Synagis Consensus Criteria
A group of pediatricians and pediatric subspecialists from Idaho has met annually since August 2006. These pediatricians decided to come together because they were vitally interested in prevention of RSV infection and ensuring access to Synagis (palivizumab) for high-risk infants during RSV season. Because Synagis is an expensive measure with challenging logistics for administration, cost-effective use was paramount in the minds of the pediatricians. The group sought to clarify criteria for use of Synagis, to define the season in the Intermountain West and Idaho, and to devise solutions to overcome obstacles to Synagis delivery.
I. RSV Season
Synagis dosing in most years should begin early December. Preauthorization should be completed substantially earlier. Occasionally (less than one out of ten seasons), local epidemiology services (see below in Logistics) may identify very early onset of RSV season and notify providers of an early RSV outbreak so that Synagis dosing can be initiated before December 1.
The end of RSV season rarely occurs before April 15, but five monthly doses are expected to provide sufficient antibody levels for the RSV season (that is, dosing ends in March or April even if RSV season persists in May or later).
Historical data for RSV season from St. Luke's Health System laboratory in Boise is attached. The onset of the season is defined as the first of at least 2 consecutive weeks with greater than 10% of tests positive for RSV, concordant with CDC definition for the onset of RSV season. The end of the season requires three criteria: fall in numbers of RSV cases without subsequent increase, less than 10% of tests positive for RSV, and no new hospitalizations for RSV bronchiolitis.
Within Idaho weekly data by health district is available online from the Idaho Epidemiology program:
Epidemiology services from neighboring states can be accessed online:
Providers are encouraged to consult data from the geographically representative center in order to make decisions appropriate to their localities. Occasionally, the season differs between centers, and the timing of Synagis use should reflect the most geographically representative data.
The Idaho AAP Chapter provides online recommendations based on current epidemiology data:
II. Selection of High-risk Infants
Most health insurance plans follow the current national AAP Committee on Infectious Diseases guidelines, published in the 2012 edition of AAP Red Book. Any updates may be found at http://aapredbook.aappublications.org/. The consensus group feels that a summation of risk factors is important in selection of high-risk infants. The following points should be taken into account:
Role of NICU/Special Care Nurseries: Maintain list of infants who received Synagis before discharge and infants for whom further Synagis dosing should be considered. Identify primary care clinic prior to discharge. Communicate the list of infants to primary care clinics in discharge summaries and by letters in the fall.
Role of primary care clinics: Make ultimate decision to order Synagis in view of risk factors and clinical status in the fall. Preauthorization may be completed by the specialty pharmacy that supplies Synagis to the primary care clinic, but some insurers require that the ordering physician submit the preauthorization. When indications for an infant do not automatically fit AAP guidelines, the ordering physician will need to provide support for a preauthorization, such as in the form of a letter.
Role of epidemiology services: Provide accessible updates on current RSV activity and when high-risk infants should be receiving doses. When there is an unusually early RSV season detected, changes are communicated to the patient care coordinators at the NICUs, to the specialty pharmacies providing Synagis, and to as many primary care clinics as possible. Pediatric infectious diseases physicians at St. Lukes in Boise confer with state epidemiologists, and recommendations are communicated through the Idaho AAP chapter and its website.
Appeal of decisions in preauthorization: For denials of preauthorization that have been appealed, a statewide mechanism for review by a pediatric specialist practicing in Idaho (neonatologist, pediatric cardiologist, or infectious diseases pediatrician) should be established.
IV. Historical onset and end of RSV season in Boise, Idaho
RSV activity monitored at St. Lukes Regional Medical Center Laboratory Boise, Idaho
V. Contributors to consensus criteria:
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