Sutent (sunitinib) - PA, NF
Indications for Prior Authorization
Sutent (sunitinib)
-
For diagnosis of Gastrointestinal Stromal Tumor (GIST)
Indicated for 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 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. -
For diagnosis of Renal Cell Carcinoma
Indicated for treatment of adult patients with advanced renal cell carcinoma (RCC) and for adjuvant treatment of adult patients at high risk of recurrent RCC 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
- For Brand Sutent only, trial or intolerance to generic sunitinib
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
- For Brand Sutent only, trial or intolerance to generic sunitinib
Brand Sutent
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Gastrointestinal Stromal Tumor (GIST)
- Submission of medical records (e.g., chart notes) confirming 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
- Both of the following:
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with generic sunitinib that has the same active ingredient
- Submission of medical records confirming generic sunitinib has not been effective AND valid clinical justification provided explaining how Brand Sutent is expected to provide benefit when generic sunitinib has not been shown to be effective despite having the same active ingredient
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
- Disease is one of the following:
- Unresectable locally advanced
- Metastatic
- For Brand Sutent only, trial or intolerance to generic sunitinib
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
- For Brand Sutent only, trial or intolerance to generic sunitinib
Brand Sutent
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Pancreatic Neuroendocrine Tumors (pNET)
- Submission of medical records (e.g., chart notes) confirming diagnosis of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) AND
- Disease is one of the following:
- Unresectable locally advanced
- Metastatic
- Both of the following:
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with generic sunitinib that has the same active ingredient
- Submission of medical records confirming generic sunitinib has not been effective AND valid clinical justification provided explaining how Brand Sutent is expected to provide benefit when generic sunitinib has not been shown to be effective despite having the same active ingredient
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
- For Brand Sutent only, trial or intolerance to generic sunitinib
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
- For Brand Sutent only, trial or intolerance to generic sunitinib
Brand Sutent
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Advanced Renal Cell Carcinoma
- Submission of medical records (e.g., chart notes) confirming diagnosis of advanced/metastatic renal cell carcinoma AND
- Both of the following:
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with generic sunitinib that has the same active ingredient
- Submission of medical records confirming generic sunitinib has not been effective AND valid clinical justification provided explaining how Brand Sutent is expected to provide benefit when generic sunitinib has not been shown to be effective despite having the same active ingredient
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
- For Brand Sutent only, trial or intolerance to generic sunitinib
Brand Sutent
Non Formulary
Length of Approval: 12 Months [A]
For diagnosis of Adjuvant Treatment of Renal Cell Carcinoma
- Submission of medical records (e.g., chart notes) confirming diagnosis of renal cell carcinoma (RCC) AND
- Used as adjuvant therapy AND
- Patient is at high risk of recurrent RCC following nephrectomy AND
- Both of the following:
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with generic sunitinib that has the same active ingredient
- Submission of medical records confirming generic sunitinib has not been effective AND valid clinical justification provided explaining how Brand Sutent is expected to provide benefit when generic sunitinib has not been shown to be effective despite having the same active ingredient
P & T Revisions
2026-02-09, 2025-12-18, 2025-12-18, 2025-02-28, 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
- Sutent Prescribing Information. Pfizer Labs. New York, NY. October 2025.
End Notes
- 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]
Revision History
- 2026-02-09: Annual Review 2026 - Updated to standard NF verbiage to require med records for diagnosis and med records confirming benefit of brand when previous trial of generic has not been effective. Removed mention of failure in generic step. Added operational note for GPI/MSC level approval for generic product. Formatting updates throughout with no change to clinical intent. Background updates.
- 2025-12-18: No criteria change, bulk copy oRX-EHB
- 2025-12-18: no criteria changes, added IL statute operational note
- 2025-02-28: 2025 Annual Review. No updates.
- 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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