Transcript RSV videoconference 2011-2012

RSV update
2011-2012
Chuck Hui MD FRCPC
Pediatric Infectious Diseases
Medical Director, RSV Prophylaxis clinic CHEO
MOHLTC Ontario RSV Prophylaxis program advisory group member
Conflict of Interest Declaration
•
•
Local investigator on two investigator driven,
Abbott funded trial
Member of the Canadian Pediatric Society Infectious
Diseases Immunization Committee, the Committee
to Advise on Tropical Medicine and Travel, and the
Ministry of Health and Long Term Care of Ontario
RSV Advisory Group
Objectives
• Address the AAP and CPS guidelines
• Identify the underlying assumptions and reasoning for the
guidelines
• Contrast the guidelines with the MOHLTC 2011-2012 guideline
• To review the process for enrolling patients into the provincial
RSV Prophylaxis for High-Risk Infants Program for the 2011-12
season
• To highlight changes to the enrolment form, enrolment process,
drug ordering process and dosing schedule
What is RSV?
• RNA paramyxovirus
– 2 strains – A and B
• Often circulate concurrently
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•
•
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Humans are only source
Almost all children infected at least once by 2 yrs of age
Re-infection is common
Presents as a common URI in older children and adults
Epidemiology
• Annual season in Canada
– November to April
• Viral shedding 3-8 days
– May be longer in young and immunosuppressed
• Incubation period 2-8 days
• Supportive care, no good treatment
Burden of RSV in Young Children
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Population based study in children < 5yrs
ER (2000-2004); Pediatric offices (2002-2004)
5067 enrolled; 919(18%) RSV infections; RSVH overall (11%)
RSV associated with:
18% ER visits
15% office visits
Average RSVH: 17/1000 <6 months of age
3/1000 < 5 years of age
Hall CB et al. NEJM 2009;360:588-598
Burden of RSV in Young Children
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•
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Majority of children had no underlying medical illness
Only risk factors identified: < 2 years of age, history of prematurity
Under 5 yrs of age RSV results in:
 1 of 38 visits to the ER
 1 of 13 visits to a primary care (FD) office
Hall CB et al. NEJM 2009;360:588-598
Global Burden
• Global burden of disease related to RSV in children younger
than 5 years
• Systematic review 1995-2009
– 33.8 million new episodes of RSV-associated ALRI occurred
worldwide in children younger than 5 years
– 3.4 million episodes representing severe RSV-associated ALRI
necessitating hospital admission
– 66 000–199 000 children younger than 5 years died from RSV
associated ALRI in 2005
• 99% of these deaths occurring in developing countries
Lancet. 2010 May 1; 375(9725)
Treatment
• Does not work…
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–
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Bronchodilators
Steroids
Hypertonic saline
Physiotherapy
Montelukast
Antibiotics
Cochrane Database Systematic Review. 2006
Cochrane Database of Systematic Reviews. 2004
Cochrane Database Systematic Reviews 2007
NEJM 357;4, July 26, 2007
NEJM 360;20 May 14, 2009
British Medical Journal 1966;1:83–5
% reduction in hospitalization
Prevention - Palivizumab Efficacy
100
80
80
60
55
39
47
40
20
0
Overall
BPD
<32 wks
32-35 wks
IMPACT Pediatrics 1998
When we don’t have anything else, we have a bunch
of grumpy old ‘experts’ sitting around a table…
American Academy of Pediatrics (AAP)
Background
• Statements 1998, 2003, 2009
• Significant geographic variability in the US
• Third party payers
• AAP recommendations are meant only for American
Pediatricians
American Academy of Pediatrics (AAP) 2009
Congenital Heart Disease (CHD) and Chronic Lung Disease (CLD)
• Unchanged
Dosing
• maximal number of 5 doses for all geographic locations for
infants with hemodynamically significant CHD, CLD, or birth
before 32 weeks' 0 days' gestation
• maximal number of 3 doses for infants with a gestational age of
32 weeks 0 days to 34 weeks 6 days without hemodynamically
significant CHD or CLD
American Academy of Pediatrics (AAP) 2009
32 0 to 34 6
•
Risk factors:
–
–
infant attends child care; or
1 or more siblings or other children younger than 5 years live permanently in the child's
household
•
Infants with a gestational age of 32 weeks 0 days through 34 weeks 6 days born within 3
months before the start of RSV season or at any time throughout the RSV season will
qualify for prophylaxis under the new recommendations if they have at least 1 of these 2 risk
factors. Previous recommendations required 2 of 5 risk factors
•
Infants born from 32 weeks' 0 days' through 34 weeks' 6 days' gestation who qualify for
prophylaxis under the new recommendations should receive prophylaxis only until they
reach 90 days of age or a maximum of 3 doses (whichever comes first). This is a change
from the previous recommendation for 5 months of prophylaxis
Risk factors for RSV hospitalization worldwide
Exposure
• Age at start of RSV season
• Siblings
• Crowding at home
• Day care attendance
• Day care attendance of siblings
• Discharge between October and
December
Social Factors
• Breast feeding
Physiologic Factors
• Low birth weight
• Male sex
• Family history of wheezing
• CLD
• Neurologic problems
• Birth order >2nd
Eur J Clin Microbiol Infect Dis (2008) 27:891–899
Variables in the final Logistic Regression Model
(Risk Scoring Tool- PICNIC Study)
Variable
SGA (GA <10%)
[ Yes/No ]
Gender (Male/Female)
Birth Month (Nov,Dec,Jan)
Subject or Siblings in Day Care [ Yes/No ]
Family History without eczema [ Yes/No ]
>5 individuals in the home counting
the subject [ Yes/No ]
Two or more smokers in the house [Yes/No ]
Total
Score
12
11
25
17
12
13
10
100
Only 3 doses?
McCormick J, Pediatr Pulmonol. 2002;34:262-266.
Canadian Paediatric Society (CPS)
Background
• Previous position statements 1999, 2003, 2009
• Updated 2011
• GRADE evidence based assessment
• Cost-effectiveness assessment
Canadian Paediatric Society (CPS) 2011
Congenital Heart Disease (CHD) and Chronic Lung Disease (CLD)
• Criteria – unchanged
• Recommendation
– receive up to five doses of palivizumab
(strong recommendation/high-quality evidence)
• Remarks - Decisions regarding the use of palivizumab in this and all
other high-risk groups need to take competing local priorities for
funding into account, which may allow for use of palivizumab in only
selected infants in this cohort
• Values and preferences - This recommendation places a high value on
preventing hospitalizations in these vulnerable infants despite the high
cost of palivizumab
Canadian Paediatric Society (CPS) 2011
Infants in remote communities who would require air transportation for
hospitalization:
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Recommendation #1
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Consideration should be given to administering up to five doses of palivizumab for all infants born before 36 weeks’ GA
and younger than six months of age at the beginning of the RSV season
(strong recommendation/high-quality evidence).
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Remarks. It is not clear whether this recommendation should apply only to Inuit infants, to all Aboriginal
infants or to all infants in remote communities. The incidence of RSV hospitalization in a remote community
in previous years should be taken into account when making this decision. A practical issue is that the onset
and duration of RSV season is unpredictable in the Far North. Occasionally, more than a year goes by
between RSV seasons (Michael Young, personal communication). To save money, one would delay
administering palivizumab until there is confirmed RSV activity in a remote community. The attendant risk is
that significant spread may have already occurred.
•
Values and preferences. This recommendation places high value on preventing RSV hospitalizations
because of the high cost of such admissions.
Canadian Paediatric Society (CPS) 2011
•
Recommendation #2
– Consideration may be given to administering up to five doses of
palivizumab to term Inuit infants younger than six months of age in
communities with documented persistent high rates of RSV
hospitalizations
(weak recommendation/no evidence)
•
Remarks. There is no direct evidence of the efficacy of palivizumab in
term Inuit infants, but observational studies in preterm Inuit infants and
in term infants with other risk factors suggest that there would be
efficacy. There are insufficient data regarding the morbidity from RSV to
recommend use in term infants in other Northern populations
Canadian Paediatric Society (CPS) 2011
32 weeks 0 days to 35 weeks 6 days’ GA:
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Recommendation #1
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A panel of experts should be convened in each province or territory
(weak recommendation/no evidence) to establish a policy for these infants
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Remarks - The upper limit of GA may need to be determined by available
funding
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Recommendation #2
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The panel may want to use the American Academy of Paediatrics (AAP) criteria, or the
Canadian risk-scoring tool, to select infants eligible for palivizumab prophylaxis
(weak recommendation/no evidence)
Remarks. It seems likely that applying the AAP criteria would result in more
infants being prophylaxed, but for a shorter time. It is impossible to predict the
relative impact on hospitalizations
Canadian Paediatric Society (CPS) 2011
• Recommendation #3
– Irrespective of the criteria chosen, giving the last dose at
three months’ chronological age should be considered in this
GA cohort (weak recommendation/no evidence)
• Remarks. This recommendation is an attempt to
balance cost and benefit, and is designed to protect
infants at greatest risk of hospitalization
Canadian Paediatric Society (CPS) 2011
Immunodeficiencies, Down syndrome, cystic fibrosis, upper airway
obstruction or a chronic pulmonary disease other than CLD:
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Recommendation
–
•
Palivizumab is not routinely recommended. However, it may be considered for children younger than
24 months of age (because they may not yet have encountered their first RSV infection) who are likely
to be exposed to RSV and are on home oxygen, have had a prolonged hospitalization for severe
pulmonary disease, or are severely immunocompromised (weak recommendation/no evidence)
Remarks. This recommendation should be expanded to include more children with
pulmonary disease if evidence becomes available that avoidance or delay of the initial RSV
hospitalization impacts long-term pulmonary function
How should palivizumab be administered?
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Recommendation
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Each jurisdiction should optimize processes to implement these recommendations in the most costeffective manner. Well-organized palivizumab clinics decrease drug wastage
(strong recommendation/no evidence)
OK, tell me what I need to know!!!!!!
MOHLTC Ontario 2011-2012
Background
• Administered through the Exceptional Access
Program (EAP) MOH
• RSV Advisory Group
• RSV Adjudicators
MOHLTC Ontario 2011-2012
Background
• Administered through the Exceptional Access
Program (EAP) MOH
• RSV Advisory Group
• RSV Adjudicators
• NO CHANGE!
MOHLTC Ontario 2011-2012
Prematurity
• ≤ 32 completed weeks gestation and aged ≤ 6 months at the
start of, or during, the local RSV season; or
• 33 – 35 completed weeks gestation and aged ≤ 6 months at the
start of, or during the local RSV season, who DO NOT live in
isolated communities AND have a Risk Assessment Tool Score
of 49 to 100; or
• 33 – 35 completed weeks gestation and aged ≤ 6 months at the
start of, or during the local RSV season, and who LIVE IN
isolated communities where paediatric hospital care is not
readily accessible and ambulance transportation for hospital
admission is required;
MOHLTC Ontario 2011-2012
CHD/BPD/Down Syndrome
• < 24 months of age with Down Syndrome / Trisomy 21; or
• < 24 months of age with BPD/CLD and who required oxygen
and/or medical therapy within the 6 months preceding the RSV
season; or
• < 24 months of age with hemodynamically significant (HS)
cyanotic or acyanotic congenital heart disease (CHD); requiring
corrective surgery or is on cardiac medication for hemodynamic
significant disease
MOHLTC Ontario 2011-2012
Special Requests
• Assessed on an individual basis
• Requires letter from requesting physician and an ID +
Respirologist signature
• Potential diagnoses:
– Upper airway anomalies, severe immunodeficiencies,
neuromuscular diseases, etc.
SEASON START / END
• START: Ontario RSV Medical Advisory Group has
recommended November 14th, 2011 as season start
• END: April 1st, 2012 or when season is declared
ended locally, whichever comes first
• Season is considered on-going when there are 2 or
more local RSV hospitalizations / week for two
consecutive weeks
Out of season process
• From May 1st – November 1st , 2011
• NICUs identify patients that qualify for prophylaxis in
a log book and send the referrals to CHEO RSV
Coordinator monthly
• Enrolment forms / appointment arrangements
completed by CHEO RSV Coordinator
During season (November – March)
• NICUs enroll their own patients with Abbott
• First dose of Synagis is administered prior to
discharge from NICU
• Follow up appointments may be made by NICUs by
directly contacting CHEO’s Ambulatory Care Call
Center (613-737-2222)
• NICUs fax / email Abbott reference no. and patient
info to CHEO RSV Coordinator
Summary of Changes: 2011-12
1. Enrolment process
2. Enrolment forms
3. Drug ordering process
4. Dosing schedule
ENROLMENT PROCESS
• All enrolments will now be
processed and reference
numbers provided by Abbott
• The ministry’s coordinator will
review all those with BPD/CHD
criteria and the special requests
• Enrolment forms are faxed
directly to the Synagis
Coordinator at Abbott Canada
(1-800-513-7337)
ENROLMENT
• Turn around time is usually one
business day (prematurity
criteria)
• For enrolments under the BPD /
CLD and CHD criteria and
Special Requests, turn around
time is three business days
ENROLMENT FORMS
• Since the form is now going to Abbott Canada and
not MOHLTC, NO personal health identifiers (name,
address, OHIP no.) are to be provided
• Fields for the child’s full name and OHIP no. have
been removed from the enrolment forms
• Really simplified – one form for all
• Risk Assessment Tool is now part of the enrolment
form on page 2
DRUG ORDERING PROCESS
• Shipment orders directed to Synagis  Coordinator
at Abbott (fax: 1-800-513-7337)
• For NICUs who will give the first dose in November, it
can be ordered using enrolment form (Section 7)
• All subsequent doses should be ordered on
Synagis order form
• Shipments occur within 24 hours, except for orders
placed on Fridays, weekends and stat holidays
• The ministry requests that all providers be mindful of costs such
that drug wastage is minimized
• When an entire vial is not required for a patient, residual product
may be used for a second patient if administered within 6 hours
from the time of reconstitution under controlled and aseptic
conditions
$752.26
$1,504.51
DOSING SCHEDULE
(as per Ontario’s RSV Medical Advisory Group
Dose
Week #
Month
1
0
Mid-November
2
3
December
3
7
January
4
11
February
5
15
March
ENROLMENT FORMS (on line)
http://www.health.gov.on.ca/english/providers/progr
am/drugs/funded_drug/fund_respiratory.aspx
CHEO RSV Clinic
• Fridays (primarily) in clinic C1 on the main floor of CHEO
• First clinic: November 18, 2011
• Team for the 2011-12 season:
Josée Chiasson, RPN
Chantal Horth, RC
Carolyn Lawrence, RN
Joanne Matton, PSC / Alyssa Long, PSC
Barbara Murchison, RC
Allyson Shephard, RN
Chuck Hui, MD (Medical Director)
Lisa Nesbitt (Clinical Manager)
CONTACT US
• By email: [email protected]
• By telephone: 613-737-7600 Ext 2406 (Coordinator)
• By fax: 613-738-4329