ModifiedEmblemHealthPolicy MG.MM.PH.198

Asparlas (calaspargase pegol-mknl) Intravenous

Medical policy governing coverage and prior authorization criteria for Asparlas (calaspargase pegol-mknl) as part of multi-agent chemotherapy for acute lymphoblastic leukemia in pediatric and young adult members of EmblemHealth/ConnectiCare.

Policy Summary

PayerEmblemHealth

PolicyAsparlas (calaspargase pegol-mknl) Intravenous

Policy CodePolicy MG.MM.PH.198

Change TypeMaterial revisions to dosing units, age eligibility, and premedication requirement

Effective Date

Next Review DateFeb 18, 2025

Key ActionSubmit prior authorization with clinical documentation showing diagnosis, age, multi-agent chemotherapy component, and absence of unacceptable toxicity.

SourceLink

POLICY UPDATE CHANGES

Updated unit reporting from 7,500 units to 750 billable units per 21 days consistent with FDA guidelines.

Expanded maximum covered age from 21 years to 21.5 years.

Requirement that patients receive premedication prior to administration to reduce infusion and hypersensitivity reactions (examples: acetaminophen, H1 and H2 blockers).

1 mo–21.5 yrcovered patient age range

750max units per 21 days (2 vials)

2,500 U/m2administration dose

6 mo

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Coverage and Medical Necessity Criteria

Initial Approval — covered when ALL of the following are met

Covered when ALL of the following are met:

Initial approval criteria for Asparlas: Patient age is between 1 month and up to 21.5 years.

From Initial Approval Criteria

Initial approval criteria for Asparlas: Asparlas is being used as a component of multi-agent chemotherapy.

From Initial Approval Criteria

Initial approval criteria for Asparlas: Patient has a diagnosis of acute lymphoblastic leukemia (ALL).

From Initial Approval Criteria

Renewal Criteria

Renewal covered when ALL of the following are met:

Renewal criterion: Patient continues to meet Initial Approval criteria.

From Renewal Criteria

Renewal criterion: Absence of unacceptable toxicity from the drug (examples include anaphylaxis, thrombosis, coagulopathy, severe hepatotoxicity, pancreatitis).

From Renewal Criteria

Renewal criterion: Disease stabilization or improvement evidenced by complete response (morphologic, cytogenetic or molecular), complete hematologic response, or partial response by CBC, bone marrow cytogenetics, QPCR, or FISH.

From Renewal Criteria

Asparlas is considered not medically necessary when the patient has any of the following prior events associated with L‑asparaginase therapy: a history of serious hypersensitivity, pancreatitis, severe hepatic impairment, thrombosis, or hemorrhagic events. Requests for indications not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature may also be deemed not approvable and not reimbursable.

Prior to administration, patients must receive premedication to reduce the risk and severity of infusion‑related and hypersensitivity reactions. Examples of recommended premedications include acetaminophen, an H‑1 receptor blocker (for example, diphenhydramine), and an H‑2 receptor blocker (for example, famotidine).

The referenced revision history and mapping entries in these chunks focus on ICD‑10 code mappings and administrative revisions; they do not state additional explicit coverage exclusions beyond those described elsewhere in the policy and coding sections.

Use of Asparlas is not medically necessary for patients with prior serious adverse events attributed to L‑asparaginase, including severe hypersensitivity (anaphylaxis), pancreatitis, severe hepatic impairment, thrombosis, or other significant hemorrhagic complications.

The chunks cited here do not include any additional 'not medically necessary' statements; content in these sections is limited to ICD‑10 code listings and revision history notes.

Billing, Dosing, and Code Lists

Applicable Procedure CodesHCPCSCovered

J9118

Injection, calaspargase pegol-mknl, 10 units

Applicable NDCsNDCCovered

72694-0515-01

Injection, calaspargase pegol-mknl, 750u/mL, 5mL vial

Applicable ICD-10 DiagnosesICD-10Covered

C83.50	Lymphoblastic (diffuse) lymphoma, unspecified site
C83.51	Lymphoblastic (diffuse) lymphoma, lymph nodes of head, face, and neck
C83.52	Lymphoblastic (diffuse) lymphoma, intrathoracic lymph nodes
C83.53	Lymphoblastic (diffuse) lymphoma, intra-abdominal lymph nodes
C83.54	Lymphoblastic (diffuse) lymphoma, lymph nodes of axilla and upper limb
C83.55	Lymphoblastic (diffuse) lymphoma, lymph nodes of inguinal region and lower limb
C83.56	Lymphoblastic (diffuse) lymphoma, intrapelvic lymph nodes
C83.57	Lymphoblastic (diffuse) lymphoma, spleen
C83.58	Lymphoblastic (diffuse) lymphoma, lymph nodes of multiple sites
C83.59	Lymphoblastic (diffuse) lymphoma, extranodal and solid organ sites

1–10 of 13

1/2

ICD-10 Diagnosis Codes - Mature T/NK-cell lymphomasICD-10

C84.91	Mature T/NK-cell lymphomas, unspecified site
C84.92	Mature T/NK-cell lymphomas, unspecified, lymph nodes of head, face, and neck
C84.93	Mature T/NK-cell lymphomas, unspecified, intrathoracic lymph nodes
C84.94	Mature T/NK-cell lymphomas, unspecified, intra-abdominal lymph nodes
C84.95	Mature T/NK-cell lymphomas, unspecified, lymph nodes of axilla and upper limb
C84.96	Mature T/NK-cell lymphomas, unspecified, lymph nodes of inguinal region and lower limb
C84.97	Mature T/NK-cell lymphomas, unspecified, intrapelvic lymph nodes
C84.98	Mature T/NK-cell lymphomas, unspecified, spleen
C84.99	Mature T/NK-cell lymphomas, unspecified, lymph nodes of multiple sites
C84.Z0	Mature T/NK-cell lymphomas, unspecified, extranodal and solid organ sites

1–10 of 11

1/2

ICD-10 Diagnosis Codes - Other mature T/NK-cell lymphomas & Extranodal NK/T-cell lymphomaICD-10

C84.Z2	Other mature T/NK-cell lymphomas, lymph nodes of head, face, and neck
C84.Z3	Other mature T/NK-cell lymphomas, intrathoracic lymph nodes
C84.Z4	Other mature T/NK-cell lymphomas, intra-abdominal lymph nodes
C84.Z5	Other mature T/NK-cell lymphomas, lymph nodes of axilla and upper limb
C84.Z6	Other mature T/NK-cell lymphomas, lymph nodes of inguinal region and lower limb
C84.Z7	Other mature T/NK-cell lymphomas, intrapelvic lymph nodes
C84.Z8	Other mature T/NK-cell lymphomas, spleen
C84.Z9	Other mature T/NK-cell lymphomas, lymph nodes of multiple sites
C86.0	Extranodal NK/T-cell lymphoma, nasal type

Dose and frequency

Dose2,500 units/m2 administered IV no more frequently than every 21 days

Maximum billable units750 billable units per 21 days (equivalent to 2 vials)

Vial equivalence2 vials = 750 billable units per 21 days

Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization / Coverage Note

Prior authorization: No explicit prior authorization requirements are stated in this section. If prior authorization is required by a member's benefit plan, providers should follow the plan's standard prior authorization process.

Asparlas is covered when used as part of multi‑agent chemotherapy for patients 1 month to 21.5 years with a diagnosis of acute lymphoblastic leukemia (ALL).
No explicit prior‑authorization trigger or denial language appears in this section.

Documentation Required

Documentation Requirements

Providers must submit clinical documentation that supports the member meets the medical necessity criteria. Failure to provide required clinical evidence may result in denial or inability to complete the review.

Documentation should demonstrate the member's diagnosis (ALL), age (1 month to 21.5 years), that Asparlas will be used as a component of multi‑agent chemotherapy, and absence of contraindicating history (e.g., serious hypersensitivity, pancreatitis, severe hepatic impairment, thrombosis, or hemorrhagic events with prior L‑asparaginase therapy).

Background

Asparlas (calaspargase pegol‑mknl) is a pegylated, Escherichia coli‑derived L‑asparaginase enzyme conjugate approved for use as a component of multi‑agent chemotherapy regimens in pediatric and young adult patients with acute lymphoblastic leukemia. The enzyme deaminates asparagine (and glutamine), depriving lymphoblasts that cannot synthesize asparagine of a required amino acid, contributing to cell death. The product is PEG‑conjugated and differs from pegaspargase by its succinimidyl carbonate linker, which affects stability and pharmacologic properties.

Drug and Code Definitions

Asparlas (calaspargase pegol-mknl)

Generic namecalaspargase pegol-mknl

Brand nameAsparlas

DescriptionAn E. coli–derived L-asparaginase enzyme conjugate (asparagine-specific) pegylated with monomethoxy polyethylene glycol (MPEG) via a succinimidyl carbonate (SC) linker; FDA‑approved as a component of multiagent chemotherapy for acute lymphoblastic leukemia in pediatric and young adults.

Pharmacologic actionDeaminates asparagine and glutamine leading to death of lymphoblasts lacking asparagine synthetase

ICD-10-CM codes — Mature T/NK‑cell lymphomas and related mappings

C84.91Mature T/NK-cell lymphomas, unspecified site

Policy Revision History

2025-02-18Annual review / unit reporting updateLatest

Annual review updated unit reporting from 7,500 units to 750 billable units per 21 days and updated Applicable Procedure/NDC fields.

2022-03-24Template transfer

Policy transferred to a new template.

2020-12-30Annual review / wording revision