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.

Last review date: August 16, 2022

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