We are pleased to announce the
Synagis® (palivizumab) distribution program for the 2012-2013
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 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
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:
- 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 2009 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 2012-2013 RSV season,
it is mandatory for all participating providers to obtain
Synagis® (palivizumab) through ACRO Pharmaceutical Services. 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 ConnectionTM. 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 2012-2013 RSV season
begins on Tuesday, October 30, 2012, and ends on Monday, April 1, 2013. 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 IBC
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 or by calling the Provider Automated System
at 1-800-ASK-BLUE.
NaviNet® is a registered trademark of
NaviNet, Inc., an independent company.