tactics-timi 18 economics & hrqol treat angina with aggrastat and determine cost of therapy with...

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


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


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


Initial Hosp Follow-up

$17,523

$6,737

$15,527

$8,128


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


$18,139

$7,039

$11,212

$6,656

$13,234

$5,704

$16,602

$8,533


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

($)


$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



$14,634

$6,074

$13,109

$7,620


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


$16,950

$4,377

$14,726

$5,829


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


$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


$16,691

$7,514

$13,701

$5,485

$13,481

$7,492


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

($)


$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


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

tactics-timi 18 economics & hrqol treat angina with aggrastat and determine cost of therapy with...

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