Pharmacy Prior Authorization Criteria

Fyarro (sirolimus albumin-bound particles for injectable suspension) - PA, NF

Indications for Prior Authorization

Fyarro (sirolimus albumin-bound particles for injectable suspension)

• For diagnosis of Perivascular Epithelioid Cell Tumor (PEComa)
  Indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Criteria

Fyarro

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of malignant perivascular epithelioid cell tumor
AND
• Disease is one of the following:
• Unresectable locally advanced
• Metastatic
AND
• One of the following:
• Trial of or intolerance to one of the following [A]:
• Sirolimus
• Everolimus
• Temsirolimus
OR
• For continuation of prior therapy

Fyarro

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient does not show evidence of progressive disease while on therapy

Fyarro

Non Formulary

Length of Approval: 12 Month(s)

• Diagnosis of malignant perivascular epithelioid cell tumor
AND
• Disease is one of the following:
• Unresectable locally advanced
• Metastatic
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming trial of or intolerance to one of the following [A]:
• Sirolimus
• Everolimus
• Temsirolimus
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of therapy, defined as no more than a 45-day gap in therapy

P & T Revisions

2024-01-04, 2023-07-03, 2023-01-04, 2022-05-04, 2021-12-28

References

1. Fyarro Prescribing Information. Aadi Bioscience. Pacific Palisades, CA. November 2021.
2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Soft Tissue Sarcoma v1.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf. Accessed May 4, 2022.

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End Notes

1. mTOR inhibitors such as sirolimus, temsirolimus, and everolimus have shown promising results in patients with metastatic PEComas and are listed as other recommended regimens in NCCN (category 2A). [2]

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Revision History

• 2024-01-04: Annual Review - no criteria changes
• 2023-07-03: Removed specialist requirement
• 2023-01-04: Annual review - no criteria changes
• 2022-05-04: Added embedded ST through mTOR inhibitor. Updated endnotes and references.
• 2021-12-28: New UM Program

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