Pharmacy Prior Authorization Criteria

Sutent (sunitinib) - PA, NF

Indications for Prior Authorization

Sutent (sunitinib)

• For diagnosis of Gastrointestinal stromal tumor (GIST)
  Indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.

• For diagnosis of Advanced pancreatic neuroendocrine tumors (pNET)
  Indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.

• For diagnosis of Advanced renal cell carcinoma
  Indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC).

• For diagnosis of Adjuvant treatment of renal cell carcinoma
  Indicated for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy.

Criteria

Brand Sutent, Generic sunitinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Gastrointestinal Stromal Tumor (GIST)

• Diagnosis of gastrointestinal stromal tumor (GIST)
AND
• History of disease progression, contraindication, or intolerance to Gleevec (imatinib)
AND
• Trial and failure or intolerance to generic sunitinib (applies to Brand Sutent only)

Brand Sutent, Generic sunitinib

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Gastrointestinal Stromal Tumor (GIST)

• Patient does not show evidence of progressive disease while on therapy
AND
• Trial and failure or intolerance to generic sunitinib (applies to Brand Sutent only)

Brand Sutent

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Gastrointestinal Stromal Tumor (GIST)

• Diagnosis of gastrointestinal stromal tumor (GIST)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming history of disease progression, contraindication, or intolerance to Gleevec (imatinib)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to generic sunitinib

Brand Sutent, Generic sunitinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Pancreatic Neuroendocrine Tumors (pNET)

• Diagnosis of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET)
AND
• One of the following:
• unresectable locally advanced disease
• metastatic disease
AND
• Trial and failure or intolerance to generic sunitinib (applies to Brand Sutent only)

Brand Sutent, Generic sunitinib

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Pancreatic Neuroendocrine Tumors (pNET)

• Patient does not show evidence of progressive disease while on therapy
AND
• Trial and failure or intolerance to generic sunitinib (applies to Brand Sutent only)

Brand Sutent

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Pancreatic Neuroendocrine Tumors (pNET)

• Diagnosis of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET)
AND
• One of the following:
• unresectable locally advanced disease
• metastatic disease
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to generic sunitinib

Brand Sutent, Generic sunitinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Advanced Renal Cell Carcinoma

• Diagnosis of advanced/metastatic renal cell carcinoma
AND
• Trial and failure or intolerance to generic sunitinib (applies to Brand Sutent only)

Brand Sutent, Generic sunitinib

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Advanced Renal Cell Carcinoma

• Patient does not show evidence of progressive disease while on therapy
AND
• Trial and failure or intolerance to generic sunitinib (applies to Brand Sutent only)

Brand Sutent

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Advanced Renal Cell Carcinoma

• Diagnosis of advanced/metastatic renal cell carcinoma
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to generic sunitinib

Brand Sutent, Generic sunitinib

Prior Authorization

Length of Approval: 12 Months [A]
For diagnosis of Adjuvant Treatment of Renal Cell Carcinoma

• Diagnosis of renal cell carcinoma (RCC)
AND
• Used as adjuvant therapy
AND
• Patient is at high risk of recurrent RCC following nephrectomy
AND
• Trial and failure or intolerance to generic sunitinib (applies to Brand Sutent only)

Brand Sutent

Non Formulary

Length of Approval: 12 Months [A]
For diagnosis of Adjuvant Treatment of Renal Cell Carcinoma

• Diagnosis of renal cell carcinoma (RCC)
AND
• Used as adjuvant therapy
AND
• Patient is at high risk of recurrent RCC following nephrectomy
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to generic sunitinib

P & T Revisions

2024-03-22, 2023-06-26, 2023-03-02, 2022-03-02, 2021-09-09, 2021-05-26, 2021-05-25, 2021-03-03, 2020-02-18

References

1. Sutent Prescribing Information. Pfizer Labs. New York, NY. August 2021.

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End Notes

1. The recommended dose of Sutent for the adjuvant treatment of RCC is 50mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2), for nine 6-week cycles (approximately 1 year). [1]

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Revision History

• 2024-03-22: 2024 annual review: updated reauth criteria to add trial and failure requirement to generic sunitinib for brand Sutent. Background updates.
• 2023-06-26: Removed specialist requirement.
• 2023-03-02: Annual review: No criteria changes. Updated indications section to align with PI verbiage.
• 2022-03-02: Updated criteria to add ST and added NF section. Annual review: updated references.
• 2021-09-09: Addition of generic as target product
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-03: 2021 Annual Review, removed reference to drug name from reauthorization criteria. No changes to clinical criteria.
• 2020-02-18: 2020 Annual Review - no changes to criteria.

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