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