Prior Auth Protocol

FDA Approved Indications:

Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

Health Net Approved Indications and Usage Guidelines:

First course of prophylaxis:

Infants born before 29 weeks, 0 days' gestation younger than 12 months at the start of RSV season.

Coverage is Not Authorized For:

Children older than 2 years of age.
More than 5 injections.
Synagis use for the following conditions is covered by CCS (California Children's Services) and not by Health Net (In some cases for up to age 24 months or for a second course of prophylaxis):

Respiratory System Disease (Cystic Fibrosis, Chronic Lung Disease [CLD] with oxygen/vent, including CLD of prematurity [defined as a requirement of >21% oxygen for at least the first 28 days after birth])
Hemodynamically significant congenital heart disease (congestive heart failure, cyanotic heart disease, pulmonary hypertension, acyanotic heart disease that will require cardiac surgical procedures)
Immunodeficiency (Congenital/Acquired, Transplant, Chemotherapy)
Undergoing cardiac transplantation during the RSV season
Severe neuromuscular disease that compromises handling of respiratory secretions
Congenital abnormalities of the airways
Need for cardiopulmonary bypass or extracorporeal membrane oxygenation
Other CCS active condition (in addition to prematurity criteria)

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and usage guidelines section unless there is sufficient documentation of efficacy and safety in the published literature

General Information:

The State of California updated their policy for treatment with Synagis on September 23, 2014 based on Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection by American Academy of Pediatrics (AAP). (http://files.medi-cal.ca.gov/pubsdoco/newsroom/newsroom_22989.asp)
Prophylaxis is administered only during the RSV season. In the temperate climates of North America, peak RSV activity typically occurs between November and April.
If an infant or child qualifies for prophylaxis, Synagis should be continued throughout the RSV season and not be stopped because the infant or child's chronological age reaches a cut off of 6 or 12 months
Although epidemiologic data suggest that RSV infection is more likely to lead to hospitalization for infants with risk factors including exposure to environmental air pollutants, passive household exposure to tobacco smoke has not been associated with an increased risk of RSV hospitalization on a consistent basis. Furthermore, exposure to tobacco smoke is a risk factor that can be controlled by the family of an infant at increased risk of severe RSV disease.
Synagis 50 mg and 100 mg vials are produced with a volume overfill greater than the labeled amount. (approximately 0.1 ml each). Consider "rounding down" rather than opening a new vial (up to 10% of the dose).
The AAP (American Academy of Pediatrics) encourages providers to prevent wastage by arranging for administration so that 2 or more eligible patients can receive the antibody within the 6-hour period after opening a vial.
Clinical evidence of CLD may include tachypnea, tachycardia, rales, intercostal recession, grunting, and nasal flaring.
Examples of cyanotic heart diseases include tetralogy of fallot, total anomalous pulmonary venous connection, hypoplastic left heart syndrome, transposition of the great arteries, truncus arteriosus, tricuspid atresia, interrupted aortic arch, pulmonary valve atresia, pulmonary stenosis with an atrial or ventricular septal defect, and patent ductus arteriosus (in late stage).
Some examples of hemodynamically significant heart disease are: pulmonary valve atresia, tetralogy of Fallot, single ventricle including hypoplastic left or right heart, tricuspid atresia, double outlet right ventricle with or without transposed great arteries, Ebstein's anomaly, D-transposition of great arteries with ventral septal defect (VSD), and atrial ventricular canal defect.
Criteria was reviewed for expanded usage for high risk infants up to 35 weeks of gestational age in November 2016. Criteria was not revised due to insufficient evidence supporting expanded usage at the time of review.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Synagis	15 mg/kg IM monthly up to 5 months during the RSV season	One injection per month during the RSV season up to 5 months (usually starting in November and last dose given in March to cover into April)

Product Availability:

Liquid solution vial: 50 mg/0.5 mL, 100 mg/1 mL

References:

Synagis [Prescribing information]. Gaithersburg, MD: MedImmune; March 2014.
Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis clinical practice guideline. Pediatrics. 2006;118(4):1174-1793.
Sondheimer HM, Cabalka AK, Feltes TF, Piazza FM, Connor EM, and the Cardiac Synagis Study Group. The safety and efficacy of palivizumab in children with congenital heart disease: results of a randomized, double-blind, placebo-controlled study. (Abstract) Presented at the Cardiology Section of the American Academy of Pediatrics Conference, Oct 18, 2002.
State of California Health and Human Services Agency, Department of Health Services. Palivizumab (Synagis). Numbered Letter -01-0113, Jan 10, 2013.
American Academy of Pediatrics Committee on Infectious Diseases. Policy statement Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for Respiratory Syncytial Virus infection. Pediatrics. 2014; 134(2): 415-420.
American Academy of Pediatrics Committee on Infectious Diseases. Technical report Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for Respiratory Syncytial Virus infection. Pediatrics. 2014; 134(2): e620-e638.