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Asparaginase erwinia chrysanthemi (Erwinaze®), asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze™)
MA08.085f

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member's medical needs and condition.

MEDICALLY NECESSARY ​​


ASPARAGINASE​ ERWINIA CHRISANTHEMI (ERWINASE) 

Acute Lymphoblastic Leukemia (ALL) 


Asparaginase Erwinia chrysanthemi (Erwinaze) is considered medically necessary and, therefore, covered for the treatment of Acute Lymphoblastic Leukemia (ALL)​ for the following indications: 
  • As part of a multi-agent chemotherapeutic regimen when all of the following criteria are met:
    • The individual is one year of age or older 
    • Asparaginase Erwinia chrysanthemi (Erwinaze) is being used as a component of a multi-agent chemotherapeutic regimen.
    • The individual has a history of documented hypersensitivity (i.e., systemic allergic reaction or anaphylaxis) to Escherichia coli--derived asparaginase (e.g., pegaspargase [Oncaspar], asparaginase [Elspar]).
    • The individual does not have any of the following contraindications:
      • History of serious hypersensitivity reactions (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Grades 3 and 4) to asparaginase Erwinia chrysanthemi (Erwinaze), including anaphylaxis
      • History of serious pancreatitis with prior L-asparaginase therapy manifested by abdominal pain for longer than 72 hours and amylase elevation greater than or equal to 2.0 times the upper limit of normal (ULN)
      • History of serious thrombosis (e.g., sagittal sinus thrombosis or pulmonary embolism) with prior L-asparaginase therapy
      • History of serious hemorrhagic events (NCI CTCAE Grade 4 with CNS involvement) with prior L-asparaginase therapy 

  • As part of an induction therapy when all of the following criteria are met:​
    • The individual is  65 years of age and older or individuals with substantial comorbidities
    • Asparaginase Erwinia chrysanthemi (Erwinaze) is being used as a component of one of the following:
      • PETHEMA-based regimen such as ALLOLD07 (vincristine, dexamethasone, idarubicin, cyclophosphamide, cytarabine, methotrexate, and L-asparaginase) (moderate intensity) for Philadelphia chromosome-negative ALL
      • Modified DFCI 91-01 protocol: dexamethasone, doxorubicin, vincristine, methotrexate, cytarabine, L-asparaginase, and IT chemotherapy) (moderate intensity) for Philadelphia chromosome-negative ALL
      • EWALL: Tyrosine kinase inhibitor (TKI)* (e.g., bosutinib, dasatinib, imatinib, nilotinib, or ponatinib) with multiagent chemotherapy (vincristine, dexamethasone, methotrexate, cytarabine, asparaginase) (moderate intensity) for Philadelphia chromosome-positive ALL
    • The individual does not have any of the following contraindications:
      • History of serious hypersensitivity reactions (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Grades 3 and 4) to asparaginase Erwinia chrysanthemi (Erwinaze), including anaphylaxis
      • History of serious pancreatitis with prior L-asparaginase therapy manifested by abdominal pain for longer than 72 hours and amylase elevation greater than or equal to 2.0 times the upper limit of normal (ULN)
      • History of serious thrombosis (e.g., sagittal sinus thrombosis or pulmonary embolism) with prior L-asparaginase therapy
      • History of serious hemorrhagic events (NCI CTCAE Grade 4 with CNS involvement) with prior L-asparaginase therapy​

* TKI/mutation contraindications: Bosutinib - T315I, V299L, G250E, or F317L; Dasatinib - T315I/A, F317L/V/I/C or V299L; Imatinib too numerous to include; Nilotinib - T315I, Y253H, E255K/V, F359V/C/I or G250E. Ponatinib is a treatment option for individuals with a T315I mutation and/or for individuals ​for whom no other TKI is indicated.



Non-Hodgkin Lymphoma (NHL)​/ Extranodal NK/T-cell lymphoma, nasal type

 

Asparaginase Erwinia chrysanthemi (Erwinaze) is considered medically necessary and, therefore, covered for the treatment of extranodal NK/T-cell lymphoma, nasal type​ when all of the following criteria are met:

  • Asparaginase Erwinia chrysanthemi (Erwinaze) is being used as a component of a multi-agent chemotherapeutic regimen
  • The individual does not have any of the following contraindications:
    • History of serious hypersensitivity reactions (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Grades 3 and 4) to asparaginase Erwinia chrysanthemi (Erwinaze), including anaphylaxis
    • History of serious pancreatitis with prior L-asparaginase therapy manifested by abdominal pain for longer than 72 hours and amylase elevation greater than or equal to 2.0 times the upper limit of normal (ULN)
    • History of serious thrombosis (e.g., sagittal sinus thrombosis or pulmonary embolism) with prior L-asparaginase therapy
    • History of serious hemorrhagic events (NCI CTCAE Grade 4 with CNS involvement) with prior L-asparaginase therapy

    ASPARAGINASE
    ​ ERWINIA CHRISANTHEMI [RECOMBINANT]-RYWN (RYLAZE)
    Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LBL)

    Asparaginase erwinia chrysanthemi [recombinant]-rywn (Rylaze) is considered medically necessary and, therefore, covered for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric individuals one month or older when all of the following criteria are met:
    • Asparaginase erwinia chrysanthemi [recombinant]-rywn (Rylaze) is being used as a component of a multi-agent chemotherapeutic regimen 
    • The individual has a history of documented hypersensitivity to E. coli-derived asparaginase (and has fully recovered), OR has silent inactivation
    • ​The individual does not have any of the following ​conditions/contraindications:
      • Relapsed ALL or LBL
      • History of ≥ Grade 3 pancreatitis
      • History of asparaginase-associated ≥ Grade 3 hemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy, excluding catheter-related thrombotic events 

    ADDITIONAL INDICATIONS FOR ERWINASE AND RYLAZE

    In accordance with the Centers for Medicare and Medicaid Services (CMS) and in addition to the indications above, asparaginase Erwinia chrysanthemi (Erwinaze) and asparaginase erwinia chrysanthemi [recombinant]-rywn (Rylaze) are covered for the following Micromedex Category IIb indications:

    • Acute myeloid leukemia
    • Chronic myeloid leukemia
    • Malignant lymphoma​

    EXPERIMENTAL/INVESTIGATIONAL


    All other uses for asparaginase Erwinia chrysanthemi (Erwinaze) and asparaginase erwinia chrysanthemi [recombinant]-rywn (Rylaze) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

    REQUIRED DOCUMENTATION

    The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

    The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

    Guidelines

    There is no Medicare coverage determination addressing asparaginase Erwinia chrysanthemi (Erwinaze) and asparaginase erwinia chrysanthemi [recombinant]-rywn (Rylaze); therefore, the Company policy is applicable.

    NATIONAL CANCER INSTITUTE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS

    National Cancer Institute Common Terminology Criteria for Adverse Events describes the severity of adverse events (i.e., organ toxicity) for individuals receiving chemotherapy. Adverse events are evaluated on a Grade Scale of 1-5 with unique clinical descriptions of severity for each adverse event. The general guideline is:
    • Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated
    • Grade 2: minimal, local, or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL)
    • Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling, limiting self ADL
    • Grade 4: life-threatening consequences, urgent intervention indicated
    • Grade 5: death related to adverse event
    For additional information about organ-specific clinical descriptions refer to https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm.

    BENEFIT APPLICATION

    Subject to the applicable Evidence of Coverage, asparaginase Erwinia chrysanthemi (Erwinaze) and asparaginase erwinia chrysanthemi [recombinant]-rywn (Rylaze) are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

    For Medicare Advantage members, certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when asparaginase Erwinia chrysanthemi (Erwinaze®) and asparaginase erwinia chrysanthemi [recombinant]-rywn (Rylaze) are covered under a member's medical benefit (Part B benefit). It does not address instances when asparaginase Erwinia chrysanthemi (Erwinaze®) and asparaginase erwinia chrysanthemi [recombinant]-rywn (Rylaze)​ are covered under a member’s pharmacy benefit (Part D benefit).

    US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

    Asparaginase Erwinia chrysanthemi (Erwinaze®) was approved by the FDA on November 2011 for the treatment of individuals with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli--derived asparaginase.

    Asparaginase erwinia chrysanthemi [recombinant]-rywn (Rylazewas approved by the FDA on​ June 30, 2021 for the treatment of individuals with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric individuals 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

    PEDIATRIC 

    The safety and effectiveness of asparaginase Erwinia chrysanthemi (Erwinaze) have been established in pediatric individuals ages 1 year and older as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.​


    The safety and effectiveness of asparaginase erwinia chrysanthemi [recombinant]-rywn (Rylazehave been established in pediatric individuals ages 1 month and older as a component of a multi-agent chemotherapeutic regimen for the treatment of individuals with acute lymphoblastic leukemia (ALL) and and lymphoblastic lymphoma (LBL)​ who have developed hypersensitivity to E. coli-derived asparaginase.​


    Description

    According to the American Cancer Society, there are approximately 6,590 new cases of acute lymphoblastic leukemia (ALL) (occurring in children and adults) in the United States. Children younger than five years of age have the highest level of risk for developing ALL. ALL, also known as acute lymphocytic leukemia, is a cancer that starts in the white blood cell precursors in the bone marrow and progresses rapidly to spread to other parts of the body.

    Treatment for ALL is typically divided into several phases: induction, consolidation, and maintenance. Induction therapy is the initial phase of treatment with the objective of achieving complete remission. Consolidation, or the intensification phase, is a shorter period of chemotherapy to further reduce the amount of leukemic cells and to prevent the development of drug resistance. The individual's level of risk will determine the intensity of the chemotherapy regimen. The maintenance phase helps to prolong the duration of remission.

    Asparaginase is commonly used for the treatment of ALL. Leukemic cells lack asparagine synthetase activity, making them unable to synthesize asparagine. They have to depend on an exogenous source of amino acid asparagine for protein metabolism and survival, which is typically part of the regimen for induction therapy. Clinical studies have demonstrated that asparaginase can be used to achieve complete remission for individuals during their first relapse.

    ASPARAGINASE​ ERWINIA CHRYSANTHEMI (ERWINAZE) 

    In November 2011, asparaginase Erwinia chrysanthemi (Erwinaze) was approved by the US Food and Drug Administration (FDA) as a component of the multi-agent chemotherapeutic regimen for the treatment of individuals with ALL who have developed a hypersensitivity to Escherichia col(E. coli) derived asparaginase. Erwinia chrysanthemi (Erwinaze) catalyzes the deamidation of asparagine to aspartic acid and ammonia, leading to a reduction of circulating asparagine.

    The safety and efficacy of asparaginase Erwinia chrysanthemi (Erwinaze), for intramuscular injection, was established in a single-arm multi-center open-label trial. Enrolled in the trial were 58 individuals who were unable to continue to receive pegaspargase due to hypersensitivity reactions. The main outcome measure was the proportion of individuals who achieved a serum trough asparaginase level of greater than or equal to 0.1 IU/mL. A serum trough asparaginase level of greater than or equal to 0.1 IU/mL has been demonstrated to correlate with asparagine depletion and to serum levels that predict clinical efficacy. Individuals received asparaginase Erwinia chrysanthemi (Erwinaze) 25,000 IU/mintramuscularly for two weeks (total six doses). Greater than 50 percent of the individuals achieved the pre-specified trough asparaginase level at 48 or 72 hours following the third dose.

    The safety and efficacy of asparaginase Erwinia chrysanthemi (Erwinaze), for intravenous infusion, was studied in an open-label, single-arm, multicenter, pharmacokinetic study. This study enrolled 30 individuals being treated for ALL or lymphoblastic lymphoma, following an allergy to E. coli asparaginase or pegaspargase. Individuals received asparaginase Erwinia chrysanthemi (Erwinaze) 25,000 IU/m2/dose, intravenously, three days per week for up to 30 weeks. The primary endpoint was determined by the proportion of individuals with a two-day pre-dose serum asparaginase activity level (48-hour levels taken after the fifth dose) greater than or equal to 0.1 IU/mL in the first two weeks of asparaginase Erwinia chrysanthemi (Erwinaze) treatment. The primary endpoint was observed in 83 percent of individuals. 

    ASPARAGINASE​ ERWINIA CHRISANTHEMI [RECOMBINANT]-RYWN (RYLAZE) 

    On June 30, 2021 asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze)​ was approved by the FDA for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric and adult individuals one month and older who have developed hypersensitivity to E. coli-derived asparaginase. 

    Asparaginase erwinia chrysanthemi (recombinant)-rywn contains an asparagine specific bacterial enzyme (L-asparaginase). L-asparaginase is a tetrameric enzyme that consists of four identical 35 kDa subunits with a combined molecular weight of 140 kDa. The amino acid sequence is identical to native asparaginase Erwinia chrysanthemi (also known as crisantaspase). The activity of asparaginase erwinia chrysanthemi (recombinant)-rywn is expressed in units, defined as the amount of enzyme that catalyzes the conversion of 1μmol of L-asparagine per reaction minute, per mg of protein. Asparaginase erwinia chrysanthemi (recombinant)-rywn is produced by fermentation of a genetically engineered Pseudomonas fluorescens bacterium containing the DNA which encodes for asparaginase Erwinia chrysanthemi. 


    The safety of Rylaze was evaluated in a cohort of 33 individuals from ​the Study JZP458-201 (NCT04145531) who received Rylaze 25 mg/m2 intramuscularly on Monday, Wednesday, and Friday for 6 doses as a replacement for a single dose of pegaspargase as a component of multi-agent chemotherapy. The individuals had a median age of 11 years (range: 1 to 24 years); the majority of individuals were male (51%) and white (73%). The individuals received a median of 4 courses of Rylaze (range: 1-14 cycles); 48% of individuals received at least four courses.  

     

    The safety and effectiveness of Rylaze​ in the treatment of ALL and LBL have been established in pediatric individuals one month to < 17 years who have developed hypersensitivity to a long-acting E. Coli derived asparaginase. The trial included 84 pediatric individuals, including 2 infants (1 month to < 2 years), 62 children (2 years to < 12 years old), and 20 adolescents (12 years to < 17 years old). The safety and effectiveness of Rylaze have not been established in pediatric individuals younger than one month of age. The most frequent serious adverse reactions (in ≥ 5% of individuals) were febrile neutropenia, dehydration, pyrexia, stomatitis, diarrhea, drug hypersensitivity, infection, nausea, and viral infection. Permanent discontinuation due to an adverse reaction occurred in 9% of individuals who received the Rylaze 25 mg/m2 dosage. Adverse reactions resulting in permanent discontinuation included hypersensitivity (6%) and infection (3%).


    ​OFF-LABEL INDICATIONS  


    There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

    References

    American Hospital Formulary Service (AHFS). Drug Information 2022. Asparaginase (Erwinia chrysanthemi) (04/27/20) and Asparaginase Erwinia chrysanthemi (Erwinaze®) (02/17/22). [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed June 22, 2022​. 

    Asparaginase Erwinia chrysanthemi (recombinant)-rywn (Rylaze™). Jazz Pharmaceuticals, Inc. 06/2021. Available at: http://www.rylaze.com/. Accessed June 23, 2022​. 

    Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual.Chapter 15: Covered medical and other health services. 120 - Prosthetic Devices (Rev. 1, 10-01-03). [CMS Web site]. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-Ioms-Items/Cms012673.html . Accessed June 23, 2022. 

    ClinicalTrials.gov. An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL). ClinicalTrials.gov Identifier: NCT04145531. First Posted: 10/30/19; Last Update Posted: 05/25/22. Available at: https://clinicaltrials.gov/ct2/show/study/NCT04145531​ ​. Accessed June 23, 2022.

    Einsiedel H, Stackelberg A, Hartmann R, et. al. Long term outcome in children with relapsed ALL by risk-stratified salvage therapy: results of trial acute lymphoblastic leukemia-relapse study of the Berlin-Frankfurt-Munster Group 87. J Clin Oncol. 2005;23(31):7942-7950.

    Elsevier’s Clinical Pharmacology Compendium. Asparaginase (Erwinia chrysanthemi). [ClinicalKey Web site]. 07/21/21. Available at: https://www.clinicalkey.com/. [via subscription only]. Accessed June 22, 2022​. 

    Elsevier’s Clinical Pharmacology Compendium. Asparaginase (Erwinia chrysanthemi [recombinant)-rywn]). [ClinicalKey Web site]. 07/29/21. Available at: https://www.clinicalkey.com/. [via subscription only]. Accessed June 22, 2022​. 

    Keating G. Asparaginase Erwinia chrysanthemi (Erwinase®): A guide to its use in acute lymphoblastic leukemia in the USA. BioDrugs. 2013;27:413-418.

    Lexi-Drugs Compendium. Asparaginase (Erwinia). [Lexicomp Online Web site]. 06/14/22​. Available at: http://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/3566871 [via subscription only]. Accessed June 22, 2022​. 

    Lexi-Drugs Compendium. Asparaginase (Erwinia [recombinant]). [Lexicomp Online Web site]. 07/02/21. Available at: http://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/7120155?cesid=8aYkOgKcRsU&searchUrl=/lco/action/search?q=rylaze&t=name&acs=false&acq=rylaze​ [via subscription only]. Accessed June 22, 2022​. 

    National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: Acute Lymphoblastic Leukemia V1.2022 (04/04/22)​. [NCCN Web site].  Available at: https://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Accessed June 22, 2022​. 

    National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: Pediatric Acute Lymphoblastic Leukemia V1.2022 (10/01/2021). [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/ped_all.pdf. Accessed June 22, 2022​. 

    National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: T-Cell Lymphomas Guidelines V2.2022 (03/07/2022)​. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/ped_all.pdf. Accessed June 22, 2022​. 

    National Comprehensive Cancer Network (NCCN). NCCN Drug and Biologics Compendium. Erwinaze & Rylaze. [National Comprehensive Cancer Network Web site]. 2022. Subscription required. Available at: https://www.nccn.org/professionals/drug_compendium/content/ . Accessed June 22, 2022​. 

    Rivera JM, Garcia O, Oriol A et al. Feasibility and results of subtype-oriented protocols in older adults and fit elderly patients with acute lymphoblastic leukemia: Results of three prospective parallel trials from the PETHEMA group. Leukemia Research. 2016;41:12-20.


    Salzer W, Asselin B, SUpko, et. al. Erwinina asparaginase achieves therapeutic activity after pegaspargase allergy: a report from the Children's Oncology Group. Blood. 2013;122(4):507-514.

    Seiter K. Acute lymphoblastic leukemia treatment & management. [Medscape Website]. 07/02/2021. Available at: http://emedicine.medscape.com/article/207631-treatment. Accessed June 23, 2022​. 

    Truven Health Analytics. Micromedex® Healthcare Series. DrugDex®. Asparaginase & Asparaginase (recombinant)-rywn[Micromedex Web site]. Last modified 06/16/22​. Available at: https://www.micromedexsolutions.com/micromedex2/librarian/ssl/true [via subscription only]. Accessed June 22, 2022​. 


    US Department of Health and Human Services. Common terminology criteria for adverse events (CTCTAE). V5.0. 09/21/2020. Available at: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm​ . Accessed June 23, 2022​. 

    US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Approval letter & Prescribing information. Asparaginase Erwinia chrysanthemi (Erwinaze®). [FDA Web site]. 12/2019. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/​ . Accessed June 22, 2022​. 


    US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Approval letter Prescribing information​. Asparaginase (Erwinia chrysanthemi [recombinant)-rywn])​. [FDA Web site]. 06/2021. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/​ . Accessed June 22, 2022​. 


    Coding

    CPT Procedure Code Number(s)
    N/A

    ICD - 10 Procedure Code Number(s)
    N/A

    ICD - 10 Diagnosis Code Number(s)

    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
    C86.0 Extranodal NK/T-cell lymphoma, nasal type
    C91.00 Acute lymphoblastic leukemia not having achieved remission
    C91.01 Acute lymphoblastic leukemia, in remission
    C91.02 Acute lymphoblastic leukemia, in relapse
    C92.00 Acute myeloblastic leukemia, not having achieved remission
    C92.01 Acute myeloblastic leukemia, in remission
    C92.02 Acute myeloblastic leukemia, in relapse
    C92.10 Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission
    C92.11 Chronic myeloid leukemia, BCR/ABL-positive, in remission
    C92.12 Chronic myeloid leukemia, BCR/ABL-positive, in relapse ​


    HCPCS Level II Code Number(s)

    J9019
    Injection, asparaginase (Erwinaze), 1,000 IU
    ​J9021Injection, asparaginase, recombinant, (rylaze), 0.1 mg


    Revenue Code Number(s)
    N/A




    Coding and Billing Requirements


    Policy History

    8/15/2022
    8/15/2022
    MA08.085
    Medical Policy Bulletin
    Medicare Advantage
    No