LENVIMA (lenvatinib)

Self-Administration – oral

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

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

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

  • Endometrial Carcinoma- In combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma (EC) that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
     

Coverage Criteria:

1.    For diagnosis of Differentiated Thyroid Carcinoma:

  • Dose does not exceed 24 mg per day; AND

  • Patient is 18 years of age or older; AND

  • Diagnosis of differentiated thyroid cancer (DTC); AND

  • Prescribed by or in consultation with an oncologist; AND

  • One of the following: 

    • Locally recurrent disease 

    • Metastatic disease; AND

  • One of the following:

    • Patient has symptomatic disease 

    • Patient has progressive disease; AND

  • Disease is refractory to radioactive iodine treatment

2.    For diagnosis of Renal Cell Carcinoma:

  • Dose does not exceed 20 mg per day; AND

  • Patient is 18 years of age or older; AND

  • Diagnosis of renal cell carcinoma; AND

  • Prescribed by or in consultation with an oncologist; AND

  • One of the following:

    • Disease has relapsed 

    • Diagnosis of stage IV disease; AND

  • One of the following: 

    • 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) for clear cell renal cell carcinoma; OR

    • Both of the following:

      • Used as first-line treatment for clear cell renal cell carcinoma 

      • Used in combination with Keytruda (pembrolizumab); OR

    • Both of the following:

      • Used in the treatment of non-clear cell renal cell carcinoma 

      • Trial and failure, contraindication, or intolerance to generic sunitinib

3.    For diagnosis of Hepatocellular Carcinoma:

  • Dose does not exceed one of the following:

    • For actual body weight greater than or equal to 60 kg, dose does not exceed 12mg per day

    • For actual body weight less than 60 kg, dose does not exceed 8mg per day; AND

  • Patient is 18 years of age or older; AND

  • Diagnosis of hepatocellular carcinoma; AND 

  • Prescribed by or in consultation with an oncologist, hepatologist, or gastroenterologist; AND

  • One of the following: 

    • Patient has metastatic disease 

    • Patient has extensive liver tumor burden 

    • Patient is inoperable by performance status or comorbidity (local disease or local disease with minimal extrahepatic disease only) 

    • Disease is unresectable

4.    For diagnosis of Endometrial Carcinoma:

  • Dose does not exceed 20 mg per day; AND

  • Patient is 18 years of age or older; AND 

  • Diagnosis of advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); AND

  • Prescribed by or in consultation with an oncologist; 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

Reauthorization Criteria:

1.    For all indications:

  • Dose does not exceed FDA label maximum dose for each indication:

    • Differentiated Thyroid Carcinoma: dose does not exceed 24 mg per day

    • Renal Cell Carcinoma: dose does not exceed 20 mg per day

    • Hepatocellular Carcinoma: dose does not exceed FDA-approved dosing (based on weight)

    • Endometrial Carcinoma: dose does not exceed 20 mg per day; AND

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

Coverage Duration:
  • Initial: 1 year

  • Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:
  • Dosage and administration:

    • Single Agent Therapy:

    • DTC: recommended dosage is 24 mg orally once daily

    • HCC: recommended dosage is based on actual body weight: 

      • 12 mg orally once daily for patients greater than or equal to 60 kg

      • 8 mg orally once daily for patients less than 60 kg

    • Combination Therapy:

      • EC: recommended dosage is 20 mg orally once daily in combination with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks

      • RCC: recommended dosage is:

        • 20 mg orally once daily with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks

        • 18 mg orally once daily with everolimus 5 mg orally once daily

    • Modify recommended daily dose for certain patients with renal or hepatic impairment

Policy Updates:
  • 06/01/2023 – New policy approved by P&T

References:
  • Lenvima Prescribing Information. Eisai Inc. Nutley, NJ. August 2022. 

  • The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed March 15, 2023. 

  • 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 March 15, 2023. 

  • National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Kidney Cancer. V1.2023. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed March 15, 2023.

Last review date: June 1, 2023

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