Centene Rylaze Coverage Prior Auth Policy

Coverage Criteria

inv-01: Initial Therapy - ALL

Covered when ALL of the following are met

ALL initial therapy criteria

Dose options: a) Dose does not exceed 25 mg/m2 every 48 hours; OR b) Dose does not exceed 25 mg/m2 on Monday and Wednesday and 50 mg/m2 on Friday; OR c) Dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

inv-02: Initial Therapy - LBL

Covered when ALL of the following are met

LBL initial therapy criteria

Dose options: a) Dose does not exceed 25 mg/m2 every 48 hours; OR b) Dose does not exceed 25 mg/m2 on Monday and Wednesday and 50 mg/m2 on Friday; OR c) Dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

inv-03: Initial Therapy - T-cell lymphoma (off-label)

Covered when ALL of the following are met (off-label)

T-cell lymphoma off-label criteria: 1) Diagnosis of extranodal NK/T‑cell lymphoma; 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Age ≥ 18 years; 4) Member has developed hypersensitivity to an E. coli–derived asparaginase product; 5) Dose is within the FDA maximum limit for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 6) Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: Medicaid/HIM 3 months; Commercial 6 months or duration of request, whichever is less

inv-04: Continued Therapy

Continued therapy is allowed when ALL of the following are met

Continued therapy criteria: 1) Member is currently receiving Rylaze via Centene benefit or documentation supports current receipt for a covered indication and member has received medication for at least 30 days; 2) Member is responding positively to therapy; 3) All indication criteria in Section I remain met; 4) Dose does not exceed 25 mg/m2 every 48 hours (or alternate approved dosing per regimen); 5) If request is for a dose increase, the new dose must meet one of the following: a) not exceed Monday/Wednesday/Friday schedule limits (25 mg/m2 Mon/Wed and 50 mg/m2 Fri); OR b) be supported by FDA/NCCN or by practice guidelines/peer‑reviewed literature (prescriber must submit supporting evidence).

Approval duration: Medicaid/HIM 6 months; Commercial 6 months or duration of request, whichever is less

inv-05: Administration and dosing

Coverage and administration details noted in policy:

Dosing regimen: When replacing a long‑acting asparaginase product the recommended dose is: 25 mg/m2 IM every 48 hours OR 25 mg/m2 IM Monday and Wednesday morning and 50 mg/m2 IM on Friday (MWF regimen).

From Dosage and Administration

Maximum dose = 50 mg/m2 per dose.<=50 mg/m2

From Dosage and Administration

Product strength: Single‑dose vial available: 10 mg/0.5 mL.

Product availability

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy. Providers should include supporting clinical evidence per the referenced off‑label use guidance when requesting coverage for such indications.

The policy has been updated to remove the discontinued Erwinaze product from active coverage language; references to that legacy product have been retired from the policy documentation. Any historical references to Erwinaze as a covered product are no longer applicable.

Requests for use of Rylaze for non‑FDA approved indications that are not addressed by this policy must be supported by sufficient evidence per the off‑label use policy. Uses lacking adequate supporting documentation in accordance with those requirements will be considered not medically necessary and may be denied.

Policy history and the coding/administrative notes document scope changes and additions (including annual review entries and added indications), but the provided excerpts do not contain a standalone, explicit 'not medically necessary' section beyond statements tying non‑FDA indications to off‑label documentation requirements. Review of the full policy history is recommended for a complete record of changes and administrative updates.

Initial Therapy Criteria

inv-24: Initial therapy

Initial therapy covered when listed diagnosis-, prescriber-, age-, regimen-, hypersensitivity-, and dosing criteria are met.

Initial therapy summary: See diagnosis‑specific criteria (ALL, LBL, T‑cell lymphoma) for detailed requirements. Prescriber must be or consult with an oncologist/hematologist; patient age must meet indication-specific minimums; therapy must be part of a multi‑agent chemotherapy regimen; documented hypersensitivity to an E. coli–derived asparaginase product is required; dosing must follow specified options or be supported by guidelines/literature with supporting evidence submitted by the prescriber.

Approval durations differ by line of business as noted in each indication.

Continuation Therapy Criteria

inv-26: Continuation therapy

Continuation therapy authorization requires ongoing response and prior receipt of Rylaze for at least 30 days.

Continuation therapy nodes: 1) Currently receiving medication via Centene benefit, or documentation supports current receipt for a covered indication for ≥30 days; 2) Member is responding positively to therapy; 3) Indication criteria remain met; 4) Dose limits respected (25 mg/m2 every 48 hours or alternate approved dosing); 5) Any dose escalation must be supported by FDA/NCCN or practice guidelines/peer‑reviewed literature (prescriber must submit supporting evidence).

Approval duration: Medicaid/HIM 6 months; Commercial 6 months or duration of request, whichever is less

Coding

HCPCS Codes referencedHCPCS

J9019	1,000 IU
J9020
J9021

Maximum dose per administration

Maximum dose per administration50 mg/m2 per dose

Typical dosing units referenced25 mg/m2 per administration or 25 mg/m2 every 48 hours

Alternate MWF regimen25 mg/m2 on Monday and Wednesday and 50 mg/m2 on Friday

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and requests must include supporting clinical documentation. Provider must submit documentation (e.g., office chart notes, relevant laboratory results, and other clinical information) demonstrating the member meets all applicable approval criteria.

Prior authorization requires meeting the listed diagnosis-, prescriber-, age-, regimen-, hypersensitivity-, and dosing-related criteria.
Provider must submit supporting evidence when the requested dose or indication is off‑label (practice guidelines or peer‑reviewed literature).

Denial Risk

Off‑label Use May Be Denied Without Adequate Documentation

Requests for indications not FDA‑approved and not specifically addressed in this policy require sufficient documentation per the applicable off‑label use policy and may be denied if documentation is inadequate.

Step Therapy / Alternatives

Policy guidance	Action / reference
If the requested use (diagnosis, age, dosing regimen) is not specifically listed in this policy	Refer to the off‑label use policy for the relevant line of business: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), CP.PMN.53 (Medicaid).
For drugs on the formulary (commercial/HIM) or PDL (Medicaid) with no coverage criteria in this policy	Follow the no coverage criteria / formulary policies for the relevant line of business: CP.CPA.190 (Commercial), HIM.PA.33 (Health Insurance Marketplace), CP.PMN.255 (Medicaid).
For drugs NOT on the formulary (commercial/HIM) or PDL (Medicaid)	Refer to the non‑formulary policies for the relevant line of business: CP.CPA.190 (Commercial), HIM.PA.103 (Health Insurance Marketplace), CP.PMN.16 (Medicaid).

Step therapy topic	Policy statement
Explicit step therapy sequence	No explicit step-therapy sequencing is described in the policy excerpts; policy history notes additions of Rylaze and NCCN-directed usage but does not define a required sequence.
If requested use is not listed in policy	Requests should follow formulary/non‑formulary and off‑label use policies referenced elsewhere in this document to determine step or alternative therapy requirements.

Quantity Limits

Rylaze — dosing and limits

ProductRylaze (Erwinia asparaginase) — single-dose vial 10 mg/0.5 mL

Maximum per-dose limit50 mg/m2 per dose

Recommended replacement dosing25 mg/m2 IM every 48 hours or 25 mg/m2 IM Monday and Wednesday with 50 mg/m2 IM Friday (MWF)

Site of Care

Note

Dosing is intramuscular (IM); site of care not restricted here

Dosing described in the policy is for intramuscular (IM) administration (e.g., 25 mg/m2 IM q48h or MWF with 50 mg/m2 on Friday); the policy does not restrict site‑of‑care in this section.

Recommended administration: IM (intramuscular)
Dosing regimens described apply regardless of site‑of‑care in this section

Billing Rule

Commercial approval durations revised to '6 months or to member's renewal date; whichever is longer'

Commercial approval durations for standard injectable therapies were revised in the policy history to '6 months or to member's renewal date; whichever is longer' — providers should expect commercial authorizations to reflect this standard.

Commercial injectable approval revised to: 6 months or to member's renewal date, whichever is longer

Definitions

ALL

TermALL: acute lymphoblastic leukemia

Covered indicationALL in patients > 1 month of age who developed hypersensitivity to E. coli–derived asparaginase products (coverage with criteria)

Dosing note for ALLRecommended replacement dosing: 25 mg/m2 IM every 48 hours or MWF regimen; maximum 50 mg/m2 per dose

LBL

TermLBL: lymphoblastic lymphoma

Covered indicationLBL in patients > 1 month of age who developed hypersensitivity to E. coli–derived asparaginase products (coverage with criteria)

Dosing note for LBL

Background

Rylaze (Erwinia chrysanthemi recombinant asparaginase) is an asparagine‑specific enzyme indicated as part of multi‑agent chemotherapy for relevant malignancies. The manufacturer product information and NCCN guidance are referenced in the policy to support clinical use and prior authorization decisions.

OpenPayer

Erwinia Asparaginase (Rylaze)