Medical Drug Criteria (MDC)

Policy Num:       P1.001.016
Policy Name:     FYARRO™ (sirolimus protein-bound particles for injectable suspension) (albumin-bound)
Policy ID:          [P1.001.016] [Ac/L/ M+ /P+ ] [0.00.00]

Last Review:       September 17, 2024
Next Review:      September 20, 2025
 

Related MDC:NONE

FYARRO™ (sirolimus protein-bound particles for injectable suspension)

(albumin-bound)

Summary

Sirolimus protein-bound particles (Fyarro) a mammalian target of rapamycin (mTOR) inhibitor, is indicated for the treatment of adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). 

Policy Statements

Coverage eligibility for Sirolimus protein-bound particles (Fyarro) will be considered when the following criteria are met:

• Fyarro may be considered medically necessary in adult for Malignant perivascular epithelioid cell tumor, locally advanced unresectable or metastatic

Policy Guidelines

Coverage eligibility for Sirolimus protein-bound particles (Fyarro) will be considered when the following criteria are met:

•    Authorization of 6 months may be granted for treatment of adult for Malignant perivascular epithelioid cell tumor, locally advanced unresectable or metastatic

DOSAGE/ADMINISTRATION

For treatment of Malignant perivascular epithelioid cell tumor, locally advanced unresectable or metastatic:  

•    100 mg/m(2) IV over 30 minutes on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity
 

REQUIRED MEDICAL INFORMATION

Initial Therapy

a) Perivascular Epithelioid Cell Tumor (PEComa), Malignant: Approve if the patient meets all of the following criteria: 

1.    Patient is ≥ 18 years of age; AND

2.    Patient meets one of the following (i or ii):

i. Patient has locally advanced unresectable disease; OR

ii. Patient has metastatic disease; AND 

3.    Prescribed by an oncologist.

Renewal Approval Criteria 

a)    Continuation of Sirolimus protein-bound particles (Fyarro) meets the definition of medical necessity when ALL of the following criteria are met: 

1.    Member has responded positively to the treatment as determined by the prescribing physician; AND 

2.    Member has not experienced unacceptable toxicity from the drug.
 

EXCLUSION CRITERIA

NONE

BENEFIT APPLICATION

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

OTHER CRITERIA

NONE

Population Reference No. 1 Policy Statement

References

1. Fyarro [package insert]. Pacific Palisades, CA; Aadi Bioscience Inc; November 2021. Accessed November 2021. 

2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) sirolimus-albumin bound. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed November 2021. 

3. Wagner AJ, Ravi V, Riedel RF, et al. nab-Sirolimus for Patients With Malignant Perivascular Epithelioid Cell Tumors. J Clin Oncol. 2021 Oct 12:JCO2101728. doi: 10.1200/JCO.21.01728. [Epub ahead of print].

4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma Version 2.2021. National Comprehensive Cancer Network, 2021. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed December 2021.

Codes

Applicable Modifiers

N/A

Policy History