DESCRIPTION
Cytomegalovirus immune globulin intravenous (CMV-IGIV) is derived from pooled adult human plasma selected for high titers of antibody for cytomegalovirus (CMV). CMV-IVIG is used to provide passive immunity to CMV in certain individuals at risk for CMV infection. CMV can cause problems for individuals with immunocompromised immune systems. CMV can cause increased bacterial and fungal infections that may be associated with an increased risk of rejection of a transplanted organ. CMV may contribute to morbidity and mortality in organ transplant recipients. CMV is not usually harmful to individuals with functional immune systems.
An example of a preparation of cytomegalovirus immune globulin intravenous is CytoGam®.
REFER TO DECISION SUPPORT TREE
POLICY
Cytomegalovirus immune globulin intravenous for the prevention or attenuation of primary cytomegalovirus disease is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Cytomegalovirus immune globulin intravenous, for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Cytomegalovirus immune globulin intravenous for prevention or attenuation of primary cytomegalovirus disease is considered medically appropriate if ALL of the following criteria are met:
The individual is an immunosuppressed, cytomegalovirus seronegative recipient of tissue transplantation from a seropositive donor
The individual has ANY ONE of the following conditions:
Is an immunosuppressed recipient of a organ transplant
Is being used in combination with ganciclovir to treat cytomegalovirus pneumonia in bone marrow transplant recipients
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 cytomegalovirus immune globulin intravenous for the treatment of other conditions/diseases.
SOURCES
CSL Behring. (2007, March). CytoGam® (cytomegalovirus immune globulin intravenous [human]). Retrieved November 12, 2008 from http://www.cslbehring-us.com/docs/335/858/CytoGam%20PI%203.07.pdf.
Lexi-Comp Online. (2008). AHFS DI. Cytomegalovirus immune globulin IV. Retrieved November 12, 2008 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2008). Cytomegalovirus immune globulin, human. Retrieved November 12, 2008 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration (2003, October). Center for Biologics Evaluation and Research. 1998 Biological License Application Supplement Approvals. Retrieved January 23, 2004 from http://www.fda.gov/cber/appr1998/1998lsup.htm.
ORIGINAL EFFECTIVE DATE: 12/4/1997
MOST RECENT REVIEW DATE: 3/25/2009
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
Is the agent being used for the prevention or attenuation of primary cytomegalovirus and does the individual show evidence ALL of the following?
The individual is an immunosuppressed, cytomegalovirus seronegative recipient of tissue transplantation from a seropositive donor
The individual has ANY ONE of the following conditions:
Is an immunosuppressed recipient of a organ transplant
Is being used in combination with ganciclovir to treat cytomegalovirus pneumonia in bone marrow transplant recipients
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.