Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The parent of a patient has requested authorization and coverage for Synagis. In 2014, the American Academy of Pediatrics (AAP) issued 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. Under these guidelines, 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.Despite these published guidelines, many practitioners support administration of palivizumab to their patients born late preterm, particularly those with additional complicating factors. Infants born at or before 35 weeks gestation have a number of physiologic factors that increase risk of severe RSV infection, including incomplete immunological maturation, incomplete pulmonary maturation, and immature premorbid lung function. True alveoli begin to form during the late preterm period from 32 to 35 weeks gestation, making this a critical period of lung development. Premature birth during this period may significantly disrupt this process and result in severe illness.In the case, the patient is a twin child who was born prematurely at 34 weeks gestation. Her NICU stay was complicated by periods of bradycardia and persistent patent foramen ovale. Her more recent history is significant for periods of extreme tachycardia that were suspicious for SVT and episodes of wheezing and reactive airways disease. The combination of the patients gestational age together with her recent history that includes respiratory illness with RSV, rhinovirus, and parainfluenza type 3 followed by bacterial superinfection with pneumonia, puts her at significant risk should she contract RSV again. Furthermore, the patients exposure risk is increased due to her twin sibling and daycare attendance. Under these circumstances, treatment with palivizumab for RSV prophylaxis is medically necessary and appropriate for the patient given her medical history, clinical situation, and current standard of care. Accordingly, the requested Synagis (palivizumab)  is medically necessary to treat the patients medical condition.Final Result: The reviewer determined that the requested medication is medically necessary to treat the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in pediatrics, with subspecialty certification in pediatric critical care medicine, and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.