CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization and medical-benefit coverage criteria, dosing, and exclusions for Fyarro (nab-sirolimus) for treatment of malignant perivascular epithelioid cell tumor (PEComa) in adults within the payer's plans.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual Revision — No criteria changes

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; approval requires meeting the specified criteria and dosing and prescribing by or in consultation with an oncologist.

SourceLink

POLICY UPDATE CHANGES

Annual Revision noted with 'No criteria changes' for review date 01/29/2025.

Prior annual revision on 01/17/2024 noted with no criteria changes.

1Covered Indications

1 yearTypical Approval Duration

≥18Minimum Age (years)

Coverage Summary

Coverage stance: covered_with_criteria for Fyarro (sirolimus protein-bound particles) intravenous infusion for the FDA‑approved indication of malignant PEComa in adults. The policy defines prior authorization and medical‑benefit coverage criteria, dosing, and exclusions for Fyarro within the payer's plans.

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FDA-Approved Indication - Malignant PEComa (Initial Authorization)

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

ALL of the following

Age: Patient is ≥ 18 years of age>= 18 years
Age at least 18 years
Patient disease status (ONE of)
- Patient has metastatic disease
- Patient has locally advanced unresectable disease
Fyarro is prescribed by or in consultation with an oncologist
Requires specialist prescribing or consultation

Dosing and Authorization Duration

Dosing / Authorization Duration

Dosing and duration conditions for approval

ALL of the following

Dosing: Dose up to 100 mg/m2 intravenously on Days 1 and 8 of each 21-day cycleup to 100 mg/m2 Days 1 and 8 q21d
Approve for 1 year if criteria met
Dose exceptions: Requests for doses outside the established dosing will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist)

Key thresholds and approval duration

Age>= 18 years

Typical approval duration1 year

IndicationLocally advanced unresectable or metastatic malignant PEComa in adults

Dosing (typical)Up to 100 mg/m2 IV on Days 1 and 8 of each 21-day cycle

Prescriber requirementPrescribed by or in consultation with an oncologist

Exclusions / Not Recommended

Conditions Not Recommended for Approval

Coverage exclusions

ALL of the following

Exclusion: Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria
Policy will be updated as new published data are available

Provider Actions / Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for medical benefit coverage of Fyarro; approval requires meeting the specified criteria and dosing and prescribing by or in consultation with an oncologist.

Documentation Required

Specialist Involvement Requirement

Fyarro must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist).

Billing Rule

Dose Exceptions Reviewed Case-by-Case

Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Clinical Evidence

Key evidence includes the pivotal publication by Wagner AJ et al., J Clin Oncol 2021 reporting activity of nab‑sirolimus in malignant PEComa, which is cited as the key trial supporting use.

The prescribing information for Fyarro (intravenous infusion) from Aadi Bioscience (December 2024) provides the product labeling and dosing details referenced in the policy.

Guideline support: NCCN Soft Tissue Sarcoma (v4.2024) lists Fyarro as a Preferred regimen for malignant PEComa (category 2A), supporting its use for locally advanced unresectable or metastatic disease.

Additional evidence context noted in the policy includes case reports and retrospective analyses described in the disease overview, reflecting the rarity of malignant PEComa and the limited but supportive clinical evidence base.

Definition

TermPEComa

DefinitionPerivascular epithelioid cell tumor, a rare mesenchymal tumor that can be benign or malignant

Background

Fyarro (nab‑sirolimus) is a mammalian target of rapamycin (mTOR) inhibitor indicated for treatment of locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa) in adults.

Malignant PEComa is a rare soft tissue sarcoma (a rare mesenchymal tumor) with an annual incidence of < 1:1,000,000; most PEComas are benign but malignant PEComa can be locally aggressive or metastatic and commonly arises in sites such as the kidney, uterus, and gastrointestinal tract.

Evidence for Fyarro in malignant PEComa includes case reports, retrospective analyses, and a pivotal study (Wagner AJ et al., J Clin Oncol 2021) that reported activity of nab‑sirolimus in this rare tumor type; these sources, along with the 2024 prescribing information, inform the policy recommendations.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual Revision — No criteria changes

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; approval requires meeting the specified criteria and dosing and prescribing by or in consultation with an oncologist.

SourceLink

On This Page

OpenPayer

UTILIZATION MANAGEMENT MEDICAL POLICY

Coverage Summary

Dosing and Authorization Duration

Exclusions / Not Recommended

Applicable Codes

Provider Actions / Prior Authorization

Clinical Evidence

Background

Revision History