Last Review Date: 10/02/2025

Date of Origin: 01/04/2022

Dates Reviewed: 01/2022, 04/2022, 05/2022, 07/2022, 5/2023, 10/2024, 10/2025

1. Length of Authorization
   • • Initial: Prior authorization validity will be provided initially for 6 months.
     • Renewal: Prior authorization validity may be renewed every 6 months thereafter.
2. Dosing Limits

Max Units (per dose and over time) [HCPCS Unit]:

• 600 billable units every 21 days

3. Initial Approval Criteria ¹

Prior authorization validity is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ¹

• Patient does not have a severe hypersensitivity to sirolimus, other rapamycin derivatives, or albumin; AND
• Therapy will not be administered concurrently with live vaccines and close contact with individuals who have received live vaccines will be avoided; AND
• Patient does not have uncontrolled or symptomatic CNS metastases (controlled and asymptomatic CNS metastases are allowed); AND
• Patient has not had prior treatment with and will not be used in combination with other mTOR inhibitors; AND
• Patient does not have lymphangioleiomyomatosis (LAM); AND
• Used as single agent therapy; AND

Perivascular Epithelioid Cell Tumor (PEComa) † Ф ^1-4

• • Patient has locally advanced unresectable or metastatic malignant disease

Uterine Sarcoma ‡ ^2,5

• Patient has perivascular epithelioid cell tumor (PEComa); AND
• Patient has advanced, recurrent/metastatic, or inoperable disease

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1-3

Prior authorization validity can be renewed based upon the following criteria:

• Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: stomatitis, myelosuppression (e.g., anemia, thrombocytopenia neutropenia), infections, hypokalemia, hyperglycemia, interstitial lung disease/non-infections pneumonitis, hemorrhage, infertility in males (azoospermia/oligospermia), severe hypersensitivity reactions, etc.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J9331 – Injection, sirolimus protein-bound particles, 1 mg; 1 billable unit = 1 mg

NDC:

• Fyarro 100 mg of sirolimus injection, single-dose vial: 80803-0153-xx

7. References

1. Fyarro [package insert].  Morristown, NJ; Aadi Bioscience Inc; December 2024. Accessed August 2025.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) sirolimus-albumin bound. National Comprehensive Cancer Network, 2025. 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 August 2025.
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 1.2025. National Comprehensive Cancer Network, 2025. 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 August 2025.
5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Uterine Neoplasms Version 3.2025. National Comprehensive Cancer Network, 2025. 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 August 2025.

Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist

Non-quantitative treatment limitations (NQTLs) refer to the methods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan. These may include things like utilization review or prior authorization. The utilization management NQTL applies comparably, and not more stringently, to mental health/substance use disorder (MH/SUD) Medical Benefit Prescription Drugs and medical/surgical (M/S) Medical Benefit Prescription Drugs. The table below lists the factors that were considered in designing and applying prior authorization to this drug/drug group, and a summary of the conclusions that Prime’s assessment led to for each.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan. 

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A