DESCRIPTION
Hepatitis B immune globulin (HBIG) is a sterile solution of the gamma globulin (IgG) fraction of human plasma collected from healthy, screened donors who are pre-selected for high titers of circulating antibodies to the hepatitis B surface antigen (anti-HBs). It is highly purified by various methods to ensure virus clearance. HBIG is used to provide passive immunization for individuals exposed to the hepatitis B virus (HBV).
Examples of preparations of hepatitis B immune globulin are: HepaGam B®, HyperHEP B® and Nabi-HB®.
REFER TO DECISION SUPPORT TREE
POLICY
Hepatitis B immune globulin for the prevention of hepatitis B recurrence is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Hepatitis B immune globulin for the prevention of infection after exposure to the hepatitis B surface antigen (HBsAg), i.e., post-exposure prophylaxis, is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Hepatitis B immune globulin for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Hepatitis B immune globulin for the prevention of hepatitis B recurrence is considered medically appropriate if ALL of the following criteria are met:
Individual is status post liver transplantation
Individual is hepatitis B surface antigen positive (HBsAg-positive)
Hepatitis B immune globulin for the prevention of infection after exposure to the hepatitis B surface antigen (HBsAg), i.e., post-exposure prophylaxis, is considered medically appropriate if ANY ONE of the following criteria are met:
Acute exposure to HBsAg-positive blood products from ANY ONE of the following:
Parenteral exposure (e.g., needlestick, bite, sharps)
Direct mucous membrane contact (e.g., accidental splash)
Oral ingestion (e.g., pipetting accident)
Perinatal exposure of infants born to HBsAg-positive mothers
Sexual exposure to a HBsAg-positive individual
Household exposure to individuals with acute HBV infection (e.g., infant less than 12 months old whose mother or primary caregiver is HBsAg-positive or other household contacts with an identifiable blood exposure to an HBsAg-positive individual)
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).
A review of the published literature found no controlled studies that validate the use of hepatitis B immune globulin for the treatment/prevention of any other conditions/diseases.
SOURCES
Lexi-Comp Online. (2010). AHFS DI. Hepatitis B Immune Globulin. Retrieved January 4, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2010, December). Hepatitis B Immune Globulin. Retrieved January 4, 2011 from MICROMEDEX Healthcare Series.
Talecris Biotherapeutics, Inc. (2008, May) HyperHEP B® S/D, Hepatitis B Immune Globulin (Human). Retrieved January 4, 2011 from http://www.talecris-pi.info/inserts/hyperhepb.pdf .
U. S. Food and Drug Administration. (2007, April). Center for Biologics Evaluation and Research. HepaGam B® [hepatitis B immune globulin (human)]. Retrieved January 4, 2011 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM119010.pdf.
U. S. Food and Drug Administration. (2008, April). Center for Biologics Evaluation and Research. Nabi-HB® [hepatitis B immune globulin (human)]. Retrieved January 4, 2011 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM117658.pdf.
ORIGINAL EFFECTIVE DATE: 6/14/2008
MOST RECENT REVIEW DATE: 3/4/2011
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
Hepatitis B Immune Globulin (HepaGam B®, HyperHEP B® and Nabi-HB®)
Does the individual have a prior diagnosis of hepatitis B and requires prevention of recurrence with ALL of the following?
Individual is status post liver transplantation
Individual is hepatitis B surface antigen positive (HBsAg-positive)
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #2
Does the individual require post-exposure prophylaxis due to ANY ONE of the following?
Acute exposure to HBsAg-positive blood products from ANY ONE of the following:
Parenteral exposure (e.g., needlestick, bite, sharps)
Direct mucous membrane contact (e.g., accidental splash)
Oral ingestion (e.g., pipetting accident)
Perinatal exposure of infants born to HBsAg-positive mothers
Sexual exposure to a HBsAg-positive individual
Household exposure to individuals with acute HBV infection (e.g., infant less than 12 months old whose mother or primary caregiver is HBsAg-positive or other household contacts with an identifiable blood exposure to an HBsAg-positive individual)
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.