vp-0647
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Fyarro™ (sirolimus albumin-bound) (Intravenous)

Policy Number: VP-0647

Last Review Date: 04/01/2022

Date of Origin: 01/04/2022

Dates Reviewed: 01/2022, 04/2022

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

I. Length of Authorization

Coverage is provided for six months and may be renewed.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Fyarro 100 mg vial: 6 vials every 21 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 300 billable units (300 mg) on days 1 and 8 of every 21-day cycle

III. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Universal Criteria

  • Patient does not have a severe hypersensitivity to rapamycin derivatives (i.e., sirolimus, everolimus, temsirolimus, etc.); AND
  • Patient will avoid concomitant therapy with any of the following:
    • Coadministration with P-gp inhibitors and/or strong CYP3A4 inhibitors (e.g., boceprevir, itraconazole, ketoconazole, etc.), if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications will be implemented; AND
          •  
    • Coadministration with combined P-gp inducers and/or strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s Wort, etc.), if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications will be implemented; AND
    • Coadministration with grapefruit or grapefruit juice; 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; AND
  • Patient has had no prior treatment with or will not be used in combination with other mTOR inhibitors (i.e., sirolimus, everolimus, temsirolimus, etc.); AND
  • Patient does not have lymphangioleiomyomatosis (LAM); AND

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

  • Used as single agent therapy; AND
  • Patient has locally advanced unresectable or metastatic disease

FDA-labeled indication; Compendia approved indication(s); Ф Orphan Drug

IV. Renewal Criteria 1-3

Coverage 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, infections, hypokalemia and hyperglycemia, interstitial lung disease, hemorrhage, azoospermia/oligospermia, severe hypersensitivity reactions, etc.

V. Dosage/Administration 1

Indication

Dose

PEComa

100 mg/m2 administered intravenously on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity

VI. Billing Code/Availability Information

HCPCS Code:

  • J9999 – Not otherwise classified, antineoplastic drug
  • C9399 – Unclassified drugs or biologicals (Hospital Out-patient Use Only) (Discontinue use on 04/01/2022)
  • C9091 – Injection sirolimus protein-bound particles, 1 mg; 1 billable unit = 1 mg (Effective 04/01/2022)

NDC:

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

VII. 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.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C48.0

Malignant neoplasm of retroperitoneum

C48.1

Malignant neoplasm of specified parts of peritoneum

C48.2

Malignant neoplasm of peritoneum, unspecified

C48.8

Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C49.4

Malignant neoplasm of connective and soft tissue of abdomen

C49.5

Malignant neoplasm of connective and soft tissue of pelvis

C49.8

Malignant neoplasm of overlapping sites of connective and soft tissue

C49.9

Malignant neoplasm of connective and soft tissue, unspecified

D49.2

Neoplasm of unspecified behavior of bone, soft tissue, and skin

Z85.831

Personal history of malignant neoplasm of soft tissue

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

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 Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

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

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA,HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC