Synagis (palivizumab)
Indications for Prior Authorization
Synagis (palivizumab)
-
For diagnosis of Prophylaxis of respiratory syncytial virus (RSV)
Indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients: with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of respiratory syncytial virus (RSV) season; with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of respiratory syncytial virus (RSV) season; with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of respiratory syncytial virus (RSV) season.Limitations of use: The safety and efficacy of Synagis have not been established for treatment of RSV disease.
Criteria
Synagis
Authorization will be issued for up to a maximum of 5 months (5 doses) during respiratory syncytial virus (RSV) season. Initiation of Synagis prophylaxis after start of respiratory syncytial virus (RSV) season will not require all 5 doses for these conditions. [A] Typical RSV season is from November through March; however, RSV season can fall outside this time frame. If outside this time frame, refer to the CDC surveillance reports (http://www.cdc.gov/surveillance/nrevss/rsv/index.html) to confirm the start of RSV season based on region.
Prior Authorization
Length of Approval: 5 Month(s)
For diagnosis of Premature Infants (without other indications)
- Born prematurely at or before 29 weeks, 0 days gestation [2, B] AND
- Age < 12 months at the start of the respiratory syncytial virus (RSV) season [A]. AND
- Used for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) during the respiratory syncytial virus (RSV) season for the patient’s geographic region. AND
- Patient has not received Beyfortus (nirsevimab) for the current RSV season [4]
Synagis
Authorization will be issued for up to a maximum of 5 months (5 doses) during respiratory syncytial virus (RSV) season. Initiation of Synagis prophylaxis after start of respiratory syncytial virus (RSV) season will not require all 5 doses for these conditions. [A] Typical RSV season is from November through March; however, RSV season can fall outside this time frame. If outside this time frame, refer to the CDC surveillance reports (http://www.cdc.gov/surveillance/nrevss/rsv/index.html) to confirm the start of RSV season based on region.
Prior Authorization
Length of Approval: 5 Month(s)
For diagnosis of Chronic Lung Disease of Prematurity
- Chronic lung disease (CLD) of prematurity [2] AND
- Born before 32 weeks, 0 days gestation [2] AND
- Received greater than 21% oxygen supplementation for at least the first 28 days after birth AND
- One of the following:
- Age < 12 months at the start of the respiratory syncytial virus (RSV) season. OR
- Both of the following:
- Age at least 12 to < 24 months at the start of the RSV season
- Received medical support (i.e., chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) within 6 months before the start of the second RSV season
- Prescribed by or in consultation with one of the following:
- Pediatric pulmonologist
- Neonatologist
- Pediatric intensivist
- Infectious disease specialist
- Used for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) during the respiratory syncytial virus (RSV) season for the patient's geographic region. AND
- Patient has not received Beyfortus (nirsevimab) for the current RSV season
Synagis
Authorization will be issued for up to a maximum of 5 months (5 doses) during respiratory syncytial virus (RSV) season. Initiation of Synagis prophylaxis after start of respiratory syncytial virus (RSV) season will not require all 5 doses for these conditions. *ONE additional postoperative dose allowed for patients undergoing cardiac transplantation, cardiac bypass or extracorporeal membrane oxygenation. [A, D] Typical RSV season is from November through March; however, RSV season can fall outside this time frame. If outside this time frame, refer to the CDC surveillance reports (http://www.cdc.gov/surveillance/nrevss/rsv/index.html) to confirm the start of RSV season based on region.
Prior Authorization
Length of Approval: 5 Month(s)
For diagnosis of Hemodynamically Significant Congenital Heart Disease
- One of the following:
- Age < 12 months at the start of the respiratory syncytial virus (RSV) season, with one of the following: [C] (persons of all ages).
- All of the following:
- Acyanotic heart failure
- Receiving medication to control congestive heart failure
- Patient will require a cardiac surgical procedure
- Moderate to severe pulmonary hypertension OR
- Cyanotic heart defect
- Both of the following*: [D]
- Age < 24 months
- Patient will or has undergone a cardiac transplantation during the respiratory syncytial virus (RSV)season
- Prescribed by or in consultation with a pediatric cardiologist AND
- Used for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) during the respiratory syncytial virus (RSV) season for the patient's geographic region AND
- Patient has not received Beyfortus (nirsevimab) for the current RSV season
Synagis
Authorization will be issued for up to a maximum of 5 months (5 doses) during respiratory syncytial virus (RSV) season. Initiation of Synagis prophylaxis after start of respiratory syncytial virus (RSV) season will not require all 5 doses for these conditions. [A] Typical RSV season is from November through March; however, RSV season can fall outside this time frame. If outside this time frame, refer to the CDC surveillance reports (http://www.cdc.gov/surveillance/nrevss/rsv/index.html) to confirm the start of RSV season based on region.
Prior Authorization
Length of Approval: 5 Month(s)
For diagnosis of Pulmonary Abnormality or Neuromuscular Disorder
- Pulmonary abnormalities (e.g., pulmonary malformations, tracheoesophageal fistula, conditions requiring tracheostomy) or neuromuscular disease (e.g., cerebral palsy) [2] AND
- Age < 12 months at the start of the respiratory syncytial virus (RSV) season. AND
- Impaired ability to clear secretions from the upper airway due to an ineffective cough AND
- Prescribed by or in consultation with one of the following:
- Pediatric pulmonologist
- Neurologist
- Used for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) during the respiratory syncytial virus (RSV) season for the patient's geographic region AND
- Patient has not received Beyfortus (nirsevimab) for the current RSV season
Synagis
Authorization will be issued for up to a maximum of 5 months (5 doses) during respiratory syncytial virus (RSV) season. Initiation of Synagis prophylaxis after start of respiratory syncytial virus (RSV) season will not require all 5 doses for these conditions. [A] Typical RSV season is from November through March; however, RSV season can fall outside this time frame. If outside this time frame, refer to the CDC surveillance reports (http://www.cdc.gov/surveillance/nrevss/rsv/index.html) to confirm the start of RSV season based on region.
Prior Authorization
Length of Approval: 5 Month(s)
For diagnosis of Immunocompromised Children
- Prescriber attests that patient is immunocompromised AND
- Age < 24 months AND
- Prescribed by or in consultation with one of the following:
- Pediatric pulmonologist
- Infectious disease specialist
- Pediatric intensivist
- Used for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) during the respiratory syncytial virus (RSV) season for the patient's geographic region AND
- Patient has not received Beyfortus (nirsevimab) for the current RSV season
Synagis
Authorization will be issued for up to a maximum of 5 months (5 doses) during respiratory syncytial virus (RSV) season. Initiation of Synagis prophylaxis after start of respiratory syncytial virus (RSV) season will not require all 5 doses for these conditions. [A] Typical RSV season is from November through March; however, RSV season can fall outside this time frame. If outside this time frame, refer to the CDC surveillance reports (http://www.cdc.gov/surveillance/nrevss/rsv/index.html) to confirm the start of RSV season based on region.
Prior Authorization
Length of Approval: 5 Month(s)
For diagnosis of Children with Cystic Fibrosis
- Diagnosis of cystic fibrosis [2] AND
- One of the following:
- Both of the following:
- Age < 12 months
- Clinical evidence of chronic lung disease (CLD) and/or nutritional compromise (i.e., failure to thrive)
- Both of the following:
- Age at least 12 to < 24 months
- Severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life, abnormalities on chest radiography or chest computed tomography that persist when stable) or weight for length < 10th percentile on pediatric growth chart [E]
- Used for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) during the respiratory syncytial virus (RSV) season for the patient's geographic region AND
- Patient has not received Beyfortus (nirsevimab) for the current RSV season
P & T Revisions
2023-10-30, 2023-09-21, 2022-03-03, 2021-10-05, 2021-09-27, 2021-05-26, 2021-05-25, 2020-08-31
References
- Synagis Prescribing Information. Swedish Orphan Biovitrum AB (publ). Stockholm, Sweden September 2021.
- Commitee on Infectious Diseases and Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalizations for respiratory syncytial virus infection. Pediatrics. 2014 Aug;134(2):415-20. doi: 10.1542/peds.2014-1665.
- Panozzo CA, Stockman LJ, et al. Use of respiratory syncytial virus surveillance data to optimize the timing of immunoprophylaxis. Pediatrics. 2010 Jul;126(1):e116-23.
- Jones JM, Fleming-Dutra KE, Prill MM, et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices – United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(34):920-925
End Notes
- Five monthly doses of palivizumab will provide more than 6 months of prophylactic serum palivizumab concentrations. Administration of more than five monthly doses is not recommended. If RSV season onset is in November, the first dose should be administered in November, and the fifth and final dose should be administered in March. If RSV season onset is in November and the first dose is given in January, the third and final dose should be administered in March. In most of North America, peak RSV activity typically occurs between November and March, usually beginning in November or December, peaking in January or February, and ending by the end of March or sometime in April. Communities in the southern United States, particularly some communities in the state of Florida, tend to experience the earliest onset of RSV. Data from the Centers for Disease Control and Prevention (CDC) have identified variations in the onset and offset of the RSV “season” in the state of Florida that could affect the timing of palivizumab administration. [2] For analysis of National Respiratory and Enteric Virus Surveillance System (NREVSS) reports in the CDC Morbidity and Mortality Weekly Report (MMWR), season onset is defined as the first of 2 consecutive weeks during which the mean percentage of specimens testing positive for RSV antigen is at least 10% and RSV season offset is defined as the last of 2 consecutive weeks during which the mean percentage of positive specimens is at least 10%. [3] NREVSS surveillance data can be viewed here (http://www.cdc.gov/surveillance/nrevss/rsv/)
- Palivizumab prophylaxis is not recommended for otherwise healthy infants born at or after 29 weeks, 0 days' gestation. [2]
- The following conditions are NOT considered hemodynamically significant congenital heart disease: secundum atrial septal defect, small ventricular septal defect, pulmonary stenosis, uncomplicated aortic stenosis, mild coaractation of the aorta, and patent ductus arteriosus; lesions adequately corrected by surgery, unless continuing required medication for congestive heart failure; mild cardiomyopathy and not receiving medical therapy for the condition; children in the second year of life. [2]
- Pediatric growth charts can be viewed here (http://www.cdc.gov/growthcharts/who_charts.htm)
- Children undergoing these procedures should receive an additional dose of palivizumab as soon as possible after the procedure. Thereafter, doses should be administered monthly as scheduled. [2]
- Monthly prophylaxis should be discontinued in any infant or child who experiences a breakthrough RSV hospitalization. [2]
- Palivizumab prophylaxis is not recommended for prevention of health care-associated RSV disease. [2]
- The burden of RSV disease and costs associated with transport from remote locations may result in a broader use of palivizumab for RSV prevention in Alaska Native populations and possibly in selected other American Indian populations. [2]
Revision History
- 2023-10-30: Updated criteria for not take in combination with Beyfortus to "Patient has not received Beyfortus for the current RSV season"
- 2023-09-21: Added criteria to not take in combination with Beyfortus
- 2022-03-03: Updated notes to add guidance on RSV season variance
- 2021-10-05: 2021 Annual Review, no changes to criteria.
- 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
- 2020-08-31: Annual Review - No changes
HEALTHY LIVING