Respiratory Syncytial Virus Prophylaxis

Restricted Product(s)

• palivizumab (Synagis® ) intramuscular injection for administration by a healthcare professional

FDA Approved Use

• For prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients:
  • With a history of premature birth (≤ 35 weeks gestational age) and who are 6 months of age or younger at the start of RSV season, 
  • With bronchopulmonary dysplasia (BPD) that required medical treatment within the prior 6 months and who are 24 months of age or younger at the start of RSV season, 
  • With hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the start of RSV season 
• Limitations of use: Not for treatment of RSV disease

Criteria for Medical Necessity

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The patient will be using monthly administration of the requested agent for immune prophylaxis for respiratory syncytial virus (RSV); AND 
2. The patient will be using the requested agent during the RSV season; AND 
3. The patient is an infant/child (≤ 24 months of age at the start of therapy); AND 
4. The patient will receive the requested agent in accordance with guideline-based recommendations; AND 
5. For patients in the first year of life (i.e., younger than 12 months at the start of the RSV season or born during the RSV season), treatment with the requested agent is recommended in one or more of the following situations [medical record documentation required]: 
   1. Infants born before 29 weeks, 0 days gestation; OR 
   2. Preterm infants with chronic lung disease (CLD) of prematurity, defined as birth at less than 32 weeks, 0 days gestation and a requirement for more than 21% oxygen for at least the first 28 days after birth; OR 
   3. Certain infants with hemodynamically significant heart disease (e.g., 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); AND 
      1. For infants with cyanotic heart defects, decisions regarding prophylactic treatment with the requested agent in the first year of life will be made by or in consultation with a pediatric cardiologist; OR
   4. Children with pulmonary abnormality or neuromuscular disease that impairs the ability to clear secretions from the upper airways (e.g., ineffective cough, recurrent gastroesophageal tract reflux, pulmonary malformations, tracheoesophageal fistula, upper airway conditions, or conditions requiring tracheostomy); OR 
   5. Children with cystic fibrosis who have at least one of the following conditions: 
      1. Clinical evidence of CLD; AND/OR 
      2. Nutritional compromise; OR
6. For patients in the second year of life (i.e., younger than 24 months at the start of the RSV season), treatment with the requested agent is recommended in one or more of the following situations [medical record documentation required]:
   1. Children who were born at less than 32 weeks, 0 days gestation and required at least 28 days of supplemental oxygen after birth and who continue to require medical intervention (e.g., supplemental oxygen, chronic corticosteroid, or diuretic therapy) during the 6- month period before the start of the second RSV season; OR 
   2. Children with cystic fibrosis who have either of the following:
      1. Manifestations of severe lung disease (i.e., previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest radiography or chest computed tomography that persist when stable); OR 
      2. Weight for length less than the 10th percentile; OR 
7. For patients in the first or second year of life, treatment with the requested agent is recommended in one or more of the following situations [medical record documentation required]:
   1. Children who will be profoundly immunocompromised (e.g., will undergo solid organ or hematopoietic stem cell transplantation or receive chemotherapy) during RSV season; OR 
8. For after surgical procedures that use cardiopulmonary bypass a postoperative dose of the requested agent is recommended for children still requiring prophylaxis in the following situations:
   1. The requested agent will be administered after cardiac bypass; OR 
   2. In children younger than 24 months, the requested agent will be administered at the conclusion of extracorporeal membrane oxygenation; AND 
9. The patient does NOT have any of the following:
   1. Hemodynamically insignificant heart disease (e.g., secundum atria septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus); OR 
   2. Lesions that are adequately corrected by surgery, unless the patient continues to require medication for heart failure; OR 
   3. Mild cardiomyopathy in infants who are not receiving medical therapy for the condition; OR 
   4. Congenital heart disease in the second year of life; AND 
10. The requested quantity does NOT exceed the maximum units/visits allowed for the duration of approval (see table below).
    
    Duration of Approval: 180 days (6 months)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

June 2021: Criteria change: Added maximum units; adjusted criteria for clarity; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.
*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.