑refractory DTC), hepatocellular carcinoma (HCC), and combination regimens in renal cell carcinoma (RCC), as well as the combination use with pembrolizumab for endometrial carcinoma. The document also provides coverage pathways and criteria for certain NCCN‑supported off‑label oncology indications when specific criteria are satisfied.

Definitions and Abbreviations

Radioactive iodine-refractory DTC

DefinitionDifferentiated thyroid cancer (papillary, follicular, oncocytic) that is recurrent, metastatic, or progressive and refractory to radioactive iodine therapy.

Common histologies includedPapillary, follicular, oncocytic (Hurthle cell / oncocytic carcinoma)

Context of use in policyRequired for initial DTC approval: disease must be radioactive iodine-refractory and recurrent, metastatic, or progressive.

pMMR / not MSI-H

TermpMMR (mismatch repair proficient) or not MSI-H

RequirementEndometrial carcinoma indication requires tumor status of pMMR / not MSI-H when used in combination with pembrolizumab.

OpenPayer

Lenvatinib (Lenvima) coverage

Coverage Criteria

Dosing, Weight Thresholds, and Codes

Provider Actions and Authorization Requirements

Initial Therapy Requirements

Continuation Criteria

Step Therapy and Prior Treatments

Background

Definitions and Abbreviations