Synagis® (Palivizumab) 2021-2022 Authorization Guidelines
Respiratory Syncytial Virus (RSV) can cause a variety of respiratory illness in infants and young children. It most commonly causes a cold like illness but can also cause lower respiratory infections like bronchitis and pneumonia.
Synagis® (Palivizumab) is a monoclonal antibody recommended by the American Academy of Pediatrics (AAP) to be administered to high-risk infants and young children likely to benefit from immunoprophylaxis for RSV, based on gestational age and certain underlying conditions. Palivizumab 15mg/kg is administered intramuscularly once per month for a maximum of five doses in the peak RSV months. Palivizumab is not effective for the treatment of RSV disease.
AAP Interim Guidance for Use of Palivizumab Prophylaxis to Prevent Hospitalization From Severe Respiratory Syncytial Virus Infection During the Current Atypical Interseasonal RSV Spread.
RSV activity in the United States remained very low through the traditional 2020-2021 fall-winter season but began to increase in the spring of 2021. This interseasonal increase in activity is a marked deviation from the typical RSV epidemiology and is believed to be the result of the relaxation of nonpharmacologic interventions that were previously implemented to prevent the spread of SARS-CoV-2. Consequently, RSV activity is on the rise in certain regions of the United States, with corresponding increases in emergency department visits and hospitalizations of infants and children.
Given the current atypical interseasonal change in RSV epidemiology, which may represent a delayed onset of the 2020-2021 season, the AAP strongly supports consideration for use of palivizumab in patients who would be candidates per current eligibility recommendations. This recommendation applies to regions experiencing high rates of RSV circulation, consistent with a typical fall-winter season. The Centers for Disease Control and Prevention (CDC) monitors RSV activity in the United States in collaboration with state and county health departments and commercial and clinical laboratories. The need for palivizumab administration to eligible infants during this atypical interseason should be supported where activity approaches fall-winter season and should be reassessed at least monthly.
The Alliance’s utilization criteria listed in Synagis policy 403-1120 follows the current AAP recommendations. The Alliance will cover Synagis for members who meet Conditions of Usage outlined in the Alliance’s Synagis policy.
For providers who wish to administer Synagis in their office, the Statement of Medical Necessity form is required to be submitted along with the prior authorization request.
These guidelines follow American Academy of Pediatrics (AAP) recommendations.
|Age 0-12 months at RSV season onset
||Age 12 – <24 months at RSV season onset
Synagis 15mg/kg IM every month in peak RSV months: Dose based on current weight ________________
Submit Alliance prior authorization forms by fax to (831) 430-5851. A single form is required for the series. Please indicate infant weight on the form. For providers administering Synagis in their office, also submit a completed “Statement of Medical Necessity” form found on the Alliance website, Pharmacy Page: https://thealliance.health/for-providers/manage-care/pharmacy-services.
Alliance Synagis Ordering and Billing Information
For providers that administer Synagis in their office, the Alliance specialty pharmacy US Bioservices must be used. CCAH staff will notify US Bioservices when Synagis has been authorized.
US Bioservices Contact Information: Phone (888) 518-7246 and Fax (888) 418-7246
Thank you for caring for young, at risk infants. If you have any questions about the Synagis recommendations, please call Yasuno Sato, Pharm D., Clinical Pharmacy Manager at (831) 430-5952.