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) will identify very early onset of RSV season and notify providers of an early RSV outbreak so that dosing can be initiated.
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).
Historical data for RSV season from St. Luke's Regional Medical Center 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: http://www.healthandwelfare.idaho.gov/default.aspx?TabId=201
Epidemiology services from neighboring states can be accessed online: https://intermountain.net/portal/site/mdvsi/menuitem for Utah and http://www.oregon.gov/DHS/ph/acd/diseases/rsv/rsv_page.shtml for Oregon.
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 guidelines, published in the 2009 edition of AAP Redbook Report of the Committee on Infectious Diseases and Pediatrics 2009 124:1694-1701. The consensus group has concluded that the current national AAP guidelines need further review and revision. One approach for revision of AAP guidelines has been taken by the National Perinatal Association and is posted online http://www.nationalperinatal.org/advocacy/pdf/Respiratory-Syncytial-Virus-Prevention-2010.pdf
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:
- Infants with airway anomalies who are less than 6 months old at the start of RSV season should receive Synagis irrespective of whether they were premature.
- With regard to risk factors, AAP criteria have listed childcare attendance, school-aged siblings, exposure to environmental air pollution, airway anomalies, and severe neuromuscular disease. The consensus group proposes adding severe socioeconomic difficulties (no telephone, foster care, mentally retarded or otherwise impaired parents), multiple birth (twins, triplets, and higher), small for gestational age (less than 10%ile), and Native American or Native Alaskan to this list; and cigarette smoke exposure appeared to qualify as environmental air pollution (a difference from interpretation by the AAP Committee on Infectious Diseases). The consensus group reinforced the standard that Synagis administration is not routine for infants greater than 32 weeks gestational age at birth, and additional risk factors need to be considered for infants to qualify for Synagis administration.
- 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, neurologic disease, cystic fibrosis, and other chronic respiratory diseases.
- The consensus group reinforces the statewide standard that Synagis dosing is not routinely given to children older than 24 months at the start of RSV season.
- 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.
III. Logistics
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 by plans in discharge summary 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 statewide mechanism for review by a pediatric specialist practicing in Idaho (neonatologist, cardiologist, or infectious diseases pediatrician) should be established.
IV. Historical onset and end of RSV season in Boise, Idaho
RSV activity monitored at St. Luke's Regional Medical Center Laboratory Boise, Idaho
Season Onset End
- 2000-01 Jan 14 May 6
- 2001-02 Jan 13 May 12
- 2002-03 Jan 19 Apr 13
- 2003-04 Dec 21 Mar 28
- 2004-05 Jan 9 Apr 24
- 2005-06 Dec 11 Apr 10
- 2006-07 Jan 15 May 28
- 2007-08 Dec 31 May 5
- 2008-09 Dec 22 May 24
- 2009-10 Jan 11 May 9
- 2010-11 Jan 3 May 7
- 2011-12 Jan 21
V. Contributors to consensus criteria:
- Travis Anschutz MD (Idaho Falls)
- Carl Bodenstein MD (Spokane)
- Perry Brown MD (Boise)
- David Christensen MD (Boise)
- Michelle Devoe DO (Ontario)
- Creighton Hardin MD (Pocatello)
- Nick Harper MD (Boise)
- Stewart Lawrence MD (Boise)
- Shannon Jenkins DO (Idaho Falls)
- Joseph Kiehl MD (Boise)
- Don McInturff MD (Pocatello)
- Jennifer Merchant MD (Boise)
- Terrence Neff MD (Coeur d’Alene)
- Heather Owens MD (Boise)
- Thomas Patterson MD (Nampa)
- Thomas Rand MD PhD (Boise)
- Jane Scott MD (Twin Falls)
- Matthew Sell, MD (Boise)
- Scott Snyder MD (Boise)
- Katherine Stevens MD (Boise)
- Benjamin Tippets DO (Boise)
- Eloisa Walker MD (Boise)
- Aaron Weiss MD (Boise)
- Michael Womack MD (Boise)
- Noreen Womack MD (Boise)
- Pawel Zieba MD (Boise)
