This policy version was replaced on October 4, 2021. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Humanized respiratory syncytial virus (RSV) monoclonal antibody (e.g., palivizumab [Synagis^®]) provides passive immunity to protect the lower respiratory tract from RSV infection. Palivizumab is administered by intramuscular injection on a monthly basis, during the RSV winter season, which is generally November through March. Each monthly dose provides protection for the following month.

In its most recent guidance on RSV prophylaxis, the American Academy of Pediatrics (AAP) states that approximately 2% to 3% of infants in the first 12 months of life are hospitalized with RSV infection each year in the United States. Although children with certain comorbidities are at increased risk of severe RSV infection compared with children without those comorbidities, chronologic age is the single most important risk factor for RSV hospitalization. The 2014 guidelines recommend up to 5 monthly doses of palivizumab during the first year of life for certain preterm infants and certain infants or children with specific chronic or congenital conditions. These guidelines were reaffirmed in 2019.  Prophylaxis with palivizumab during the second year of life is recommended for certain children with specific pulmonary conditions.

Definitions

Congenital Heart Disease (CHD):  Condition resulting from structural and/or functional defects of the heart at birth. CHD may be classified into acyanotic and cyanotic disease, depending on whether the patient clinically exhibits cyanosis (i.e.., blue or purple coloration of the skin or mucous membranes due to circulation of deoxygenated blood). Examples of acyanotic and cyanotic CHD include the following:

• Acyanotic CHD: aortic stenosis, atrial septal defect, atrioventricular canal, coarctation of the aorta, patent ductus arteriosis, pulmonic stenosis, and ventricular septal defect.
• Cyanotic CHD: Ebstein's anomaly, hypoplastic left heart, pulmonary atresia, tetralogy of Fallot, total anomalous pulmonary venous return, transposition of the great vessels, tricuspid atresia, and truncus arteriosus.

Immunocompromised Status: A state in which an individual's immune system is weakened or absent.

I.    Use of immune prophylaxis (e.g., palivizumab [Synagis®]) for RSV may be considered MEDICALLY NECESSARY AND APPROPRIATE when ONE of the following criteria are met:

• Chronic Lung Disease (CLD) of Prematurity
  • Infant is  ≤12 months of age at the onset of RSV season AND meets BOTH of the following:
    • Infant was born at <32 weeks, 0 days gestation; AND
    • Infant requires >21% oxygen for at least the first 28 days after birth.
  • OR
  • Child is 12 months to <24 months of age at the onset of RSV season AND meets BOTH of the following:
    • Child was born at <32 weeks, 0 days of gestation; AND
    • Child continues to require at least ONE of the following within 6 months of the start of RSV season:
      • Supplemental oxygen; OR
      • Chronic systemic corticosteroid therapy; OR
      • Diuretic therapy.
• Congenital Heart Disease (CHD)
  • Infant is ≤12 months of age at the onset of RSV season AND meets ONE of the following:
    • Acyanotic CHD, when the infant is receiving medication to control congestive heart failure and will require a cardiac surgical procedure; OR
    • Cyanotic CHD, when palivizumab is recommended after consultation with a pediatric cardiologist; OR
    • Diagnosis of moderate to severe pulmonary hypertension.
  • OR
  • Child is <24 months of age at the onset of RSV season AND meets ONE of the following:
    • Child undergoes cardiac transplantation during the RSV season; OR
    • Child is receiving RSV prophylaxis and continues to require more prophylaxis after a surgical procedure involving cardiac bypass or at the conclusion of extracorporeal membrane oxygenation.
• Anatomic Pulmonary Abnormalities OR Neuromuscular Disorder (e.g., cerebral palsy, muscular dystrophy)
  • Infant is ≤12 months of age at the onset of RSV season AND meets ONE of the following:
    • Infant has a pulmonary abnormality that impairs the ability to clear secretions from the upper airway: OR 
    • Infant has a neuromuscular disease that impairs the ability to clear secretions from the upper airway.
• Cystic Fibrosis
  • Child is <24 months of age at the onset of RSV season; AND
  • Child has cystic fibrosis with evidence of CLD and/or malnutrition.
• Immunocompromised Status
  • Child is <24 months of age at the onset of RSV season; AND
  • Child is profoundly immunocompromised (e.g., due to solid organ transplantation, hematopoietic stem-cell transplantation, or chemotherapy).
• Prematurity without CLD or CHD
  • Infant is <12 months of age at the onset of RSV season; AND
  • Infant was born at <29 weeks, 0 days gestation (i.e., 28 weeks, 6 days, or less).

II.   Use of immune prophylaxis (e.g.,palivizumab [Synagis]) for RSV is considered EXPERIMENTAL/INVESTIGATIVE for all other indications due to the lack of evidence demonstrating an impact on improved health outcomes.

Coverage

Administration of RSV Prophylaxis

• When the appropriate criteria above are met, a maximum of five (5) monthly doses, administered between October 1 and April 30, of palivizumab (Synagis®) will be covered per RSV season.
• A post-operative dose of palivizumab (Synagis®) will be covered for children <24 months who are receiving RSV prophylaxis and continue to require prophylaxis after a surgical procedure involving cardiac bypass or at the conclusion of extracorporeal membrane oxygenation.