BlueCross BlueShield of Tennessee Medical Policy Manual

Laronidase

NDC CODE(S)

58468-0070-XX - Aldurazyme 2.9 MG/5ML SOLN (GENZYME)

DESCRIPTION

Laronidase is a recombinant form of the human enzyme L-iduronidase (alpha-L-iduronidase).  L-iduronidase is a lysosomal enzyme that is necessary for the degradation of glycosaminoglycans to its substrates dermatan sulfate and heparan sulfate.  Without this enzyme these substrates accumulate throughout the body leading to widespread cellular, tissue and organ dysfunction.

Individuals with inherited deficiency of L-iduronidase have the lysosomal storage disease mucopolysaccharidosis type I.  Treatment with laronidase reverses the metabolic and pathologic abnormalities outside the central nervous system.  Mucopolysaccharidosis type I is classified into three distinct subgroups:

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Mucopolysaccharidosis I (MPS I)

0.58 mg/kg of body weight administered once weekly (by intravenous infusion) over 3-4 hours.

LENGTH OF AUTHORIZATION

Coverage will be provided for twelve 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

Clarke, L. A., (2002, October Updated 2016, February). Mucopolysaccharidosis Type I. In: Adam, M. P., Ardinger, H. H., Pagon, R. A., et al., eds., GeneReviews®. Seattle (WA): University of Washington, Seattle; 1993-2018. Retrieved April 5, 2018 from https://www.ncbi.nlm.nih.gov/books/NBK1162/.

Lexicomp Online. (2018, February). AHFS DI. Laronidase. Retrieved April 5, 2018 from Lexicomp Online with AHFS DI.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, October). Laronidase. Retrieved February 11, 2019 from MICROMEDEX Healthcare Series.  

U. S. Food and Drug Administration. (2013, April). Center for Drug Evaluation and Research. Aldurazyme (laronidase). Retrieved February 11, 2019 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125058s220lbl.pdf.

ORIGINAL EFFECTIVE DATE: 2/1/2005

MOST RECENT REVIEW DATE:  4/9/2019

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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; 1 billable unit = 0.1 mg

DIAGNOSIS

MAXIMUM UNITS

Mucopolysaccharidosis I (MPS I)

667 billable units every 7 days