BlueCross BlueShield of Tennessee Medical Policy Manual

Elosulfase Alfa

NDC CODE(S)

68135-0100-XX - Vimizim 5mg/5ml injection (Biomarin Pharmaceutical)

DESCRIPTION

Elosulfase alfa is a purified human enzyme produced by recombinant DNA technology.  It is used for enzyme replacement therapy for individuals with mucopolysaccharidosis IVA (MPS IVA, Morquio A syndrome). Mucopolysaccharidoses are a group of lysosomal storage disorders caused by the deficiency of specific enzymes required for the catabolism of glycosaminoglycans (GAG).  The enzyme deficient or absent in MPS IVA is N-acetylgalactosamine-6-sufatase leading to accumulation of the GAG substrates keratan sulfate (KS) and chondroitin-6-sulfate (C6S) throughout the body, eventually leading to widespread cellular, tissue and organ dysfunction.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Mucopolysaccharidosis IVA 2 mg per kg body weight administered once every week as an intravenous infusion over a minimum of 3.5 to 4.5 hours, based on infusion volume

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 elosulfase alfa for the treatment of other conditions or diseases

SOURCES

Lexi-Comp Online. (2016, March). AHFS DI. Elosulfase alfa. Retrieved October 27, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, August). Elosulfase alfa. Retrieved October 27, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2014, February). Center for Drug Evaluation and Research. Vimizim® (elosulfase alfa) injection, for intravenous use. Retrieved October 27, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125460s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  3/5/2014

MOST RECENT REVIEW DATE:  12/1/2016

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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.

Pharmaceutical Decision Support Tree

Elosulfase Alfa (Vimizim ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #6

  1. Is the individual 5 years of age or older with a documented baseline six minute walk test (6-MWT) (current test results [within 30 days] will be needed for renewal)?

If yes, go to question #3

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

  1. Does the individual have a documented diagnosis of mucopolysaccharidosis IVA (MP IVA, Morquio A syndrome) with biochemical/genetic confirmation by 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 product prepared and administered under supervision of a healthcare professional able to manage medical emergencies?

If yes, go to question #5

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

  1. Is the request for 230 billable units or less every 7 days for 184 vials of 5mg/ml every 28 days at dosage of 2 mg per kg of body weight weekly for an authorization length 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. Does the individual have disease response as indicated by improvement in 6MWT from baseline?

If yes, go to question #7

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

  1. Is there absence of unacceptable toxicity from the agent, including hypersensitivity reactions?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

This document has been classified as public information.