INLYTA (axitinib)

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.