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Annual Synagis® (palivizumab) distribution program 

September 1, 2011    

We are pleased to announce the SynagisŪ (palivizumab) distribution program for the 2011-2012 respiratory syncytial virus (RSV) season, which is November through April in the United States. RSV is the most common cause of bronchiolitis and pneumonia among children younger than 1.

During the RSV season, we will approve the monthly administration of SynagisŪ (palivizumab) for at-risk children younger than 2. SynagisŪ (palivizumab) is a humanized monoclonal antibody that provides passive immunity against RSV. It is intended to decrease the morbidity and mortality associated with RSV lower respiratory tract disease in at-risk children. At-risk children include those with one of the following conditions or risk factors:

  • chronic lung disease of prematurity (CLD, formerly called bronchopulmonary dysplasia);
  • history of preterm birth (< 35 weeks 0 days gestation);
  • congenital heart disease;
  • severe neuromuscular disease;
  • congenital abnormalities of the airway.

Recommendations for premature infants

Specific recommendations have been made to reduce the risk of RSV hospitalization for infants who are born at 32 through less than 35 weeks gestation (defined as 32 weeks 0 days through 34 weeks 6 days). SynagisŪ (palivizumab) prophylaxis should be limited to these infants who are at greatest risk of hospitalization due to RSV. This includes at-risk infants who are younger than 3 months and 0 days (less than 90 days) at the start of the RSV season, as well as those who are born during the RSV season and are likely to have an increased risk of exposure to RSV.

Epidemiologic data suggests that RSV infection is more likely to occur and lead to hospitalization for infants in this gestational age group when at least one of the following risk factors is present:

  • The infant attends child care (defined as a home or facility where care is also provided for any number of infants or young toddlers in the same facility).
  • The infant has a sibling younger than 5.

Prophylaxis may be considered for infants born at 32 to less than 35 weeks gestation whose chronological age is less than 3 months before the onset or during RSV season, and for whom at least one of the above factors is present.

Infants in this gestational age category should receive prophylaxis only until they reach 3 months of age. In addition, these infants should receive a maximum of three monthly doses; many will receive only one or two doses until they reach 3 months of age.

Once an infant has passed 3 months of age (older than 90 days), the risk of hospitalization attributable to RSV lower respiratory tract disease is reduced. Administration of SynagisŪ (palivizumab) is not recommended after 3 months of age. This criterion for premature infants is based on guidelines published in the 2009 American Academy of Pediatrics (AAP) Red BookŪ.

> How to obtain SynagisŪ (palivizumab) for use in your office

SynagisŪ (palivizumab) is covered under the member’s medical benefits. For the 2011-2012 RSV season, it is mandatory for all participating providers to obtain SynagisŪ (palivizumab) through ACRO Pharmaceutical Services, an independent company. IBC will coordinate with ACRO Pharmaceutical Services to facilitate delivery of SynagisŪ (palivizumab) to your office.

Note: MedImmune, LLC, the makers of SynagisŪ (palivizumab), has a voluntary program called RSV Connection™. However, IBC does not participate in this program. All requests for SynagisŪ (palivizumab) should be sent directly to ACRO Pharmaceutical Services.

Guidelines for ordering SynagisŪ (palivizumab)

The following guidelines apply when ordering SynagisŪ (palivizumab):

  • SynagisŪ (palivizumab) will generally be approved for office administration only, unless a patient is receiving home nursing services for a separate indication.
  • The RSV Enrollment Form must include sufficient clinical information to meet our SynagisŪ (palivizumab) medical policy criteria, which is based on AAP recommendations.
  • Tobacco smoke will not be accepted as an environmental pollutant. This guideline is based on the indication from the AAP Committee on Infectious Disease that, while at-risk infants should never be exposed to tobacco smoke, passive household exposure to tobacco smoke has not been associated with an increased risk of RSV hospitalization on a consistent basis.
  • Fee-for-service providers will be reimbursed for the Evaluation & Management procedure codes that correspond to the patient's office visit. Since IBC pays ACRO Pharmaceutical Services directly, you neither pay for doses ordered through ACRO Pharmaceutical Services nor receive reimbursement for the actual pharmaceutical.
  • Upon approval of your request, SynagisŪ (palivizumab) will be shipped to your office monthly during RSV season. Overnight shipping for the 2011-2012 RSV season begins on Wednesday, October 26, 2011, and ends on Thursday, March 29, 2012. Up to five doses (one shipment every 30 days) will be shipped per patient.

If you have questions about the SynagisŪ (palivizumab) distribution program, please contact Customer Service at 1-800-ASK-BLUE.

Note: SynagisŪ (palivizumab) is not effective in the treatment of RSV disease, and it is not approved for this indication.

This is not a statement of benefits. Benefits may vary according to state requirements, product line (HMO, PPO, etc.), and/or employer groups. Member coverage can be verified through the NaviNetŪ web portal or by calling the Provider Automated System at 1-800-ASK-BLUE.

NaviNetŪ is a registered trademark of NaviNet, Inc., an independent company.

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