Synagis Consensus Criteria
A group of pediatricians and pediatric subspecialists from Idaho met annually 2006-2012. 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.
Potential for an unusually early season with need for dosing before December has been addressed by pediatric infectious diseases specialists at St. Luke Children’s Hospital and state epidemiologist at Idaho Health & Welfare. There has not been an instance where early dosing was needed during use of RSV immunoprophylaxis since the late 1990s. If state and regional epidemiology services indicate that dosing should be initiated before December 1, then the state epidemiologist will authorize this change and clinic providers will be notified.
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 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, and the end of season is the last of at least 2 consecutive weeks with greater than 10% of tests positive, concordant with CDC definition. In addition, we do not notify of end of the season until no new hospitalizations for RSV bronchiolitis are observed.
Within Idaho weekly data by health district is available online from the Idaho Epidemiology program: http://healthandwelfare.idaho.gov/Health/DiseasesConditions/RSV/tabid/201/Default.aspx
Epidemiology services from neighboring states can be accessed online:
Eastern Washington and Northern Idaho: We suggest the clinic provider contact the neonatology office at Sacred Heart Childrens Hospital in Spokane to be included on the email listserve.
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: http://www.idahoaap.org/monitor.htm
II. Selection of High-risk Infants
Most health insurance plans follow the current national AAP Committee on Infectious Diseases guidelines, published 2014 Pediatrics 134:415-420 and 2015 Red Book. These recommendations are significantly more restrictive than earlier AAP guidelines.The following points should be taken into account:
- Infants with a variety of medical problems should be considered on a case-by-case basis, as it is not possible to make uniform recommendations with regard to immune deficiency and other cardiopulmonary diseases. For infants that do not fit a strict reading of guidelines but yet merit prophylaxis, a letter from provider to petition insurance preauthorization is appropriate.
- The consensus group reinforces the statewide standard that Synagis dosing is not given to children older than 24 months at the start of RSV season. Note that a second season of prophylaxis is reserved for chronic lung disease of prematurity continuing to require medical support and for profound immunosuppression.
- For determining eligibility, the start of RSV season is interpreted as December 1 to allow uniform preauthorization in advance of the actual season onset for that year.
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. Luke’s 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 review by a pediatric specialist practicing in Idaho (neonatologist, pediatric cardiologist, or infectious diseases pediatrician) is encouraged.
IV. Historical onset and end of RSV season in Boise, Idaho
RSV activity monitored at St. Lukes Health System laboratory in Boise, Idaho
|2000-2001||January 14||May 6|
|2001-2002||January 13||May 12|
|2002-2003||January 19||April 13|
|2003-2004||December 21||March 28|
|2004-2005||January 9||April 24|
|2005-2006||December 11||April 10|
|2006-2007||January 15||May 28|
|2007-2008||December 31||May 5|
|2008-2009||December 22||May 24|
|2009-2010||Janary 11||May 9|
|2010-2011||January 3||May 7|
|2011-2012||January 21||June 9|
|2012-2013||December 15||April 13|
|2013-2014||January 25||May 10|
|2014-2015||November 29||March 28|
|2015-2016||January 2||April 23|