Appeal type: Medical necessity
Decision: Overturned

Diagnosis: RSV
Issue under review: Synagis

Determination:
The Synagis is medically necessary.

The patient is a male infant born via spontaneous vaginal delivery at 32 weeks' gestation with birth weight 1685 grams and Apgar scores 9 at 1 minute and 9 at 5 minutes. The mother had been treated with betamethasone and penicillin G prior to delivery. He was admitted to the NICU for management of prematurity, respiratory distress syndrome, and possible sepsis (maternal GBS status unknown). Chest x-ray was consistent with respiratory distress syndrome. Sepsis workup was completed and he was placed on parenteral antibiotics pending culture results. He was placed on nasal CPAP with 30% supplemental oxygen. Head ultrasound was normal. Eye exam revealed immature retinae, and physical exam revealed hypospadius requiring referral to Urology. He received his first dose of Synagis prior to discharge. At issue is continued monthly injections for the duration of the RSV season.

In 2014, the AAP issued new guidelines for Synagis for RSV prophylaxis. 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. (1)

Despite these published guidelines, there remains debate about use of Synagis in late preterm infants. The literature falls on both sides of the debate. One article recently published supports and substantiates the changes in administration guidelines made by the AAP.  Interestingly, the overall hospitalization rate for infants with RSV disease has decreased compared to the initial studies of palivizumab. One interesting finding in this study was that infants that received palivizumab prophylaxis had an increased hospitalization rate for bronchiolitis due to other causes. (2)

On the other side of the debate, Horn and Smout (3) found that infants < 1 year of age born at 33-35 weeks gestation fared worse than those born more prematurely over all measures.  Further, Carbonell-Estrany et al (4) noted, "there is a growing body of evidence suggesting that infants born between 33 and 35 weeks GA may be equally at risk for RSV LRTI as infants born < 32 weeks GA. Interrupted lung development and an immature immune system have been linked with an increased susceptibility for RSV LRTI." Finally, Simoes et al (5) have developed a model based on 7 risk factors to predict which infants born between 32-35 weeks are at highest risk of severe RSV disease.  (6)

All thing considered, most practitioners err on the side of caution and administer Synagis to their late preterm patients, particularly if there are concerning risk factors (birth weight, hospital course, etc). In this case, the baby was born at 32 weeks' gestation with respiratory distress syndrome requiring non-invasive ventilatory support with supplemental oxygen and birth weight 1685 grams, placing him at risk for development of severe disease should he become infected with RSV. Synagis is medically necessary and appropriate for the full duration of the 2019-20 RSV season based on the literature and the current standards of care.