DESCRIPTION
Crisantaspase contains an enzyme known as asparaginase, which is produced from the bacteria Erwinia chrysanthemi. It catalyzes the deamidation of asparagine to aspartic acid and ammonia, resulting in a reduction in circulating levels of asparagine. It’s mechanism of action is based on the inability of leukemic cells to synthesize asparagine resulting in cytotoxicity specific for leukemic cells that depend on an exogenous source of the amino acid asparagine for their protein metabolism and survival.
An example of a preparation of crisantaspase is Erwinaze™.
REFER TO DECISION SUPPORT TREE
POLICY
Crisantaspase for the treatment of acute lymphoblastic leukemia (ALL) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Crisantaspase for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Crisantaspase for the treatment of acute lymphoblastic leukemia (ALL) is considered medically appropriate if ALL of the following criteria are met:
The agent is being used as a component of a multi-agent chemotherapeutic regimen
Individual has developed hypersensitivity to E. coli-derived asparaginase
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 dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
SOURCES
U. S. Food and Drug Administration. (2011, November). Center for Drug Evaluation and Research. Erwinia (asparaginase Erwinia chrysanthemi) for injection, intramuscular use. Retrieved December 1, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125359lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/2/2011
MOST RECENT REVIEW DATE: 12/2/2011
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.
Pharmaceutical Decision Support Tree
Crisantaspase (Erwinaze™)
Does the individual have a diagnosis of acute lymphoblastic leukemia (ALL) and ALL of the following?
The agent is being used as a component of a multi-agent chemotherapeutic regimen
Individual has developed hypersensitivity to E. coli-derived asparaginase
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.