Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

Synagis (Palivizumab) is indicated for the prevention of pneumonia caused by the respiratory syncytial virus (RSV) in infants and children at high risk for RSV.

The medication is administered intramuscularly once a month during the RSV season, usually from October through May.

Synagis requires preauthorization.

Palivizumab (Synagis™) is considered medically necessary for use in protection against lower respiratory tract infection with respiratory syncytial virus (RSV), under the following conditions:

1.     Infants 28 weeks 6 days or less gestational age (GA) who are younger than 12 months at the start of the RSV season.  For infants born during the RSV season, fewer than five (5) monthly doses will be needed.

2.     Pre-term infants who develop chronic lung disease (CLD) of prematurity defined as gestational age < 32 weeks, 0 days and a requirement for >21% oxygen for at least the first 28 days after birth, OR

3.     Children 12 months of age or younger with hemodynamically significant congenital heart disease (CHD) are most likely to benefit from Palivizumab prophylaxis.  Those most likely to benefit include infants with acyanoticheart disease who are receiving medication to control congestive heart failure and will require cardiac surgical procedures and infants with moderate to severe pulmonary hypertension. OR

4.     Infants, in the first year of life, with neuromuscular disease or congenital anomaly that impairs the ability to clear secretions from the upper airway because of ineffective cough. OR

5.     Children younger than 24 months of age who are profoundly immunocompromised during the RSV season.  This may include children receiving chemotherapy or who are immunocompromised because of other conditions (e.g. solid organ or hematopoietic stem cell transplantation).

6.     Palivizumab prophylaxis is only approved in the second year of life in children who required at least 28 days of supplemental oxygen after birth and who continue to require medical intervention (supplemental oxygen, chronic corticosteroid, or diuretic therapy).

It is considered medically necessary to initiate prophylaxis against RSV just before onset of the RSV season, and to terminate prophylaxis at the end of the RSV season. Administration of RSV prophylaxis beyond the RSV season is considered medically necessary only if the Centers for Disease Control and Prevention (CDC) or a local health department reporting to and confirmed by the CDC indicates an outbreak of RSV in the member`s geographic area that persists beyond the RSV season.

Note: To determine if there is an RSV outbreak in the member`s geographic area, please refer to CDC surveillance summaries of weekly RSV laboratory test result data for each region of the United States, posted at the following website:

http://www.cdc.gov/surveillance/nrevss/rsv/default.html

Surveillance summaries for RSV are also published periodically in the Morbidity and Mortality Weekly Report at http://www.cdc.gov/mmwr/ .

Codes Used In This BI:

90378 – Respiratory Syncytial Virus, Monoclonal Antibody, Recombinant, for

              Intramuscular use, 50mg, each.

Synagis is considered a specialty drug and, as such, is limited to distribution by the contracted specialty pharmacy.  Application to Products:

This policy applies to all QualChoice Health Plans, unless there is indication otherwise or a stated exclusion.  Consult individual plan sponsor Summary Plan Description (SPD) for self-insured plans.  In the event of a discrepancy between this policy and a self-insured customer’s SPD, the SPD will prevail.  State and federal mandates will be followed as they apply.

Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection.  (Committee on Infectious Diseases and Bronchiolitis Guidelines Committee). Pediatrics 2014; 134; 415; originally published online July 28, 2014; DOI: 10.1542/peds.2014-1665.

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.