CurrentMass General Brigham Health PlanPolicy N/A

Asparaginase Agents (Asparlas, Erwinase, Rylaze) — Medical Benefit Prior Authorization

Medical-benefit prior authorization policy governing use of asparaginase agents for treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in eligible pediatric and adult members under Mass General Brigham Health Plan (MassHealth).

Policy Summary

PayerMass General Brigham Health Plan

PolicyAsparaginase Agents (Asparlas, Erwinase, Rylaze) — Prior Authorization, Medical Benefit

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain medical-benefit prior authorization and submit required clinical documentation including prescriber attestation of hypersensitivity or rationale for product selection.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3products covered

Medicalbenefit designation

8winitial approval

36wtypical max duration

Coverage Criteria

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COVERAGE CRITERIA

Approval of requested medication will be granted if the member meets all following criteria and documentation has been submitted:

Asparlas (calaspargase pegol-mknl) initial criteria

Diagnosis and age: 1. Diagnosis of acute lymphoblastic leukemia (ALL); 2. Member is ≥ 1 month and < 22 years of age
Prescriber: 3. Prescriber is a hematologist or oncologist
Prior asparaginase exposure/rationale: 4. ONE of the following: a) Physician attestation of inadequate response, adverse reaction, or contraindication to Oncaspar (pegaspargase); b) Appropriate rationale for use instead of Oncaspar (e.g., documentation that Asparlas is preferred due to every three-week dosing to align with other chemotherapy agents)
Dosing: 5. Appropriate dosing provided

Rylaze (asparaginase erwinia chrysanthemi-rywn) criteria

Diagnosis: 1. Diagnosis of acute lymphoblastic leukemia (ALL)
Prescriber: 2. Prescriber is a hematologist or oncologist
Hypersensitivity: 3. Hypersensitivity to E. coli-derived asparaginase (i.e., Oncaspar, Asparlas)
Dosing: 4. Appropriate dosing provided

Erwinase (asparaginase erwinia chrysanthemi) criteria

Diagnosis: 1. Diagnosis of acute lymphoblastic leukemia (ALL)
Prescriber: 2. Prescriber is a hematologist or oncologist
Hypersensitivity: 3. Has developed hypersensitivity to E. coli-derived asparaginase
Dosing: 4. Appropriate dosing provided

Continuation Therapy and Duration Limits

Continuation of therapy / Reauthorization

Reauthorization inference: Reauthorizations by physician will infer a positive response to therapy

Duration limits: 1. Initial approvals: 8 weeks; 2. Reauthorizations: up to an additional 28 weeks for a total treatment duration of 36 weeks. Requests that exceed a total treatment duration of 36 weeks require documentation of clinical evidence supporting the extended duration.

Authorization may not be granted for members who are new to the plan if they are not already receiving treatment with the requested asparaginase product. Exceptions apply when prior therapy is ongoing at the time of plan enrollment; requests relying solely on samples or manufacturer patient assistance program supplies do not meet this continuity requirement and may be denied.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required — Medical Benefit

Prior authorization through the medical benefit is required for Asparlas, Erwinase, and Rylaze. Contact the Medical Benefit for prior authorization requests: Phone: 833-895-2611; Fax: 888-656-6671. (Pharmacy benefit contact provided for reference: Phone: 800-711-4555; Fax: 844-403-1029.)

Affected products: Asparlas (calaspargase pegol-mknl), Erwinase (asparaginase erwinia chrysanthemi), Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn)
Medical Benefit prior authorization contact: Phone 833-895-2611; Fax 888-656-6671
Pharmacy Benefit contact (reference only): Phone 800-711-4555; Fax 844-403-1029

Step Therapy

Step/Therapeutic Sequencing for Asparlas

Step/therapeutic sequencing requirement for Asparlas: approval requires ONE of the following — physician attestation of inadequate response, adverse reaction, or contraindication to Oncaspar (pegaspargase), or documentation that Asparlas is preferred for regimen scheduling (e.g., every three‑week dosing to align with other chemotherapy agents).

Applies to Asparlas (calaspargase pegol-mknl)
Required: trial of or intolerance/contraindication to Oncaspar OR documented rationale for preferring Asparlas (scheduling/alignment reasons)

Documentation Required

Required Clinical Documentation

Required clinical documentation: prescriber attestation and clinical notes must be submitted with the authorization request. Examples of acceptable documentation include physician attestation of hypersensitivity or adverse reaction to E. coli–derived asparaginase (Oncaspar/Asparlas), documentation of inadequate response to alternative asparaginase agents, or clinical rationale for selecting an alternative agent (e.g., dosing schedule alignment). Prescriber must be a hematologist or oncologist where specified.

For Asparlas: physician attestation of inadequate response, adverse reaction, or contraindication to Oncaspar OR documentation of rationale for use instead of Oncaspar
For Rylaze/Erwinase: documentation of hypersensitivity to E. coli–derived asparaginase
Include diagnosis (e.g., acute lymphoblastic leukemia), patient age where required, and prescribed dosing
Prescriber specialty: hematologist or oncologist for Asparlas and Rylaze

Denial Risk

New-to-Plan Treatment Continuity

New-to-plan treatment continuity: authorization may be granted for members new to the plan who are currently receiving treatment with the requested medication. Requests may be denied if the member is new to the plan and not currently receiving the medication. Exceptions: medications obtained only as samples or through a manufacturer's patient assistance program do not qualify for continuity.

Continuity applies only if member is actively receiving the requested product at the time of plan enrollment
Does not apply to therapies obtained solely as samples or via manufacturer's patient assistance programs
Operational note: submit documentation demonstrating active receipt of therapy (e.g., recent infusion records, clinic notes, or prescription records)

Covered Regimens

Regimen	Covered indication / notes	Coverage status
Multi-agent chemotherapy including asparaginase formulations	Asparlas (calaspargase pegol-mknl): component of multi-agent chemotherapy for treatment of acute lymphoblastic leukemia (ALL) in pediatric and young adult patients ages 1 month to 21 years.	Covered
Multi-agent chemotherapy including asparaginase formulations	Erwinase (asparaginase erwinia chrysanthemi): component of multi-agent chemotherapy for treatment of ALL in patients who have developed hypersensitivity to E. coli–derived asparaginase.	Covered
Multi-agent chemotherapy including asparaginase formulations	Rylaze (asparaginase erwinia chrysanthemi-rywn): component of multi-agent chemotherapy for treatment of ALL and lymphoblastic lymphoma (LBL) in adult and pediatric patients ≥ 1 month who have developed hypersensitivity to E. coli–derived asparaginase.	Covered

Definitions

Hypersensitivity to E. coli–derived asparaginase — definition and implications

DefinitionClinical allergy or hypersensitivity reaction to E. coli–derived asparaginase formulations (e.g., Oncaspar, Asparlas) that warrants use of Erwinia-derived products.

Clinical implicationMembers who develop this hypersensitivity are eligible for Erwinia-derived formulations (Erwinase or Rylaze) as component of multi-agent chemotherapy for ALL/LBL.

Typical affected productsE. coli–derived formulations include pegaspargase (Oncaspar) and calaspargase pegol (Asparlas).

Alternative products indicatedErwinase (asparaginase erwinia chrysanthemi) and Rylaze (recombinant asparaginase erwinia chrysanthemi) are indicated for patients with this hypersensitivity.

Age considerationsRylaze and Erwinase are indicated for patients 1 month of age and older who have developed hypersensitivity to E. coli–derived asparaginase; product-specific age ranges may vary (Asparlas indicated 1 month to 21 years).

OpenPayer

Asparaginase Agents (Asparlas, Erwinase, Rylaze) — Medical Benefit Prior Authorization

Coverage Criteria

Provider Actions and Prior Authorization

Covered Regimens

Definitions

Line of Therapy Information

Background