CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Elitek (rasburicase) — Drug Coverage Criteria

Defines coverage, medical necessity criteria, and utilization management rules for Elitek (rasburicase) for prevention and treatment of tumor lysis syndrome and related indications for members served by the payer's UM program.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyElitek (rasburicase) — Drug Coverage Criteria

Policy CodePolicy N/A

Change TypeMinor administrative update — no material clinical changes

Effective DateMay 31, 2024

Next Review DateMay 8, 2024

Key ActionSubmit prior authorization requests to Evolent (UM) with supporting evidence per FDA labeling, CMS compendia, NCCN/ASCO or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

0.2 mg/kgsingle dose limit

6 mgmax fixed dose

5 daysmax duration

TLS prevention/treatmentprimary covered indication

Coverage Criteria

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inv-01: Tumor Lysis Syndrome (TLS) — Covered Indication

Covered when ALL of the following are met:

TLS coverage criteria: 1) Patient is an adult or pediatric member with a hematologic malignancy or solid tumor who is receiving anti-cancer therapy; 2) Patient is expected to be at significant risk of developing tumor lysis syndrome (TLS) OR has clinical/laboratory evidence of TLS with an increase in plasma uric acid above the upper limit of normal; 3) Rasburicase (Elitek) is being used as a single agent or in combination with allopurinol for prevention and/or treatment of TLS.plasma uric acid: increase above the upper limit of normal

Supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines or acceptable peer-reviewed literature

inv-02: Continuation requests exemption

Continuation requests for previously used, non-approvable medications may be exempt when ALL are met:

Continuation exemption: 1) The requested medication was used within the last year; 2) The member has not experienced disease progression and/or intolerance to the requested medication; 3) Additional medication(s) are not being added to the continuation request.

Applies to continuation requests as described in policy

Use of Elitek (rasburicase) for investigational or off-label indications is considered not medically necessary when supporting evidence is insufficient or not generally accepted by the medical community. The policy defines insufficient evidence as situations where the published literature does not adequately represent the patient or cancer clinical characteristics, the administered anticancer regimen, or clinically meaningful patient outcomes. Case reports, abstracts without full peer‑reviewed articles, and evidence not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature are explicitly identified as inadequate to establish medical necessity.

Provider Actions and Utilization Management

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Medication requests are processed by Evolent (Utilization Management). Final approval authority rests with the Utilization Management Committee. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Evolent processes all medication requests from network ordering providers.
Final approval authority: Utilization Management Committee.
Medications not authorized may be denied as not reimbursable.

Step Therapy

Step Therapy Note

Elitek (rasburicase) may be used as a single agent or in combination with allopurinol for prevention and/or treatment of tumor lysis syndrome (TLS) in adult or pediatric members with hematologic malignancies or solid tumors who are receiving anti-cancer therapy and are at significant risk for TLS or have clinical/laboratory evidence of TLS. No formal step therapy (requiring failure of another agent) is mandated.

Elitek can be administered alone or with allopurinol.
Indicated for prevention and/or treatment of TLS in patients receiving anti-cancer therapy who are at significant risk or have evidence of TLS.

Documentation Required

Supporting Evidence Required

Supporting evidence is required for use of Elitek. Requests must be supported by FDA-approved product labeling; CMS-recognized compendia; National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO) clinical guidelines; or peer-reviewed literature that meets CMS standards.

Accepted evidence sources: FDA labeling; CMS-approved compendia; NCCN; ASCO guidelines; peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Denial Risk

Authorization and Investigational/Off-Label Denial Risk

Authorization and investigational/off-label denial risk — Requests for Elitek that exceed dosing or duration limits, or that propose investigational or insufficiently supported off-label indications, may be denied and deemed not reimbursable.

Dosing limit: single dose should not exceed 0.2 mg/kg (maximum 6 mg fixed single dose).
Duration limit: treatment should not exceed 5 days (one course).
Off-label/investigational use lacking adequate evidence (per criteria listed) may be denied.

Background

Rasburicase (Elitek) is a recombinant uricolytic enzyme indicated for prevention and treatment of tumor lysis syndrome (TLS) in patients at risk for or with biochemical evidence of TLS. It is used in adult and pediatric patients with hematologic malignancies or solid tumors who are receiving anti‑cancer therapy and are at significant risk of rapid tumor cell lysis leading to elevations in plasma uric acid. Administration and monitoring recommendations are available in the FDA label; this policy applies utilization limits and evidentiary standards to support appropriate use.

Definitions

inv-11: Tumor Lysis Syndrome (TLS) — definition as metabolic complication with elevated uric acid and related labs

DefinitionTumor Lysis Syndrome (TLS) is a metabolic complication of cancer treatment characterized by rapid tumor cell breakdown causing elevations in uric acid and related metabolic abnormalities (e.g., potassium, phosphate, calcium) with clinical and/or laboratory evidence including increased plasma uric acid.

Typical settingOccurs in patients with hematologic malignancies or solid tumors receiving anti-cancer therapy who are at significant risk for TLS

Relevance to treatmentElitek (rasburicase) is indicated for prevention and/or treatment of TLS when these metabolic abnormalities and elevated uric acid are present

Continuation Therapy Criteria

inv-13: Continuation Therapy

Continuation requests exemption for previously used medications

Continuation therapy criteria: Medication was used within the last year; member has not experienced disease progression or intolerance to the medication; no additional medications are being added to the continuation request.

Continuation requests meeting these criteria may be exempt from requirements for new approvals

Step	Requirement/Note
1	Elitek (rasburicase) may be used as a single agent or in combination with allopurinol for prevention and/or treatment of tumor lysis syndrome (TLS); no formal prior step-therapy requirement is specified.