BlueCross BlueShield of Tennessee Medical Policy Manual

Calaspargase Pegol-mknl

NDC CODE(S)

72694-0515-XX Asparlas 3,750 units SOLN (Servier Pharmaceuticals)

DESCRIPTION

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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

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

 

RENEWAL CRITERIA

 

INDICATION(S)

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.

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 

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

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761102s000lbl.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; 5mL single use vial = 3750 units

DIAGNOSIS

MAXIMUM UNITS

Acute lymphoblastic leukemia 7500 units (2 vials) per 21 days