Palivizumab
Palivizumab is a humanized monoclonal antibody (IgG1k) produced by recombinant DNA technology. It is supplied as a sterile lyophilized product; thus, it is a passive immunizing agent.
An example of a preparation of palivizumab is Synagis®.
The American Academy of Pediatrics (AAP) states, The current recommendations for infants born between 32 and 35 weeks of gestation (i.e., defined as 32 weeks, 0 days, through 34 weeks, 6 days) are intended to reduce the risk of respiratory syncytial virus (RSV) hospitalizations during the period of greatest risk among infants with consistently identified risk factors. The AAP recommends the following preventative measures regarding high-risk infants:
Never expose the high-risk infant to tobacco. Smoking is a risk factor that can be controlled by the family of the infant at increased risk of RSV disease. Cessation of smoking is highly encouraged. At the very least going outside to smoke is essential.
Keep the high-risk infant away from crowds and from situations in which exposure to infected individuals cannot be controlled.
Restrict the high-risk infant's participation in child-care during the RSV season whenever feasible.
Enforce careful hand hygiene.
Immunize the high-risk infant against influenza beginning at 6 months of age.
Palivizumab for the prevention of serious lower respiratory tract infection is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Palivizumab for the prevention of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Palivizumab for the prevention of serious lower respiratory tract infection is considered medically appropriate if ALL of the following:
The agent is being used for the prevention of serious lower respiratory tract infection caused by respiratory syncytial virus (RSV)
The individual meets ANY ONE of the following:
Infants less than 6 months of age who were born at 29-32 weeks gestation
Infants who were born before 35 weeks gestation with congenital abnormalities of the airway, or severe neuromuscular disease that compromises handling of respiratory secretions for the first year of life
Infants less than 12 months of age who were born at or before 28 weeks gestation or less
Infants and children less than 24 months of age with chronic lung disease (CLD) who have received medical therapy (e.g., oxygen, diuretics, corticosteroids, mechanical ventilation, or bronchodilators) for CLD within the previous 6 months
Children 24 months of age or younger with a diagnosis of hemodynamically significant congenital heart disease (e.g., moderate severe pulmonary hypertension, receiving medication to control congestive heart failure, acyanotic heart disease or cyanotic heart disease)
Infants from 32-35 weeks gestation who were born less than 3 months before the onset or during the RSV season with ANY ONE of the following risk factors:
Infant attends child care (defined as a home or facility where care is provided for any number of infants or young toddlers)
Infant has a sibling younger than 5 years of age
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).
RSV prophylaxis should be initiated just before the onset of the RSV season and terminated at the end of the RSV season. In most seasons and in most areas of the United States, the first dose should be administered at the beginning of November and the last dose should be administered at the beginning of March. The onset of RSV infection occurs earlier in southern states. Practitioners should contact their health departments and/or diagnostic virology laboratories in their geographic areas to determine the optimal time to begin administration.
No evidence was found to support the year round administration of RSV prophylaxis.
Children, who still require prophylaxis, should be considered for a postoperative dose of palivizumab, when medically stable after surgical procedures that use cardiopulmonary bypass.
Infants or children who are receiving immunoprophylaxis and experience a breakthrough RSV infection, prophylaxis should continue until a maximum of 3 doses have been administered to infants in the 32 to less than 35 weeks (defined as 32 weeks, 0 days, through 34 weeks, 6 days) gestation group or until a maximum of 5 doses for infants with congenital heart disease, CLD, congenital abnormalities of the airway, severe neuromuscular disease, or preterm birth before 32 weeks’ gestation.
American Academy of Pediatrics recommends that the following infants and children are not at increased risk from RSV and generally should not receive RSV immunoprophylaxis:
Infants and children with hemodynamically insignificant heart disease (e.g., secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus)
Infants with lesions adequately corrected by surgery unless they continue to require medication for congestive heart failure
Infants with mild cardiomyopathy who are not receiving therapy
Center for Disease Control and Prevention recommended preventative measures:
Perform frequent washing of hands
Do not share items such as cups, glasses, and utensils with persons who have RSV illness
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2007). Immune prophylaxis for respiratory syncytial virus (5.01.10). Retrieved August 27, 2009 from BlueWeb.
Center for Disease Control and Prevention. (2008, October). Respiratory syncytial virus: transmission and prevention. Retrieved August 27, 2009 from http://www.cdc.gov/rsv/about/transmission.html.
Lexi-Comp Online. (2009). AHFS DI. Palivizumab. Retrieved August 24, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Palivizumab. Retrieved August 24, 2009 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2009). NCCN Drugs & Biologics Compendium™. Palivizumab. Retrieved August 10, 2009 from the National Comprehensive Cancer Network.
Pickering L. K., Baker C. J., Kimberlin, D. W., Long, S. S. (2009). Respiratory Syncytial Virus. In American Academy of Pediatrics: Red Book: 2009 Report of the Committee on Infectious Diseases (28th ed., pp. 560-569). Elk Grove Village, IL: American Academy of Pediatrics.
U. S. Food and Drug Administration. (2009, March). Center for Drug Evaluation and Research. FDA Label and Approval History. Synagis® (palivizumab). Retrieved August 24, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103770s5116lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/4/1997
MOST RECENT REVIEW DATE: 9/18/2009
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
Palivizumab (Synagis®)
Is the agent being used for the prevention of serious lower respiratory tract infection caused by respiratory syncytial virus (RSV)?
If yes, go to question #2
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the agent being used in an infant less than 6 months of age who was born at 29-32 weeks gestation?
If yes, approve for up to a maximum of five months of therapy, but no later than March 31st
If no, go to question #3
Is the agent being used in an infant who was born before 35 weeks gestation with congenital abnormalities of the airway, or severe neuromuscular disease that compromises handling of respiratory secretions for the first year of life?
If yes, approve for up to a maximum of five months of therapy, but no later than March 31st
If no, go to question #4
Is the agent being used in an infant less than 12 months of age and is there evidence that ALL of the following criteria are met?
At birth, the gestational age was 28 weeks or less
The individual was born between March 31st and October 31st
If yes, approve for up to a maximum of five months of therapy, but no later than March 31st
If no, go to question #5
Is the agent being used in an infant or child less than 24 months of age and is there evidence of chronic lung disease (CLD) and have they received medical therapy (e.g., oxygen, diuretics, corticosteroids, mechanical ventilation, or bronchodilators) for CLD within the previous 6 months?
If yes, approve for up to a maximum of five months of therapy, but no later than March 31st
If no, go to question #6
Is the agent being used in an infant or child 24 months of age or younger and is there evidence of hemodynamically significant congenital heart disease (e.g., moderate severe pulmonary hypertension, and is receiving medication to control congestive heart failure, acyanotic heart disease or cyanotic heart disease)?
(NOTE: The AAP states the following are not at increased risk: “Infants and children with hemodynamically insignificant heart disease [e.g., secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus])”
If yes, approve for up to a maximum of five months of therapy, but no later than March 31st
If no, go to question #7
Is the agent being used in an infant from 32-35 weeks gestation (i.e., defined as 32 weeks, 0 days, through 34 weeks, 6 days) who was born less than 3 months before the onset of RSV season (August 1 through October 31) or during the current RSV season (November 1 through March 31) with at least one of the following risk factors?
Infant attends child care (defined as a home or facility where care is provided for any number of infants or young toddlers)
Infant has a sibling younger than 5 years of age
If yes, approve for up to a maximum of 3 doses, but no later than March 31st (Note: The AAP states this category should receive prophylaxis until they reach 3 months of age so they may only need 1 or 2 doses until they reach 3 months of age)
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.