Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Premature birth
Treatment: Synagis 100 milligram (mg) vial
The insurer denied coverage for Synagis 100 milligram (mg) vial
The denial is upheld

 
This is an infant born at 33.5 weeks and weighing 2183 grams at birth. She was born by repeat Cesarian section because of premature labor and a breech presentation. Apgar scores were 8 at 1 minute and 9 at 5 minutes but when the baby was noted to be grunting in the delivery room, she was started on continuous positive airway pressure (CPAP) and transferred to the neonatal intensive care unit (NICU). She continued on a CPAP for 2 days and received one treatment with Surfactant. 

Synagis has been approved for prophylaxis of Respiratory syncytial virus (RSV) infection in premature infants who because of immaturity of their lungs are at increased risk of severe lung disease secondary to the development of bronchiolitis when exposed to the RSV virus in the first two years of life. 

The patient was born at 33.5 weeks and does not require oxygen supplementation. She does not have a complex cardiac malformation. Based on the American Academy of Pediatric Synagis prophylaxis Guidelines she does not qualify as high risk for severe disease related to an RSV illness and the insurer's decision to deny the coverage for Synagis is consistent with the guidelines.

Palivizumab was licensed in June 1998 by the Food and Drug Administration for the reduction of serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at increased risk of severe disease. Since that time, the American Academy of Pediatrics has updated its guidance for the use of palivizumab 4 times as additional data became available to provide a better understanding of infants and young children at greatest risk of hospitalization attributable to RSV infection. The updated recommendations in this policy statement reflect new information regarding the seasonality of RSV circulation, palivizumab pharmacokinetics, the changing incidence of bronchiolitis hospitalizations, the effect of gestational age and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, the effect of prophylaxis on wheezing, and palivizumab-resistant RSV isolates. 

Palivizumab prophylaxis may be administered to infants born before 29 weeks, 0 days' gestation who are younger than 12 months at the start of the RSV season. For infants born during the RSV season, fewer than 5 monthly doses will be needed.

Available data for infants born at 29 weeks, 0 days' gestation or later do not identify a clear gestational age cutoff for which the benefits of prophylaxis are clear. For this reason, infants born at 29 weeks, 0 days' gestation or later are not universally recommended to receive palivizumab prophylaxis. Infants 29 weeks, 0 days' gestation or later may qualify to receive prophylaxis on the basis of congenital heart disease (CHD), chronic lung disease (CLD), or another condition.

Palivizumab prophylaxis is not recommended in the second year of life on the basis of a history of prematurity alone.

Some experts believe that on the basis of the data quantifying a small increase in risk of hospitalization, even for infants born earlier than 29 weeks, 0 days' gestation, palivizumab prophylaxis is not justified.

Prophylaxis may be considered during the RSV season during the first year of life for preterm infants who develop CLD of prematurity defined as gestational age <(less than)32 weeks, 0 days and a requirement for >(greater than) 21%(percent) oxygen for at least the first 28 days after birth.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Synagis 100 milligram (mg) vial is not substantiated.