Asparaginase Erwinia chrysanthemi
57902-0249-XX Erwinaze 10000 UNIT SOLR (JAZZ PHARMACEUTICALS)
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.
Asparaginase Erwinia chrysanthemi for the treatment of acute lymphoblastic leukemia (ALL) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Asparaginase Erwinia chrysanthemi for the treatment of other conditions/diseases is considered investigational.
Asparaginase Erwinia chrysanthemi is considered medically appropriate if ALL of the following:
Diagnosis of acute lymphoblastic leukemia (ALL) if ALL of the following:
Individual is one year old or older
Any prior L-asparaginase* therapy must have no history of serious pancreatitis, thrombosis, or hemorrhagic events
Used as a component of multi-agent chemotherapy as a substitute for pegaspargase or E. coli-derived asparaginase in cases of systemic allergic reaction or anaphylaxis
Asparaginase Erwinia chrysanthemi is considered medically appropriate for renewal if ALL of the following:
Individual continues to meet initial approval criteria
Disease stabilization or improvement as evidenced by a complete response (e.g., morphologic, cytogenetic or molecular complete response CR), complete hematologic response or a partial response by CBC, bone marrow cytogenic analysis, QPCR or FISH
Absence of unacceptable toxicity from the drug, e.g., severe hypersensitivity reactions including anaphylaxis, hyperglycemia, pancreatitis, thrombosis, bleeding, etc.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
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.
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.
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).
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
ORIGINAL EFFECTIVE DATE: 5/31/2019
MOST RECENT REVIEW DATE: 5/31/2019
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.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1,000 IU