CurrentViva HealthPolicy IC-0367

Elitek (rasburicase) (Intravenous) Coverage Criteria

Policy governing prior authorization, dosing, and coverage criteria for rasburicase (Elitek) for treatment or prophylaxis of hyperuricemia due to tumor lysis syndrome for Viva Health members.

Policy Summary

PayerViva Health

PolicyElitek (rasburicase) (Intravenous) Coverage Criteria

Policy CodePolicy IC-0367

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization for a single 5-day course (maximum 45 HCPCS units/day); renewals are not permitted.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 daysmaximum authorized course duration

45maximum billable HCPCS units per day

J2783HCPCS code

1 mominimum age

E88.3covered diagnosis code

Coverage Criteria for Rasburicase (Elitek)

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Initial Approval Criteria

Covered when ALL of the following are met:

Eligibility and contraindications: Patient is at least 1 month of age; no known glucose-6-phosphate dehydrogenase (G6PD) deficiency; and patient is receiving chemotherapy for leukemia, lymphoma, or a solid tumor.

Indication type: Either used prophylactically when chemotherapy is expected to cause tumor lysis in a patient at high risk OR used therapeutically to treat established hyperuricemia despite standard prophylactic measures (e.g., hydration, allopurinol, febuxostat).

High-risk features (one or more required for prophylaxis): High-risk tumor type or treatment (e.g., Burkitt lymphoma/leukemia, lymphoblastic lymphomas, ALL, DLBCL, other high proliferative tumors; or receipt of high‑risk medications such as venetoclax, chemoimmunotherapy, lenalidomide, obinutuzumab) OR bulky disease/large tumor burden (any lymph node ≥10 cm), LDH ≥2x ULN, ALC ≥25,000/mcL, WBC >50,000/mcL, organ infiltration or bone marrow involvement, spontaneous TLS, dehydration/volume depletion, renal disease or tumor renal involvement, or pre-existing hyperuricemia (>7.5 mg/dL) or hyperphosphatemia (>4.5 mg/dL).

Renewal Criteria

Renewal

Renewal restriction: Authorization may not be renewed; duration of initial authorization is a single course of up to 5 days (refer to Length of Authorization).

Dosing beyond 5 days or administration of more than one course is not recommended. Elitek (rasburicase) is indicated for a single course of treatment only; additional courses or renewal authorizations are not supported by the product labeling.

Use of rasburicase is contraindicated in patients with a known deficiency of glucose-6-phosphate dehydrogenase (G6PD). Requests for therapy in members with documented G6PD deficiency will be denied due to the risk of hemolysis.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J2783

Injection, rasburicase, 0.5 mg

NDCsNDC

00024-5150-xx	Elitek 1.5 mg single-dose vial NDC
00024-5151-xx	Elitek 7.5 mg single-dose vial NDC

Covered Diagnosis CodesICD-10Covered

E88.3

Tumor lysis syndrome

inv-08: Maximum HCPCS units per day

Maximum HCPCS units per day45 billable units daily (1 billable unit = 0.5 mg); authorized for a single 5-day course

HCPCS unit definition1 billable unit = 0.5 mg (J2783 represents 0.5 mg)

Maximum course durationOne 5-day therapy course only (authorization covers up to 5 days)

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for a single 5-day course (up to 45 units/day). Authorization is valid only for one course and will not be renewed.

Single-course prior authorization: up to 5 days
Maximum: 45 billable units per day
No renewals — requests for additional courses or renewals will be denied

Note

Use Relative to Standard Prophylaxis

Use of therapy may be for prophylaxis in patients at high risk for tumor lysis syndrome or for treatment of established hyperuricemia despite standard prophylactic measures. Document the indication (prophylactic vs therapeutic) and clinical rationale.

Prophylactic use: patients receiving chemotherapy expected to cause tumor lysis who are high-risk
Therapeutic use: patients who develop hyperuricemia despite standard prophylaxis (hydration, allopurinol, febuxostat)

Documentation Required

Documentation Requirements

Required clinical documentation must be provided with the prior authorization request to support medical necessity.

Patient age
Absence of G6PD deficiency (document G6PD status) — presence of G6PD deficiency is a contraindication and will result in denial
Indication (prophylaxis vs treatment) and supporting risk factors or clinical evidence of tumor lysis/hyperuricemia (e.g., bulky disease, elevated LDH, high WBC, organ infiltration, dehydration, renal disease, pre-existing hyperuricemia)
Chemotherapy regimen or agents expected to cause tumor lysis (if prophylaxis)

Denial Risk

Single-course Only — No Renewals

Authorization is limited to a single course only. Requests that exceed a single 5-day course or seek renewal/extension will be denied.

One 5-day therapy course only
No renewals or extensions permitted

Denial Risk

G6PD Deficiency Contraindication

Known G6PD deficiency is a contraindication to therapy. Requests for patients with documented G6PD deficiency will be denied.

Document G6PD status prior to approval
Denial will occur if G6PD deficiency is present

Regimen	Indication / Notes
0.2 mg/kg IV daily up to 5 days
Alternative: single fixed dose 3–6 mg IV in adults; additional doses may be considered based on tumor bulk, hydration status, or presence of acute renal failure

Definitions and High-risk Features

inv-15: High-risk for tumor lysis syndrome

High-risk tumor typesHigh proliferative tumors (e.g., Burkitt lymphoma/leukemia, lymphoblastic lymphomas, acute lymphoblastic leukemia [ALL], diffuse large B-cell lymphoma [DLBCL])

Bulky disease or high tumor burdenAny lymph node ≥10 cm or other large tumor burden

Laboratory and hematologic risk markersElevated LDH ≥2×ULN; absolute lymphocyte count ≥25,000/mcL; white blood cell count >50,000/mcL

Renal/volume risk factorsRenal disease or tumor renal involvement, dehydration/volume depletion, or situations limiting adequate hydration

Pre-existing metabolic abnormalitiesPre-existing hyperuricemia (serum/plasma uric acid >7.5 mg/dL) or hyperphosphatemia (serum/plasma phosphate >4.5 mg/dL)

Other high-risk features/agentsOrgan infiltration or bone marrow involvement; spontaneous TLS; treatment with high-risk agents (e.g., venetoclax, chemoimmunotherapy, lenalidomide, obinutuzumab)