Pegaspargase (Oncaspar), Asparaginase Erwinia Chrysanthemi (Erwinaze, Rylaze), and Calaspargase Pegol-mknl (Asparlas)

Policy ID: I-158-009

Section: Injections

Effective Date: May 01, 2019

Revised Date: May 08, 2024

Revision Effective Date: July 01, 2024

Last Reviewed: May 14, 2024

Applies To: Commercial and Medicaid Expansion

Description

Pegaspargase (Oncaspar®) is an asparagine specific enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia.

Asparaginase Erwinia Chrysanthemi (Rylaze™) is an asparagine specific enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of individuals who have developed hypersensitivity to E. coli-derived asparaginase.

Calaspargase pegol-mknl (Asparlas ^TM ) is an asparagine specific enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The pharmacological effect is thought to be based on selective killing of leukemic cells due to depletion of plasma L-asparagine. Leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize L-asparagine, and therefore depend on an exogenous source of L-asparagine for survival.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Pegaspargase (Oncaspar) may be considered medically necessary when ANY of the following criteria are met:

As a component of a multiagent chemotherapeutic regimen for the first-line treatment of pediatric and adult individuals with acute lymphoblastic leukemia (ALL); or
As a component of a multiagent chemotherapeutic regimen for the treatment of pediatric and adult individuals with ALL and hypersensitivity to native forms of L-asparaginase.

The use of pegaspargase (Oncaspar) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9266

In combination with other chemotherapeutic agents in individuals ages one (1) month or older with ALL or lymphoblastic lymphoma (LBL) who have developed hypersensitivity to E. coli-derived asparaginase.

The use of asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9021

Calaspargase pegol-mknl (Asparlas) may be considered medically necessary for the following indications:

As a component of a multi-agent chemotherapeutic regimen for the treatment of ALL in individuals ages one (1) month to 21 years.

The use of calaspargase pegol-mknl (Asparlas) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9118

Compendia Sources

Pegaspargase (Oncaspar), asparaginase erwinia chrysanthemi (Rylaze) and calaspargase pegol-mknl (Asparlas) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Procedure Codes

J9021

J9118

J9266

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Covered Diagnosis Codes for procedure code J9266

C83.50

C83.51

C83.52

C83.53

C83.54

C83.55

C83.56

C83.57

C83.58

C83.59

C84.90

C84.91

C84.92

C84.93

C84.94

C84.95

C84.96

C84.97

C84.98

C84.99

C84.Z0

C84.Z1

C84.Z2

C84.Z3

C84.Z4

C84.Z5

C84.Z6

C84.Z7

C84.Z8

C84.Z9

C86.0

C86.1

C91.00

C91.01

C91.02

Covered Diagnosis Codes for procedure code J9021

C83.50

C83.51

C83.52

C83.53

C83.54

C83.55

C83.56

C83.57

C83.58

C83.59

C84.90

C84.91

C84.92

C84.93

C84.94

C84.95

C84.96

C84.97

C84.98

C84.99

C84.Z0

C84.Z1

C84.Z2

C84.Z3

C84.Z4

C84.Z5

C84.Z6

C84.Z7

C84.Z8

C84.Z9

C86.0

C91.00

C91.01

C91.02

Covered Diagnosis Codes for procedure code J9118

C83.50

C83.51

C83.52

C83.53

C83.54

C83.55

C83.56

C83.57

C83.58

C83.59

C91.00

C91.01

C91.02

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020

Updated description,
Added additional NCCN indications,
Updated dx codes and references, will require pre-certification as of 2/1/2020

Internal Medical Policy Committee 1-19-2021

Updated NCCN recommendations

Internal Medical Policy Committee 1-20-2022 Annual review, no clinical content change

Internal Medical Policy Committee 5-24-2022

Added asparaginase erwinia chrysanthemi (Rylaze), J9021, to the policy,
Removed NCCN recommendations and
Added this statement 'Pegaspargase (Oncaspar), asparaginase erwinia chrysanthemi (Erwinaze, Rylaze) and calaspargase pegol-mknl (Asparlas) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'

Internal Medical Policy Committee 5-23-2023 - Effective July 1, 2023

Removed Erwinaze from the policy
Updated diagnosis codes for J9021
Updated E/I statement

Internal Medical Policy Committee 5-14-2024 Effective July 01, 2024

Annual review no clinical content change

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-158-008

Section: Injections

Effective Date: May 01, 2019

Revised Date: May 17, 2023

Revision Effective Date: July 01, 2023

Last Reviewed: May 23, 2023

Archived Date: June 30, 2024

Applies To: Commercial and Medicaid Expansion

Description

Pegaspargase (Oncaspar®) is an asparagine specific enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Pegaspargase (Oncaspar) may be considered medically necessary when ANY of the following criteria are met:

As a component of a multiagent chemotherapeutic regimen for the first-line treatment of pediatric and adult individuals with acute lymphoblastic leukemia (ALL); or
As a component of a multiagent chemotherapeutic regimen for the treatment of pediatric and adult individuals with ALL and hypersensitivity to native forms of L-asparaginase.

Procedure Code

J9266

Asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) may be considered medically necessary for the following:

In combination with other chemotherapeutic agents in individuals ages one (1) month or older with ALL or lymphoblastic lymphoma (LBL) who have developed hypersensitivity to E. coli-derived asparaginase.

Procedure Code

J9021

Calaspargase pegol-mknl (Asparlas) may be considered medically necessary for the following indications:

As a component of a multi-agent chemotherapeutic regimen for the treatment of ALL in individuals ages one (1) month to 21 years.

Procedure Code

J9118

Compendia Sources

Procedure Codes

J9021

J9118

J9266

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Covered Diagnosis Codes for procedure code J9266

C83.50

C83.51

C83.52

C83.53

C83.54

C83.55

C83.56

C83.57

C83.58

C83.59

C84.90

C84.91

C84.92

C84.93

C84.94

C84.95

C84.96

C84.97

C84.98

C84.99

C84.Z0

C84.Z1

C84.Z2

C84.Z3

C84.Z4

C84.Z5

C84.Z6

C84.Z7

C84.Z8

C84.Z9

C86.0

C86.1

C91.00

C91.01

C91.02

Covered Diagnosis Codes for procedure code J9021

C83.50

C83.51

C83.52

C83.53

C83.54

C83.55

C83.56

C83.57

C83.58

C83.59

C84.90

C84.91

C84.92

C84.93

C84.94

C84.95

C84.96

C84.97

C84.98

C84.99

C84.Z0

C84.Z1

C84.Z2

C84.Z3

C84.Z4

C84.Z5

C84.Z6

C84.Z7

C84.Z8

C84.Z9

C86.0

C91.00

C91.01

C91.02

Covered Diagnosis Codes for procedure code J9118

C83.50

C83.51

C83.52

C83.53

C83.54

C83.55

C83.56

C83.57

C83.58

C83.59

C91.00

C91.01

C91.02

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020

Updated description,
Added additional NCCN indications,
Updated dx codes and references, will require pre-certification as of 2/1/2020

Internal Medical Policy Committee 1-19-2021

Updated NCCN recommendations

Internal Medical Policy Committee 1-20-2022 Annual review, no clinical content change

Internal Medical Policy Committee 5-24-2022

Added asparaginase erwinia chrysanthemi (Rylaze), J9021, to the policy,
Removed NCCN recommendations and
Added this statement 'Pegaspargase (Oncaspar), asparaginase erwinia chrysanthemi (Erwinaze, Rylaze) and calaspargase pegol-mknl (Asparlas) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'

Internal Medical Policy Committee 5-23-2023 - Effective July 1, 2023

Removed Erwinaze from the policy
Updated diagnosis codes for J9021
Updated E/I statement

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