Fyarro™
Drug - Fyarro™ (sirolimus albumin-bound) [Aadi Bioscience]
October 2022
Therapeutic area - Oncology, Injectable
Initial approval criteria
- Patient is at least 18 years of age AND
Universal Criteria
- Patient does not have a severe hypersensitivity to rapamycin derivatives (e.g., 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 (e.g., sirolimus, everolimus, temsirolimus, etc.) AND
- Patient does not have lymphangioleiomyomatosis (LAM) AND
Perivascular Epithelioid Cell Tumor (PEComa)
- Used as single agent therapy AND
- Patient has locally advanced unresectable or metastatic disease
Initial approval is for 6 months
Renewal 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 the initial approval criteria 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.
- Renewal approval is for 6 months
Quantity limits
- 100 mg/m2 on days 1 and 8 of each 21-day cycle
- Patient’s body surface area (in m2) must be submitted at time of request
Billing for Fyarro
Fyarro must be billed as a medical claim.
Questions?
MHCP Provider Resource Center 651-431-2700 or 800-366-5411
