|00944-3810-XX Oncaspar 750 UNIT/ML SOLN (SHIRE US INC)|
Pegaspargase is a conjugate of monomethoxypolyethylene glycol (mPEG) and L-asparaginase (L-asparagine amidohydrolase), a polymerized asparagine specific enzyme. This produces an agent with reduced immunogenicity and a prolonged plasma half-life compared to native L-asparaginase. Additionally, dosing is less frequent, there is a lower incidence of toxicity, less tendency for resistance development and better efficacy and safety for those refractory to or intolerant of native L-asparaginase.
L-asparaginase is produced endogenously by E. coli. It catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The leukemic effect of pegaspargase is thought to be due to depletion of plasma L-asparagine. Leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize L-asparagine and therefore depend on an exogenous source of L-asparagine for survival.
Pegaspargase for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Acute Lymphoblastic Leukemia
Extranodal NK/T-Cell Lymphoma that is nasal disease
Pegaspargase for the treatment of other conditions/diseases is considered investigational.
Pegaspargase is considered medically appropriate if ALL of the following criteria are met:
Individual is 1 year of age or older
Any prior L-asparaginase* therapy has no history of serious pancreatitis, thrombosis or hemorrhagic events
Treatment is used as a component of multi-agent chemotherapy
Diagnosis of ANY ONE of the following:
Acute Lymphoblastic Leukemia used as ANY ONE of the following:
First line therapy
Hypersensitivity to native forms of L-asparaginase*
Systemic CNS-directed therapy
Relapsed/refractory disease that is ANY ONE of the following:
Ph chromosome-positive and ANY ONE of the following:
Refractory to tyrosine kinase inhibitor (TKI) therapy
Used in conjunction with a TKI (if not used previously)
Extranodal NK/T-Cell Lymphoma that is nasal disease used as ANY ONE of the following:
Additional therapy with a positive biopsy following partial or no response to induction therapy
Pegaspargase is considered medically appropriate for renewal/maintenance therapy if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the drug, e.g., allergic reactions (including anaphylaxis), central nervous system (CNS) thrombosis, coagulopathy, severe hepatotoxicity, severe hyperglycemia, pancreatitis, etc.
Diagnosis of ANY ONE of the following:
Extranodal NK/T-Cell Lymphoma with tumor response by stabilization of disease or decrease in size of tumor or tumor spread
Acute lymphoblastic leukemia (ALL) with disease stabilization or improvement as evidenced by a complete response [CR] (i.e., morphologic, cytogenetic or molecular complete response CR), complete hematologic response or a partial response by CBC, bone marrow cytogenic analysis, QPCR, or FISH
|INDICATION(S)||DOSAGE & ADMINISTRATION|
2,500 International Units/m2 intramuscularly or intravenously administered
Store refrigerated at 2 to 8° C
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. Pegaspargase. Retrieved January 15, 2019 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, November). Pegaspargase. Retrieved January 15, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Pegaspargase. Retrieved January 15, 2019 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2019, January). Center for Drug Evaluation and Research. Oncaspar® (pegaspargase) injection, for intramuscular or intravenous use. Retrieved January 15, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/193411s5196lbl.pdf.
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.
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Maximum billable units per dose and over time by indication as a Medical Benefit