BlueCross BlueShield of Tennessee Medical Policy Manual
Palivizumab (Synagis®)
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients:
Limitations of Use:
The safety and efficacy of Synagis have not been established for treatment of RSV disease.
Compendial Uses
All other indications are considered experimental/investigational and not medically necessary.
COVERAGE CRITERIA
Authorization of up to 5 doses per RSV season may be granted for the prevention of serious lower respiratory tract disease caused by RSV when a member has any of the following diagnoses and meets the criteria pertaining to the diagnosis:
Prematurity
All of the following criteria are met:
CLD of Prematurity
ALL of the following criteria must be met:
CHD
All of the following criteria are met:
Congenital Airway Abnormality
All of the following criteria must be met:
Neuromuscular Condition
All of the following criteria must be met:
Immunocompromised Children
All of the following criteria must be met:
Cystic Fibrosis
Either of the following criteria must be met:
OTHER
For all off-season Synagis requests, authorization of 1 dose per request, up to a maximum of 5 doses per RSV season, may be granted if the RSV activity for the requested region is ≥ 3% (with real-time polymerase chain reaction (PCR) test) within 2 weeks of the intended dose according to the CDC National Respiratory and Enteric Virus Surveillance System (NREVSS). The local health department or the CDC NREVSS will be consulted to assess the RSV activity for that region or state (http://www.cdc.gov/nrevss/index.htmll). Other Specialty Guideline Management criteria apply.
Synagis Season will be from November 1st to March 31st. Other health plans may differ.
EXCLUSIONS
Coverage will not be provided for members who have received Beyfortus (nirsevimab-alip) in the same RSV season.
APPENDIX
Appendix A: Recommended Use of Synagis for Prevention of RSV Infection
Recommendations from the American Academy of Pediatrics for the prevention of RSV infection with Synagis are summarized in Table below. Synagis should be administered intramuscularly at a dose of 15 mg/kg once per month beginning prior to the onset of the RSV season, which typically occurs in November. Because 5 monthly doses of Synagis will provide more than 6 months of serum Synagis concentrations above the desired serum concentration for most infants, administration of more than 5 monthly doses is not recommended within the continental United States.
Table. Recommended Use of Synagis for Prevention of RSV Infection
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Prematurity |
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Congenital Heart Disease |
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Chronic Lung Disease of Prematurity |
Preterm infants who develop CLD of prematurity defined as:
Preterm infants who:
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Congenital Abnormality of the Airway/ Neuromuscular Condition |
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Immunocompromised children |
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Cystic Fibrosis |
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Abbreviations: CHD = congenital heart disease; CLD = chronic lung disease (formerly bronchopulmonary dysplasia); RSV = respiratory syncytial virus.
Appendix B: Examples of Congenital Heart Anomalies*
Must be hemodynamically significant. See Table above for examples of infants and children who are most likely to benefit from Synagis.
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
ORIGINAL EFFECTIVE DATE: 12/4/97
MOST RECENT REVIEW DATE: 11/11/2025
ID_CHS
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.
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