A group of pediatricians and pediatric subspecialists from Idaho met on August 29, 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. Individuals expressed varying amounts of frustration with the preauthorization process. 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 should begin in November for most high-risk infants in
most years. Preauthorization should be completed substantially earlier.
Occasionally (less than one out of five 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. Preauthorization
should cover dosing for high-risk infants through April 15. If local epidemiology
indicates that the season is unusually long or short, then providers and
insurers will be notified when dosing can be discontinued (see below in
Logistics). Note that infants starting Synagis before November 15 will
receive six doses of Synagis prior to April 15.
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 week with sustained RSV positive tests in consecutive weeks.
In some but not all years, this definition of season onset is the same
as the CDC definition of greater than 10% of tests positive for RSV. 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.
Three epidemiology services advise local and regional providers on RSV
activity:
• Salt Lake City, Utah (Primary Children’s Hospital), accessed
online www.ped.med.utah.edu/geninfo/Resp.pdf
• Boise, Idaho (Idaho AAP Chapter in cooperation with St. Luke’s
Children’s Hospital), accessed online www.idahoaap.org
• Spokane, Washington (Sacred Heart Children’s Hospital),
accessed by email distribution list from olsonac@shmc.org
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.
II. Selection of high-risk infants
The consensus group supports the AAP criteria, which are similar in both
2006 and 2003 editions of AAP Redbook: Report of the Committee on Infectious
Diseases, and in the publication Pediatrics 112:1442, 2003. The consensus
group specified clarifications for high-risk infants for whom the AAP
criteria do not fit well:
• 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.
• AAP guidelines have indicated that two additional criteria are
necessary for selection of infants born at 32-35 weeks prematurity who
are less than 6 months old at the beginning of RSV season. The AAP criteria
list childcare attendance, school-aged siblings, exposure to environmental
air pollution, airway anomalies, and severe neuromuscular disease. The
consensus group proposes adding 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 prematurity, 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 November 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 or late 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.
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
V. Contributors to consensus criteria:
Carl Bodenstein MD (Spokane), Perry Brown MD (Boise), David Christensen
MD (Boise), Michelle Devoe DO (Ontario), Nick Harper MD (Boise), Don McInturff
MD (Pocatello), Jennifer Merchant MD (Boise), Terrence Neff MD (Coeur
d’Alene), Thomas Rand MD PhD (Boise), Jane Scott MD (Twin Falls),
Scott Snyder MD (Boise), Michael Womack MD (Boise), Pawel Zieba MD (Boise)