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We are pleased to announce the Synagis® (palivizumab)
distribution program for the 2013-2014 respiratory
syncytial virus (RSV) season, which is November through
March 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 years of age. 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:
- 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 to 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:
- 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 Synagis® (palivizumab) is not recommended after
3 months of age. This criterion for premature infants is
based on guidelines published in the 2012 American Academy of Pediatrics (AAP)
Red Book®.
How to obtain Synagis® (palivizumab) for use
in
your office
Synagis® (palivizumab) is covered under the member?s
medical benefits. For the 2013-2014 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):
- Synagis® (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 Synagis® (palivizumab)
medical policy criteria, which is based on AAP
recommendations.
- The RSV Enrollment Form can be obtained by
contacting ACRO Pharmaceutical Services at 1-800-
906-7798 and should be faxed to 1-877-381-3806.
- 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, Synagis® (palivizumab)
will be shipped to your office monthly during RSV
season. Overnight shipping for the 2013-2014 RSV
season begins on Wednesday, October 30, 2013, and
ends on Monday, March 31, 2014. 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.
Note: Synagis® (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 NaviNet® web portal.
NaviNet® is a registered trademark of
NaviNet, Inc, and independent company.
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