FYARRO (sirolimus protein-bound particles)

FYARRO (sirolimus protein-bound particles)

Medical Administration - intravenous (IV)

Diagnosis considered for coverage: 

• Malignant perivascular epithelioid cell tumor (PEComa): Indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant PEComa.

Coverage Criteria:

For diagnosis of PEComa:

• Dose does not exceed 100 mg/m² administered as an IV infusion over 30 minutes on Days 1 and Day 8 of each 21-day cycle; AND
• Patient is 18 years or older; AND
• Prescribed by or in consultation with an oncologist; AND
• Documented diagnosis of locally advanced unresectable or metastatic malignant PEComa; AND
• Patient does not have PEComa type lymphangioleiomyomatosis; AND
• Patient has tried and failed or had intolerance to one of the following: sirolimus, everolimus, or temsirolimus.

Reauthorization Criteria:

For diagnosis of PEComa:

• Dose is at least 45 mg/m² and does not exceed 100 mg/m² administered as an IV infusion over 30 minutes on Days 1 and Day 8 of each 21-day cycle, AND
• Prescribed by or in consultation with an oncologist, AND
• Patient does not show evidence of progressive disease while on therapy.

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

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: 

• Contraindication: History of severe hypersensitivity to sirolimus, other rapamycin derivatives, or albumin
• Drug Interactions
  • Strong CYP3A4 and/or P-gp Inhibitors or Inducers: Avoid concomitant use. 
  • Moderate or Weak CYP3A4 Inhibitors: Reduce Fyarro dose

Policy Updates:

• 05/17/2022 – New policy approved by P&T.
• 08/16/2022 – Updated criteria to required trial and failure of one NCCN guideline recommended mTOR inhibitor (i.e., sirolimus, everolimus, or temsirolimus) for PEComa.

References:

• Fyarro [package insert], Pacific Palisades, CA: Aadi Bioscience, Inc.; December 2021.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: Soft Tissue Sarcoma. Version 2.2022 – May 17, 2022. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf. Accessed August 3, 2022.