Rh0(D) Immune Globulin
DESCRIPTION
Rh0(D) immune globulin is a gamma globulin (IgG) containing antibodies to the rhesus D antigen or Rh0(D) antigen. It is derived from pooled human plasma from healthy Rh0(D)-negative donors who have been immunized with Rh0(D)-positive red blood cells. Measured in international units, donors are vigorously screened and the plasma is treated against hepatitis B, hepatitis C and HIV.
Examples of preparations of Rh0(D) immune globulin are: Rhophylac® and WinRho®.
REFER TO DECISION SUPPORT TREE
POLICY
Rh0(D) immune globulin for the treatment of immune thrombocytopenic purpura (ITP) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Rh0(D) immune globulin) for the prevention or suppression of rhesus (Rh) isoimmunization is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Rh0(D) immune globulin for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Rh0(D) immune globulin for the treatment of immune thrombocytopenic purpura (ITP) is considered medically appropriate if ANY ONE of the following are met:
Individual is an adult with chronic ITP
Individual is a child with chronic or acute ITP
Individual (child or adult) with ITP resulting from HIV infection
Rh0(D) immune globulin for the prevention or suppression of rhesus (Rh) isoimmunization is considered medically appropriate for ANY ONE of the following:
Individual is a pregnant woman with Rh0(D)-negative blood not previously sensitized to Rh0(D)-positive blood (e.g., first pregnancy) whose unborn child’s blood type or the father of the unborn child’s blood type is Rh0(D)-positive or Rh0(D) unknown for ANY ONE of the following:
Routine antepartum and postpartum Rh prophylaxis care
Complications of pregnancy (e.g., miscarriage, spontaneous or induced abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage, ruptured tubal pregnancy)
Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy)or obstetric manipulative procedures (e.g., external version, abdominal trauma)
Individual is a Rh0(D)-negative female child or adult in childbearing years transfused with Rh0(D)-positive red blood cells or blood components containing Rh0(D)-positive red blood cells
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 published literature disclosed no controlled studies that validate the use of Rh0(D)immune globulin for the treatment/prevention of any other conditions/diseases.
SOURCES
Lexi-Comp Online. (2010, June). AHFS DI. Rh0(D) Immune Globulin. Retrieved October 13, 2010 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2010, June). Rh0(D) Immune Globulin. Retrieved October 13, 2010 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2010, May). Center for Biologics Evaluation and Research. Rhophylac®. Retrieved November 1, 2010 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM119473.pdf.
U. S. Food and Drug Administration. (2010, May). Center for Biologics Evaluation and Research. WinRho®. Retrieved November 1, 2010 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM198717.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
Rh0(D) Immune Globulin (Rhophylac®, WinRho®)
Does the individual have a diagnosis of immune thrombocytopenic purpura (ITP) with ANY ONE of the following?
Individual is an adult with chronic ITP
Individual is a child with chronic or acute ITP
Individual (child or adult) with ITP resulting from HIV infection
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #2
Is the individual a pregnant woman with Rh0(D)-negative blood not previously sensitized to Rh0(D)-positive blood (e.g., first pregnancy) whose unborn child’s blood type or the father of the unborn child’s blood type is Rh0(D)-positive or Rh0(D) unknown?
If yes, go to question #3
If no, go to question #4
Does the individual require or have evidence of ANY ONE of the following?
Routine antepartum and postpartum Rh prophylaxis care
Complications of pregnancy (e.g., miscarriage, spontaneous or induced abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage, ruptured tubal pregnancy)
Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy)or obstetric manipulative procedures (e.g., external version, abdominal trauma)
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #4
Is the Individual is a Rh0(D)-negative female child or adult in childbearing years transfused with Rh0(D)-positive red blood cells or blood components containing Rh0(D)-positive red blood cells?
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.