We are pleased to announce the Synagis? (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 Synagis?
(palivizumab) for at-risk children younger than 2. Synagis? (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:
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chronic lung disease of prematurity (CLD, formerly called bronchopulmonary
dysplasia);
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history of preterm birth (< 35 weeks 0 days gestation);
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congenital heart disease;
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severe neuromuscular disease;
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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). Synagis?
(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:
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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).
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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 Synagis? (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 Book?.
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How to obtain Synagis? (palivizumab) for use in your office
Synagis? (palivizumab) is covered under the member?s medical benefits. For the
2011-2012 RSV season, it is mandatory for all participating providers to obtain
Synagis? (palivizumab) through ACRO Pharmaceutical Services, an independent
company. IBC will coordinate with ACRO Pharmaceutical Services to facilitate
delivery of Synagis? (palivizumab) to your office.
Note: MedImmune, LLC, the makers of Synagis? (palivizumab), has a voluntary
program called RSV Connection?. However, IBC does not participate in this
program. All requests for Synagis? (palivizumab) should be sent directly to
ACRO Pharmaceutical Services.
Guidelines for ordering Synagis? (palivizumab)
The following guidelines apply when ordering Synagis? (palivizumab):
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Synagis? (palivizumab) will generally be approved for office administration
only, unless a patient is receiving home nursing services for a separate
indication.
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The RSV Enrollment Form must include sufficient clinical information to meet
our Synagis? (palivizumab) medical policy criteria, which is based on AAP
recommendations.
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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.
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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.
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Upon approval of your request, Synagis? (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 Synagis? (palivizumab) distribution program,
please contact Customer Service at 1-800-ASK-BLUE.
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