SUTENT (sunitinib)

SUTENT (sunitinib)

Self-Administration - Oral

Indications for Prior Authorization:

• Indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate
• Indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease
• Indicated for the treatment of advanced renal cell carcinoma
• Indicated for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy

Coverage Criteria:

For diagnosis of gastrointestinal stromal tumor (GIST):

• Dose does not exceed 50 mg once-daily on a schedule of 4 weeks on treatment followed by 2 weeks off (scheduled 4/2), AND
• Prescribed by or in consultation with an oncologist, AND
• History of disease progression, contraindication, or intolerance to Gleevec (imatinib), AND
• For Brand Sutent capsules only: Trial and Failure, contraindication, or intolerance to generic Sutent capsules

For the diagnosis of pancreatic neuroendocrine tumors (pNET):

• Dose does not exceed 37.5 mg once-daily, AND
• Prescribed by or in consultation with an oncologist, AND
• One of the following:
  • Unresectable locally advanced disease
  • Metastatic disease, AND
• For Brand Sutent capsules only: Trial and Failure, contraindication, or intolerance to generic Sutent capsules

For diagnosis of advanced renal cell carcinoma:

• Dose does not exceed 50 mg once-daily on a schedule of 4 weeks on treatment followed by 2 weeks off (scheduled 4/2), AND
• Prescribed by or in consultation with an oncologist, AND
• For Brand Sutent capsules only: Trial and Failure, contraindication, or intolerance to generic Sutent capsules

For diagnosis of adjuvant treatment of renal cell carcinoma:

• Dose does not exceed 50 mg once-daily on a schedule of 4 weeks on treatment followed by 2 weeks off (scheduled 4/2) for nine-6-week cycles, AND
• Prescribed by or in consultation with an oncologist, AND
• Used as adjuvant therapy, AND
• Patient is at high risk of recurrent renal cell carcinoma following nephrectomy, AND
• For Brand Sutent capsules only: Trial and Failure, contraindication, or intolerance to generic Sutent capsules

Reauthorization Criteria:

For diagnosis of gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma:

• Dose does not exceed 50 mg once-daily on a schedule of 4 weeks on treatment followed by 2 weeks off (scheduled 4/2), AND
• Patient does not show evidence of progressive disease while on therapy

For diagnosis of pancreatic neuroendocrine tumors (pNET):

• Dose does not exceed 37.5 mg once-daily, AND
• Patient does not show evidence of progressive disease while on therapy

Coverage Duration:

• For adjuvant treatment of renal cell carcinoma
  • 1 year
• For all other indications:
  • Initial: 1 year
  • Reauthorization: 1 year

Dosing:

For diagnosis of gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma:

• 50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off

For diagnosis of pancreatic neuroendocrine tumors (pNET):

• 37.5 mg orally once daily, continuously without a scheduled off-treatment period

For diagnosis of adjuvant renal cell carcinoma:

• 50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off for nine-6-week cycles

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:

• Boxed warning: Hepatotoxicity – monitor hepatic function and interrupt, dose reduce, or discontinue Sutent as recommended
• Drug interactions:
  • Consider dose reduction of Sutent when administered with strong CYP3A4 inhibitors
  • Consider dose increase of Sutent when administered with CYP3A4 inducers
• Withhold Sutent treatment for at least 3 weeks prior to elective surgery; do not administer Sutent for at least 2 weeks after major surgery and until adequate wound healing.  If possible, withhold Sutent for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures

Policy Updates:

• 11/16/2021 – New policy approved by P&T

References:

• Sutent Prescribing Information. Pfizer Labs. New York, NY. October 2020.
• National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Kidney Cancer. v.2.2021. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed February 15, 2021.