Palivizumab (Synagis)

Palivizumab (Synagis) is covered only as RSV prophylaxis (not for treatment) for specified high‑risk pediatric patients — including preterm infants born <29w0d and ≤12 months at season start; chronic lung disease of prematurity born <32w0d who required >21% O2 for ≥28 days (≤12 months or <24 months if requiring ongoing therapy); hemodynamically significant or specified CHD or cardiac transplant recipients (age limits as specified); congenital airway/neuromuscular disease that impairs secretion clearance (<12 months); and profoundly immunocompromised children (<24 months), limited to FDA‑approved or approved compendial uses. Approvals require documentation of gestational and chronological age, oxygen/medical therapy needs, specialist prescription/consultation where specified, weight and clinical records, and authorize monthly 15 mg/kg IM dosing for up to five doses during the RSV season.

"Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with a history of premature birth (FDA-approved indication)."