CurrentHealth NetPolicy CP PHAR.353

Pegaspargase (Oncaspar); Calaspargase Pegol-mknl (Asparlas)

Defines medical necessity criteria, approval durations, dosing limits, contraindications, and coding guidance for coverage of Oncaspar and Asparlas for acute lymphoblastic leukemia and limited off-label T-cell lymphoma regimens across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyPegaspargase (Oncaspar); Calaspargase Pegol-mknl (Asparlas)

Policy CodePolicy CP PHAR.353

Change TypeClarifiedUpdated (4Q 2024)

Effective Date09.05.17

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting diagnosis, oncologist/hematologist consultation, multi-agent regimen use, dosing and response to therapy.

SourceLink

POLICY UPDATE CHANGES

4Q 2024 annual review: for T-cell lymphoma removed hepatosplenic T-cell lymphoma indication and added GELAD regimen option; references reviewed and updated.

Clarified age 1 month to <21 years for Asparlas per prescribing information.

1FDA-approved primary indication (ALL)

1Off-label T-cell lymphoma regimens

2Products covered

2Defined HCPCS J-codes

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Scope: This policy (CP PHAR.353) defines medical necessity criteria, approval durations, dosing limits, contraindications, and coding guidance for coverage of Oncaspar (pegaspargase) and Asparlas (calaspargase pegol‑mknl) primarily for the FDA‑approved indication of acute lymphoblastic leukemia (ALL) and for limited off‑label use in extranodal nasal‑type NK/T‑cell lymphoma when used in specified regimens. Effective date: 09.05.17; Last review/approval date: 11.24.24. Policy number: CP PHAR.353.

Key Thresholds & Quick Facts

Asparlas dosing interval/maxAge 1 month to <21 years: ≤ 2,500 units/m2 IV no more frequently than every 21 days

Oncaspar dosing interval/max (age <21)≤ 2,500 IU/m2 IM or IV no more frequently than every 14 days

Oncaspar dosing interval/max (age ≥21)≤ 2,000 IU/m2 IM or IV no more frequently than every 14 days

Products coveredOncaspar (pegaspargase) and Asparlas (calaspargase pegol-mknl)

Primary vs off-label indicationsPrimary FDA-approved indication: ALL (1); Limited off-label indication set: extranodal nasal-type NK/T-cell lymphoma regimens allowed with Oncaspar (1)

Initial Therapy Criteria — Acute Lymphoblastic Leukemia (ALL)

Initial Approval Criteria - Acute Lymphoblastic Leukemia (ALL)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of acute lymphoblastic leukemia (ALL).
Prescribing requirements
- Prescribed by or in consultation with an oncologist or hematologist.
- Prescribed as part of a multi-agent chemotherapeutic regimen.
Provider documentation: Provider submits documentation (e.g., office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
Required documentation for PA
Product-specific age/dose conditions (ONE of)
- If request is for Asparlas: member age 1 month to < 21 years and dose does not exceed 2,500 units/m2 every 21 days.Age 1 month to <21 years; ≤ 2,500 units/m2 every 21 days
- If request is for Oncaspar: dose does not exceed 2,500 IU/m2 every 14 days for age < 21 years or 2,000 IU/m2 every 14 days for age ≥ 21 years.Oncaspar: ≤2,500 IU/m2 q14d (<21); ≤2,000 IU/m2 q14d (≥21)
Off-label dose support: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use when applicable (prescriber must submit supporting evidence).
Required when dose outside FDA limits or for off-label uses

Initial Therapy Criteria — T‑cell Lymphoma (Off‑Label, Oncaspar Only)

Initial Approval Criteria - T-cell lymphoma (off-label)

Covered when ALL of the following are met (Oncaspar only):

ALL of the following

Diagnosis of extranodal nasal-type NK/T-cell lymphoma.
Request is for Oncaspar.
Prescribed by or in consultation with an oncologist or hematologist.
Allowed regimens (ONE of)
- Modified-SMILE (dexamethasone, methotrexate, ifosfamide, pegaspargase, etoposide).
- P-GEMOX (gemcitabine, pegaspargase, oxaliplatin).
- DDGP (dexamethasone, cisplatin, gemcitabine, pegaspargase).
- AspaMetDex (pegaspargase, methotrexate, dexamethasone).
- GELAD (gemcitabine, etoposide, pegaspargase, dexamethasone).
Dose/supporting evidence: Dose is within 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).

Other Diagnoses / Off‑Label Use Handling

Other diagnoses/indications

Coverage for other diagnoses requires ONE of the following:

ANY of the following

If drug is on the formulary (commercial/marketplace) or PDL (Medicaid), follow the applicable no-coverage criteria/policy for the line of business (CP.CPA.190 commercial; HIM.PA.33 marketplace; CP.PMN.255 Medicaid).
If drug is NOT on the formulary/PDL, follow the non-formulary policy for the line of business (CP.CPA.190 commercial; HIM.PA.103 marketplace; CP.PMN.16 Medicaid).
If requested use (diagnosis, age, dosing regimen) is not listed in Section III and criterion 1 above does not apply, refer to off-label use policy for the line of business (CP.CPA.09 commercial; HIM.PA.154 marketplace; CP.PMN.53 Medicaid) and prescriber must submit supporting evidence.

Not Authorized / Contraindications & Exclusions

Diagnoses/Indications Not Authorized

Not covered when:

Non-FDA approved indications that are not addressed in this policy, unless sufficient documentation of efficacy and safety is provided per off-label use policies (CP.CPA.09 commercial; HIM.PA.154 marketplace; CP.PMN.53 Medicaid).

Contraindications / Exclusion Criteria

Coverage excluded when any of the following are present:

ANY of the following

History of serious allergic reactions to Oncaspar or to pegylated L-asparaginase therapy.
History of serious thrombosis with prior L-asparaginase therapy.
History of serious hemorrhagic events with prior L-asparaginase therapy.
History of pancreatitis with prior L-asparaginase therapy.
Severe hepatic impairment.

Provider Actions & Prior Authorization Requirements

Prior Authorization

Submit documentation for prior authorization

Provider must submit office chart notes, lab results, or other clinical information supporting diagnosis, prescribing oncologist/hematologist consultation, use as part of a multi-agent chemotherapeutic regimen, dosing and response to therapy. Include supporting HCPCS/J-codes: J9118 and J9266 when applicable.

J9118
J9266
Office chart notes
Lab results
Oncologist/hematologist consultation
Documentation of multi-agent regimen
Dosing and response to therapy

Documentation Required

Support off-label use with evidence

For off-label indications or requests for doses outside the FDA limits, the prescriber must submit supporting evidence such as practice guideline recommendations or peer-reviewed literature to justify the use or dosing.

Billing Rule

Refer to coding guidance

The HCPCS/J-codes listed in this policy (J9118, J9266) are informational only. Inclusion or exclusion of codes does not guarantee coverage; providers should reference the most up-to-date professional coding guidance when submitting claims for reimbursement.

J9118
J9266

Clinical Evidence & References

Evidence/References: Prescribing information for Oncaspar (Servier; March 2024) and Asparlas (Servier; December 2023) are cited as primary references. NCCN guidance is cited for both Acute Lymphoblastic Leukemia (ALL) and T‑Cell Lymphomas (versions referenced 2024). These sources underpin the FDA‑approved indications, dosing limits, and the limited off‑label NK/T‑cell lymphoma regimens listed in the policy.

Background & Definitions

Background: Pegaspargase (Oncaspar) and calaspargase pegol‑mknl (Asparlas) are pegylated, asparagine‑specific enzymes used as components of multi‑agent chemotherapy regimens primarily for acute lymphoblastic leukemia (ALL). Oncaspar is indicated for pediatric and adult patients with ALL; Asparlas is indicated for pediatric and young adult patients age 1 month to 21 years. Definitions: ALL = acute lymphoblastic leukemia; NCCN = National Comprehensive Cancer Network.

Revision History

11.24.24annual_review_materialLatest

4Q 2024 annual review: for T-cell lymphoma removed hepatosplenic T-cell lymphoma indication and added GELAD regimen option; references reviewed and updated. Approval Date = 11.24.24

11.22clarification

4Q 2022 review: clarified age 1 month to <21 years for Asparlas per prescribing information; references reviewed and updated.