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Prior Authorization Protocol
LENVIMAR (lenvatinib)

NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC)
    • In combination with everolimus for the treatment of patients with advanced renal cell cancer (RCC) following one prior anti-angiogenic therapy
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of locally recurrent or metastatic, progressive, radioactive iodine refractory differentiated thyroid cancer

    OR

    • Diagnosis of advanced or metastatic renal cell carcinoma

    AND

    • Failure or clinically significant adverse effects to one of the following: Sutent, Nexavar, Votrient, Inlyta, Avastin in combination with Intron-A, Proleukin, Torisel

    AND

    • Failure or clinically significant adverse effects to Opdivo or Cabometyx

    AND

    • Must be used in combination with everolimus (Afinitor)
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • In the SELECT trial, evidence of RAI-refractory disease was defined as satisfying ONE of the following criteria:
      • At least one measurable lesion without iodine uptake
      • At least one measurable lesion that had progressed (according to RECIST version 1.1 criteria) within 12 months after RAI therapy
      • No improvement or disease progression despite receiving RAI equivalent to cumulative activity of >600 mCi
    • National Comprehensive Cancer Network (NCCN) guidelines recommend tyrosine kinase inhibitor (TKI)-based treatment, such as Lenvima, for patients with metastatic, RAI-refractory DTC
    • Advanced renal cell carcinoma includes relapsed disease or Stage IV and medically or surgically unresectable disease.
    • NCCN guidelines recommend first-line agents (Sutent, Nexavar, Votrient, Inlyta, Avastin with Intron-A,Torisel) and subsequent therapy (Opdivo and Cabometyx) prior to use of Lenvima plus everolimus for treatment of advanced or metastatic renal cell carcinoma.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    NexavarR (sorafenib)
    Locally recurrent or metastatic, progressive, DTC refractory to RAI:
    400 mg PO BID without food

    Advanced RCC:
    400 mg PO BID

    800 mg/day

    Sutent (sunitinib)

    Advanced RCC:
    50 mg PO QD for 4 weeks followed by 2 weeks off.

    Advanced RCC:
    87.5 mg/day

    Votrient (pazopanib)

    Advanced RCC:
    800 mg PO QD

    Advanced RCC:
    800 mg/day

    Inlyta (axitinib)

    Advanced RCC:
    5 mg PO BID

    Advanced RCC:
    10 mg PO BID

    Torisel (temsirolimus)

    Advanced RCC:
    25 mg IV once a week.

    Advanced RCC:
    50 mg/week

    Avastin (bevacizumab) in combination with Intron AR (interferon alfa-2b)

    Advanced RCC:
    10 mg/kg IV every 2 weeks in combination with interferon alfa 3 million IU SC/IM 5 times per week up to 36 million IU SC/IM 3 times per week

    Advanced RCC:
    15 mg/kg every 3 weeks or 10 mg/kg every 2 weeks in combination with interferon alfa 20 million IU/m2/day IV; 35 million IU/m2/dose SC/IM

    Proleukin (aldesleukin, rIL-2)

    Advanced RCC:
    600,000 IU/kg IV Q8 hrs for 14 doses, repeat after a rest period of 9 days

    Advanced RCC:
    600,000 IU/kg IV Q8 hrs;
    18 million IU/m2/day IV has been used off-label for RCC

    Opdivo (nivolumab)

    Advanced RCC:
    3 mg/kg IV infusion every 2 weeks

    Advanced RCC:
    3 mg/kg

    Cabometyx (cabozantinib)

    Advanced RCC:
    60 mg PO QD

    Advanced RCC:
    60 mg/day

    Afinitor (everolimus)

    Advanced RCC:
    10 mg PO QD

    Advanced RCC:
    10 mg/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Lenvima

    Locally recurrent or metastatic, progressive, DTC refractory to RAI:
    24 mg PO QD

    Advanced RCC:
    18 mg PO QD

    Length of Benefit

  7. Product Availability:
    Capsules: 4 mg, 10 mg (supplied as six 5-day blister cards)
  8. References:
    1. Lenvima [Prescribing Information]. Woodcliff Lake, NJ: Eisai Inc; May 2016.
    2. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 13, 2016.
    3. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com. Accessed June 13, 2016.
    4. Schlumberger M, Tahara M, Wirth LJ, et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med 2015; 372 (7): 621-630.
    5. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed June 13, 2016.
    6. National Comprehensive Cancer Network. Thyroid Carcinoma. 1.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf. Accessed January 11, 2016.
    7. National Comprehensive Cancer Network.Kidney Cancer. 2.2017. Available at: https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed December 5, 2016.
    8. American Hospital Formulary Drug Information. AHFS Web site. Available at: https://www.medicinescomplete.com/mc/. Accessed June 13, 2016.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.
Draft Prepared: 05-MAR-15 DM
Approved By Health Net National P&T: 06-MAY-15, 18-NOV-15, 24-AUG-16
Revised: 03-JUL-15 MV, 13-JUN-16 TS, 29-AUG-16 NN, 05-DEC-16 NN