CurrentCareSourcePolicy N/A

Oncaspar (pegaspargase) — Medical Benefit Coverage Criteria

Defines prior authorization, coverage criteria, dosing, and prescribing requirements for Oncaspar (pegaspargase) for medical benefit use, primarily for acute lymphoblastic leukemia and select T-cell lymphomas; applies to providers submitting authorization requests to CareSource.

Policy Summary

PayerCareSource

PolicyOncaspar (pegaspargase) — Medical Benefit Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJun 5, 2024

Key ActionSubmit prior authorization and documentation showing Oncaspar is prescribed by or in consultation with an oncologist and meets the policy's dosing criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearstandard approval duration

2,500 IU/m2pediatric dosing (<21)

2,000 IU/m2adult dosing (>21)

every 14 daysmax frequency

PA recommendedauthorization

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FDA-Approved Indication (Acute Lymphoblastic Leukemia)

Covered when ALL of the following are met for the FDA-approved indication:

FDA-Approved Indication for ALL

Dosing options: Approve ONE of the following dosing regimens: (1) Patient <21 years: 2,500 International Units/m2 administered IV or IM no more frequently than once every 14 days; OR (2) Patient >21 years: 2,000 International Units/m2 administered IV or IM no more frequently than once every 14 days.

Other Uses with Supportive Evidence

Covered when ALL of the following are met for other uses with supportive evidence:

Other supported uses: Patient meets BOTH: (A) age ≥ 8 years; AND (B) Oncaspar is prescribed by or in consultation with an oncologist.

Dosing: Approve ONE of the following age-based regimens: Patient <21 years: 2,500 International Units/m2 IV or IM no more frequently than once every 14 days; OR Patient >21 years: 2,000 International Units/m2 IV or IM no more frequently than once every 14 days.

Coverage is not recommended for circumstances that are not specifically listed in the Recommended Authorization Criteria. The policy criteria represent the current basis for approval decisions; requests that do not meet those criteria may be denied. The criteria will be updated as new published data become available, and providers should consult the latest policy version when preparing authorization requests.

Provider Requirements, Authorization, and Denial Triggers

Prior Authorization

Prior authorization recommended for Oncaspar

Prior Authorization is recommended for medical benefit coverage of Oncaspar (pegaspargase). Approvals are recommended when patients meet the policy's Criteria and Dosing for the listed indications; approvals are provided for the duration noted in the criteria (e.g., 1 year for the FDA-approved ALL indication).

Step Therapy

Nonstandard dosing reviewed case-by-case

Requests for doses outside the established dosing documented in this policy will be considered and reviewed on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Documentation Required

Prescriber and approval-duration requirements

Oncaspar must be prescribed by or in consultation with an oncologist or a physician who specializes in the condition treated; prior authorization is recommended and approvals are provided for the duration noted in the criteria (for example, 1 year for the FDA-approved ALL indication).

Denial Risk

Requests outside listed criteria may be denied

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria; requests that do not meet the criteria may be denied.

Regimens and Recommended Use

Regimen	Indication / Rationale	Coverage status
Pegaspargase as part of multi-agent chemotherapy (per NCCN guidance)	Component of multi-agent chemotherapeutic regimens for induction and consolidation therapy in acute lymphoblastic leukemia (ALL); also recommended as part of therapy for extranodal NK/T‑cell lymphoma and select T‑cell lymphomas per NCCN guidelines.	Covered

Key Definitions

Oncaspar (pegaspargase) — agent description

Generic namepegaspargase

Brand nameOncaspar

Molecular descriptionConjugate of Escherichia coli-derived L-asparaginase and monomethoxypolyethylene glycol (mPEG)

Routes of administrationIntravenous (IV) or intramuscular (IM)

Indicated use summaryComponent of multi-agent chemotherapy for first-line treatment of acute lymphoblastic leukemia (ALL) in pediatric and adult patients, including patients with hypersensitivity to asparaginase.

Background and Clinical Context

Oncaspar (pegaspargase) is a pegylated Escherichia coli–derived L-asparaginase formulation used as a component of multi‑agent chemotherapy regimens. It is indicated for use in acute lymphoblastic leukemia (ALL) and is administered either intramuscularly or intravenously as part of induction and consolidation treatment strategies; guideline committees such as NCCN recommend pegaspargase in these multi‑agent regimens and in selected T‑cell lymphomas.