BlueCross BlueShield of Tennessee Medical Policy Manual

Taliglucerase Alfa

NDC CODE(S)

00069-0106-XX - Elelyso 200 unit powder for injection (Pfizer)

DESCRIPTION

Taliglucerase alfa is a recombinant active form of the lysosomal enzyme, β-glucocerebrosidase.  It is derived from genetically modified carrot plant root cells.  Native human β-glucocerebrosidase is a lysosomal glycoprotein enzyme that catalyzes the hydrolysis of glucocerebroside to glucose and ceramide. Taliglucerase alfa differs from native human β-glucocerebrosidase by two amino acids on the N terminal and up to seven amino acids at the C terminal yet it effectively functions in the necessary breakdown of glucocerebroside to glucose and ceramide

Gaucher disease is a chronic congenital disorder of lipid metabolism caused by deficiency of β-glucocerebrosidase. This leads to accumulation of glycolipids in the liver, spleen and bone marrow.  As a result, the individual may develop an enlarged liver and/or spleen, increased skin pigmentation and painful bone lesions.  Gaucher disease exists in three clinical subtypes, Type I, Type II and Type III; however enzyme replacement therapy is effective treatment only for confirmed Type I Gaucher disease, the only form determined to be non-neuronopathic.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Type 1 Gaucher Disease

Up to 60 units/kg every other week as a 60-120-minute IV infusion

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).

There is insufficient evidence supporting the use of taliglucerase alfa for the treatment of other conditions or diseases including Type II and Type III Gaucher disease.

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Taliglucerase alfa. Retrieved November 21, 2016 from Lexi-Comp Online with AHFS-DI.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, October). Taliglucerase alfa. Retrieved November 21, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2016, June). Center for Drug Evaluation and Research. Elelyso® (taliglucerase alfa). Retrieved November 21, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022458s012lbl.pdf.

ORIGINAL EFFECTIVE DATE:  6/15/2012

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

Taliglucerase Alfa (Elelyso ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #6

  1. Does the individual have a confirmed diagnosis of Type I Gaucher disease (non-neuronopathic)?

If yes, go to question #3

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

  1. Will treatment be as a single agent?

If yes, go to question #4

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

  1. Is the individual ANY ONE of the following?

If yes, go to question #5

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

  1. Is the request for 700 billable units every 14 days for dosage of up to 60 units per kg every other week as a 60 to 120 minute intravenous infusion for an authorization period of 12 months with possible renewal?

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 continue to meet initial approval criteria in questions 2 through 5?

If yes, go to question #7

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

  1. Is disease response to treatment indicated by ANY ONE of the following as compared to pre-treatment baseline?

If yes, go to question #8

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 anaphylaxis, allergic, infusion reactions, etc.?

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.