Pharmacy Prior Authorization Criteria

Lenvima (lenvatinib)

Indications for Prior Authorization

Lenvima (lenvatinib)

• For diagnosis of Differentiated Thyroid Carcinoma
  Indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).

• For diagnosis of Renal Cell Carcinoma
  1) Indicated for use in combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC). 2) Indicated for use in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy.

• For diagnosis of Hepatocellular Carcinoma
  Indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

• For diagnosis of Endometrial Carcinoma
  In combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR), as determined by an FDA-approved test, 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

Criteria

Lenvima

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Differentiated thyroid cancer (DTC)

• Diagnosis of differentiated thyroid cancer (DTC) [A]

Lenvima

*Criterion is part of FDA-approved label.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Renal Cell Carcinoma (RCC)

• Diagnosis of renal cell carcinoma
AND
• One of the following:
• Both of the following*:
• Used as first-line treatment
• Used in combination with Keytruda (pembrolizumab)
OR
• Both of the following*:
• Treatment follows one prior anti-angiogenic therapy [e.g., Inlyta (axitinib), Votrient (pazopanib), Nexavar (sorafenib), Sutent (sunitinib)]
• Used in combination with Afinitor (everolimus)

Lenvima

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Hepatocellular Carcinoma (HCC)

• Diagnosis of hepatocellular carcinoma

Lenvima

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Endometrial Carcinoma

• Diagnosis of advanced endometrial carcinoma that is mismatch repair proficient (pMMR), or not microsatellite instability-high (MSI-H), as detected by a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Patient has disease progression following systemic therapy
AND
• Used in combination with Keytruda (pembrolizumab) therapy
AND
• Patient is not a candidate for curative surgery or radiation

Lenvima

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications

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

P & T Revisions

2024-11-06, 2023-07-06, 2023-05-04, 2023-03-20, 2022-11-03, 2022-07-22, 2021-10-26, 2021-08-25, 2021-05-25, 2021-04-07, 2020-10-26, 2019-10-17

References

1. Lenvima Prescribing Information. Eisai Inc. Nutley, NJ. June 2024.
2. The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed October 24, 2024.
3. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Hepatobiliary Cancers. v3.2018. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Accessed September 5, 2018.
4. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Kidney Cancer. V2.2025. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed October 24, 2024

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End Notes

1. Differentiated thyroid carcinoma includes papillary carcinoma, follicular carcinoma, Hurthle cell carcinoma, and poorly differentiated carcinoma. [2]

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Revision History

• 2024-11-06: 2024 Annual Review. Renal Cell Carcinoma: Removal of T/F/C/I to generic sunitinib as this is not currently supported by NCCN. Streamlined other criteria to align with FDA label. Endometrial Carcinoma: Revised verbiage for mismatch repair to align with FDA label. Added standard verbiage for genetic testing. Removed prescriber requirement. Background updates.
• 2023-07-06: Updated criteria and removed specialist requirement
• 2023-05-04: Annual review: Updated criteria and references.
• 2023-03-20: COT allowance to support formulary strategy for non-clear cell renal cell carcinoma.
• 2022-11-03: Annual review: No criteria changes. Updated references.
• 2022-07-22: Update Guideline
• 2021-10-26: Annual Review - new criteria for updated RCC indication
• 2021-08-25: Background diagnosis update
• 2021-05-25: Addition of EHB formulary. No changes to criteria
• 2021-04-07: Updated GPI'S
• 2020-10-26: No changes to clinical criteria updated reference
• 2019-10-17: made criteria more concise by specifying diagnosis

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