tactics-timi 18 economics & hrqol treat angina with aggrastat and determine cost of therapy with...
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TACTICS-TIMI 18TACTICS-TIMI 18Economics & HRQOLEconomics & HRQOL
TTreat Angina with reat Angina with AAggrastat and ggrastat and Determine Determine CCost of ost of TTherapy with herapy with
an an IInvasive or nvasive or CConservative onservative SStrategy trategy
Economic Data CoordinationEconomic Data Coordination William Weintraub, MD, William Weintraub, MD, Steven Culler, PhD Steven Culler, PhD
Emory UniversityEmory University Elizabeth Mahoney, ScD Elizabeth Mahoney, ScD Claudine Jurkovitz, MD, MPH Claudine Jurkovitz, MD, MPH
Edmund Becker, PhDEdmund Becker, PhD Karen Parker, BS Karen Parker, BS
Haitao Chu, MSHaitao Chu, MS John Spertus, MD, MPHJohn Spertus, MD, MPH
TIMI Study GroupTIMI Study Group Christopher Cannon, MD Christopher Cannon, MD
Brigham & Women’s HospitalBrigham & Women’s Hospital Carolyn McCabe, BS Carolyn McCabe, BS
Eugene Braunwald, MDEugene Braunwald, MD
Sponsor - Merck:Sponsor - Merck: Charles Alexander, MD Charles Alexander, MD Laura Demopoulos, MDLaura Demopoulos, MD
John Cook, PhD John Cook, PhD Peter DiBattiste, MDPeter DiBattiste, MD
Paul DeLucca, PhD Paul DeLucca, PhD Soma Nag, MSSoma Nag, MS
Debbie Robertson, RD MSDebbie Robertson, RD MS
Economic & QoL SubstudyEconomic & QoL Substudy
Unstable angina and non-ST elevation MI: 1.3 Unstable angina and non-ST elevation MI: 1.3 million hospital admissions/year in the US alonemillion hospital admissions/year in the US alone
Since society cannot afford to pay for all Since society cannot afford to pay for all possible medical services, and since both the possible medical services, and since both the costs and benefits of services vary, decisions costs and benefits of services vary, decisions should consider cost.should consider cost.
This is the first prospective evaluation of the This is the first prospective evaluation of the cost of an invasive vs conservative strategy in cost of an invasive vs conservative strategy in UA/NSTEMIUA/NSTEMI
Study Background and GoalStudy Background and Goal
TACTICS-TIMI 18 Study DesignTACTICS-TIMI 18 Study Design
UA/NSTEMI
EarlyInvasive
EarlyConservative
PCI/ CABG
Cath/ PCI/ CABG
Medical Rx
Medical Rx
Endpoints
6 mos
Randomize- 24 hrs
Chest pain
4 - 48 108 hrs hrs
ASA, Hep,Tirofiban
Angio
Hour 0
ETT
+ischemia
BaselineTroponin
N=2220 totalN=1722 US non VA
No. Pts
1o Endpoint
Death/MI
Death
MI
Rehosp ACS
1114
15.9
7.3
3.3
4.8
11.0
1106
19.4
9.5
3.5
6.9
13.7
P valueINV (%)CONS (%)
Cardiac Events at 6 MonthsCardiac Events at 6 Months
0.78
0.74
0.93
0.67
0.78
OR
0.025
0.0498
0.74
0.029
0.054
Economic StudyEconomic StudyEconomic StudyEconomic Study
Hypothesis:Hypothesis:
Costs over a six month period Costs over a six month period will be similar with an invasive will be similar with an invasive or conservative approach to or conservative approach to
UA/NSTEMIUA/NSTEMI
Economic MethodsEconomic MethodsEconomic MethodsEconomic Methods
11oo Endpoint:Endpoint: TotalTotal 6 month costs6 month costs (hospital, professional, meds, ER,(hospital, professional, meds, ER,ER, outpatient procedures, nursing home, rehab, visiting ER, outpatient procedures, nursing home, rehab, visiting
nurse, indirect)nurse, indirect)
Power:Power: Equivalence design with 80% power:Equivalence design with 80% power:the treatments will be judged equivalent if the 90% the treatments will be judged equivalent if the 90%
CI for the true cost difference lies within CI for the true cost difference lies within the the equivalence region (-$1200, $1200)equivalence region (-$1200, $1200)
C-E Analysis :C-E Analysis : If one strategy is found to be both more costly and If one strategy is found to be both more costly and more effective than another, determine the more effective than another, determine the
incremental cost-effectivenessincremental cost-effectiveness
22oo Endpoints: Endpoints: Initial hospitalization costsInitial hospitalization costs (hospital plus professional)(hospital plus professional)
30-day costs30-day costsQuality of LifeQuality of Life
Economic MethodsEconomic MethodsEconomic MethodsEconomic Methods
CostCost Hospital Costs: UB92 formulation of hospital billHospital Costs: UB92 formulation of hospital bill
(93% complete for initial hospitalization)(93% complete for initial hospitalization) Physician Costs: Model based on share of hospital Physician Costs: Model based on share of hospital
bill by DRGbill by DRG Outpatient Costs: Medicare Fee ScheduleOutpatient Costs: Medicare Fee Schedule Medication Costs: Average Wholesale PriceMedication Costs: Average Wholesale Price Indirect Costs: Lost wages estimatedIndirect Costs: Lost wages estimated
Quality of LifeQuality of Life Angina: Seattle Angina Questionnaire Angina: Seattle Angina Questionnaire Utility: Health Utilities IndexUtility: Health Utilities Index
Cost of Initial HospitalizationCost of Initial Hospitalization
ProfessionalCosts
HospitalCosts
Difference between groups = $1,994 (95% C.I. $688, $3329)
$9,619
$3,372
$3,047
$11,288
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
Invasive Conservative
Co
st (
$)
$14,660
$12,667
6 Month Follow-Up Costs6 Month Follow-Up Costs
Indirect
Other Direct
Rehosp
Difference -$1,140 (95% C.I. -$2165, -$50)
$2,910$3,891
$1,120
$1,125$2,033
$2,187
0
1000
2000
3000
4000
5000
6000
7000
8000
Invasive Conservative
Co
st (
$)
$6,063
$7,203
Primary Endpoint: Total Costs 6 MonthsPrimary Endpoint: Total Costs 6 Months
Follow-up
Initial Hosp
$14,553$12,784
$6,063$7,203
0
5,000
10,000
15,000
20,000
25,000
Invasive Conservative
Co
st (
$)
$20,616 $19,987
Events = -35/1000 patients
(90% CI: -$912, $2162)
Cost = $629 (95% CI: -$1273, $2465)
Cost = $605 (95% CI: -$2466, $3466)
Effect of Troponin Status on Effect of Troponin Status on 6 Month Primary Events & Costs6 Month Primary Events & Costs
$11,096
$5,410
$9,403
$6,179
Invasive Conservative
Initial Hosp Follow-up
$17,523
$6,737
$15,527
$8,128
Invasive Conservative
Troponin +
Events = -99/1000 ptsCost = $924 (95% CI: -$2043, $3654)
Troponin -Events = +24/1000 pts
$24,260 $23,655
$16,506 $15,582
Tot
al C
ost
($)
Effect of ST Segment Status on Effect of ST Segment Status on 6 Month Primary Events & Costs6 Month Primary Events & Costs
Invasive Conservative
$18,139
$7,039
$11,212
$6,656
$13,234
$5,704
$16,602
$8,533
Invasive Conservative
Cost = $42 (95% CI: -4801, 4050)
ST Segment +
Events = -99/1000 ptsCost = $1070 (95% CI: -772, 2887)
ST Segment -
Events = +3/1000 pts
Tot
al C
ost
($)
Initial Hosp Follow-up
$25,178 $25,135
$18,938 $17,868
Effect of Gender on Effect of Gender on 6 Month Primary Events & Costs6 Month Primary Events & Costs
$14,418
$6,045
$12,226
$6,489
Invasive Conservative
Initial Hosp Follow-up
$14,634
$6,074
$13,109
$7,620
Invasive Conservative
Cost = $21 (95% CI: -2105, 2073) Cost = $1,748 (95% CI: -2163, 4760)
Male FemaleEvents = -41/1000 pts Events = -26/1000 pts
Tot
al C
ost
($) $20,708 $20,729 $20,463 $18,715
$12,589
$7,444
$11,172
$8,343
Invasive Conservative
$16,950
$4,377
$14,726
$5,829
Invasive Conservative
Tot
al C
ost
($)
Cost = $772 (95% C.I. -2377, 3668) Cost = $518 (95% C.I. -1976, 2596)
Age > 65 Age < 65Events = -46/1000 pts Events = -29/1000 pts
Effect of Age on Effect of Age on 6 Month Primary Events & Costs6 Month Primary Events & Costs
Initial Hosp Follow-up
$21,327 $20,555 $20,033 $19,515
Effect of Diabetes on Effect of Diabetes on 6 Month Primary Events & Costs6 Month Primary Events & Costs
$12,504
$7,088
Invasive Conservative
$16,691
$7,514
$13,701
$5,485
$13,481
$7,492
Invasive Conservative
Cost = $3,232 (95% CI: -676, 6573)
Diabetes
Events = -76/1000 pts
Cost = -$406 (95% CI: -2458, 1746)
No DiabetesEvents = -22/1000 pts
Tot
al C
ost
($)
Initial Hosp Follow-up
$24,205
$20,973 $19,186 $19,592
CoefficientCoefficient t valuet value p valuep value
InterceptIntercept 14,07214,072 16.2516.25 <.0001<.0001
Troponin Troponin 0.01 0.01 6,9786,978 6.646.64 <.0001<.0001
ST ShiftST Shift 5,9495,949 5.095.09 <.0001<.0001
DiabetesDiabetes 3,0213,021 2.662.66 .08.08
RR2 2 = 0.070= 0.070
Multivariate Predictors Multivariate Predictors of Total Six Month Costsof Total Six Month Costs
p-value
0.200.710.70
0.56
0.48
0.6640.7460.761
0.486
0.358
0.6420.7400.755
0.488
0.364
Invasive Conservative
0.0220.0060.006
-0.002
-0.006
Utility: Baseline30 Day6 Month
Life Years
QALYs
Utility, Life Years andUtility, Life Years andQuality-Adjusted Life Years (QALYs)Quality-Adjusted Life Years (QALYs)
Utility and Cost-Utility AnalysisUtility and Cost-Utility Analysis
Fewer Cardiovascular Events With Invasive Strategy
However:• No significant difference in Cost• No significant difference in Survival• No significant difference in Utility
Thus:• Marginal Cost/QALY with Invasive vs Conservative
Strategy Cannot be Reliably Estimated
Seattle Angina ScoresSeattle Angina Scores
Physical Functioning
Angina Stability
Angina Frequency
Treatment Satisfaction
Quality of Life
Invasive Conservative 6M6M BLBL
74
44
65
91
56
10.3
32.6
22.3
0.40
21.2
74
45
65
90
56
11.4
32.4
22.1
0.54
21.0
SummarySummary
Total 6 month costs are similar in the two Total 6 month costs are similar in the two treatment armstreatment arms Initial hospital costs are higher with an Initial hospital costs are higher with an invasive strategyinvasive strategy
Follow-up costs are higher with a Follow-up costs are higher with a conservative strategyconservative strategy
ST+ & Troponin+ subgroups show greaterST+ & Troponin+ subgroups show greater
benefit at similar six month costbenefit at similar six month cost
ConclusionConclusion
In UA/NSTEMI treated withIn UA/NSTEMI treated with
GPIIb/IIIa blockade: The benefitGPIIb/IIIa blockade: The benefit
of the invasive strategy isof the invasive strategy is
achieved without an economicallyachieved without an economically
relevant increase in costrelevant increase in cost