BlueCross BlueShield of Tennessee Medical Policy Manual

Asparaginase Erwinia chrysanthemi

NDC CODE(S)

57902-0249-XX Erwinaze 10000 UNIT SOLR (JAZZ PHARMACEUTICALS)

DESCRIPTION

Asparaginase Erwinia chrysanthemi is a programmed death ligand-1 (PD-L1) blocking antibody.  PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment.  By binding to receptors found on T cells and antigen presenting cells, PD-L1 suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine proliferation.  Avelumab binds to PD-L1 and its receptors and blocks its inhibitory effects on the immune response, including those on the anti-tumor immune responses.  

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION

All indications

To substitute for a dose of pegaspargase (Oncaspar®):

The recommended dose for each planned dose of pegaspargase is 25,000 IU/m2

administered IM or IV 3 times a week

 

To substitute for a dose of native E. coli asparaginase*:

The recommended dose is 25,000 IU/m2 administered IM or IV for each scheduled dose of native E. coli asparaginase

*Note: Commercial Elspar®(asparaginase) was discontinued in 2012 for business reasons

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed

Refer to DOSAGE LIMITS below

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION  

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

Lexicomp Online. (2019). AHFS DI. Asparaginase (Erwinia chrysanthemi). Retrieved January 14, 2019 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, December). Asparaginase. Retrieved January 14, 2019 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Asparaginase Erwinia chrysanthemi. Retrieved January 14, 2019 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, March). Center for Drug Evaluation and Research. ERWINAZE (asparaginase Erwinia chrysanthemi) for injection, intramuscular (IM) or intravenous (IV) use. Retrieved January 14, 2019 from

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125359s088lbl.pdf.

ORIGINAL EFFECTIVE DATE:  5/31/2019

MOST RECENT REVIEW DATE:  5/31/2019

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1,000 IU

DIAGNOSIS

MAXIMUM UNITS

Acute lymphoblastic leukemia (ALL)

190 billable units per week