Last Review Date: 07/05/2023

Date of Origin: 10/02/2018

Dates Reviewed: 10/2018, 07/2019, 07/2020, 07/2021, 07/2022, 07/2023

I. Length of Authorization

Coverage will be provided for a single course of treatment, consisting of 5 days of therapy, and may not be renewed.

II. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Elitek 1.5 mg single-dose vial: 4 vials per day
• Elitek 7.5 mg single-dose vial: 3 vials per day

2. Max Units (per dose and over time) [HCPCS Unit]:

• 230 billable units total

III. Initial Approval Criteria

Coverage is provided in the following conditions:

Hyperuricemia due to Tumor Lysis † Ф ¹

• Patient is at least 1 month of age; AND
• Patient must not have a deficiency in glucose-6-phosphate dehydrogenase (G6PD); AND
• Patient must be receiving chemotherapy for leukemia, lymphoma, or solid tumors; AND
  • Used as prophylactic therapy in patients whose chemotherapy is expected to result in tumor lysis and subsequent elevation of plasma uric acid; AND
    • Patient must be at high-risk* for developing hyperuricemia; OR
  • Used for treatment in patients who develop hyperuricemia despite standard prophylactic therapies (i.e., hydration, allopurinol, febuxostat, etc.)

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

IV. Renewal Criteria ¹

Coverage may not be renewed.

V. Dosage/Administration ^1,7-15

VI. Billing Code/Availability Information

HCPCS Code:

• J2783 – Injection, rasburicase, 0.5 mg; 1 billable unit = 0.5 mg

NDC(s):

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

VII. References

1. Elitek [package insert]. Bridgewater, NJ; Sanofi-Aventis U.S. LLC.; December 2019. Accessed June 2023.
2. Coiffer B, Altman A, Pui C, et al. Guidelines for the management of pediatric and adult tumor lysis syndrome: an evidence-based review. J Clin Oncol 2008;26:2767-2778.
3. Jones GL, Will A, Jackson GH, Webb NJ, Rule S; British Committee for Standards in Haematology. Guidelines for the management of tumour lysis syndrome in adults and children with haematological malignancies on behalf of the British Committee for Standards in Haematology. Br J Haematol. 2015 Jun;169(5):661-71.
4. Cairo MS, Coiffier B, Reiter A, et al. Recommendations for the evaluation of risk and prophylaxis of tumour lysis syndrome (TLS) in adults and children with malignant diseases: an expert TLS panel consensus. Br J Haematol 2010; 149:578.
5. Cortes J, Moore JO, Maziarz RT, et al. Control of plasma uric acid in adults at risk for tumor lysis syndrome: efficacy and safety of rasburicase alone and rasburicase followed by allopurinol compared with allopurinol alone—results of a multicenter phase III study. J Clin Oncol. 2010;28(27):4207-4213.
6. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Guidelines Version 3.2023. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed June 2023.
7. Giraldez M, Puto K: A single, fixed dose of rasburicase (6 mg maximum) for treatment of tumor lysis syndrome in adults. Eur J Haematol 85: 177– 179,2010.
8. McDonnell AM, Lenz KL, Frei-Lahr DA, et al: Single-dose rasburicase 6 mg in the management of tumor lysis syndrome in adults. Pharmacotherapy 26: 806– 812,2006.
9. Liu CY, Sims-McCallum RP, Schiffer CA: A single dose of rasburicase is sufficient for the treatment of hyperuricemia in patients receiving chemotherapy. Leuk Res 29: 463– 465,2005.
10. Trifilio S, Gordon L, Singhal S, et al: Reduced-dose rasburicase (recombinant xanthine oxidase) in adult cancer patients with hyperuricemia. Bone Marrow Transplant 37: 997– 1001,2006.
11. Hutcherson DA, Gammon DC, Bhatt MS, et al: Reduced-dose rasburicase in the treatment of adults with hyperuricemia associated with malignancy. Pharmacotherapy 26: 242– 247,2006.
12. Hummel M, Reiter S, Adam K, et al: Effective treatment and prophylaxis of hyperuricemia and impaired renal function in tumor lysis syndrome with low doses of rasburicase. Eur J Haematol 80: 331– 336,2008.
13. Reeves DJ, Bestul DJ: Evaluation of a single fixed dose of rasburicase 7.5 mg for the treatment of hyperuricemia in adults with cancer. Pharmacotherapy 28: 685– 690,2008.
14. Campara M, Shord SS, Haaf CM: Single-dose rasburicase for tumour lysis syndrome in adults: Weight-based approach. J Clin Pharm Ther 34: 207– 213,2009.
15. Trifilio SM, Pi J, Zook J, et al: Effectiveness of a single 3-mg rasburicase dose for the management of hyperuricemia in patients with hematological malignancies. Bone Marrow Transplant. 2011 Jun;46(6):800-5. Doi: 10.1038/bmt.2010.212.
16. Larson RA, Pui CH (May 2022). Tumor lysis syndrome: Pathogenesis, clinical manifestations, definition, etiology and risk factors. Drews RE, Freedman AS, Poplack DG, Rosmarin AG (Eds.). In UpToDate. Last updated: May 24,2022. Accessed: June 14, 2023. Available from: https://www.uptodate.com/contents/tumor-lysis-syndrome-pathogenesis-clinical-manifestations-definition-etiology-and-risk-factors?search=Tumor%20lysis%20syndrome:%20Pathogenesis,%20clinical%20manifestations,%20definition,%20etiology%20and%20risk%20factors&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Article (LCAs) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A