BlueCross BlueShield of Tennessee Medical Policy Manual

Velaglucerase Alfa

DESCRIPTION

Gaucher's disease is a chronic congenital disorder of lipid metabolism caused by a deficiency of the enzyme beta-glucocerebrosidase. Three clinical subtypes of the disease exist (Type 1, Type 2 & Type 3). Type 1 is characterized by an accumulation of glycolipids in the liver, spleen and bone marrow. The accumulation may lead to an enlarged liver and/or spleen, increased skin pigmentation and painful bone lesions.

Velaglucerase alfa is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT). Long-term glucocerebrosidase enzyme replacement therapy is an effective treatment for Type 1 (i.e., non-neuronopathic) Gaucher's disease.

An example of a preparation of velaglucerase alfa is Vpriv™.

REFER TO DECISION SUPPORT TREE

POLICY

• Velaglucerase alfa for the treatment of Gaucher's disease is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

• Velaglucerase alfa for the treatment of other conditions/diseases, including, but not limited to, type 2 and type 3 Gaucher's disease are considered investigational.  

MEDICAL APPROPRIATENESS

• Velaglucerase alfa for the treatment of type I (i.e., non-neuropathic) Gaucher's disease is considered medically appropriate.

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute:  The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.  

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 dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).

There is insufficient evidence supporting the use of velaglucerase alfa for the treatment of other conditions/diseases.

SOURCES

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2010). Velaglucerase alfa. Retrieved March 17, 2010 from MICROMEDEX Healthcare Series.  

U. S. Food and Drug Administration. (2010, February). Center for Drug Evaluation and Research. VPRIV™ (velaglucerase alfa). Retrieved March 2, 2010 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022575lbl.pdf.

ORIGINAL EFFECTIVE DATE:  9/12/2010

MOST RECENT REVIEW DATE:  9/12/2010

ID_BT

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

Velaglucerase Alfa (Vpriv™)

1. Is the requested medication being used to treat type 2 or type 3 Gaucher's disease?

If yes, this does not meet medical necessity and/or medical appropriateness criteria

If no, go to question #2

2. Does the individual have a diagnosis of type I (i.e., non-neuropathic) Gaucher's disease?

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.