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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsViva Health Elitek Coverage Policy | OpenPayer
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    CurrentViva Health PlanPolicy IC-0367

    Elitek (rasburicase) Coverage Criteria

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    This policy governs prior authorization, medical necessity, dosing, and billing requirements for intravenous Elitek (rasburicase) used to prevent or treat hyperuricemia associated with tumor lysis in Viva Health Plan members receiving chemotherapy for leukemia, lymphoma, or solid tumors.

    Policy Summary
    PayerViva Health Plan
    PolicyElitek (rasburicase) Coverage Criteria
    Policy CodePolicy IC-0367
    Change TypeNo material change
    Effective DateN/A
    Last ReviewJul 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization for a single 5-day course when all clinical criteria for hyperuricemia due to tumor lysis are met.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    5 daysMaximum therapy duration
    45Maximum daily HCPCS units
    1Maximum treatment courses
    E88.3Covered diagnosis
    J2783

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    HCPCS code

    Coverage Criteria

    Initial Therapy

    Coverage is provided when ALL of the following criteria are met:

    ALL of the following

    • Member is at least 1 month of age.
    • Member does NOT have any FDA-labeled contraindications to rasburicase, including glucose-6-phosphate dehydrogenase (G6PD) deficiency or a history of reactions to rasburicase such as anaphylaxis, severe hypersensitivity, hemolysis, or methemoglobinemia.
    • Member is receiving chemotherapy for leukemia, lymphoma, or solid tumors.
    • ONE of the following

      • Prophylaxis

        • Rasburicase is being used as prophylactic therapy when chemotherapy is expected to result in tumor lysis and subsequent elevation of plasma uric acid.
          • ANY of the following

            • High-risk tumor type, including Burkitt lymphoma/leukemia, lymphoblastic lymphomas, acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL), or another tumor type with a high proliferative rate or high sensitivity to cytotoxic therapy; or treatment with high-risk medications such as venetoclax, chemoimmunotherapy, lenalidomide, or obinutuzumab.
            • Progressive disease after small-molecule inhibitor therapy.
            • Bulky disease or large tumor burden, including any lymph node ≥10 cm, elevated LDH ≥2 times the upper limit of normal, absolute lymphocyte count ≥25,000/mcL, white blood cell count >50,000/mcL, organ infiltration, or bone marrow involvement.
            • Spontaneous tumor lysis syndrome.
            • Dehydration, volume depletion, or a situation in which adequate hydration may be difficult or impossible.
      • Treatment

        • Rasburicase is being used to treat hyperuricemia that developed despite standard prophylactic therapies, such as hydration, allopurinol, or febuxostat.

    Rasburicase is contraindicated in members with glucose-6-phosphate dehydrogenase (G6PD) deficiency and in members with a history of reactions to rasburicase, including anaphylaxis, severe hypersensitivity, hemolysis, or methemoglobinemia.

    Initial prior authorization is valid for a single course of treatment consisting of up to 5 days of therapy. Renewal is not permitted. Dosing beyond 5 days or administration of more than one course is not recommended; Elitek is indicated only for a single course of treatment.

    Billing and Coding

    HCPCS CodeHCPCSCovered
    J2783Injection, rasburicase, 0.5 mg; 1 billable unit = 0.5 mg
    NDC(s)NDCCovered
    00024-5150-xxElitek 1.5 mg single-dose vial
    00024-5151-xxElitek 7.5 mg single-dose vial
    Covered Diagnosis CodesICD-10Covered
    E88.3Tumor lysis syndrome
    Daily HCPCS unit limit
    Daily limit45 billable HCPCS units per day
    Duration5 days
    Course limitOne 5-day therapy course only
    Bulky disease
    ConditionBulky disease or large tumor burden
    Lymph-node thresholdAny lymph node ≥10 cm
    Measurement

    Provider Actions

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for Elitek. Initial authorization is limited to one treatment course consisting of up to 5 days of therapy for eligible members with hyperuricemia due to tumor lysis.

    • Member is receiving chemotherapy for leukemia, lymphoma, or solid tumors.
    • Use is for prophylaxis when chemotherapy is expected to cause tumor lysis and elevated plasma uric acid in a member at high risk for hyperuricemia, or for treatment of hyperuricemia despite standard prophylaxis such as hydration, allopurinol, or febuxostat.
    Denial Risk

    Clinical Eligibility Required

    Coverage is not approved when clinical eligibility requirements are not met, including age or FDA-labeled contraindications to rasburicase.

    • Member must be at least 1 month of age.

    Background

    Rasburicase is used to reduce uric acid in patients at risk for or experiencing tumor lysis syndrome during cancer treatment. Coverage may apply for prophylaxis when chemotherapy is expected to cause tumor lysis and elevated plasma uric acid in a member at high risk for hyperuricemia, or for treatment when hyperuricemia develops despite standard prophylaxis such as hydration, allopurinol, or febuxostat.

    Definitions and Risk Factors

    High risk for hyperuricemia
    High-risk tumor or treatmentHigh-risk tumor type or high-risk medication, such as venetoclax, chemoimmunotherapy, lenalidomide, or obinutuzumab
    Disease burden or progressionProgressive disease after small-molecule inhibitor therapy, bulky disease or large tumor burden, or spontaneous tumor lysis syndrome
    Hydration riskDehydration, volume depletion, or situations where adequate hydration may be difficult or impossible
    Renal riskRenal disease or renal involvement by tumor, including pre-existing nephropathy, nephrotoxin exposure, oliguria, or acidic urine
    Pre-existing laboratory abnormalitiesPre-existing hyperuricemia or hyperphosphatemia

    Initial Therapy Criteria

    Hyperuricemia Due to Tumor Lysis — Initial Therapy Criteria

    Initial approval is provided for hyperuricemia due to tumor lysis when all applicable criteria are met.

    Initial Elitek approval

    • Qualifying use pathway

      • High-risk prophylaxis

        • High-risk factor

          • The member has a high-risk tumor type or is receiving a high-risk medication.

            Examples include Burkitt lymphoma or leukemia, lymphoblastic lymphoma, acute lymphoblastic leukemia, diffuse large B-cell lymphoma, other tumors with a high proliferative rate or high sensitivity to cytotoxic therapy, venetoclax, chemoimmunotherapy, lenalidomide, or obinutuzumab.

          • The member has progressive disease after small-molecule inhibitor therapy.

    Continuation and Renewal

    No Renewal

    Renewal is not available; authorization cannot extend beyond the initial single course.

    No renewal: Prior authorization may not be renewed, and there is no covered continuation or repeat course.Single 5-day course

    Initial authorization is limited to one course consisting of 5 days of therapy; authorization cannot extend beyond that course.

    Quantity Limits

    Elitek (rasburicase)
    DrugElitek (rasburicase)
    Daily HCPCS limit45 billable HCPCS units daily
    Duration and course limit5 days; one 5-day therapy course only
    Policy Summary
    PayerViva Health Plan
    PolicyElitek (rasburicase) Coverage Criteria
    Policy CodePolicy IC-0367
    Change TypeNo material change
    Effective DateN/A
    Last ReviewJul 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization for a single 5-day course when all clinical criteria for hyperuricemia due to tumor lysis are met.
    SourceLink
    On This Page
    Coverage CriteriaBilling and CodingProvider ActionsBackgroundDefinitions and Risk FactorsInitial Therapy CriteriaContinuation and RenewalQuantity Limits
    Renal disease or renal involvement by tumor, including pre-existing nephropathy, exposure to nephrotoxins, oliguria, or acidic urine.
  1. Pre-existing hyperuricemia (serum/plasma uric acid >7.5 mg/dL) or hyperphosphatemia (serum/plasma phosphate >4.5 mg/dL).
  2. Lymph-node size
    Elevated LDH
    ConditionElevated lactate dehydrogenase (LDH)
    ThresholdLDH ≥2 times the upper limit of normal (ULN)
    ComparisonUpper limit of normal
    Absolute lymphocyte count
    TestAbsolute lymphocyte count
    Qualifying threshold≥25,000/mcL
    UnitCells per microliter (mcL)
    White blood cell count
    TestWhite blood cell count
    Qualifying threshold>50,000/mcL
    UnitCells per microliter (mcL)
    Pre-existing hyperuricemia
    ConditionPre-existing hyperuricemia
    Qualifying thresholdSerum or plasma uric acid >7.5 mg/dL
    SpecimenSerum or plasma
    Pre-existing hyperphosphatemia
    ConditionPre-existing hyperphosphatemia
    Qualifying thresholdSerum or plasma phosphate >4.5 mg/dL
    SpecimenSerum or plasma
  3. Member must not have an FDA-labeled contraindication, including G6PD deficiency or a history of rasburicase-associated anaphylaxis, severe hypersensitivity, hemolysis, or methemoglobinemia.
  4. Denial Risk

    Repeat Course or Extended Therapy

    Authorization will not be renewed when the authorized duration has been exceeded. Elitek is indicated for a single course only; therapy beyond the initial course or administration beyond 5 days is not recommended and may result in denial or non-renewal.

    • Prior authorization validity may not be renewed.
    • Do not administer more than one course of treatment.
    • Do not extend therapy beyond 5 days; the usual dose is 0.2 mg/kg intravenously daily for up to 5 days.
  5. The member has bulky disease or a large tumor burden.

    Examples include any lymph node ≥10 cm, elevated LDH ≥2 times the upper limit of normal, absolute lymphocyte count ≥25,000/mcL, white blood cell count >50,000/mcL, organ infiltration, or bone marrow involvement.

  6. The member has spontaneous tumor lysis syndrome.
  7. The member has dehydration, volume depletion, or a situation in which adequate hydration may be difficult or impossible.
  8. The member has renal disease or renal involvement by tumor.

    Examples include pre-existing nephropathy, exposure to nephrotoxins, oliguria, or acidic urine.

  9. The member has pre-existing hyperuricemia or hyperphosphatemia.Serum/plasma uric acid >7.5 mg/dL or phosphate >4.5 mg/dL
  10. Treatment after failed prophylaxis: The member developed hyperuricemia despite standard prophylactic therapies such as hydration, allopurinol, or febuxostat.
  11. No FDA-labeled contraindication: The member does not have G6PD deficiency or a history of rasburicase-associated anaphylaxis, severe hypersensitivity, hemolysis, or methemoglobinemia.