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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-70

Original Effective Date: 07/15/12

Reviewed: 06/11/14

Revised: 09/15/17

Subject: Asparaginase (Erwinaze™) Injection

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

The asparaginases are a group of bacteria-derived enzymes that catalyze the deamidation of asparagine to aspartic acid and ammonia, which leads to a deficiency of circulating asparagine.1-3 When asparaginases are used in combination with other chemotherapy agents for the treatment of acute lymphoblastic leukemia (ALL), the resulting asparagine deficiency has been shown to be cytotoxic to leukemic cells dependent on exogenous asparagine.1,2 Three main types of asparaginase have been used in clinical practice: 1) native asparaginase derived from Escherichia coli (L-Asparaginase E. coli, Elspar®), 2) a pegylated form of the native E. coli asparaginase (pegaspargase, Oncaspar®), and 3) an asparagine enzyme isolated from Erwinia chrysanthemi (Asparaginase Erwinia chrysanthemi, Erwinaze™).1

Asparaginases derived from E. coli have been associated with hypersensitivity reactions due to antiasparaginase antibody production; this well-established side effect has been observed in up to 60% of individuals at some time during treatment and appears to occur more commonly with the native E. coli asparaginase product.1 Approximately 30% of individuals receiving any asparaginase product will develop a “silent hypersensitivity” in which antibodies in response to asparaginase do not lead to clinical hypersensitivity but may cause rapid inactivation of the asparaginase, resulting in suboptimal asparagine depletion.4 Typically, individuals exhibiting clinical allergy symptoms to one formulation of asparaginase are switched to another product.4-6

L-Asparaginase E. coli (Elspar®) was discontinued in December 2012 leaving only two commercially available asparaginase products in the US: pegaspargase (Oncaspar®) and Asparaginase Erwinia chrysanthemi (Erwinaze™).7,8 Several new asparaginase preparations are undergoing clinical evaluation.9

POSITION STATEMENT:

Asparaginase Erwinia chrysanthemi (Erwinaze™) meets the definition of medical necessity for members meeting the following criteria:

  1. Diagnosis of acute lymphoblastic leukemia (ALL)
  2. Treatment plan includes a multi-agent chemotherapy regimen
  3. Documented hypersensitivity reaction to L-Asparaginase E. coli (Elspar®) or pegaspargase (Oncaspar®)
  4. Dose does not exceed 25,000 IU/meter squared three times a week

Duration of approval: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

To substitute for a dose of pegaspargase: 25,000 IU/meter squared administered intramuscularly (IM) or intravenously (IV) for three times a week for six doses for each planned dose of pegaspargase

To substitute for a dose of native E. coli asparaginase: 25,000 IU/meter squared administered intramuscularly (IM) or intravenously (IV) for each scheduled dose of native E. coli asparaginase

Drug Availability

Asparaginase Erwinia chrysanthemi is available as a 10,000 IU/vial

PRECAUTIONS:

Contraindications

• History of hypersensitivity reactions to Asparaginase Erwinia chrysanthemi

• History of serious pancreatitis, thrombosis, or hemorrhagic events with prior L-asparaginase therapy

Precautions/Warnings

• Serious hypersensitivity reactions, including anaphylaxis, has occurred in 5% of individuals administered Asparaginase Erwinia chrysanthemi in clinical trials

• Pancreatitis

• Thrombosis and hemorrhage

BILLING/CODING INFORMATION:

HCPCS Coding

J9019

Injection, asparaginase (Erwinase, 1,000 IU)

ICD-10 Diagnoses Codes That Support Medical Necessity

C91.00 – C91.02

Acute lymphoblastic leukemia [ALL]

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Allogeneic Bone Marrow and Stem Cell Transplantation, 02-38240-01
Autologous Bone Marrow and Stem Cell Transplantation, 02-38241-01

Dasatinib (Sprycel®) Tablets, 09-J1000-43

Imatinib Mesylate (Gleevec®) Tablets, 09-J1000-46

Immune Globulin Therapy, 09-J0000-06

OTHER:

None

REFERENCES:

  1. Pieters R, Hunger SP, Boos J, et al. L-Asparaginase treatment in acute lymphoblastic leukemia: A focus on Erwinia Asparaginase. Cancer. 2011;117:238-49.
  2. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2014 [cited 2014 Apr 25]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  3. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2014 [cited 2014 Apr 25]. Available from: http://www.clinicalpharmacology.com/.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2014 Apr 25]. Available from: http://www.thomsonhc.com/.
  5. NCCN Clinical Practice Guidelines: Acute Lymphoblastic Leukemia [Internet]. Version 1.2013. Fort Washington (PA): National Comprehensive Cancer Network; 2014 [cited 2014 Apr 25]. Available from: http://www.nccn.org/professionals/physician_gls/pdf/all.pdf./
  6. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2014 [cited 2014 Apr 25]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  7. Sanofi-Aventis U.S. LLC. Erwinaze (asparaginase) injection, powder, lyophilized, for solution. 2011 [rev 2013 Jan; cited 2014 Apr 25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=30bdf2ea-008b-4cbb-81e4-c3474f2ad286/.
  8. Asparaginase Injection [Internet]. Bethesda (MD): American Society of Health-System Pharmacy, Inc.; 2013 Feb 7 [cited 2013 Apr 25]. Available from: http://www.ashp.org/DrugShortages/NotAvailable/Bulletin.aspx?id=958/.
  9. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2013 Apr 25]. Available from: http://clinicaltrials.gov/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 06/11/14.

GUIDELINE UPDATE INFORMATION:

07/15/12

New Medical Coverage Guideline.

01/01/13

Annual HCPCS Update; added HCPCS code J9019

07/15/13

Review and review to revision of guideline; consisting of description, position statement, dosage and administration, precautions, decision tree

10/15/13

Revision to guideline; consisting of administrative action to update coding.

07/15/14

Review and revision to guideline; consisting of references

11/01/15

Revision: ICD-9 Codes deleted.

09/15/17

Revised coding.

Date Printed: October 20, 2017: 02:06 PM