CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lenvima (lenvatinib) — Coverage Criteria (Oncology)

Defines accepted indications, inclusion and exclusion criteria, and utilization management authority for lenvatinib (Lenvima) for oncology indications for Neighborhood Health Plan of Rhode Island members; applies to providers requesting authorization through the UM process.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLenvima (lenvatinib) — Coverage Criteria (Oncology)

Policy CodePolicy N/A

Change TypeAdministrative (no material clinical changes)

Effective DateOct 25, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent/Utilization Management with supporting evidence per FDA label, CMS compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4oncology indications listed

24 mg/daymax daily dose (thyroid)

60/90monthly pill limits

Child-Pugh AHCC initial request

Coverage Criteria for Lenvima (lenvatinib)

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Indication-specific coverage criteria

Covered when ALL of the following indication-specific criteria are met (per indication below):

Continuation requests exemption: Continuation requests are exempt if (1) the requested medication was used within the last year, AND (2) the member has not experienced disease progression and/or intolerance to the requested medication, AND (3) additional medication(s) are not being added to the continuation request.

from policy continuation provision (chunk 3)

Thyroid cancer: Monotherapy for locally recurrent or metastatic differentiated thyroid cancer (papillary, follicular, Hürthle cell) that is refractory to radioactive iodine.

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Renal cell carcinoma: Either: (A) first-line advanced/metastatic RCC as combination lenvatinib + pembrolizumab OR (B) subsequent single-agent lenvatinib for advanced/metastatic RCC after disease progression on prior anti-angiogenesis therapy (oral TKI and/or bevacizumab) AND an immune checkpoint inhibitor.

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Hepatocellular carcinoma: Monotherapy for unresectable or metastatic hepatocellular carcinoma AND member must have Child-Pugh Class A on initial request.

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Endometrial cancer: Subsequent-line therapy: lenvatinib in combination with pembrolizumab for MSI-stable/MMR-proficient (not MSI-High/MMR-deficient) metastatic endometrial cancer after progression on one line of chemotherapy.

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Coverage will be denied when there is documented disease progression while taking lenvatinib or progression on a prior lenvatinib-containing regimen. Requests that would result in doses exceeding specified maximum daily limits are excluded: 24 mg/day for thyroid cancer, 20 mg/day for renal cell carcinoma, 12 mg/day for hepatocellular carcinoma, and 20 mg/day for endometrial cancer. Additionally, treatment that would exceed the policy's monthly tablet limits is excluded — specifically a maximum monthly supply corresponding to 60 tablets of 10 mg strength or 90 tablets of 4 mg strength.

Use of lenvatinib for investigational or off-label indications that lack adequate supporting evidence is considered not medically necessary. The policy defines insufficient evidence as clinical reports that do not adequately represent the patient population, regimen, or clinically meaningful outcomes, reliance on uncontrolled case reports or abstracts without full peer-reviewed publication, or other limitations that leave the use unsupported by CMS-recognized compendia or acceptable peer-reviewed literature.

Covered Regimens and Dosing

Regimen	Indication	Line of therapy / Initial request requirements	Coverage status
Lenvima (lenvatinib) monotherapy	Locally recurrent or metastatic differentiated thyroid cancer (papillary, follicular, Hürthle cell) refractory to radioactive iodine	Monotherapy; initial request for thyroid cancer per indication — disease refractory to radioactive iodine	Covered when criteria met
Lenvima (lenvatinib) monotherapy	Unresectable or metastatic hepatocellular carcinoma (HCC)	Monotherapy; initial request requires Child‑Pugh Class A	Covered when criteria met

Regimen	Indication	Line of therapy / Biomarker requirement	Coverage status
Lenvima (lenvatinib) + Keytruda (pembrolizumab)	Advanced or metastatic renal cell carcinoma (RCC)	First‑line combination therapy	Covered when criteria met
Lenvima (lenvatinib) + Keytruda (pembrolizumab)	Metastatic endometrial cancer, MSI‑stable / MMR‑proficient (not MSI‑High/deficient MMR)	Subsequent‑line therapy after progression on one line of chemotherapy; MSI‑stable/MMR‑proficient required	Covered when criteria met

Line of Therapy Specifications

first-line | second-line

RCC lines: First-line: lenvatinib in combination with pembrolizumab for advanced/metastatic renal cell carcinoma; OR Subsequent-line: single-agent lenvatinib for advanced/metastatic RCC after progression on prior anti-angiogenesis agent (oral TKI and/or bevacizumab) and an immune checkpoint inhibitor.

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subsequent

Endometrial: Subsequent-line (after one line of chemotherapy): lenvatinib in combination with pembrolizumab for MSI-stable/MMR-proficient metastatic endometrial cancer (not for MSI-High/MMR-deficient disease).

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Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Medication requests are processed by Evolent/UM and require review by the Utilization Management Department with final approval by the Utilization Management Medical Director.

Requests are processed by Evolent and reviewed by the Utilization Management Department.
Final approval is by the Utilization Management Medical Director/Committee.

Note

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Documentation Required

Supporting Evidence Required

Supporting evidence requirement — Use must be supported by FDA approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Acceptable evidence: FDA labeling, CMS compendia, NCCN, ASCO, or CMS-compliant peer-reviewed literature.

Denial Risk

Exclusion Criteria

Exclusion conditions — Requests will be excluded for disease progression while taking lenvatinib or on a prior lenvatinib-containing regimen; requests exceeding specified maximum doses or monthly limits; investigational or off-label uses lacking sufficient evidence per CMS-recognized standards.

Disease progression while taking lenvatinib or on a prior lenvatinib-containing regimen.
Maximum dose limits: 24 mg/day (thyroid), 20 mg/day (renal cell), 12 mg/day (hepatocellular), 20 mg/day (endometrial).
Monthly maximum limits: 60 tablets (10 mg) or 90 tablets (4 mg).
Investigational or off-label indications without sufficient evidence per CMS compendia or acceptable peer-reviewed literature will be excluded.

Definitions and Background

Acceptable supporting evidence

Primary accepted sourcesFDA approved product labeling.

Compendia and guidelinesCMS-recognized compendia, NCCN, and ASCO clinical guidelines.

Peer-reviewed literature standardPeer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 criteria.

Lenvatinib (Lenvima) is an oral tyrosine kinase inhibitor used in oncology for several FDA‑approved and guideline‑supported indications. It is approved as monotherapy for locally recurrent or metastatic differentiated thyroid cancer refractory to radioactive iodine, and for unresectable or metastatic hepatocellular carcinoma. In renal cell carcinoma, lenvatinib is indicated in combination with pembrolizumab for first‑line treatment of advanced/metastatic disease and may be used as single‑agent subsequent therapy after prior anti‑angiogenesis and checkpoint inhibitor regimens. For endometrial cancer, lenvatinib combined with pembrolizumab is an option as subsequent‑line therapy in MSI‑stable / MMR‑proficient metastatic disease after progression on one line of chemotherapy.

Policy Revision History

2016-03-23committee_review

Policy was reviewed by the committee on 03/23/2016 as part of ongoing oversight of Lenvima (lenvatinib).

2016-05-20committee_review

Policy was reviewed by the committee on 05/20/2016 as part of ongoing oversight of Lenvima (lenvatinib).

2017-06-29committee_review

Policy was reviewed by the committee on 06/29/2017 as part of ongoing oversight of Lenvima (lenvatinib).

2017-07-26committee_review

Policy was reviewed by the committee on 07/26/2017 as part of ongoing oversight of Lenvima (lenvatinib).

2018-07-06committee_review

Policy was reviewed by the committee on 07/06/2018 as part of ongoing oversight of Lenvima (lenvatinib).

2019-06-12committee_review

Policy was reviewed by the committee on 06/12/2019 as part of ongoing oversight of Lenvima (lenvatinib).

2019-12-11committee_review

Policy was reviewed by the committee on 12/11/2019 as part of ongoing oversight of Lenvima (lenvatinib).

2020-04-08committee_review

Policy was reviewed by the committee on 04/08/2020 as part of ongoing oversight of Lenvima (lenvatinib).

2021-03-10committee_review

Policy was reviewed by the committee on 03/10/2021 as part of ongoing oversight of Lenvima (lenvatinib).

2021-11-15committee_review

Policy was reviewed by the committee on 11/15/2021 as part of ongoing oversight of Lenvima (lenvatinib).

2022-03-09committee_review

Policy was reviewed by the committee on 03/09/2022 as part of ongoing oversight of Lenvima (lenvatinib).

2022-05-11committee_review

Policy was reviewed by the committee on 05/11/2022 as part of ongoing oversight of Lenvima (lenvatinib).

2022-07-13committee_review

Policy was reviewed by the committee on 07/13/2022 as part of ongoing oversight of Lenvima (lenvatinib).

2022-09-20committee_review

Policy was reviewed by the committee on 09/20/2022 as part of ongoing oversight of Lenvima (lenvatinib).

2023-07-12committee_review

Policy was reviewed by the committee on 07/12/2023 as part of ongoing oversight of Lenvima (lenvatinib).

2023-10-11committee_review

Policy was reviewed by the committee on 10/11/2023 as part of ongoing oversight of Lenvima (lenvatinib).

2024-10-09committee_approval

Committee approved the Lenvima (lenvatinib) policy; approval date recorded as 10/09/2024.

2024-10-25effective_dateLatest

Policy effective date set to 10/25/2024.