Diagnosis: Prematurity
Treatment: Synagis 100 mg/mL vial via intramuscular injection as directed monthly x 5 months
The insurer denied Synagis 100 mg/mL vial via intramuscular injection as directed monthly x 5 months.
The determination is overturned.


The patient was born prematurely. He was hospitalized in the Neonatal Intensive-Care Unit (NICU) for three weeks due to respiratory distress, intrauterine growth restriction, and small for gestation age. Since birth, he has reportedly experienced slow weight gain. He is being followed by Pediatric Ophthalmology, Neurology, and Audiology. The request is for Synagis monthly for five months for the duration of the respiratory syncytial virus (RSV) season.

At issue is the medical necessity of the Synagis.

The Synagis is medically necessary for this infant.

In 2014, the American Academy of Pediatrics issued new guidelines for the administration of Synagis for RSV prophylaxis based on review of current peer-reviewed literature related to burden of RSV in infants and children with emphasis on those at highest risk of severe disease. The following groups of patients are considered at highest risk, with recommendations for administration of Synagis: infants born before 29 weeks' gestation younger than 12 months of age at the start of RSV season; infants with chronic lung disease of prematurity born before 32 weeks' gestation during the first year of life, with some consideration during the second year of life if continued medical support is necessary; infants 12 months of age or younger with hemodynamically significant congenital heart disease (excluding those with lesions adequately corrected by surgery unless medication is necessary for ongoing congestive heart failure); consideration for infants 12 months of age or younger with anatomic pulmonary abnormalities or neuromuscular disorders that have difficulty clearing secretions; consideration for infants less than 24 months of age that are profoundly immunocompromised; and consideration for infants with Down syndrome or cystic fibrosis that have evidence of other risk factors such as chronic lung disease or congenital heart disease. (1)

Based strictly on the American Academy of Pediatrics (AAP) guidelines, Synagis would not be recommended for this infant born prematurely at 31 weeks' gestational age. The letter of medical necessity alluded to several factors that might support use of Synagis in this infant, such as low birth weight, intrauterine growth restriction, and respiratory distress syndrome. The literature acknowledges increased risk of severe RSV infection in infants born with low birth weight regardless of gestational age.

Clinical records were submitted, beginning with a well child appointment at approximately six weeks of age. At that visit, his weight was recorded at 2550 grams. No birth weight was mentioned in that documentation or any subsequent documentation, although it can be surmised that his birth weight was lower than 2500 grams. The records also documented presence of mild hypospadias and umbilical hernia. He was otherwise growing and developing appropriate for age. At the next visit two weeks later, his weight had increased to 3010 grams. He had a scheduled follow-up with urology. Although there are no current articles addressing intrauterine growth restriction or extremely low birth weight and the impact of respiratory syncytial virus (RSV) infection, an older article published in 2003 noted the following: an infant with a birth weight between 1500 grams and 2500 grams is five times more likely to die from RSV infection than an infant with a birth weight greater than 2500 grams. (3) Extremely low birth weight, or intrauterine growth restriction as in this case, is a significant risk factor for increased mortality from RSV infection. This male infant did not have any significant respiratory sequelae. His neonatal course was punctuated by issues with mild hypospadias and umbilical hernia and the usual issues of prematurity. However, his risk of contracting severe RSV disease including increased risk of mortality is significant and justifies medical necessity of Synagis administration for the full duration of the RSV season.