CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1361

Rylaze (asparaginase Erwinia chrysanthemi recombinant-rywn) coverage

Defines medical necessity, inclusion and exclusion criteria, coding, and utilization management requirements for Rylaze for treatment of acute lymphoblastic leukemia and continuation requests for existing therapies for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRylaze (asparaginase Erwinia chrysanthemi recombinant-rywn) coverage

Policy CodePolicy UM ONC_1361

Change TypeNo material changes

Effective DateJan 31, 2025

Next Review DateJan 8, 2025

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

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

25 mg/m2single dose limit (48 hrs)

50 mg/m2single dose limit (weekly)

J9021HCPCS

ALL (Ph- / Ph+)covered diagnosis

Allowed if no progression

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Coverage criteria for Rylaze

Initial and Continuation Coverage Criteria

Covered when ALL of the following are met

Primary inclusion: Member has acute lymphoblastic leukemia (Philadelphia chromosome-negative or -positive) AND Rylaze is being used as part of a multi-agent chemotherapy regimen for induction, consolidation, or relapsed/refractory disease

AND member has history of hypersensitivity or adverse effects to pegaspargase (Oncaspar) or calaspargase pegol (Asparlas).

Continuation exemption: For continuation requests: member has not experienced disease progression on the requested medication AND the requested medication was used within the last year without a lapse >30 days of active authorization AND no additional medications are being added to the continuation request

Applies to continuation of previously authorized therapy.

Exclusions for Rylaze include: disease progression while on Rylaze. Requests will also be excluded when dosing exceeds the stated single‑dose limits — 25 mg/m2 for an every‑48‑hour schedule or 50 mg/m2 for a once‑weekly schedule. Additionally, investigational use or off‑label indications that do not meet the policy's evidence standards are excluded.

Use of Rylaze for off‑label indications is considered not medically necessary when the indication lacks sufficient supporting evidence or is not generally accepted by the medical community. The policy defines insufficient evidence as, for example, inadequate representation of the patient or regimen in published studies, lack of clinically meaningful outcomes (per ASCO benchmarks such as hazard ratio < 0.80 or at least a 3‑month OS/PFS benefit), inappropriate experimental design for the question, reliance on uncontrolled case reports or meeting abstracts without full peer‑reviewed publication, or absence of support in CMS‑recognized compendia or acceptable peer‑reviewed literature.

Coding and dosing limits

Covered HCPCS CodesHCPCSCovered

J9021

Injection, asparaginase, recombinant, (rylaze), 0.1 mg

Single dose limits

Single‑dose limit — every 48 hours schedule25 mg/m2

Single‑dose limit — once per week schedule50 mg/m2

Exclusion for dosing exceedanceRequests will be excluded if dosing exceeds the single dose limits above

Provider responsibilities and authorization

Prior Authorization

Prior authorization required — Evolent UM review; final approval by UM Committee

Prior authorization for Rylaze (J9021) must be submitted to and processed by Evolent's Utilization Management; final coverage approval is determined by the Utilization Management Committee. Medication requests require supporting evidence as specified by the policy and will be deemed not approvable if not authorized by Evolent.

Submit all Rylaze (J9021) medication requests to Evolent for review.
Final approval authority resides with the Utilization Management Committee.

Step Therapy

Continuation request conditions for previously authorized therapy

Continuation (renewal) requests are allowed only when the member has not experienced disease progression on the requested medication, the medication was used within the last year without a lapse greater than 30 days of active authorization, and no additional medications are being added to the continuation request.

No disease progression on the requested medication.

Multi-agent chemotherapy regimens and substitution guidance

Regimen / Clinical Context	Permitted substitution	Coverage status
Multi-agent chemotherapy regimens for acute lymphoblastic leukemia (ALL) — induction, consolidation, or relapsed/refractory therapy	Substitute Rylaze (asparaginase Erwinia chrysanthemi recombinant-rywn) when member has a history of hypersensitivity reaction or other adverse effects to pegylated E. coli–derived asparaginase products (e.g., Oncaspar [pegaspargase] or Asparlas [calaspargase pegol]).	Covered

Placement in therapy

first-line | subsequent

Permitted lines: Induction; consolidation; relapsed/refractory therapy as part of multi-agent chemotherapy when prior hypersensitivity to pegaspargase or calaspargase pegol prevents their use

Key indication and definitions

Indication

Indication — disease contextAcute lymphoblastic leukemia (Philadelphia chromosome‑negative or Philadelphia chromosome‑positive)

Treatment settingAs part of a multi‑agent chemotherapy regimen for induction, consolidation, or relapsed/refractory disease

Required clinical conditionMember has history of hypersensitivity reaction or other adverse effects from pegylated E. coli‑derived asparaginase products (Oncaspar or Asparlas)

Background on Rylaze

Rylaze is a recombinant Erwinia‑derived formulation of asparaginase (asparaginase Erwinia chrysanthemi recombinant‑rywn) used as part of multi‑agent chemotherapy regimens for acute lymphoblastic leukemia (ALL). It is intended for use when members have hypersensitivity or adverse reactions to pegylated E. coli‑derived asparaginase formulations and may be administered in induction, consolidation, or relapsed/refractory treatment settings as clinically indicated.