Monthly administration of immune prophylaxis for respiratory syncytial virus (RSV) with palivizumab during the RSV season may be considered medically necessary in the following infants and children in accordance with guidelines-based recommendations; reaffirmed in 2019 (see Supplemental Information section):
In the first year of life, ie, younger than 12 months at the start of the RSV season or born during the RSV season:
Infants born before 29 weeks, 0 days of gestation;
Preterm infants with chronic lung disease (CLD) of prematurity, defined as birth at less than 32 weeks, 0 days of gestation and a requirement for more than 21% oxygen for at least the first 28 days after birth;
Certain infants with hemodynamically significant heart disease (eg, infants with acyanotic heart disease who are receiving medication to control congestive heart failure and will require cardiac surgical procedures; infants with moderate-to-severe pulmonary hypertension; infants with lesions adequately corrected by surgery who continue to require medication for heart failure);
Decisions regarding palivizumab prophylaxis for infants with cyanotic heart defects in the first year of life may be made in consultation with a pediatric cardiologist.
Children with pulmonary abnormality or neuromuscular disease that impairs the ability to clear secretions from the upper airways (eg, ineffective cough, recurrent gastroesophageal tract reflux, pulmonary malformations, tracheoesophageal fistula, upper airway conditions, or conditions requiring tracheostomy);
Children with cystic fibrosis who have at least one of the following conditions:
Clinical evidence of CLD; and/or
In the second year of life, ie, younger than 24 months at the start of the RSV season:
Children who were born at less than 32 weeks, 0 days of gestation and required at least 28 days of supplemental oxygen after birth and who continue to require medical intervention (supplemental oxygen, chronic corticosteroid, or diuretic therapy) during the 6-month period before the start of the second RSV season.
Children with cystic fibrosis who have either:
Manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest radiography or chest computed tomography that persists when stable); or
Weight for length less than the 10th percentile.
In the first or second year of life:
Children who will be profoundly immunocompromised (eg, will undergo solid organ or hematopoietic cell transplantation or receive chemotherapy) during the RSV season.
After surgical procedures that use cardiopulmonary bypass, for children who still require prophylaxis, a postoperative dose of palivizumab may be considered medically necessary after cardiac bypass or at the conclusion of extracorporeal membrane oxygenation for infants and children younger than 24 months.
Immunoprophylaxis for respiratory syncytial virus is considered not medically necessary in:
Infants and children with hemodynamically insignificant heart disease (eg, secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus);
Infants with lesions adequately corrected by surgery, unless they continue to require medication for heart failure;
Infants with mild cardiomyopathy who are not receiving medical therapy for the condition; or
Children with congenital heart disease in the second year of life.
Other indications for immune prophylaxis for RSV are considered investigational including, but not limited to, controlling outbreaks of healthcare-associated disease; or use in children with cystic fibrosis or Down syndrome without other risk factors; or in children over 2 years of age, unless criteria for medical necessity (outlined above) are satisfied.
For the Commonwealth of Puerto Rico, adminstrative order No. 340 Ammendment B of November 10, 2015states specific criteria for the propohylactic use of Palvizumab.