CurrentmhnPolicy CP.PHAR.301

Clinical Policy: Erwinia Asparaginase (Rylaze)

Defines medical necessity criteria, prior authorization expectations, dosing limits, approved indications (ALL, LBL, selected T-cell lymphoma), approval durations by line of business, contraindications, and coding information for Rylaze (Erwinia asparaginase). Applies to Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Erwinia Asparaginase (Rylaze)

Policy CodePolicy CP.PHAR.301

Change TypeAnnual review (revised)

Effective Date02.01.17

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

1Q 2025 annual review: added 'severe hepatic impairment' to contraindications section per PI; references reviewed and updated.

1Q 2024 annual review: for ALL, added Asparlas to criteria that member developed hypersensitivity to; removed discontinued Erwinaze product from policy; references reviewed and updated.

1Q 2023 annual review: added age requirements for ALL and LBL indication; added usage for ALL for those age ≥ 18 with substantial comorbidities per NCCN; added T-cell lymphoma criterion; added MWF dosing regimen; revised commercial approval duration language.

3Covered Indications (listed)

1Off-label Indication explicitly listed

3Approval duration categories

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Coverage Summary

Scope: This policy (Ref: CP.PHAR.301) defines medical necessity criteria, prior authorization expectations, dosing limits, approved indications (ALL, LBL, selected T‑cell lymphoma), approval durations by line of business, contraindications, and coding information for Rylaze (Erwinia asparaginase) and applies to Commercial, HIM, and Medicaid lines of business. Coverage stance: covered_with_criteria. Status: CURRENT. Policy number: CP.PHAR.301. Subject: Erwinia asparaginase (Rylaze) coverage policy. Effective date: 02.01.17. Last review date: 02.25 (2025-02-01). Background: Rylaze (recombinant Erwinia asparaginase) is indicated for treatment of ALL or LBL in patients who have developed hypersensitivity to E. coli‑derived asparaginase products; the policy provides criteria when Rylaze is medically necessary and outlines dosing regimens recommended when replacing long‑acting asparaginase products.

Key Thresholds / Limits

Age for ALL and LBL≥ 1 month

Age for T-cell lymphoma (extranodal NK/T-cell lymphoma)≥ 18 years

Dose option A≤ 25 mg/m2 every 48 hours

Dose option B (MWF)25 mg/m2 Mon & Wed; 50 mg/m2 Fri (per regimen)

Maximum dose50 mg/m2 per dose

Minimum prior exposure for continuationReceived medication for at least 30 days

Initial Therapy Criteria

Continuation / Renewal Criteria

Approval durations vary by line of business and are specified in the policy durations section (see Medicaid/HIM and Commercial approval duration categories). Approval duration categories are defined per line of business and differ between initial and continued therapy as noted in the policy.

Unproven / Exclusions

Applicable Codes

HCPCS codes referenced (informational)HCPCS

J9019	Injection, asparaginase, (Erwinaze), 1,000 IU
J9020	Injection, asparaginase, not otherwise specified, 10,000 units
J9021	Injection, asparaginase, recombinant, (Rylaze), 0.1 mg

Provider Actions / Authorization Requirements

Prior Authorization

Prior authorization required

Requests must meet the policy criteria for initial or continued therapy; approval durations vary by line of business (see durations).

Documentation Required

Submit supporting documentation

Provider must submit documentation (office chart notes, lab results, other clinical information) supporting that member meets all approval criteria.

Clinical Evidence & Guidance

Evidence: Rylaze Prescribing Information, April 2024 is cited as the FDA indication source. NCCN recommendations and compendium entries are cited for regimen support. Dosing regimens referenced in this policy follow product guidance (Rylaze PI) and NCCN where applicable.

Background

Rylaze (recombinant Erwinia asparaginase) is indicated as a component of a multi‑agent chemotherapeutic regimen for treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients aged 1 month and older who have developed hypersensitivity to E. coli‑derived asparaginase products. This policy outlines when Rylaze is medically necessary, the approval criteria, and dosing regimens—including recommended dosing when replacing long‑acting asparaginase products (e.g., the IM 25 mg/m2 every 48 hours or the M/W/F 25 mg/m2, 25 mg/m2, 50 mg/m2 schedule). The policy also notes use of Rylaze as a replacement for long‑acting asparaginase products and specifies documentation and prior authorization requirements.

Definitions

ALLacute lymphoblastic leukemia

LBLlymphoblastic lymphoma

NCCNNational Comprehensive Cancer Network

Revision History

1Q 2025revisedLatest

1Q 2025 annual review: added 'severe hepatic impairment' to contraindications section per PI; references reviewed and updated. (Materiality: no significant coverage changes noted.)

1Q 2024revised

1Q 2024 annual review: for ALL, added calaspargase pegol-mknl (Asparlas) to the list of E. coli–derived asparaginase products to which a member must have developed hypersensitivity; removed discontinued Erwinaze product from the policy; references reviewed and updated. (Material change.)

1Q 2023