Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Fyarro (sirolimus protein-bound particles) requires prior authorization.

2)    Fyarro is used to treat adults with locally advanced unresectable or metastatic malignant pervascular epithelioid cell tumor (PEComa).

3)    Fyarro is covered under the medical benefit.

Fyarro (sirolimus protein-bound particles) is considered medically necessary for members meeting the following criteria:

1)    Diagnosis of locally advanced unresectable or metastatic malignant pervascular epithelioid cell tumor (PRComa);

2)    Prescribed by or in consultation with an oncologist;

3)    Age > 18 years;

4)    Use as a single agent;

5)    Member does not have PEComa type lymphangioleimoyomatosis;

6)    Request meets on of the following (a or b):

a.    Dose does not exceed 100mg/m2 IV on Days 1 and 8 of each 21-day cycle;

b.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval Duration: 6 months

Continuation of Therapy

1)    Member is responding positively to therapy;

2)    If request is for a dose increase, request meets one of the following (a or b):

a.    Both of the following (i and ii):

                                          i.    New dose does not exceed 100mg/m2 IV on Days 1 and 8 of each 21-day cycle;

                                        ii.    Dose is at least 45mg/m2 IV on Days 1 and 8 of each 21-day cycle;

b.    New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regiment must be FDA-approved or recommended by NCCN.

Approval Duration: 12 months

Codes Used In This BI:

1)    J9331 – injection, sirolimus protein-bound particles, 1mg

1)    Fyarro Prescribing Information. Pacific Palisades, CA. Aadi Bioscience, Inc: November 2021.

2)    NCCN. Soft Tissue Sarcoma Version 2.2021. Accessed December 8, 2021.

3)    ClinicalTrials.gov. A Phase 2 Study of ABI-009 in Patients with Advanced Malignant PEComa (AMPECT). Accessed December 8, 2021.

4)    Bissler JJ, McCormack FX, Young LR et al. Sirolimus for Angiomyolipoma in Tuberous Sclerosis complex or Lymphangioleiomyomatosis. The New England Journal of Medicine. 208; 358:140-51.

5)    Wagner AJ, Malinowska-Kolodziej I, Morgan, JA et al. Clinical Activity of mTOR Inhibition with Sirolimus in Malignant Pervaxcular Epithelioid Cell Tumors: Targeting the Pathogenic Activatoin of mTORC1 in Tumors. Journal of Clinical Oncology. 2010; DOI:10.1200/JCO.2009.25.2981.