Subcutaneous Immune Globulin
DESCRIPTION
Subcutaneous immune globulin is manufactured from human plasma by cold alcohol fractionation. It is not chemically altered or enzymatically degraded. It supplies a broad spectrum of opsonizing and neutralizing IgG antibodies that help protect against a wide variety of bacterial and viral agents.
An example of a preparation of subcutaneous immune globulin is Vivaglobin®.
REFER TO DECISION SUPPORT TREE
POLICY
Subcutaneous immune globulin for the treatment of primary immune deficiency is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Subcutaneous immune globulin for the treatment of other conditions/diseases is considered investigational.
See also: Intravenous Immune Globulin (IVIG)
MEDICAL APPROPRIATENESS
Subcutaneous immune globulin for the treatment of primary immune deficiency is considered medically appropriate if ALL of the following criteria are met:
The individual is 2 years of age or older
Has no known antibodies to IgA
Has no history of anaphylactic or severe systemic response to immune globulin preparations
Has a recent serum IgA level greater than 0.05 g/L
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.
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 subcutaneous immune globulin for the treatment of other conditions/diseases.
SOURCES
Lexi-Comp Online. (2008). AHFS DI. Immune globulin. Retrieved May 8, 2008 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2008). Immune globulin. Retrieved May 8, 2008 from MICROMEDEX Healthcare Series.
Subcutaneous immune globulin. (2007, April). The Medical Letter On Drugs and Therapeutics, 49 (Issue 1258), 31-32.
U. S. Food and Drug Administration. (2006, January). Center for Biologics Evaluation and Research. Product Approval Information - Licensing Action. Immune globulin subcutaneous (human). Retrieved July 7, 2006 from http://www.fda.gov/cber/products/vivaglobin.htm.
ORIGINAL EFFECTIVE DATE: 1/13/2007
MOST RECENT REVIEW DATE: 9/24/2008
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
Subcutaneous Immune Globulin (Vivaglobin®)
Does the individual have a diagnosis of primary immune deficiency?
If yes, go to question #2
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual show evidence of ALL the following?
The individual is 2 years of age or older
Has no known antibodies to IgA
Has no history of anaphylactic or severe systemic response to immune globulin preparations
Has a recent serum IgA level greater than 0.05 g/L
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.