Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Immune prophylaxis with palivizumab (Synagis) for a maximum of five (5) doses within the RSV season (typically November through April) may be considered medically necessary for passive immunoprophylaxis against RSV when ANY the following criteria are met:
- Infants with preterm birth less than 29 weeks 0 days gestation less than or equal to 12 months of age at the start of the RSV season; or
- Certain infants less than or equal to 12 months of age, born at less than 32 weeks 0 days with chronic lung disease (CLD) defined as a greater than 21% oxygen requirement for at least the first 28 days after birth; or
- Children younger than 12 months of age with hemodynamically significant congenital heart disease who are most likely to benefit from immunoprophylaxis which include:
- Infants who are receiving medication to control congestive heart failure and will require cardiac surgical procedures; or
- Infants with moderate to severe pulmonary hypertension; or
- Infants with cyanotic heart disease; or
- Children less than or equal to 12 months of age born with congenital abnormalities of the airway or a neuromuscular condition that compromises handling of respiratory secretions; or
- Children younger than 24 months of age who are profoundly immunocompromised during the RSV season; or
- Children younger than 24 months of age who are undergoing cardiac transplantation; or
- An infant with cystic fibrosis with clinical evidence of CLD or nutritional compromise in the first year of life; the continued use of palivizumab (Synagis) prophylaxis in the second year of life may be considered medically necessary for infants with cystic fibrosis for EITHER of the following:
- With symptoms of severe lung disease; e.g. (previous hospitalization for pulmonary exacerbation in the first year of life or an abnormal chest radiograph, computed tomography scan that persist when stable); or
- Weight or length less than the 10th percentile.
NOTE: Prophylaxis is not recommended in the second year of life on the basis of a history of prematurity alone. Prophylaxis may be considered medically necessary during the RSV season during the second year of life only for infants who meet the definition of chronic lung disease prematurity and continue to require medical support (chronic corticosteroid therapy, diuretic therapy or supplemental oxygen).
NOTE: An additional dose of palivizumab (Synagis) may be considered medically necessary for children in approved course of treatment who undergo cardiopulmonary bypass (as soon as possible after surgery even if next dose is not due based upon standard schedule) if any other medically necessary criteria are present (for example, prematurity).
Palivizumab (Synagis) for any other indication, it is considered experimental/investigational and therefore, non-covered. Available scientific evidence does not support its use for any other indication.