SYNAGIS (palivizumab)

SYNAGIS (palivizumab)

OFFICE ADMINISTRATION

Indication for Prior Authorization:

• Infants born at less than 29 weeks, 0 days, of gestation and who are less than 12 months and 0 days of age at the start of RSV season (November)
• Children in the first year of life with pulmonary abnormality or neuromuscular disease that impairs the ability to clear secretions from the upper airways
• Children less than 24 months old with severe immunodeficiency (e.g., severe combined immunodeficiency, acquired immunodeficiency syndrome, transplant recipients, or children who are immunocompromised due the chemotherapy. Insufficient data are available to recommend palivizumab prophylaxis for children with cystic fibrosis or Down syndrome
• Children who are at high risk for developing severe complications due to RSV infection and have congenital heart disease and are less than 12 months old at the start of the RSV season with at least one of the following: receiving medications to control heart disease, moderate to severe pulmonary hypertension or cyanotic heart disease
• Palivizumab prophylaxis is not recommended in the second year of life except for children who required at least 28 days of oxygen after birth and who continue to require medical intervention (supplemental oxygen, chronic corticosteroid, or diuretic therapy)

This medication is not approvable for the following conditions:

• Indications not covered by the current American Academy of Pediatrics Guidelines (July 2014)
• Secundum atrial septal defect
• Small ventricular septal defect
• Pulmonic stenosis
• Uncomplicated aortic stenosis
• Mild coarctation of the aorta
• Patent ductus arteriosus
• Lesions corrected by surgery unless they continue to require medication for CHF
• Mild cardiomyopathy not receiving medical therapy
• Treatment of RSV disease
• Children in the second year of life (except as noted above)
• Prevention of health care associated RSV disease

Dosing:

• Palivizumab is administered once per month beginning at the onset of the RSV season (November), for a maximum of five monthly doses (15 mg/Kg per dose).
• Qualifying infants born during the RSV season may require fewer doses.
  • For example infants born in January would receive their last dose in March
• Palivizumab prophylaxis should be discontinued in any child who experiences a breakthrough RSV hospitalization

Approval:

• Palivizumab requires separate authorization for outpatient administration
  • Palivizumab injections are administered monthly and may be authorized for up to a total of five injections given November to March
• Palivizumab does not need a separate authorization for inpatient administration