CurrentCareSourcePolicy N/A

Rylaze (asparaginase erwinia chrysanthemi recombinant) — Coverage Criteria for Prior Authorization

This policy governs prior authorization and coverage criteria for Rylaze (intramuscular) for treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LBL), and extranodal NK/T-cell lymphoma when prescribed by or in consultation with an oncologist.

Policy Summary

PayerCareSource

PolicyRylaze (asparaginase erwinia chrysanthemi recombinant) — Coverage Criteria for Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateApr 24, 2024

Key ActionObtain prior authorization and ensure Rylaze is prescribed by or in consultation with an oncologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yeartypical approval duration

up to 11max doses (48-hr)

up to 9max doses (Mon/Wed/Fri)

oncologistspecialist requirement

Coverage Criteria for Rylaze

Initial FDA-Approved Indication

Covered when ALL of the following are met for FDA-approved indication (Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma):

FDA-Approved Indication - ALL/LBL: A) Patient has a systemic allergic reaction or anaphylaxis to a pegylated asparaginase product; AND B) Rylaze is prescribed by or in consultation with an oncologist

Approve for 1 year if both A and B are met.

Dosing options: Approve ONE of the following dosing regimens: (1) Once-every-48-hour administration: 25 mg/m2 IM no more frequently than every 48 hours for up to 11 doses per treatment cycle; OR (2) Monday/Wednesday/Friday administration: 25 mg/m2 IM on Monday and Wednesday and 50 mg/m2 IM on Friday for up to 9 doses per treatment cycle.

Approvals per dosing regimen as stated.

Other Uses with Supportive Evidence

Covered when ALL of the following are met for Other Uses with Supportive Evidence (Extranodal NK/T-Cell Lymphoma):

Policy Summary

PayerCareSource

PolicyRylaze (asparaginase erwinia chrysanthemi recombinant) — Coverage Criteria for Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateApr 24, 2024

Key ActionObtain prior authorization and ensure Rylaze is prescribed by or in consultation with an oncologist.

SourceLink

On This Page

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Supportive Evidence Indication - Extranodal NK/T-Cell Lymphoma: A) Patient has a systemic allergic reaction or anaphylaxis to a pegylated asparaginase product; AND B) Rylaze is prescribed by or in consultation with an oncologist

Approve for 1 year if both A and B are met.

Approvals per dosing regimen as stated.

Coverage is not recommended for circumstances that are not listed in the Recommended Authorization Criteria. The authorization criteria will be reviewed and updated as new published evidence becomes available.

Dosing Regimens and Limits

Regimen	Details
Once-every-48-hour administration	25 mg/m2 intramuscular (IM) no more frequently than every 48 hours for up to 11 doses per treatment cycle.
Monday/Wednesday/Friday administration	25 mg/m2 IM on Monday and Wednesday, and 50 mg/m2 IM on Friday for up to 9 doses per treatment cycle.

Line of Therapy / Salvage Use

salvage

Line-of-therapy context: Use indicated as component of multi-agent chemotherapy in patients who have developed hypersensitivity to E. coli–derived asparaginase (i.e., substitution after allergic reaction to pegylated asparaginase)

NCCN recommends Rylaze for patients who develop systemic allergic reaction or anaphylaxis to pegaspargase.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for medical benefit coverage of Rylaze. Approvals follow the policy Criteria and Dosing and must be provider-submitted. Extended approvals are allowed if the patient continues to meet the Criteria and Dosing. Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist).

All approvals are provided for the duration noted in the policy.
Automation: None.

Note

Use After Hypersensitivity to E. coli–Derived Asparaginase

Rylaze is indicated as part of multi-agent chemotherapy for ALL and LBL in patients who have developed hypersensitivity to E. coli–derived asparaginase (including pegylated asparaginase). Use is intended for patients who develop a systemic allergic reaction/anaphylaxis to E. coli–derived asparaginase products, consistent with NCCN guidance.

Indication: Acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients with hypersensitivity to E. coli–derived asparaginase.
NCCN: Recommends Rylaze for patients with systemic allergic reaction/anaphylaxis to pegaspargase (various guideline versions).

Documentation Required

Prescriber and Documentation Requirements

Rylaze must be prescribed by or in consultation with a physician who specializes in the condition treated (e.g., oncologist). Documentation supporting the diagnosis, prior hypersensitivity to E. coli–derived asparaginase (including description of the reaction), and rationale for use of Rylaze should be submitted with the authorization request. Requests for continued therapy should include documentation that the patient continues to meet Criteria and Dosing.

Prescriber requirement: specialist (oncologist) involvement or consultation.
Documentation to submit: diagnosis, description of hypersensitivity/anaphylaxis, prior therapy history, dosing rationale, and ongoing eligibility for extended approvals.

Denial Risk

Denial for Not Meeting Criteria

Requests that do not meet the Recommended Authorization Criteria are not recommended for approval. Coverage is not recommended for uses or circumstances not listed in the Recommended Authorization Criteria; criteria will be updated as new published data are available.

Denial risk applies when the request lacks documented hypersensitivity to E. coli–derived asparaginase or does not meet the policy dosing/indication criteria.
Requests for doses outside the established dosing may be denied unless approved on a case-by-case basis by a clinician.

Definitions

Hypersensitivity to E. coli–derived asparaginase — definition

DefinitionSystemic allergic reaction or anaphylaxis to pegylated asparaginase products (hypersensitivity to E. coli–derived asparaginase).

Clinical contextIndication for substitution of Rylaze when patients developing this hypersensitivity cannot tolerate E. coli–derived or pegylated asparaginase.

PopulationAdult and pediatric patients (≥ 1 month) who have developed hypersensitivity to E. coli–derived asparaginase.

Background

Rylaze (asparaginase erwinia chrysanthemi recombinant) is indicated as a component of multi‑agent chemotherapy for acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients who develop hypersensitivity to E. coli–derived asparaginase products. The agent provides an alternative asparaginase formulation for patients with systemic allergic reactions or anaphylaxis to pegylated asparaginase and should be prescribed by or in consultation with an oncologist as part of combination chemotherapy regimens.