INLYTA (axitinib)

Self-Administration – oral

Diagnosis considered for coverage:
  • Advanced Renal Cell Carcinoma
    • In combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC)
    • In combination with pembrolizumab, for the first-line treatment of patients with advanced RCC
    • As a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy
Coverage Criteria:

For diagnosis of advanced renal cell carcinoma (RCC):

  • Dose does not exceed 10 mg twice daily; 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:
    • Used as first-line treatment in combination with avelumab or pembrolizumab
    • Used after failure of one prior systemic therapy (e.g., cabozantinib + nivolumab, lenvatinib + pembrolizumab, etc.)
Reauthorization Criteria:

For diagnosis of advanced renal cell carcinoma (RCC):

  • Dose does not exceed 10 mg twice daily; 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: 
  • Recommended dose
    • 5 mg orally twice daily with avelumab 800 mg every 2 weeks
    • 5 mg orally twice daily with pembrolizumab 200 mg every 3 weeks or 400 mg every 6 weeks
    • 5 mg orally twice daily (as a single agent)
  • NCCN Recommended Uses (off-label):
    • Commercially available small molecule kinase inhibitors (e.g., axitinib) can be considered if clinical trials or other systemic therapies are not available or appropriate for the following:
      • Papillary Carcinoma
      • Follicular Carcinoma
      • Hürthle Cell Carcinoma
      • Refer to NCCN Thyroid Carcinoma guidelines for further guidance
  • Avoid strong CYP3A4/5 inhibitors. If a strong CYP3A4/5 inhibitor is required, decrease the Inlyta dose by approximately half
  • Avoid strong CYP3A4/5 inducers 
  • For patients with moderate hepatic impairment, decrease the starting dose by approximately half
Policy Updates:
  • 12/1/2022 – New policy approved by P&T
References:
  • Inlyta Prescribing Information. Pfizer Labs. New York, NY. June 2020. 
  • National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Kidney Cancer. v.4.2021. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed April 11, 2022. 
  • National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Thyroid Carcinoma. v.2.2022. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf. Accessed October 13, 2022. 

Last review date: December 1, 2022

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