CurrentAetnaPolicy N/A

FYARRO (sirolimus protein-bound particles) precertification request

This document is Aetna's precertification request form for FYARRO (sirolimus protein-bound particles for injectable suspension) used to request start or continuation of therapy for covered indications; it is completed by the provider and submitted to Aetna for authorization review.

Policy Summary

PayerAetna

PolicyFYARRO (sirolimus protein-bound particles) precertification request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a precertification request using the FYARRO precertification form with required clinical and administrative information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 pagesform length

1 phoneAetna Precertification phone

1 faxAetna Precertification fax

Medicare Part B noteMedicare Part B note

Coverage Criteria

inv-01: Initial Therapy — Covered when documentation supporting the following is provided

Covered when documentation supporting the following is provided

Initiation for malignant PEComa: Diagnosis of malignant perivascular epithelioid cell tumor (PEComa) AND documentation of clinical setting (locally advanced unresectable or metastatic or other) AND indication whether FYARRO will be used as a single agent

Form lists these diagnosis and setting options for initiation requests

Initiation for uterine sarcoma (PEComa): Diagnosis of uterine sarcoma (PEComa) AND documentation of clinical setting (advanced, recurrent, metastatic, inoperable, or other) AND indication whether FYARRO will be used as a single agent

Form lists these diagnosis and setting options for initiation requests

inv-02: Continuation Therapy — Covered for continuation when ALL of the following are addressed

Covered for continuation when ALL of the following are addressed

Policy Summary

PayerAetna

PolicyFYARRO (sirolimus protein-bound particles) precertification request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a precertification request using the FYARRO precertification form with required clinical and administrative information.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Continuation of therapy: Documentation addressing whether there is evidence of unacceptable toxicity or disease progression on the current regimen (respond to form question)

Form asks specifically if there is evidence of unacceptable toxicity or disease progression

The FYARRO precertification form documents the clinical indications for use and does not provide a broad list of covered diagnoses beyond those queried on the form. The form specifically captures malignant perivascular epithelioid cell tumor (PEComa) and uterine sarcoma (PEComa) and asks providers to indicate the clinical setting (for example, locally advanced unresectable, metastatic, advanced, recurrent, inoperable, or other) and whether FYARRO will be used as a single agent. Coverage consideration is driven by completion of these indication and setting fields on the form.

The form does not list explicit conditions that are designated as not medically necessary. However, the precertification review requires the specified clinical documentation to be completed in full; failure to provide the required information (diagnosis, clinical setting, and single‑agent status for initiation, or documentation about toxicity/progression for continuation) may result in denial of the request.

Coding

Administration CPT codes (provider to supply)CPT

Administration code(s) (CPT)

Field for CPT administration codes (exact codes not specified on form)

Diagnosis codesICD-10

Primary ICD Code	Field to record primary diagnosis ICD-10 code
Secondary ICD Code	Field to record secondary diagnosis ICD-10 code
Other ICD Code	Field to record other applicable ICD-10 codes

Provider Actions and Requirements

Documentation Required

Administrative information required

Complete and legible administrative information is required for all precertification requests. Include patient demographics (first/last name, DOB, full address, contact numbers, email), current weight and height (specify units), allergies, and indication whether this is a start of treatment (include start date) or a continuation (include date of last treatment). Provide complete insurance/payer information and the precertification requester contact (name, phone, fax).

Patient: first/last name, DOB, address, city, state, ZIP, home/work/cell phone, email
Patient clinical measurements: current weight (lbs or kgs) and height (inches or cms)
Allergies
Treatment status: Start of treatment (start date) OR Continuation (date of last treatment)
Precertification requested by: name, phone, fax

Documentation Required

Prescriber and dispensing/administration details

Provide complete prescriber and dispensing/administration details. Include prescriber name, credentials (MD/DO/NP/PA), specialty, address, phone, fax, state license number, NPI, DEA, UPIN, provider email, and office contact name/phone. For dispensing or administration, include place of administration (self, physician office, outpatient infusion center, home infusion), center/agency name and phone, dispensing provider/pharmacy choice and contact details (name, address, phone, fax, TIN/PIN), and any applicable administration CPT codes and dates.

Prescriber: first/last name, credential checkbox (M.D./D.O./N.P./P.A.), specialty, address, city, state, ZIP, phone, fax, state lic #, NPI #, DEA #, UPIN, provider email, office contact name & phone
Dispensing/Administration: place of administration (self-administered, physician's office, outpatient infusion center, home infusion), center/agency name and phone, administration CPT code(s), address
Dispensing Provider/Pharmacy selection and contact: physician's office, retail pharmacy, specialty pharmacy or other; name, address, phone, fax, TIN, PIN

Step Therapy

Step therapy

Step therapy: there are no step therapy requirements or prior medication failure sequencing specified on this precertification form. Complete clinical justification per initiation or continuation guidance instead of submitting step-failure documentation.

Documentation Required

Required clinical documentation

For initiation requests, include diagnosis (specify PEComa subtype: malignant perivascular epithelioid cell tumor or uterine sarcoma PEComa), the clinical setting (locally advanced unresectable, metastatic, advanced, recurrent, inoperable, or other), and whether the medication will be used as a single agent. For continuation requests, document evidence of clinical benefit and note whether there is unacceptable toxicity or disease progression on the current regimen. Attach supporting clinical records as needed.

Initiation: diagnosis, clinical setting checkbox, single-agent use (Yes/No)
Continuation: documentation of clinical response and statement whether there is unacceptable toxicity or disease progression (Yes/No)
Attach relevant clinical records to support the request

Denial Risk

Fraudulent information risk and submission contacts

By signing, requestor attests that information provided is complete and accurate. Providing materially false information or concealing material information may be considered fraudulent and could affect authorization and lead to penalties. The plan may request additional information for evaluation. For precertification submission use Aetna Precertification Notification: Phone 1-866-752-7021 (TTY: 711) or Fax 1-888-267-3277. For Medicare Advantage Part B, use the Medicare request form.

Signature and date required on the request form
Fraudulent information may result in criminal and civil penalties and affect authorization
Aetna Precertification Notification: Phone 1-866-752-7021 (TTY: 711); Fax 1-888-267-3277
Medicare Advantage Part B: use Medicare Request Form

Background

The clinical information section captures the on‑label indications and required fields for FYARRO. For initiation requests the form lists Malignant perivascular epithelioid cell tumor (PEComa) and Uterine sarcoma (PEComa), asks whether FYARRO will be used as a single agent, and requires selection of the applicable clinical setting (for example, locally advanced unresectable, metastatic, advanced, recurrent, inoperable, or other). For continuation requests the form requires documentation addressing whether there is evidence of unacceptable toxicity or disease progression on the current regimen.

Definitions

inv-13: Initiation Requests — definition and required documentation elements

DefinitionInitiation Requests: requests to start FYARRO therapy; require documentation of diagnosis (malignant PEComa or uterine sarcoma), the clinical setting, and whether FYARRO will be used as a single agent.

Required documentation — diagnosesIndicate malignant perivascular epithelioid cell tumor (PEComa) OR uterine sarcoma (PEComa) on the form.

Required documentation — clinical settingSelect and document the clinical setting: for PEComa — locally advanced unresectable, metastatic, or other; for uterine sarcoma — advanced, recurrent, metastatic, inoperable, or other.

Required documentation — single‑agent statusDocument whether the requested medication will be used as a single agent (Yes or No).

Submission noteComplete Section G clinical information in its entirety for all precertification initiation requests.

inv-14: Continuation Requests — definition and required documentation for continuation (toxicity, progression)

DefinitionContinuation Requests: requests to continue FYARRO therapy; require documentation addressing whether there is evidence of unacceptable toxicity or disease progression on the current regimen.

Required documentation — toxicity/progression questionState whether there is evidence of unacceptable toxicity or disease progression on the current regimen by selecting Yes or No on the form.

Use of completed clinical informationEnsure Section G clinical information is completed in its entirety for continuation requests to support ongoing authorization review.

Implication for coverageAetna uses the documented response regarding toxicity or progression to determine ongoing approval for continuation of FYARRO.

Initial Therapy Criteria

inv-15: Initial therapy — Information required for initiation requests

Information required for initiation requests

Required initiation elements: Specify product, requested dose and frequency (product information section) AND document primary diagnosis (malignant PEComa or uterine sarcoma [PEComa]) AND indicate clinical setting per diagnosis (PEComa: locally advanced unresectable, metastatic, or other; uterine sarcoma: advanced, recurrent, metastatic, inoperable, or other) AND indicate whether FYARRO will be used as a single agent

Dose and frequency fields provided on product information section

Continuation Therapy Criteria

inv-16: Continuation therapy — Requirements to continue FYARRO

Requirements to continue FYARRO

Continuation requirements: Provider must indicate whether there is evidence of unacceptable toxicity or disease progression on the current regimen (answer Yes or No on form)

Used by Aetna to determine ongoing approval

Step Therapy

Step	Requirement
No step therapy steps specified	The FYARRO precertification form does not list any step therapy requirements or prior medication failure sequencing; no steps are required per this document.

Site of Care

Note

Specify place of administration

Indicate the place of administration on the form by selecting the appropriate option: self-administered, physician's office, outpatient infusion center, or home infusion.

Select one: Self‑administered; Physician's Office; Outpatient Infusion Center; Home Infusion Center.
Provide administration center phone and name when applicable and supply administration CPT code(s) if available.