72694-0515-XX Asparlas 3,750 units SOLN (Servier Pharmaceuticals)
Calaspargase pegol-mknl contains an asparagine specific enzyme derived from Escherichia coli. This is a conjugate of L-asparaginase and monomethoxypolyethylene glycol (mPEG) with a succinimidyl carbonate (SC) linker. L-asparaginase is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia.
It is thought that a depletion of plasma L-asparagine causes the selective killing of leukemic cells. Due to a low expression of asparagine synthetase, leukemic cells have a reduced ability to synthesize L-asparagine and depend on an exogenous source of L-asparagine for survival.
Calaspargase pegol-mknl for the treatment of Acute Lymphoblastic Leukemia is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Calaspargase pegol-mknl for the treatment of other conditions/diseases is considered investigational.
Calaspargase pegol-mknl is considered medically appropriate if ALL of the following:
Diagnosis of Acute Lymphoblastic Leukemia (ALL) if ALL of the following:
Individual is between the ages of 1 month and 21 years
Administered as a component of a multi-agent chemotherapeutic regimen
No history of a serious reaction to any prior L-asparaginase* product including hypersensitivity/allergic reaction, thrombotic event, pancreatitis, hemorrhagic events or hepatoxicity
*Note: Commercial Elspar®(asparaginase) was discontinued in 2012 for business reasons
Calaspargase pegol-mknl is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the agent, e.g., allergic reactions (including anaphylaxis), thrombosis, coagulopathy, severe hepatotoxicity, pancreatitis, etc.
Disease stabilization or improvement as evidenced by a complete response (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
DOSAGE & ADMINISTRATION
|Acute Lymphoblastic Leukemia (ALL)||
2,500 units/m2 intravenously no more frequently than every 21 days.
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).
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, December). Calaspargase pegol-mknl. Retrieved January 10, 2019 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2018, December). Center for Drug Evaluation and Research. ASPARLAS™ (calaspargase pegol-mknl) injection, for intravenous use. Retrieved January 10, 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; 5mL single use vial = 3750 units