Health Plan Data to Build the
Evidence Base on Use of Targeted
Tests & Therapies:
Example of Breast Cancer
Jennifer Haas, MD, Kathryn Phillips,
Su-Ying Liang, Michael Hassett,
Carol Keohane, Elena Elkin
Academyhealth 2010
“Personalized” Care for Breast Cancer
• Testing/ treatment based on genomic
information.
information
• HER2 testing – trastuzumab treatment
– Established “prototype”
– But, concerns about test performance
• Testing strategy/ availability?
• GEP – adjuvant
dj
t chemotherapy
h
th
– More debate, conflicting data
Prototype
yp for Translation
• HER2:
– ~25%of breast cancers over-express
– Poor prognosis
• Trastuzumab:
– Fast track approval based on survival benefit for
women with
ith HER2-positive
HER2
iti tumor
t
– Well tolerated
– Expensive
• ~ $35,000 for 12-month course
• BUT,
BUT some areas of uncertainty
Gene Expression
p
Profilingg
• Gene expression strongly correlated with
disease-free survival
• OncotypeDX – 21 gene panel
– Genomic Health reports >90,000
>90 000 tests
– ~ $3,500/ test, covered by Medicare since 2006
• Do all women need adjuvant chemotherapy?
Study Procedure
• Claims algorithm to identify cases
• Records
R
d reviewed
i
d by
b 3rd party
t vendor:
d
– Requested charts
• 82% had chart from both med onc and surg onc
– Performed chart abstraction
– Provided de-identified dataset
• Data sources
– Claims
– Charts
– Other: race/ ethnicity, SES
Sample (n=775)
• 36 – 64 years
• New
N ddx off early,
l iinvasive
i breast
b
t cancer, 2006 2007:
• Continuously enrolled
• Coverage:
– HER2 tests, trastuzumab, adjuvant chemo
– OncotypeDX
yp
startingg 12/1/2006
– Variety of plan types
• GEP/ adjuvant chemo: ER+,
ER+ LN-,
LN HER2HER2 or small
HER2+(n= 393)
Demographics
Median
di age:
Race/ ethnicity:
Income
Comorbidity
544 years
White
80%
Black
12%
Hispanic
5%
< $40,000
25%
$40,000 - $74,999
35%
$75,000 - $124,999
23%
> $125,000
17%
0
77%
>2
5%
Demographics
Median
di age:
Race/ ethnicity:
Income
Comorbidity
544 years
White
80%
Black
12%
Hispanic
5%
< $40,000
25%
$40,000 - $74,999
35%
$75,000 - $124,999
23%
> $125,000
17%
0
77%
>2
5%
Tumor Characteristics
Stage:
I
58%
II
33
III
9
ER
Positive
76
HER2
Positive
24
Intermediate
11
Negative
65
High
i h grade
d
37
Results: HER2 testing
• Almost all had a HER2 test (97%):
– 58%
8% received
i d IHC
C alone
l
– 20% received FISH alone
– 22% received both
• No clinical or non-clinical predictors of use
Results: Trastuzumab
60%
58%
50%
Positive
40%
Int.
30%
Negative
egat e
20%
10%
0%
9%
8%
1%
HER2 Status
Not done/
documented
Predictors of Trastuzumab Use Among
HER2+(“appropriate
HER2+(
appropriate use
use”))
Post-meno (vs. pre)
Nonwhite (vs. white)
4.8
< $40,000 (vs >= $125,000)
$40-74,999 (vs >=125,000)
$75,000-124,999
$75,000
124,999 (vs >
>=125,000)
125,000)
Stage II (vs. I)
Stage III (vs
(vs. I)
Suggests fairly global underuse
0.1
1
10
Odds Ratio (95% C.I.)
Adjusted: age, race/ethnicity, income,
comorbidity, stage, surgery, region
Predictors of Trastuzumab Use Among
Non HER2+(“overuse”)
Non-HER2+(
overuse )
Post-meno (vs. pre)
2.5
Nonwhite (vs. white)
< $40,000 (vs >= $125,000)
$40-74,999 (vs >=125,000)
$75,000-124,999
$75,000
124,999 (vs >
>=125,000)
125,000)
Stage II (vs. I)
Stage III (vs
(vs. I)
Not much “overuse” ~ 4%
0.1
1
10
Odds Ratio (95% C.I.)
Adjusted: age, race/ethnicity, income,
comorbidity, stage, surgery, region
Overall Recurrence Score Use = 25%
38.2%
40%
35%
30%
25%
20%
31.0%
27.0%
20.0%
23.3%
15%
10%
5%
0%
Health Plan
p<0.18
NCCN
p<0.01
2006
2007
2008
GEP & Adjuvant Chemo
Overall Chemo Use = 39%
90%
80%
70%
60%
Not done
Low
Medium
High
50%
40%
30%
20%
10%
0%
Adjuvant Chemo
P < 0.001
Predictors of Recurrence Score Use
0.5
05
Nonwhite (vs. white)
0.4
<$40 000 (vs >=125,000)
<$40,000
>=125 000)
0.4
$40,000-74,999
0.5
$75,000-124,999
2.1
Midwest (vs. south)
0.1
1
10
Odds Ratio (95% C.I.)
Adjusted: age, race/ethnicity, income, comorbidity,
stage, surgery, HER2, region
Predictors of Adjuvant Chemo Use
0.5
Non hite (vs.
Nonwhite
( s white)
hite)
0.4
<$40,000 (vs >=125,000)
0.4
$40 000 74 999
$40,000-74,999
0.5
$75,000-124,999
2.1
0.5
Low RS (vs. not done)
7.4
15.6
0.1
1
10 100
Odds Ratio (95% C.I.)
Midwest (vs. south)
Med RS (vs. not done)
High RS (vs. not done)
Adjusted: age, race/ethnicity, income,
comorbidity, stage, surgery, HER2, RS, region
Limitations
• Single health plan, but diverse sites, plan
types
• Only women < 65 years
• Imputed race/ ethnicity/ SES
• Small numbers for GEP
• No information about decision-making
decision making
Conclusions
• HER2 – trastuzumab
– Universal use of HER2 testing
– “Underuse” of trastuzumab
• Need
N d tto understand
d t d ddecision-making
ii
ki
– No evidence of disparities
• GEP – adjuvant chemo
– Modest use of GEP testing.
g
– GEP score associated with use of adjuvant
chemotherapy
– Evidence for disparities
Monitoring Access/Impact of
T
Targeted
t d Tests
T t & Treatments
T t
t
• D
Do th
these new advances
d
measurably
bl improve
i
outcomes in practice?
– Different responses for some groups?
• Does everyone
y
have equal
q access to
beneficial advances?
• In what ways does genomic medicine raise
new or different issues vs. those related to
health care more generally?
– Cost
– Preferences