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2024-2025 palivizumab (Synagis®) authorization guidelines

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Respiratory syncytial virus (RSV) can cause a variety of respiratory illnesses in infants and young children. It most commonly causes a cold-like illness but can also cause lower respiratory infections like bronchiolitis and pneumonia.

Palivizumab (Synagis) is a monoclonal antibody recommended by the American Academy of Pediatrics (AAP). It is recommended for high-risk infants and young children, based on gestational age and certain underlying conditions.

Palivizumab 15mg/kg is administered intramuscularly once per month for a maximum of five doses from November through March, the peak RSV months. Palivizumab is not effective for the treatment of RSV disease.

The Alliance’s utilization criteria follows the current AAP recommendations. The Alliance will cover palivizumab for members who meet the requirements outlined in our health policy.

Please note: For nirsevimab (Beyfortus), see our policy.

Conditions for using palivizumab (Synagis)
Age 0 to 12 months at RSV season onset

  • Infant born <29 weeks, 0 days gestation at birth.
  • Preterm infant with chronic lung disease (CLD) of prematurity defined as gestational age <32 weeks, 0 days and a requirement for >21% oxygen for at least the first 28 days after birth.
  •  Infant with hemodynamically significant congenital heart disease (CHD). This includes infants with acyanotic heart disease who are receiving medication to control congestive heart failure and will require cardiac surgical procedure and infants with moderate to severe pulmonary hypertension.
  • Infant with cyanotic heart defects if deemed warranted by the infant’s pediatric cardiologist.
  •  Infant who undergoes cardiac transplantation during the RSV season.
  • Infant with neuromuscular disease, significant respiratory disease or congenital anomaly that impairs the ability to clear secretions from the upper airway due to ineffective cough.
  • Infant who is profoundly immunocompromised during the RSV season.
  • Infant with cystic fibrosis and clinical evidence of chronic lung disease of prematurity and/or nutritional compromise.
Age 12 to <24 months at RSV season onset

  • Preterm infant with chronic lung disease (CLD) of prematurity, who continued to require supplemental oxygen, chronic systemic corticosteroids or diuretic therapy during the six month period before the start of the second RSV season.
  • Child who undergoes cardiac transplantation during the RSV season.
  • Child who is profoundly immunocompromised during the RSV season.
  • Infant with cystic fibrosis and manifestations of severe lung disease or weight for length <10th percentile.

Considerations when administering palivizumab versus nirsevimab for high-risk infants

  • If nirsevimab is administered, palivizumab should not be administered later that season.
  • If palivizumab was administered initially for the season and under five doses were administered:
    • The infant should receive one dose of nirsevimab.
    • No further palivizumab should be administered.
    • Because protection from palivizumab wanes after 30 days, nirsevimab should be administered no later than 30 days after the last palivizumab dose, when possible. There is no minimum interval between the last dose of palivizumab and the dose of nirsevimab.
    • If palivizumab was administered in season one and the child is eligible for RSV prophylaxis in season two, the child should receive nirsevimab in season two, if available. If nirsevimab is not available, palivizumab should be administered as previously recommended by AAP.

Alliance authorization for palivizumab billed as a medical claim

For providers who wish to bill the Alliance as a medical claim using a HCPCS code or “buy and bill,” please:

Medi-Cal Rx authorization for palivizumab billed as a pharmacy claim

Prescriptions that are filled at a pharmacy are covered by Medi-Cal Rx, not the Alliance. For more information on billing and prior authorization requests, please refer to the Medi-Cal Rx website.

Thank you for caring for young, at-risk infants. If you have any questions about palivizumab recommendations, please call the Alliance Pharmacy Department at 831-430-5507.