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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsViva Health Plan Fyarro Prior Auth | OpenPayer
    Ask Trek AI about this page
    CurrentViva Health PlanPolicy IC-0647

    Fyarro (sirolimus albumin-bound) intravenous therapy

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    This policy governs prior authorization, coverage criteria, dosing, renewal, and billing for intravenous Fyarro in adult members with specified advanced or metastatic PEComa-related disease.

    Policy Summary
    PayerViva Health Plan
    PolicyFyarro (sirolimus albumin-bound) intravenous therapy
    Policy CodePolicy IC-0647
    Change TypeNo material change
    Effective DateN/A
    Last ReviewOct 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization for 6 months initially and renew it every 6 months when applicable criteria are met.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    18+Minimum member age for initial approval
    6 monthsAuthorization validity
    600 unitsMaximum quantity every 21 days
    100 mg/m²Dose on days 1 and 8
    J9331

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    HCPCS billing code

    Coverage Criteria

    Initial Approval — Universal Criteria

    Covered when ALL of the following initial approval criteria are met:

    ALL of the following

    • Member is at least 18 years of age.
    • Member does NOT have any FDA labeled contraindications to the requested agent, including severe hypersensitivity to rapamycin derivatives or albumin.
    • Therapy will not be administered concurrently with live vaccines, and close contact with individuals who have received live vaccines will be avoided.
    • Member does not have uncontrolled or symptomatic CNS metastases; controlled and asymptomatic CNS metastases are allowed.
    • Member does not have severe hepatic impairment, defined as total bilirubin > 3 times the upper limit of normal (ULN) and any aspartate aminotransferase (AST).
    • Member has not had prior treatment with and will not be used in combination with other mTOR inhibitors.
    • Member does not have lymphangioleiomyomatosis (LAM).
    • Fyarro will be used as single-agent therapy.

    Perivascular Epithelioid Cell Tumor (PEComa)

    Coverage for Fyarro is provided when the following disease-specific criterion is met:

    Member has locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

    Uterine Sarcoma

    Coverage for Fyarro is provided when ALL of the following disease-specific criteria are met:

    ALL of the following

    • Member has perivascular epithelioid cell tumor (PEComa).
    • Member has advanced, recurrent/metastatic, or inoperable disease.

    Continuation and Renewal Therapy

    Renewal coverage is provided when ALL of the following criteria are met:

    ALL of the following

    • Member continues to meet universal and other indication-specific relevant criteria identified in the initial approval criteria, such as concomitant therapy requirements (not including prerequisite therapy), performance status, and other applicable requirements.
    • Disease response with treatment is demonstrated, defined as stabilization of disease or a decrease in the size of the tumor or tumor spread.
    • Member has absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include stomatitis; myelosuppression (e.g., anemia, thrombocytopenia, or neutropenia); infections; hypokalemia; hyperglycemia; interstitial lung disease or noninfectious pneumonitis; hemorrhage; infertility in males (azoospermia or oligospermia); severe hypersensitivity reactions; and other clinically significant toxicity.

    Coverage is excluded when the member has any FDA-labeled contraindication to Fyarro, including severe hypersensitivity to rapamycin derivatives or albumin.

    Fyarro must not be administered concurrently with live vaccines. Close contact with individuals who have received live vaccines must be avoided.

    Coverage is excluded for uncontrolled or symptomatic CNS metastases; controlled and asymptomatic CNS metastases are allowed. Coverage is also excluded for severe hepatic impairment, defined as total bilirubin > 3 times the upper limit of normal (ULN) and any aspartate aminotransferase (AST), lymphangioleiomyomatosis (LAM), prior treatment with other mTOR inhibitors, concurrent use with other mTOR inhibitors, and use other than single-agent therapy.

    Billing and Coding

    Covered HCPCS CodesHCPCSCovered
    J9331Injection, sirolimus protein-bound particles, 1 mg; 1 billable unit = 1 mg
    Covered NDC CodesNDCCovered
    80803-0153-xxFyarro 100 mg of sirolimus injection, single-dose vial
    Covered Diagnosis CodesICD-10Covered
    C48.0Malignant neoplasm of retroperitoneum
    C48.1Malignant neoplasm of specified parts of peritoneum
    C48.2Malignant neoplasm of peritoneum, unspecified
    C48.8Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
    C49.0Malignant neoplasm of connective and soft tissue of head, face and neck
    C49.10Malignant neoplasm of connective and soft tissue of unspecified upper limb, including shoulder
    C49.11Malignant neoplasm of connective and soft tissue of right upper limb, including shoulder
    C49.12Malignant neoplasm of connective and soft tissue of left upper limb, including shoulder
    C49.20Malignant neoplasm of connective and soft tissue of unspecified lower limb, including hip
    Covered Diagnosis CodesICD-10Covered
    C49.21Malignant neoplasm of connective and soft tissue of right lower limb, including hip
    C49.22Malignant neoplasm of connective and soft tissue of left lower limb, including hip
    C49.3Malignant neoplasm of connective and soft tissue of thorax
    C49.4Malignant neoplasm of connective and soft tissue of abdomen
    C49.5Malignant neoplasm of connective and soft tissue of pelvis
    C49.6Malignant neoplasm of connective and soft tissue of trunk, unspecified
    C49.8Malignant neoplasm of overlapping sites of connective and soft tissue
    C49.9Malignant neoplasm of connective and soft tissue, unspecified
    C54.0Malignant neoplasm of isthmus uteri
    C54.1Malignant neoplasm of endometrium
    1–10 of 18
    1/2
    Maximum billable units
    Limit typeMaximum billable units
    Quantity limit600 billable units
    Time periodEvery 21 days
    Billing unitHCPCS unit
    Dose and schedule
    Dose100 mg/m²
    Route

    Provider Requirements and Denial Risks

    Prior Authorization

    Six-Month Authorization Period

    Initial prior authorization is valid for 6 months (180 days). Renewal authorization may be granted for additional 6-month (180-day) periods.

    • Initial authorization: 6 months (180 days)
    • Renewal authorization: every 6 months (180 days)
    Prior Authorization

    Initial Approval Requirements

    Approve initial therapy only when the member is at least 18 years old, meets all universal safety and treatment requirements, and satisfies the applicable disease-specific criteria for the requested indication.

    • Member is at least 18 years of age
    • Member meets all universal criteria
    • For PEComa: locally advanced unresectable or metastatic malignant disease
    • For uterine sarcoma: perivascular epithelioid cell tumor (PEComa) and advanced, recurrent/metastatic, or inoperable disease

    Policy Background

    Fyarro is an intravenous sirolimus formulation and an mTOR-targeted antineoplastic therapy. This policy addresses treatment in adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), including uterine sarcoma presentations involving PEComa with advanced, recurrent/metastatic, or inoperable disease. Treatment continues until disease progression or unacceptable toxicity.

    Initial Therapy

    Initial Therapy

    Initial therapy is authorized for 6 months when ALL applicable criteria are met:

    Initial therapy

    • The member is at least 18 years of age and meets all initial universal safety and treatment criteria.Age >=18 years

    • ONE covered indication

      • The member has locally advanced, unresectable, or metastatic malignant perivascular epithelioid cell tumor (PEComa).Locally advanced unresectable or metastatic

      • Uterine sarcoma indication

    Continuation Therapy

    Continuation Therapy

    Renewal is available every 6 months when ALL criteria are met:

    Continuation therapy

    • The member continues to meet applicable universal and indication-specific criteria identified in the initial approval section.
    • Disease response is demonstrated by stabilization of disease or a decrease in the size of the tumor or tumor spread.Disease stabilization or decrease in tumor size or tumor spread
    • The member has no unacceptable toxicity from Fyarro.

      Examples include stomatitis, myelosuppression, infections, hypokalemia, hyperglycemia, interstitial lung disease or noninfectious pneumonitis, hemorrhage, male infertility, and severe hypersensitivity reactions.

    Quantity Limits

    Fyarro quantity limit
    DrugFyarro (sirolimus albumin-bound)
    Maximum quantity600 billable units
    FrequencyEvery 21 days
    Billing unitHCPCS unit
    Policy Summary
    PayerViva Health Plan
    PolicyFyarro (sirolimus albumin-bound) intravenous therapy
    Policy CodePolicy IC-0647
    Change TypeNo material change
    Effective DateN/A
    Last ReviewOct 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization for 6 months initially and renew it every 6 months when applicable criteria are met.
    SourceLink
    On This Page
    Coverage CriteriaBilling and CodingProvider Requirements and Denial RisksPolicy BackgroundInitial TherapyContinuation TherapyQuantity Limits
    Administered intravenously
    ScheduleOn days 1 and 8 of each 21-day cycle
    Treatment durationUntil disease progression or unacceptable toxicity
    Prior Authorization

    Renewal Requirements

    Renewal authorization requires that the member continues to meet the applicable universal and indication-specific criteria, demonstrates disease response or stabilization, and has no unacceptable toxicity from treatment.

    • Continued compliance with universal and relevant indication-specific criteria, including applicable concomitant therapy requirements and performance status requirements identified in the initial criteria; prerequisite therapy is not included
    • Disease response shown by stabilization of disease or decrease in the size of the tumor or tumor spread
    • Absence of unacceptable drug toxicity, including stomatitis, myelosuppression such as anemia, thrombocytopenia, or neutropenia, infections, hypokalemia, hyperglycemia, interstitial lung disease or noninfectious pneumonitis, hemorrhage, male infertility such as azoospermia or oligospermia, or severe hypersensitivity reactions
    Denial Risk

    Universal Criteria Not Met

    Deny initial approval when the member does not meet the minimum age requirement or any universal safety or treatment criterion.

    • Member is younger than 18 years of age
    • FDA-labeled contraindication is present, such as severe hypersensitivity to rapamycin derivatives or albumin
    • Therapy would be administered concurrently with live vaccines, or close contact with individuals who received live vaccines cannot be avoided
    • Uncontrolled or symptomatic CNS metastases are present; controlled and asymptomatic CNS metastases are allowed
    • Severe hepatic impairment is present, defined as total bilirubin greater than 3 times the upper limit of normal (ULN) and any AST
    • Member has received prior treatment with another mTOR inhibitor or Fyarro would be used in combination with another mTOR inhibitor
    • Lymphangioleiomyomatosis (LAM) is present
    • Fyarro would not be used as single-agent therapy
    Denial Risk

    Disease-Specific Indication Not Met

    Deny initial approval when the requested indication-specific disease criteria are not documented.

    • PEComa: locally advanced unresectable or metastatic malignant disease is not documented
    • Uterine sarcoma: perivascular epithelioid cell tumor (PEComa) is not documented, or disease is not advanced, recurrent/metastatic, or inoperable
    Denial Risk

    Renewal Denial Risks

    Deny renewal when the member no longer meets the applicable criteria, treatment has not produced disease response or stabilization, or toxicity is unacceptable.

    • Universal or relevant indication-specific criteria are no longer met
    • No disease response, defined as no stabilization of disease and no decrease in tumor size or tumor spread
    • Unacceptable toxicity is present, including stomatitis, myelosuppression, infections, hypokalemia, hyperglycemia, interstitial lung disease or noninfectious pneumonitis, hemorrhage, male infertility, or severe hypersensitivity reactions
    Billing Rule

    Quantity Limit

    Do not approve or reimburse quantities exceeding the plan’s maximum allowed dose limit.

    • Maximum: 600 billable HCPCS units every 21 days
    The member has perivascular epithelioid cell tumor (PEComa).
  1. The member has advanced, recurrent/metastatic, or inoperable disease.Advanced, recurrent/metastatic, or inoperable disease