Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patients parent has requested authorization and coverage for Synagis (palivizumab). The American Academy of Pediatrics (AAP) guidelines for the administration of Synagis for respiratory syncytial virus (RSV) prophylaxis are based on a review of current peer-reviewed literature related to the burden of RSV in infants and children, with an emphasis on those at highest risk of severe disease. The administration of Synagis is recommended for the following groups of patients considered at highest risk: infants born before 29 weeks of gestation younger than 12 months of age at the start of RSV season; infants with chronic lung disease of prematurity born before 32 weeks of 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); infants 12 months of age or younger with anatomic pulmonary abnormalities or neuromuscular disorders that have difficulty clearing secretions; infants less than 24 months of age that are profoundly immunocompromised; and 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. Researchers report that otherwise healthy premature infants born at or beyond 29 weeks of gestation may be vulnerable to RSV and recommend a reevaluation of the role of palivizumanb prophylaxis in the over 29 weeks of gestation subpopulation of premature infants when specific risk factors are present. Abraha and colleagues note that infants born at or before 35 weeks of 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. In this case, the patient was born at 34 weeks of twin gestation with respiratory insufficiency necessitating supplemental oxygen. In combination with her gestational age, her recent hospitalization likely due to RSV puts her at significant risk should she contract RSV again. Her exposure risk is increased due to her twin sibling and daycare attendance. In this clinical setting, given the patients medical history, the requested medication is medically indicated. Therefore, Synagis (palivizumab), is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in pediatrics with sub-specialty 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.