BlueCross BlueShield of Tennessee Medical Policy Manual

Laronidase

NDC CODE(S)

58468-0070-XX - Aldurazyme 2.9 mg (Genzyme Corporation)

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:

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Mucopolysaccharidosis I (MPS I)

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

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).

No controlled studies were found in the published literature that validate the use of laronidase for the treatment of other conditions or diseases.

SOURCES

Lexicomp Online. (2016). AHFS DI. Laronidase. Retrieved November 8, 2016 from Lexicomp Online with AHFS DI.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, September). Laronidase. Retrieved November 8, 2016 from MICROMEDEX Healthcare Series.  

U. S. Food and Drug Administration. (2013, April). Center for Drug Evaluation and Research. Aldurazyme (laronidase). Retrieved November 8, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125058s220lbl.pdf.

ORIGINAL EFFECTIVE DATE:  2/1/2005

MOST RECENT REVIEW DATE:  12/1/2016

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.

Pharmaceutical Decision Support Tree

Laronidase (Aldurazyme ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #5

  1. Does the individual have a diagnosis of Mucopolysaccharidosis type I further classified as ANY ONE of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the individual six months of age or older with documentation of ANY ONE of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for billable units of 667 every 7 days for dosage of 0.58 mg/kg administered once weekly IV for an authorization period of 12 months?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the agent, such as hypersensitivity reactions; acute respiratory complications; acute cardiorespiratory reactions; infusion reactions, etc.?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual show ANY ONE of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria for renewal

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.