Transcript old pp Multiallergen Immunotherapy IT

Multiallergen Immunotherapy
The Experience
Linda Cox, MD
WAO 2011 Congress
Cancun, Mexico
Linda Cox, MD Disclosure
Allergist/Immunologist: solo private practice
Associate Clinical Professor of Medicine Nova Southeastern
University
Medical advisory board/consultant: Stallergenes,
Genentech/Novartis, ISTA
Speakers fee: Phadia
Organizational interests:
• FDA Allergenic Products Advisory Committee –consultant
• AAAAI-Secretary/Treasurer
• Joint Task Force on Practice Parameters-member
• ABAI Board of Directors -member
Multiallergen Immunotherapy:
Learning Objectives
• Immunotherapy outcome measures
• Efficacy of multiallergen immunotherapy as
demonstrated by indirect outcome measures
– Cost-effectiveness
– Comparative-effectiveness
– Quality measures
– Preventive
Allergen Immunotherapy Outcome Assessment
What is Important?
• Subjective measures
• Primary outcome in clinical trials and what is generally
followed in clinical practice
• Objective measure
• Not accepted by FDA/other regulatory authorities as
primary outcome
• Not practical for clinical practice at present …. but may
be useful tool for predicting responders & monitoring
outcomes in the future
• Other outcome measures:
• Validated questionnaires
• Cost-efficacy
Comparison of Magnitude of Improvement Between 2 SCIT
Studies Using the Same Dose & Product: 100,000 SQ-U*
Frew 20061
20 µg Phl p 5T
n = 187 SLIT
n = 89 placebo
Symptom
scores
Rescue medication
scores
Varney19912
~20 µg Phl p
n = 21 SLIT
n = 19 placebo
- 61%
- 29%
- 32%
- 79%
*Alum-precipitated grass pollen extract (Alutard SQ®, ALK-Abello)
Severity group2
SCIT
Placebo
A= “extremely hypersensitive”
9
9
B =“very hypersensitive”
12
10
A= SPT>16mm; positive CPT <300 BU/ml(~0.2 µg Phl p5; h/o symptoms for>10 days associated
with asthma and previous oral or injected corticosteroid
B= moderate to severe hay fever that did not fill above criteria
1.Frew et al, JACI 2006;117:319-25. 2. Varney et al, BMJ 1991;302:265-9.
5
Recommendations for standardization of clinical trials with
Allergen Specific Immunotherapy for respiratory allergy.
A statement of a WAO taskforce
• “Clinical trials of efficacy must always include a
measurement of the symptoms and the use of
concomitant medications, which represent the primary
outcome.”
• Symptoms: most frequently used approach is a 4-point
rating scale (from 0 = absent to 3 =severe)
• “Pragmatic solution assumes equivalent importance of
symptoms and medication scores indicating that each of
these account for half of the clinical burden of the
disease.”
• Recommend combined symptom + medication score be
utilized as the primary outcome measure.”
Canonica et al., Allergy 2007;62:317-24.
MULTIALLERGEN IMMUNOTHERAPY
EXTRAPOLATING EFFICACY FROM THE
US EXPERIENCE
The US Experience
US is a Polysensitized Population: 3rd National Health
and Nutrition Examination Survey Test Results
54% positive to ≥ 1
allergen
Mean = 3.5
Median = 3.0
10,508 subjects in general US population tested to 10
allergens from 1988 through 1994
Arbes et al., J Allergy Clin Immunol 2005;116:377-83
8
Multiallergen extracts are the ‘rule’ in the US
• CPT code 95165 (US billing code for AIT) is based on average
cost of using 6 allergens.
• Mean number of component extracts was 8 in mixtures
formulated for 20 US allergists in 2002 at Greer;
2. Esch R, Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M 2003:17-22; discussion 3.
MULTIALLERGEN IMMUNOTHERAPY
COST EFFICACY AND COMPARATIVE
EFFECTIVENESS
Comparative-effectiveness research
• January 2009, as part of the American Recovery and Reinvestment
Act Congress set aside $1.1 billion in funding for CER defined as
– The conduct and synthesis of research comparing the benefits
and harms of different interventions and strategies to prevent,
diagnose, treat and monitor health conditions in “real world”
settings.
– The purpose of this research is to improve health outcomes by
developing and disseminating evidence-based information to
patients, clinicians, and other decision-makers, responding to
their expressed needs, about which interventions are most
effective for which patients under specific circumstances.
• To provide this information, CER must assess a comprehensive
array of health-related outcomes for diverse patient
populations and subgroups.
US Department of Health and Human Services. Federal Coordinating Council for Comparative Effectiveness
Research : June 20,2009. http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf
Multiallergen Immunotherapy for Asthma In Allergic
Children.
• Methods: DBPC multiple-allergen immunotherapy in 121
allergic children with moderate-to-severe, perennial
asthma randomized after 1 year of observation and
stabilization to SCIT with up to 7 allergens or placebo
injections.
• Medications were adjusted every 2-3 weeks on the basis
of PEFR and symptoms the previous 14 days.
• Principal outcome was the daily medication scores.
• Study was essentially asking at least 2 questions: Is
multiallergen SCIT effective ? & Is effective as add-on to
optimal pharmocotherapy & environmental control
measures?
Adkinson F, et al., N Engl J Med 1997; 336
Multiallergen Immunotherapy: No significant
difference in symptoms/medication scores
• Results: No difference between groups in medication
score (1° outcome), use of medical care, symptoms,
median PC20 or PEFR
Adkinson F, et al., N Engl J Med 1997; 336
Multiallergen Immunotherapy: trend toward
significant difference in healthcare utilization
• Subgroup analysis - approached statistical significance in favor
of SCIT in: younger age (8.5 years; p =0.02) & Mild asthma
(medication score ≤ 5; p= 0.19 and no ICS use)
• And trend toward favoring SCIT in 8/10 outcomes
Adkinson F, et al., N Engl J Med 1997; 336
Pharmacoeconomics of SCIT compared with symptomatic
drug treatment in patients with allergic rhinitis and asthma
Method: 30 pts (mean age, 35 yrs ) with Parietariainduced rhinitis & asthma randomized to SCIT (20 pts) or
medications (10 pts) for 3 years
• Inclusion: PST >5 mm wheal, AR + Ashma (GINA class 2
or 3) for 2 years
• Evaluated before treatment and annually for 6 years in
the pollen period
– Nose, eyes, and lung symptom scores, and drug
consumption via patent diary
– Economic costs: pt registered monthly:# of medical
visit, medications, allergy injections
Ariano et al, Allergy Asthma Proc 2006;27
Pharmacoeconomics of allergen immunotherapy
Significant improvement in symptom scores and
medication use after 1st year of treatment
Ariano et al, Allergy Asthma Proc 2006;27
Sustained significant reductions in cost beginning in the 3rd
year subcutaneous allergen immunotherapy
• Results: In additional to reduced symptom/medication scores there
was a significant difference in costs favor of SIT vs control
– 15% the second year
– 48% the third year (80% reduction )
– 80% reduction maintained up to 6th year, 3 years after stopping
immunotherapy
• Net saving per patient: $830/year.
• Conclusion: SCIT has significant economic advantages over
pharmocotherapy alone
Ariano et al Allergy Asthma Proc 2006;27
Health Economics of SIT (15 Studies from 1995 to 2011)
YR/AUTHOR
CT
SOURCE
SUBJECTS
ILLNESS
COMPARATORS
RESULTS
95
Buchner
DE
Lit Rev
Unspecified
AR; Asthma
SIT vs SDT
AR $7,335/10 Years; Asthma
$14,137/10 Years
‘97
Le Pen
FR
Survey
Unspecified
Various
1-2 Years SIT vs <1 Year SIT
Not Provided
‘00
Schadlich
DE
Clin Trial
Unspecified
AR
3 Years SIT vs SDT
$960/10 Years Mite;
$1,109/10 Years Pollen
‘05
Berto
IT
MR
Children
AR ± Asthma
Year Prior vs Year of SLIT
$363/Year
‘05
Peterson
DK
Survey
16-60 Years
AR ± Asthma
4 Years SIT vs SDT
$1,447/4 Years
‘06
Ariano
IT
Diary
Adults
AR + Asthma
3 Years SIT v SDT; 3 Years FU
$932/Year in Year 6 (3rd Year FU)
‘06
Berto
IT
RC
16-45 Years
AR ± Asthma
3 Years SLIT+‘SDT vs SDT
$632/6 Years (3rd Year FU)
‘07
Bachert
Eur
Clin Trial
Adults
AR ± Asthma
3 Years SLIT+SDT vs SDT;
6 Years FU
$19,345 to $27,324 cost per QALY
gained
‘07
Keiding
UK
Clin Trial
18-60 Years
AR
3 Years SLIT+SDT vs SDT; 6
Years FU
$14,536 to $38,695 cost per QALY
gained
Delphi
Adults/
Children
AR ± Asthma
3 Years SIT Adults; 4 Years SIT
Children; 3 Years FU
ICER (add’l improved pt): SCIT vs
SDT $517 to $1,964; SLIT vs SDT
$933 to $5,829
‘07
Omnes
FR
Poor outcomes for SIT are shown in red font.
18
Provided with permission from Cheryl Hankin, PhD
U.S. Health Economics of SIT
YR/AUTHOR
CT
‘95
Donahue
US
’00
Sullivan
’08
’10
‘11
SOURCE
SUBJECTS
ILLNESS
COMPARATORS
RESULTS
RC
Adults/
Children
AR ± Asthma
SIT Completer vs Noncompleter
$538/Year
US
Lit Rev
Unspecified
AR
SIT vs SDT
$8,851/5 Years
Hankin
US
RC
Children
AR ± Asthma
6 Months Pre- vs Post-SIT
$401/6 Months (P <.001)
Hankin
US
RC
Children
AR ± Asthma
18 Months SIT vs SDT
$1,625/18 Months (P <.001)
Hankin
US
RC
Adults
AR ± Asthma
18 Months SIT vs SDT
$7,286/18 Months (P <.001)
AR = allergic rhinitis; RC = retrospective claims analysis; SDT = symptomatic drug therapy; SIT = allergen-specific immunotherapy.
•
Donahue 1995: Patients with AR completing 3.5 years of SIT incurred higher health care costs than those with
<3.5 years of SIT (not adjusted for baseline differences in disease severity and costs)
•
Sullivan 2000: $8,851/5 years = $1,770 annual benefit for SIT vs SDT among patients with AR
•
Hankin 2008: $401/6 months = $802 median annual benefit for SIT (children with AR in the 6 months after SIT
discontinuation vs 6 months prior to SIT initiation)
•
Hankin 2010: $1,625/18 months = $1,218 mean annual benefit for SIT among children with AR vs match controls
not receiving SIT
•
Hankin 2011: 7,286/18 months = $5,465 mean annual benefit for SIT among adults with AR vs match controls
19
not receiving SIT
Why is Florida is important State for this discussion?
• Allergy season is long: many
’seasonal’ allergens perennial.
• Florida Allergy, Asthma and
Immunology Society (FAAIS)
forefront of standardization of SIT
practice standardize skin test and
immunotherapy practices at the
1998 FAAIS annual meeting
through a series of workshop.
AUG17 2009SAR
Sarasota, Florida
Mary Jelks
TREES
0 ABSENT
WEEDS
43
MOD
GRASS
24
HIGH
FUNGI
28461
HIGH
Background: Florida Medicaid (1997-2008)
• Computerized Florida Medicaid claims records contain
– HIPAA-compliant unique patient identifiers
– Basic demographics (e.g., sex, age, and race/ethnicity)
– Family identifiers (e.g., mother-child)
– Health services use
• ICD diagnosis and HCPCS/CPT treatment codes
– By settings, dates, physician specialties
• NDC prescription drug claims
– Include doses, quantities filled, dates of fill
– Primary and secondary insurers (e.g., Medicaid with
Medicare or self-pay ) 21
Exploratory Study: Pre-Post SCIT Study in Children
Hankin CS, Cox L, Lang D, et al. J Allergy Clin Immunol 2008;121:227-32.
(
Sample Identification among 4,807,429
total Florida Medicaid enrollees)
Newly-diagnosed
AR Patients
aged < 18 years
(N=102,390)
No IT at any
time during
study period
(N=99,342)
Rec’d IT at
any time during
study period
(N =3,048)
3.0% of
children with
AR received IT
< 4 years of
data following
1st AR dx
(N=2,358)
> 4 years of
data following
1st AR dx
(N=690)
IT preceded
1st AR dx
(N=170)
IT followed
1st AR dx
(N=520)
< 6 months FU
data after last
IT admin
(N=166)
> 6 months FU
data after
last IT admin
(N=354)
Hankin CS, Cox L, Lang D, et al. J Allergy Clin Immunol 2008;121:227-32.
Duration of Treatment (n=520)
Poor Adherence to SCIT
50%
Only 16% of patients received
IT for 3 years
% of Patients
39%
25%
18%
14%
<6 Mo
6 Mo
to
< 1 Yr
13%
1 Yr
to
< 2 Yr
2 Yr
to
< 3 Yr
16%
3+ Yr
0%
• Patients received an average of 31.3 IT administrations (SD 34.3).
• The mean duration of treatment was 17 months (SD 17.6).
Hankin CS, Cox L, Lang D, et al. J Allergy Clin Immunol 2008;121:227-32.
Exploratory Study: Pre-Post SCIT Study in Children
• 7-year (1997-2004) retrospective claims analysis of Florida
Medicaid-enrolled children (age <18 years) newly diagnosed with
AR (with or without asthma) and naïve to SIT
• Compared health care use and costs of SAME CHILDREN 6 months
pre-SIT initiation versus 6 months post-SIT discontinuation
CHANGE IN MEAN NUMBER OF
CLAIMS (6 MONTHS PRE- VS 6
MONTHS POST-SIT)
HEALTH
SERVICES
CHANGE IN MEAN
COSTS (6 MONTHS PRE- VS 6
MONTHS POST-SIT)
CHANGE
P VALUE
CHANGE
P VALUE
PHARMACY
-3.2 FILLS
<.0001
-$54
<.0001
OUTPATIENT
-7.8 VISITS
<.0001
-$233
<.0001
INPATIENT
-0.8 STAYS
.02
-$2,316
<.0001
AVERAGE 6-MONTH WEIGHTED COST SAVINGS PER PATIENT: $401
Hankin CS, Cox L, Lang D, et al. Allergy immunotherapy among Medicaid-enrolled children with allergic
rhinitis: Patterns of care, resource use, and costs. J Allergy Clin Immunol 2008;121:227-32.
25
Matched Cohort Study in Children
Florida Medicaid data set from 1997-2007
• Definition of Terms:
• AR = ICD-9 code 477.X. IT = CPT 95115, 95117, 95120,
95125,95144, 95165, 95180, and 95199.
• Comorbid allergy-related illness: Asthma = 493.X; Atopic
dermatitis = 691.8; Conjunctivitis = 372.X
• Newly diagnosed AR = those whose first AR diagnosis was
preceded by a full year in which no AR diagnoses occurred
• De novo immunotherapy = first documented immunotherapy
claim followed (rather than preceded) their first AR diagnosis
Analysis: Data were highly skewed
Wilcoxon signed rank tests to compare the groups’ 18-month
median per-patient health care use and costs
Health care components included total inpatient stays, total
outpatient visits , total pharmacy fills, and total health care use.
26
Hankin CS, Cox L, Lang D, Ann Allergy Asthma Immunol 2010;103:79-85.
Matched Cohort Study in Children: from 1997-2007
Each IT-treated patients was matched on up to 5 controls based on age
at first AR diagnosis, sex, race/ethnicity, and diagnosis of
asthma,conjunctivitis, or atopic dermatitis
No AR dx
(n=3,208,639)
Pts aged
<18 yrs
(1997-2007)
(N=3,472,786)
AR dx in
yr before 1st
AR dx
(n=82,326)
AR-dx
(n=264,147)
Represents newly- ARdiagnosed children =
5.2%
(181,821 / 3,472,786)
IT in yr
preceding
1st AR dx
(n=139)
<2 IT admin at
any time after
1st AR dx
(n=177,111)
No IT in yr
preceding
1st AR dx
(n=181,682)
Represents newly-ARdiagnosed children
receiving course of de novo
IT= 2.5% (4571 / 181,821)
≥2 IT admin at
any time after
1st AR dx
(n=4,571)
No IT
(n=176,202)
<18 mo of
data after
1st IT
(n=1,586)
≥18 mo of
data after 1st
IT (n=2,985)
1. Hankin CS, Cox L, Lang D, et al. Allergen immunotherapy and health care cost benefits for children with allergic rhinitis: a largescale, retrospective, matched cohort study. Ann Allergy Asthma Immunol 2010;103:79-85.
1-to-5 match
Represents number
of children with AR
diagnosis from 1997
to 2007= 7.6%
(264,147 /
3,472,786)
No AR dx in
yr before 1st
AR dx
(n=181,821)
Pool of
control
candidates
“ ITTreated
Patients”
27
Matched Cohort Study in Children
• 10-year (1997-2007) retrospective, matched cohort, claims analysis
of Florida Medicaid-enrolled children (age <18 years) newly
diagnosed with AR (with or without asthma) and naïve to SIT
• Compared 18-month health care use and costs: SIT versus matched
non-SIT groups: cost-savings of $1,625 per patient (~33%)
CHILDREN: Net Savings Conferred (SIT Group Minus Non-SIT Group)
Δ AT 3
Δ AT
Δ AT
Δ AT
MONTHS
6 MONTHS
12 MONTHS
18 MONTHS
PHARMACY
-$44
-$68
-$107
-$208
OUTPATIENT (WITH SIT)
-$405
-$691
-$1,131
-$1,519
OUTPATIENT (WITHOUT SIT)
-$170
-$281
-$529
-$765
INPATIENT
-$803
$303
-$1,764
-$513
NS at any time point
TOTAL
-$248
-$527
-$1,061
-$1,625
P <.001
HEALTH SERVICES
P VALUE (BETWEEN GROUP
DIFFERENCES)
P <.001
at all time
points
*Matched on age at AR diagnosis; gender; race/ethnicity; comorbid illness burden; and the presence of asthma, conjunctivitis , or dermatitis.
Hankin CS, Cox L, Lang D, et al. Allergen immunotherapy and health care cost benefits for children with allergic rhinitis: a large-scale, retrospective,
28
matched cohort study. Ann Allergy Asthma Immunol 2010;103:79-85.
COST-EFFECTIVENESS ATTRACTS
MEDIA ATTENTION
29
30
Does Allergen-Specific Immunotherapy Provide Cost Benefits
for Children and Adults with Allergic Rhinitis?
Results from Large-Scale Retrospective Analyses Jointly
Funded by AAAAI and ACAAI
11-year period(1997-2008)
Cheryl Hankin, PhD;1 Linda Cox, MD;2
Zhaohui Wang, MS;1 Amy Bronstone, PhD1
1BioMedEcon,
2Nova
LLC, Moss Beach, CA
Southeastern University College of Osteopathic Medicine, Fort Lauderdale, FL
Session #274 March 19, 2011, 2:00-3:15 pm
Presented at the 2011 Annual Meeting of the American Academy
of Allergy, Asthma, and Immunotherapy, March 18-21, 2011
San Francisco, CA
Research jointly funded by the American Academy of Allergy, Asthma, and
Immunotherapy and the American College of Allergy, Asthma, and
Immunology
31
Identification of Adults Newly Diagnosed with AR
Who Received De Novo SIT (for Matching)
≥1 year of data preceding
1st AR claim (“index
diagnosis”) with no AR
claim filed
N=61,598
Medicaid
Adults (≥18
yrs)
7/97-6/08
N=3,008,865
No SIT in
prior year
N=61,471
AR
N=91,103
≥2 SIT admin
after index AR dx
N=2,089
For adults, there were 1,306 SIT patients matched to
5,137 non-SIT patients.
Hankin et al, Session #274 March 19, 2011 Presented at the 2011 AAAAI
No SIT
N=58,725
≥ 18 months of
data following
1st SIT
N=1,499
Adults-significant and progressive differences in all
components of health care costs including hospitalization
11-year (1997-2008) retrospective matched cohort claims analysis of Florida Medicaidenrolled adults newly diagnosed AR compared 18-month health care use/costs in pts
who received SIT vs Non-SIT matched cohort savings 7,286 per patient (41%)*
TIME FROM SIT INITIATION
Health Services
Pharmacy
Outpatient (w/
SIT)
Inpatient
3
months
6
months
12
months
18
months
P value
-$151
-$246
-$454
-$685
P < 0.0001 AT
ALL TIME POINTS
-$248
-$4,207 NS
-$477
-$2,340 NS
-$943
-$2,687
-$1,433
-$4,444
P < 0.0001 AT
FROM 12
MONTHS
P < 0.0001 AT
TOTAL
-$1,257
-$2,382
-$4,687
-$7,286
ALL TIME POINTS
*Mean, Per-Patient, 18-Month Cost Differences: SIT versus Matched Controls) of 1,306 SIT patients matched to
5,137 non-SIT patients on age at AR diagnosis; gender; race/ ethnicity; and the presence of asthma, conjunctivitis,
or dermatitis. NS=not significant. (Negative values denote savings conferred by SIT)
33
Identification of Children Newly Diagnosed with AR
Who Received De Novo SIT (for Matching)
SIT in
prior year
N=145
Medicaid
Children
(<18 yrs)
7/97-6/08
N=3,604,711
AR
N=293,778
≥1 year of data
preceding 1st AR
claim (“index
diagnosis”) with
no AR claim
filed
N=205,090
For children, there were 3,305 SIT
patients matched to 13,151 non-SIT
patients.
No SIT in
prior year
N=204,94
5
No SIT
N=198,729
<2 SIT admin
after index AR
dx N=199,772
≥2 SIT admin
after index AR
dx N=5,173
Hankin et al, Session #274 March 19, 2011 Presented at the 2011 AAAAI
<18 months of
data following 1st
SIT N=1,618
≥ 18 months of
data following 1st
SIT
N=3,555
34
Mean, per-Patient, 18-Month Savings for Children with Newly
Diagnosed AR Who Received versus Did Not Receive SIT
Savings $5,921 per patient
TYPE OF HEALTH
SERVICES
1997-2008
PHARMACY
OUTPATIENT (INCLUDING
SIT)
INPATIENT
TOTAL
TIME FROM SIT INITIATION
3 MONTHS
6 MONTHS
12 MONTHS
-$148
P<.0001
-$589
P<.0001
+$1,505
NS
-$1,008
P<.0001
-$271
P<.0001
-$1,136
P<.0001
-$1,497
NS
-$1,968
P<.0001
-$531
P<.0001
-$2,182
P<.0001
-$3,417
P=.04
-$3,835
P<.0001
18
MONTHS
-$1,166
P<.0001
-$3,256
P<.0001
-$5,463
NS
-$5,921
P<.0001
*Matched on age at AR diagnosis; gender; race/ethnicity; and the presence of asthma,
conjunctivitis, or dermatitis.
There were 3,305 SIT patients matched to 13,151 non-SIT patients
Negative Values Denote Savings Conferred by SIT versus Non-SIT
NS=not significant.
Hankin et al, Session #274 March 19, 2011 Presented at the 2011 AAAAI
35
Cost Savings Seen Despite Suboptimal SIT Duration
Adults (N=1,265)
Only
once
<6
mos
6-12
mos
1-2
yrs
2-3
yrs
3-4
yrs
Adults (N=1,265)
Only 1
N
230
%
18.2%
Cum %
18.2%
<6 months
379
30.0%
48.2%
6 to <12 months
127
10.0%
58.2%
1 to <2 years
170
13.4%
71.6%
2 to <3 years
121
9.6%
81.2%
3 to <4 years
67
5.3%
86.5%
≥4 years
171
13.5%
100.0%
Mean (SD)
552 days (761)
Median
217 days
>4
yrs
Children (N=2,886)
Only 1
29.6%
Children (N=2,886)
13.6%
11.6%
16.0%
11.7%
11.2%
6.3%
Only
once
<6
mos
6-12
mos
1-2
yrs
2-3
yrs
3-4
yrs
Only
18.8% of
adults
completed
a 3-year
course of
SIT
>4
yrs
N
334
%
11.6%
Cum %
11.6%
<6 months
854
29.6%
41.2%
6 to <12 months
392
13.6%
54.8%
1 to <2 years
462
16.0%
70.8%
2 to <3 years
338
11.7%
82.5%
3 to <4 years
183
6.3%
88.8%
≥4 years
323
11.2%
100.0%
Mean (SD)
554 days (653)
Median
296 days
Only
17.5% of
children
completed
a 3-year
course of
SIT
Building the Case for Multiallergen Immunotherapy
Efficacy
• Published controlled studies suggest that:
– Effective SIT is associated with significant cost-savings
– Reductions in costly health services e.g. ER, hospitalization even if
no significant change in primary clinical outcomes
• Multiallergen IT is the ‘rule’ in the US
– Retrospective claims data analysis of a large US population
comparing newly diagnosed AR patients
• Found 30-40% reduction in total health costs in pts who
received SIT vs. those who did not
• Reduction in outpatient & pharmacy costs suggests reduced
symptoms & medications
• Reduced hospitalization costs in the adults but not children:
had the disease marched?????
Preventing the progression of the
allergic disease
Allergy-related Illness Allergic Rhinitis versus no
Allergic Rhinitis in Pediatric Population
100%
91%
75%
50%
67%
47%
46%
38%
37%
29%
25%
22%
20%
13%
10%
9%
9%
3%
5% 7%
0%
AR
Mean (SD) Number of
No AR
Allergy related illness
AR (N=205,090)
3.7(1.9)
No AR (N=3,301,854)
1.1(1.5)
P<0.0001 between AR vs no AR
From Florida Medicaid 1997-2008 adult and pediatric database not published
Allergy-related Illness AR versus no AR in Adults:
Acute Respiratory Infections
Diagnosis (ICD-9 CM)
AR patients
(N=61,598)
No AR patients
(N=2,917,148)
464: Acute laryngitis and
tracheitis
12.0 times more likely
(OR=11.969 95%CI 11.552-12.402 p<0.0001)
18.3 times more likely
(OR=18.267 95%CI 17.932-18.608 p<0.0001)
11.9 times more likely
(OR=11.895 95%CI 11.687-12.106 p<0.0001)
10.6 times more
(OR=10.616 95%CI 10.310-10.931 p<0.0001)
12.8 times more likely
(OR=12.788 95%CI 12.151-13.459 p<0.0001)
382: Suppurative and
unspecified otitis media
10.9 times more likely
(OR=10.939 95%CI 10.696-11.189 p<0.0001)
466: Acute bronchitis and
bronchiolitis
11.2 times more likely
(OR=11.180 95%CI 10.992-11.371 p<0.0001)
460: Acute nasopharyngitis
461: Acute sinusitis
462: Acute pharyngitis
463: Acute tonsillitis
From Florida Medicaid 1997-2008 adult and pediatric database not published
40
SIT as Preventive Care in US
2010 Patient Protection and Affordable Care Act (PPACA)
 Mission: to identify and reduce the incidence of
preventable chronic illness and disability
 “Preventive Clinical Services” designation based on EB
methods to evaluate the expected net health associated
with delivery of a specified service
 As of September 2010, all new insurance policies fully
cover preventive care services that receive a grade of A
or B
o No patient co-pays or deductibles can be applied to the
cost for these services
SIT as Preventive Care: AAAAI/ACAAI
Response
• Specific Allergen
Immunotherapy: A Model of
Preventive Care for a Large
Segment of the United States
Population. Ira Finegold, MD,
Linda Cox, MD, Cheryl Hankin,
PhD:
• Final draft completed 2/27/2011
approved and submitted by
AAAAI/ACAAI/JCAAI
Pediatric IMAGINE AIRE Study In Progress
ALL Medicaid-enrolled patients July 1997- June 2009 (N=7,524,231 )
Patients diagnosed with AR (477.x) in childhood: AR-Diagnosed patients < 18 years at 1st
AR claim (“index AR diagnosis”) (N= 330,993 )
No premorbid asthma: Pts who had no asthma
diagnosis (493.x) > 1 year prior to their index
AR diagnosis (N= 117,273 )
1st De novo IT in childhood: Patients < 18
years at 1st IT (N= 1,960 )
B. Remaining pool of patients with
AR diagnosed in childhood who had
no premorbid or concomitant
asthma or confounding diagnoses,
never received IT, and did not receive
their 1st asthma diagnosis during
pregnancy (N= 100,282 )
Had >3 years follow-up data after 2nd IT
administration (N=981 )
A. Remaining pool of patients with AR diagnosed in childhood who had no premorbid
or concomitant asthma or counfounding diagnoses, received de novo active IT in
childhood, and did not receive their 1st asthma diagnosis during pregnancy (N= 981 )
Study in progress: funded by JCAAI
Allergen Immunotherapy Quality Measures
• ABAI/AAAAI/ACAAI a task force: specific measures can
use to demonstrate that they are providing care c/w
the Allergen Immunotherapy Practice Parameters
• Example: “Was patient reassessed for
immunotherapy efficacy within 12 months of
commencing treatment?
• This quality indicator would be presented as the
number of patients assessed within 12 months of
commencing SIT divided by all appropriate patients.
• The definition of appropriate patients would be
determined a priori by the specialty task force
Efficacy Data That Could be Collected Through a ABAI
Module Registry
Measure
Registry to assess the following
questions
Was patient reassessed for Immunotherapy a. Assess symptom improvement
efficacy within twelve months of starting
b. Validated questionnaire at monthly inter
immunotherapy treatment?
intervals to determine improvement
c. Assess medication use(possibly quantify)
Numerator- Number of patients who
while on IT
have consistently received SIT over
 Antihistamine- daily, several days/
past year with at least one injection
within past month who have been
week, weekly, several times per
reassessed within one year
month monthly
Denominator: All patients who have
 Nasal ICS- daily, several days/ week,
started SIT within the past year and
weekly, several times per month,
have received at least one injection
monthly
within 3 past months
d. Assess sleep improvement
Cox, et al Allergen immunotherapy practice in the United States : guidelines, measures, and
outcomes Ann Allergy Asthma Immunol. 2011 Nov in press
‘Real Life’ Experience Suggest Multiallergen
Immunotherapy is Effective
• Efficacy supported by
– Reduced 18 month health care costs & utilization associated
SIT demonstrated in a large US study , where 8 allergen
mixtures is the average
• Studies of the Florida Medicaid database in progress :
– Evaluate what specific component of health care costs are
reduced (e.g., which medications, what type of hospitalization
etc.)
– Does SIT prevent allergic rhinitis co-morbid conditions and if
so which ones?
– Does SIT in newly prevent asthma?
The SIT that will be answering these questions is multiallergen