Pharmacy Prior Authorization Criteria

Votrient (pazopanib)

Indications for Prior Authorization

Votrient (pazopanib)

• For diagnosis of Renal Cell Carcinoma (RCC)
  Indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

• For diagnosis of Soft tissue sarcoma (STS)
  Indicated for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.

  Limitation of Use: The efficacy of Votrient for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.

Criteria

Brand Votrient, Generic pazopanib

Prior Authorization (Initial Authorization)

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

• Diagnosis of renal cell carcinoma
AND
• One of the following: [2]
• Disease has relapsed
• Diagnosis of stage IV disease
AND
• Trial and failure, or intolerance to generic pazopanib (applies to brand Votrient only)
AND
• One of the following: [2]
• One of the following:
• Both of the following:
• Used in the treatment of non-clear cell renal cell carcinoma
• Trial and failure, contraindication or intolerance to generic sunitinib
OR
• For continuation of prior therapy
OR
• Patient has clear cell renal cell carcinoma

Brand Votrient, Generic pazopanib

Prior Authorization (Reauthorization)

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

• Patient does not show evidence of progressive disease while on therapy
AND
• Trial and failure, or intolerance to generic pazopanib (applies to brand Votrient only)
AND
• One of the following:
• One of the following:
• Both of the following:
• Used in the treatment of non-clear cell renal cell carcinoma
• Trial and failure, contraindication or intolerance to generic sunitinib
OR
• For continuation of prior therapy
OR
• Patient has clear cell renal cell carcinoma

Brand Votrient, Generic pazopanib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Soft tissue sarcoma (STS)

• Diagnosis of advanced soft tissue sarcoma (STS) [4, A]
AND
• Trial and failure, or intolerance to generic pazopanib (Applies to Brand Votrient only)

Brand Votrient, Generic pazopanib

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Soft tissue sarcoma (STS)

• Patient does not show evidence of progressive disease while on therapy
AND
• Trial and failure, or intolerance to generic pazopanib (Applies to Brand Votrient only)

P & T Revisions

2024-02-19, 2023-11-23, 2023-06-22, 2023-06-08, 2023-03-21, 2023-03-21, 2022-08-01, 2022-03-02, 2021-09-27, 2021-05-25, 2021-04-13, 2020-03-12

References

1. Votrient Prescribing Information. Novartis Pharmaceuticals. East Hanover, NJ. December 2021.
2. National comprehensive cancer network (NCCN). Clinical practice guidelines in oncology. Kidney cancer v.4.2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed February 28, 2023.
3. PALETTE: a randomized, double-blind, phase III trial of pazopanib versus placebo in patients (pts) with soft-tissue sarcoma (STS) whose disease has progressed during or following prior chemotherapy-An EORTC STBSG Global Network Study (EORTC 62072). Available at: www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=83283. Accessed April 30, 2012.
4. National comprehensive cancer network (NCCN). Clinical practice guidelines in oncology. Soft tissue sarcoma v.2.2022. Available at: http://www.nccn.org/professionals/physician_gls/PDF/sarcoma.pdf. Accessed February 28, 2023.

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End Notes

1. Votrient is an active drug in anthracycline pretreated STS patients with an increase in median PFS of 13 weeks. [3]

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Revision History

• 2024-02-19: 2024 Annual Review
• 2023-11-23: Addition of generic Votrient, PA applied.
• 2023-06-22: Removed Oncology specialist requirement
• 2023-06-08: Update for Soft Tissue Sarcoma to remove criterion that requires "patient received at least one prior chemotherapy."
• 2023-03-21: Annual Review: Updated Soft Tissue Sarcoma criteria to remove listed chemotherapy examples.
• 2023-03-21: COT allowance to support formulary strategy for non-clear cell renal cell carcinoma.
• 2022-08-01: Guideline Update
• 2022-03-02: No criteria changes, updated references.
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-04-13: 2021 Annual Review: no changes. Updated GPIs
• 2020-03-12: Annual Review: updated background & references

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