Palivizumab denials: what the review data shows

Where the denial was 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 hemodyna…

The parent of a seven-month-old female enrollee has requested for Synagis vaccine for treatment of the enrollee’s prematurity and respiratory distress due to transient tachypnea of newborn. Findings: The physician reviewer found that there are a number of risk factors that increase the chance of morbidity from RSV disease in infants born at 32-35 weeks gestation, up to 12 months of age. The most notable of these factors is a birth weight less than 2500 grams (Holman, et al). In addition, Horn and Smout analyzed retrospective data from 304 infants less than 1 year of age with bronchiolitis or RSV pneumonia admitted to the hospital. Data were subdivided by gestational age (less than 32 weeks, 33-35 weeks, and greater than 36 weeks) and compared, looking at rates of intubation and ICU admission, as well as length of stay.

Where the denial was upheld

The patient is a male infant born on 11/10/03. The patient’s mother was noted to have received prenatal care and her pregnancy was complicated by pregnancy-induced hypertension. Her estimated date of confinement (EDC) was 12/14/03. Given this EDC, the patient was born at 35 weeks, 0 days gestational age.The patient was delivered by urgent cesarean section on 11/10/03. The patient had APGAR scores of 8 at 1 minute and 8 at 5 minutes. Birth weight was 1.734 kg.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient’s parent has requested authorization and coverage for Synagis (palivizumab) given once monthly during respiratory syncytial virus (RSV) season. As noted by the American Academy of Pediatrics (AAP) and American Academy of Pediatrics Bronchiolitis (AAPB), RSV prophylaxis with Synagis (palivizumab) may be appropriate for preterm infants who are in the first year of life at the start of the RSV season and who have chronic lung disease of prematurity to a maximum of five monthly doses. Chronic lung disease of prematurity is defined as infants with gestational age less than 32 weeks and a requirement for greater than 21% oxygen for at least the first 28 days after birth. For infants born during the RSV season, fewer than five monthly doses may be needed to complete the RSV season.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Palivizumabwhen you appeal: reviewers routinely find that denials like yours didn’t hold up.