Cost-Effectiveness of

Drug-Eluting Stents in 2005:

Insights from Recent Clinical Trials
and the Real World

David J. Cohen, M.D., M.Sc.

Beth Israel Deaconess Medical Center
Harvard Clinical Research Institute, Boston MA
 Disclosures

Equity
– None

Grant Support/Drugs
– Millenium - Eli Lilly
– The Medicines Co. - BMS/Sanofi
– CV Therapeutics

Grant Support/Devices
– Cordis - Guidant
– Boston Scientific - Medtronic
– Edwards Lifesciences - Worldheart

DJC: 3/05
Cost-Effectiveness of Drug-Eluting Stents

•• Do
Do they
they save
save money?
money?

•• Do
Do they
they save
save lives?
lives?

•• Do
Do they
they improve
improve quality
quality of
of life?
life?

•• Are
Are they
they cost-effective (for
cost-effective (for which
which patients)?
patients)?

•• What ’s changed
What’s changed in
in 2005?
2005?
Medicare PCI 1998-9

Repeat Revascularization in the BMS Era

20%
N=11,920
Any
16.2%
15%

12.7%
Estimated
Estimated clinical
clinical restenosis
restenosis rate
rate PCI
10% == 0.85
0.85 ** 16.2%
16.2% == 13.8%
13.8%

5%
4.2%
CABG

1 2 3 4 5 6 7 8 9 10 11
Time from Index Procedure (months) Clark MA et al. Circ 2004
Medicare PCI 1998-99

Mean 1-year F/U Cost per Patient

$30,000
$23,808±19,506
MD Services “Attributable”
$25,000 “Attributable” cost
cost of
of
Outpatient restenosis
restenosis =$18,944
=$18,944
Inpatient (95%
(95% CI,
CI, $18,410-
$18,410-
$20,000
$19,477
$19,477 )*)*
Δ = $19,721
** After
After risk
riskadjustment
adjustment
$15,000

$10,000 Economic
Economic Burden
Burden of
of
Restenosis
Restenosis
$4,087±9,528 == $18,944
$5,000 $18,944 *13.8%
*13.8%
== $2550/PCI
$2550/PCI patient
patient
$0
Restenosis No Restenosis
Principles of Economic Evaluation

Cost-Saving ≠ Cost-Effective

• Fact: Very few modern medical innovations

actually save money
• A new treatment may still be “cost-effective” if its
benefits are “worth the cost”
– It may cost slightly more than the alternative
– It improves life expectancy or quality adjusted life
expectancy for the patient
– The cost per additional quality adjusted year of life
gained will be competitive with other potential uses
for the same health care dollar
Cost-Effectiveness of Drug-Eluting Stents

•• Do
Do they
they save
save money?
money?

•• Do
Do they
they save
save lives?
lives?

•• Do
Do they
they improve
improve quality
quality of
of life?
life?

•• Are
Are they
they cost-effective (for
cost-effective (for which
which patients)?
patients)?

•• What ’s changed
What’s changed since
since 2003?
2003?
Do Drug-Eluting Stents Save Lives?

Babapulle MN et al. Lancet 2004;364:583-91

Stent PAMI

Impact of Restenosis on Quality of Life

100

No TVR

TVR

80
Δ=10.1
Δ=10.1
P<0.001
P<0.001

60 Δ=10.0 Δ=7.8
Δ=10.0 Δ=7.8
P<0.001
P<0.001 P=0.006
P=0.006
Δ=6.4
Δ=6.4 Δ=14.5
Δ=14.5
P=0.03
P=0.03 P=0.008
P=0.008
40
SAQ anginal SAQ disease SF-36 Bodily SF-36 Vitality SF-36 Role
freq burden Pain Physical
Rinfret SA et al. J Am Coll Cardiol 2001;38:1614021
Cost-Effectiveness of Drug-Eluting Stents

•• Do
Do they
they save
save money?
money?

•• Do
Do they
they save
save lives?
lives?

•• Do
Do they
they improve
improve quality
quality of
of life?
life?

•• Are
Are they
they cost-effective (for
cost-effective (for which
which patients)?
patients)?

•• What ’s changed
What’s changed since
since 2003?
2003?
Economics of Restenosis

Cost-Effectiveness Measures

Cost
Cost per
per quality -adjusted year
quality-adjusted year of
of life
life gained
gained
•• Standard
Standardmetric
metricfor
forCEA
CEA
•• Allows
Allows comparison
comparisonacross
acrossdifferent
differentdiseases
diseases
•• C/E
C/E threshold
threshold of
of ~$50,000
~$50,000reasonably
reasonablywell-accepted (dialysis
well-accepted (dialysis
benchmark)
benchmark)

Cost
Cost per
per repeat
repeat revascularization
revascularization avoided
avoided
•• Readily
Readilymeasured
measuredinin both
both clinical
clinical trials
trials and
andobservational
observational
studies
studies
•• Interpretable
Interpretableto
toboth
bothpatients
patientsand
andclinicians
clinicians
•• Appropriate
Appropriatethreshold
threshold within
withinU.S.
U.S.healthcare
healthcaresystem
systemless
less
well -defined (?
well-defined (? $10,000
$10,000 per
perrepeat
repeatrevasc
revascavoided)
avoided)
 Cost-Effectiveness of DES in 2003:
Impact of Bare Metal Stent TVR Rate

Healthcare system perspective

$25,000
2003 Model Assumptions
Cost per repeat revasc avoided

• TVR risk reduction 75%

$20,000
• Incremental DES cost =
$2000/stent
$15,000
• 1.4 stents/pt

$10,000
Conclusions
Conclusions
$5,000 •• DES
DES reasonably
reasonably cost-cost-
effective
effective ifif bare
bare stent
stent
TVR
TVR rate
rate >> 12%
12%
$0
5% 10% 15% 20% 25%
TVR rate with bare stent
Cost-Effectiveness of Drug-Eluting Stents

•• Do
Do they
they save
save money?
money?

•• Do
Do they
they save
save lives?
lives?

•• Do
Do they
they improve
improve quality
quality of
of life?
life?

•• Are
Are they
they cost-effective (for
cost-effective (for which
which patients)?
patients)?

•• What ’s changed
What’s changed since
since 2003?
2003?
DES Econ Update 2005

Relative U.S. Stent Prices

$4,000
DES
Δ=$2,000
BMS
Δ=$1,900
$3,000
$3,100 Δ=$1,600
$2,700

$2,000 $2,300

$1,000
$1,100
$800
$700

$0

2003 2004 2005

BIDMC 2003-2005

DES Use per Case

2.0

Raw
1.8 Case-Mix Adjusted

1.6

1.4

1.2
3-month moving average

1.0
3/03 6/03 9/03 12/03 3/04 6/04 9/04 12/04
Month
 Improving DES Efficacy:
“New” vs. “Old” SIRIUS:

Old SIRIUS New SIRIUS

44.2%

36.3%

75% ↓
88% ↓
20.9%
16.6%
75% ↓
8.9% 82% ↓
5.1%
4.1% 3.1%
In-Stent In-Segment TLR In-Stent In-Segment TLR
Restenosis Restenosis Restenosis Restenosis
 Cost-Effectiveness of Drug-Eluting Stents:
2005 vs. 2003

Healthcare system perspective

$25,000
New Assumptions
Cost per repeat revasc avoided

$20,000 • Incremental cost per

DES = $1600
$15,000 • DES per case = 1.6
(case-mix adjusted)
$10,000 • 82% reduction in
TVR with DES vs.
$5,000 BMS

$0
5% 10% 15% 20% 25%

TVR rate with uncoated stent

 Predicted Clinical Restenosis Rate
Diabetes
Vessel Lesion Length
Diameter 10 mm 15 mm 20 mm 25 mm 30 mm
2.5 mm 23% 26% 29% 31% 34%
3.0 mm 15% 17% 20% 22% 24%
3.5 mm 10% 11% 13% `5% 16%
4.0 mm 6% 7% 8% 9% 10%

No Diabetes
2.5 mm 18% 20% 22% 25% 27%
3.0 mm 11% 13% 15% 17% 18%
3.5 mm 7% 8% 10% 11% 12%
4.0 mm 4% 5% 5% 7% 7%

Adapted from Ho KKL et al. AHA 1998

 Expected Cost-Effectiveness- 2003
Diabetes
Vessel Lesion Length
Diameter 10 mm 15 mm 20 mm 25 mm 30 mm
2.5 mm 23% 26% 29% 31% 34%
3.0 mm 15% 17% 20% 22% 24%
3.5 mm 10% 11% 13% 15% 16%
4.0 mm 6% 7% 8% 9% 10%

No Diabetes
2.5 mm 18% 20% 22% 25% 27%
3.0 mm 11% 13% 15% 17% 18%
3.5 mm 7% 8% 10% 11% 12%
4.0 mm 4% 5% 5% 7% 7%
 Expected Cost-Effectiveness- 2005
Diabetes
Vessel Lesion Length
Diameter 10 mm 15 mm 20 mm 25 mm 30 mm
2.5 mm 23% 26% 29% 31% 34%
3.0 mm 15% 17% 20% 22% 24%
3.5 mm 10% 11% 13% 15% 16%
4.0 mm 6% 7% 8% 9% 10%

No Diabetes
2.5 mm 18% 20% 22% 25% 27%
3.0 mm 11% 13% 15% 17% 18%
3.5 mm 7% 8% 10% 11% 12%
4.0 mm 4% 5% 5% 7% 7%
DES Economics
Unresolved Questions

• Comparative studies of alternative DES designs

• Treatment of multivessel disease

– Can we obtain similar long-term outcomes to CABG, even
for complex patient subsets at a similar (or lower) cost?
– Stay tuned….ARTS II, SYNTAX, FREEDOM

• Should we begin to treat preclinical

disease/vulnerable plaque?
– Can we identify lesion or patient subsets at sufficiently high
risk of near-term events (death, MI) that prophylactic
stenting is both effective and cost-effective?