Rho (D) Immune Globulins
DESCRIPTION
Rho (D) immune globulin preparations are made from the plasma of individuals with high titers of Rh antibodies. Immune globulins are used to provide passive immunity or to alter the immune response by increasing the individual's antibody titer and antigen-antibody reaction potential.
Examples of preparations of Rho (D) immune globulins are: Rhophylac® and WinRho® SDF.
REFER TO DECISION SUPPORT TREE
POLICY
Rho (D) immune globulin for the treatment of pregnancy and other obstetric conditions is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Rho (D) immune globulin for the treatment of immune thrombocytopenic purpura is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Rho (D) immune globulin for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Rho (D) immune globulin for the treatment of pregnancy and other obstetric conditions is considered medically appropriate if ALL of the following criteria are met:
The mother has Rh hemolytic disease (i.e. Rh incompatibility disease) related to full-term or incomplete pregnancy
ANY ONE of the following when the mother is Rho (D) negative and has been exposed to Rho (D) positive blood):
Spontaneous or induced abortion
Ruptured tubal pregnancy
Amniocentesis or abdominal trauma where the mother is Rho (D) negative (Note: administration would be contraindicated if the fetus or the father were known to be Rho (D) negative also.)
Antepartum prophylaxis
Transfusion induced antibody reaction
Rho (D) immune globulin for the treatment of immune thrombocytopenic purpura in non-splenectomized Rho (D) positive individuals is considered medically appropriate if ANY ONE of the following criteria are met:
Adults with chronic ITP
Child with acute or chronic ITP
Adult or child with ITP as a result of HIV infection
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).
No controlled studies were found in published literature that validate the use of Rho (D) immune globulin for the prevention or treatment of other conditions/diseases.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2003). Rho (D) immune globulins (4.01.05). Retrieved April 15, 2009 from BlueWeb.
Lexi-Comp Online. (2009). AHFS DI. Rho (D) immune globulin. Retrieved April 15, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Rho (D) immune globulins. Retrieved April 15, 2009 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2005, December). Center for Drug Evaluation and Research. FDA Labeling Information. Rho (D) immune globulin intravenous (WinRho® SDF). Retrieved January 9, 2008 from http://www.fda.gov/medwatch/safety/2006/WinRho_PI_%2021-DEC-2005.pdf.
U. S. Food and Drug Administration. (2007, March). Center for Drug Evaluation and Research. FDA Labeling Information. Rhophylac® (Rho [D] immune globulin). Retrieved December 18, 2007 from http://www.fda.gov/cber/label/rhophylacLB.pdf.
ORIGINAL EFFECTIVE DATE: 6/14/2008
MOST RECENT REVIEW DATE: 6/24/2009
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
Rho (D) Immune Globulins (Rhophylac® and WinRho® SDF)
Is the requested medication being used to treat pregnancy or other obstetric conditions?
If yes, go to question #2
If no, go to question #3
2. Does the individual show evidence of ALL of the following?
The mother has Rh hemolytic disease (i.e. Rh incompatibility disease) related to full-term or incomplete pregnancy
ANY ONE of the following when the mother is Rho (D) negative and has been exposed to Rho (D) positive blood):
Spontaneous or induced abortion
Ruptured tubal pregnancy
Amniocentesis or abdominal trauma where the mother is Rho (D) negative (Note: administration would be contraindicated if the fetus or the father were known to be Rho (D) negative also.)
Antepartum prophylaxis
Transfusion induced antibody reaction
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the Rho (D) being used for the treatment of immune thrombocytopenic purpura in non-splenectomized Rho (D) positive individuals with evidence of ANY ONE of the following?
Adults with chronic ITP
Child with acute or chronic ITP
Adult or child with ITP as a result of HIV infection
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.