BlueCross BlueShield of Tennessee Medical Policy Manual

Imiglucerase

NDC CODE(S)

58468-1983-xx - Cerezyme 200 unit injection (Genzyme Corporation)

 

58468-4663-xx - Cerezyme 400 unit injection (Genzyme Corporation)

DESCRIPTION

Imiglucerase is a recombinant analog of the human enzyme β-glucocerebrosidase, a lysosomal glycoprotein enzyme, which normally catalyzes the hydrolysis of glucocerebroside to glucose and ceramide.  Mutations of the gene encoding β-glucocerebrosidase prevent this breakdown and lead to accumulation of massive amounts of glucocerebrosides in cells of the macrophage-monocyte system. This condition is known as Gaucher disease, the most common lysosomal storage disease.

Three types of Gaucher disease are delineated by absence or presence and progression of neurologic involvement. Type I disease accounts for 99% of cases and is known as the chronic non-neuronopathic form.  Its glucocerebrosidase storage is limited to phagocytes throughout the body although are seen primarily in the spleen and bone marrow.  Type II or acute neuronopathic Gaucher disease, is the infantile acute cerebral pattern of the disease dominated by progressive central nervous system disease.  Type III disease combines types I and II, with systemic glucocerebrosidase storage throughout the body as well as progressive central nervous system disease. Of the three types, only Type I disease is treatable through recombinant enzyme replacement therapy.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Type 1 Gaucher Disease

Initial dosages range from 2.5 U/kg of body weight 3 times a week to 60 U/kg once every 2 weeks based on disease severity. Cerezyme is administered by intravenous infusion over 1–2 hours.

Dosage adjustments should be made on an individual basis and may increase or decrease, based on achievement of therapeutic goals as assessed by routine comprehensive evaluations of the patient’s clinical manifestations.

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 imiglucerase for the treatment of other conditions or diseases.

SOURCES

Lexi-Comp, Inc. (2016). AHFS DI. Imiglucerase. Retrieved October 31, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, August). Imiglucerase. Retrieved October 31, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2005, March). Center for Drug Evaluation and Research. Label and Approval History. Cerezyme® (imiglucerase for injection). Retrieved October 31, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20367s066lbl.pdf.

ORIGINAL EFFECTIVE DATE:  8/1/2004

MOST RECENT REVIEW DATE:  2/6/2017

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

Imiglucerase (Cerezyme®)

  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 diagnosis of Type 1 Gaucher disease (non-neuronopathic)?

If yes, go to question #3

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 #4

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

  1. Is the request for use as a single agent?

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 or less every 14 days for dosage of between 2.5 U/kg 3 times a week to 60 U/kg once every 2 weeks based on severity of disease 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. Does the individual continue to meet the 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 the individual pediatric?

If yes, go to question #9

If no, go to question #8

  1. Is the individual an adult with disease response indicated by one or more of the following as compared to pretreatment baseline?

If yes, go to question #9

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

  1. Is there absence of 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

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