Synagis® (palivizumab)

Synagis (palivizumab) is covered only for prevention of serious RSV lower respiratory tract disease in pediatric patients who meet specified FDA-approved indications (preterm infants, chronic lung disease of prematurity, hemodynamically significant CHD) or approved compendial off‑label uses (congenital airway abnormalities, neuromuscular disorders, profound immunocompromise, and peri‑cardiac transplant), and is not covered for other indications or adult patients. Key requirements include strict age and condition criteria (e.g., ≤28w6d gestation for the preterm indication; BPD with >21% oxygen for ≥28 days; <12 or <24 months at RSV‑season start as specified), required documentation and specialist prescription/consultation for several indications, dosing of 15 mg/kg IM monthly up to five doses per season, and allowance of an off‑season dose only if regional CDC NREVSS positivity thresholds are met.

"Record of prior palivizumab doses during the current RSV season to ensure dose counts do not exceed the maximum (up to 5 monthly doses)."