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Policy Number: MEDS12
JOHNS HOPKINS HEALTHCARE
Effective Date: 10/1/2006
Revision Date: 10/1/2006,
7/1/2009, 5/1/2012, 9/22/2014
Subject: SYNAGIS (palivizumab)
Department: Pharmacy
Lines of Business: PPMCO, USFHP,EHP
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POLICY:
Synagis (palivizumab) will require prior authorization to ensure appropriate use. The process for initiating a prior
authorization request can be found in policy PHARM 20.
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The Synagis Referral Form, including a copy of the Synagis prescription, should be filled out
completely and submitted to the Johns Hopkins HealthCare Pharmacy Department for review. All
requests will be reviewed in early October prior to the start of the Synagis season.
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PPMCO members are subject to the Priority Partners formulary, available at www.ppmco.org.

USFHP members are subject to prior authorization criteria, step-edits and days-supply limits outlined in
the Tricare Policy Manual. Tricare Policy supersedes JHHC Medical/Pharmacy Policies. Tricare limits
may be accessed at: http://pec.ha.osd.mil/formulary_search.php?submenuheader=1
POLICY CRITERIA:
Synagis may be approved for patients who meet one or more of the following criteria:
Age of 12 months or less at the start of RSV season:
Premature Infant without Chronic Lung Disease of prematurity or Congenital Heart Disease
• born before 29 weeks, 0 days gestation
Pre-term Infants with Chronic Lung Disease (CLD) of prematurity
• less than 32 weeks, 0 days gestation at birth AND
• requirement for >21% oxygen for at least 28 days after birth
Infants with Hemodynamically Significant Congenital Heart Disease (CHD)
• with acyanotic heart disease and receiving medication to control congestive heart failure and will
require cardiac surgery OR
• with moderate to severe pulmonary hypertension
Infants with Anatomic Pulmonary Abnormalities or Neuromuscular disorder
• with impaired ability to clear secretions from the upper airway
Immunocompromised Children
• who are or will be profoundly immunocompromised during RSV season
Cystic Fibrosis
• with clinical evidence of CLD and/or nutritional compromise
Age of 13-23 months at the start of RSV season:
Infants with Chronic Lung Disease (CLD) of prematurity
• were less than 32 weeks, 0 days gestation at birth AND
• during first year of life required >21% oxygen for at least 28 days after birth AND
Privileged and Confidential
Policy Number: MEDS12
JOHNS HOPKINS HEALTHCARE
Effective Date: 10/1/2006
Revision Date: 10/1/2006,
7/1/2009, 5/1/2012, 9/22/2014
Subject: SYNAGIS (palivizumab)
Department: Pharmacy
Lines of Business: PPMCO, USFHP,EHP
•
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In second year of life continue to require medical support (chronic corticosteroid therapy, diuretic
therapy, or supplemental oxygen) within 6 months prior to the start of RSV season.
Infants with Hemodynamically significant Congenital Heart Disease (CHD)
• who will undergo cardiac transplantation during RSV season OR
• who are receiving prophylaxis and continue to require prophylaxis after a surgical procedure, one
post-operative dose of palivizumab (15mg/kg) should be considered after cardiac bypass or at the
conclusion of extracorporeal membrane oxygenation
Immunocompromised Children
• who are or will be profoundly immunocompromised during RSV season
Cystic Fibrosis
• continued used in second year may be considered for infants with manifestations of severe lung
disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities
on chest radiography or chest computed tomography that persist when stable) or weight for length
less than the 10th percentile
Other indication(s) for consideration of Prophylaxis therapy:
Children with Down Syndrome
• not recommended for routine use, unless age of 23 month or less at the beginning of RSV season
AND qualifying heart disease, CLD, airway clearance issues, or prematurity (<29 weeks, 0 days’
gestation) is present
AUTHORIZATION PERIOD/LIMITATIONS:
• All other infants approved for Synagis will be approved for therapy until the end of the RSV season, with a
maximum of five monthly doses.
• Discontinuation required for infant with breakthrough RSV hospitalization
• RSV season for this region, as defined by the Centers for Disease Control and Prevention(CDC)
EXCLUSIONS:
The following indications are considered experimental, investigational or unproven uses for RSV prophylaxis:
 Infants and children with hemodynamically insignificant heart disease (atrial septal defect, small ventricular
septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta and paten
ductus arteriosus)
 Infants with CHD corrected by surgery (unless require continuing medications)
 Infants with mild cardiomyopathy who are not receiving medical therapy
 Treatment of RSV disease
Privileged and Confidential
Policy Number: MEDS12
JOHNS HOPKINS HEALTHCARE
Effective Date: 10/1/2006
Revision Date: 10/1/2006,
7/1/2009, 5/1/2012, 9/22/2014
Subject: SYNAGIS (palivizumab)
Department: Pharmacy
Lines of Business: PPMCO, USFHP,EHP
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Infants with mild or moderate pulmonary or gastrointestinal conditions such as wheezing, bronchitis or
GERD
Use of Synagis to prevent asthma or reactive airway disease
Use of Synagis for patient that does not fall under the American Academy of Pediatrics (AAP) guidelines
BACKGROUND/DEFINITIONS:
Synagis (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by
respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease. Safety and efficacy were
established in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤ 35
weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD).
Synagis is a humanized monoclonal antibody that selectively binds to RSV antigens to prevent viral replication.
The monoclonal antibody sequence is 95% human and 5% murine to reduce the risk of antibody formation.
Administration of Synagis results in a reduction in pulmonary RSV titer. Its activity against RSV titers is 50 to
100 times more than RSV-IGIV in in vitro models. The half-life of Synagis is 19.3 to 26.8 days; with mean
half-life 20 days in pediatric patients less than 24 months of age.
RSV causes acute upper respiratory tract infection in patients of all ages and is one of the most common
diseases of childhood. Most infants are infected during the first year of life, with virtually all having been
infected at least once by the second birthday. Most previously healthy infants who develop RSV bronchiolitis
do not require hospitalization, and most who are hospitalized improve with supportive care and are discharged
in fewer than 5 days.
Characteristics that increase the risk of severe RSV disease are preterm birth, cyanotic or complicated
congenital heart disease, chronic lung disease of prematurity and immunodeficiency disease. These high-risk
patients are most likely to benefit from RSV prophylaxis.
Chronic lung disease of prematurity, also known as bronchopulmonary dysplasia, develops in infants being
treated with oxygen and positive pressure ventilation for respiratory failure or respiratory distress syndrome
(RDS). The diagnostic criteria for CLD/BPD are based on the infant’s gestational age:
 Infants less than 32 weeks gestation treated with oxygen for at least 28 days who require oxygen at 36
weeks post menstrual age or discharge, whichever comes first.
 Infants 32 weeks gestation or more treated with oxygen for at least 28 days who require oxygen at 56
days postnatal age or discharge, whichever comes first.
According to the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics
(AAP), a total of five doses are generally sufficient to provide protections during the entire RSV season, which
is from November to March for most regions. For most infants, 5 monthly doses will provide >20 weeks of
serum antibody levels, which should be protective and cover most of the RSV season even with variation in
season onset and end. For coverage of greater than 5 doses, the JHHC Pharmacy Department will monitor the
Privileged and Confidential
Policy Number: MEDS12
JOHNS HOPKINS HEALTHCARE
Effective Date: 10/1/2006
Revision Date: 10/1/2006,
7/1/2009, 5/1/2012, 9/22/2014
Subject: SYNAGIS (palivizumab)
Department: Pharmacy
Lines of Business: PPMCO, USFHP,EHP
Page 4 of 4
recommendations from the CDC and local health departments to support medical necessity for administration
after March.
POLICY APPROVED BY:
Signature on file at JHHC
DATE OF
REVISION
9/22/2014
SUMMARY OF CHANGE
Per The American Academy of Pediatrics 7/28/2014 Guidance for Palivizumab
Prophylaxis
REFERENCES:
1. Johns Hopkins HealthCare Pharmacy Policy PHARM20, Step Therapy, Prior Authorization and Quantity
Limits
2. American Academy of Pediatrics. "Policy Statement: Updated Guidance for Palivizumab Prophylaxis
Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus
Infection," Pediatrics 134, no. 2 (2014): 415-20. Available at
http://pediatrics.aappublications.org/content/134/2/415.full.html. Accessed on Sept. 9, 2014
3. The Impact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody,
reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics.
1996;97:137-140.
4. Centers for Disease Control and Prevention (CDC), National Center for Infecious Diseases, Respiratory and
Enteric Viruses Branch. Respiratory Syncytial Virus Regional Trends [website]. Atlanta, GA: CDC;
September 1, 2006. Available at: http://www.cdc.gov/ncidod/dvrd/revb/nrevss/rsvtre1.htm.
5. Synagis (palivizumab) [Prescribing information]. Gaithersburg, MD: MedImmune; 2012 April.
6. American Academy of Pediatrics. Red Book. Section 3: Summaries of Infectious Diseases, Respiratory
Syncytial Virus. Updated 2012.
7. Jobe, AH, Bancalari, E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med 2001; 163:1723.
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