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TACTICS-TIMI 18 Economics & HRQOL

TACTICS-TIMI 18 Economics & HRQOL. T reat Angina with A ggrastat and Determine C ost of T herapy with an I nvasive or C onservative S trategy . Economic & QoL Substudy. Economic Data Coordination William Weintraub, MD, Steven Culler, PhD

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TACTICS-TIMI 18 Economics & HRQOL

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  1. TACTICS-TIMI 18 Economics & HRQOL Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy

  2. Economic & QoL Substudy Economic Data Coordination William Weintraub, MD, Steven Culler, PhD Emory University Elizabeth Mahoney, ScD Claudine Jurkovitz, MD, MPH Edmund Becker, PhD Karen Parker, BS Haitao Chu, MS John Spertus, MD, MPH TIMI Study Group Christopher Cannon, MD Brigham & Women’s Hospital Carolyn McCabe, BS Eugene Braunwald, MD Sponsor - Merck: Charles Alexander, MD Laura Demopoulos, MD John Cook, PhD Peter DiBattiste, MD Paul DeLucca, PhD Soma Nag, MS Debbie Robertson, RD MS

  3. Study Background and Goal • Unstable angina and non-ST elevation MI: 1.3 million hospital admissions/year in the US alone • Since society cannot afford to pay for all possible medical services, and since both the costs and benefits of services vary, decisions should consider cost. • This is the first prospective evaluation of the cost of an invasive vs conservative strategy in UA/NSTEMI

  4. TACTICS-TIMI 18 Study Design PCI/ CABG N=2220 total N=1722 US non VA Early Invasive Angio Medical Rx UA/ NSTEMI ASA, Hep,Tirofiban Endpoints Early Conservative Baseline Troponin Medical Rx ETT +ischemia Chest pain Cath/ PCI/ CABG Randomize - 24 hrs Hour 0 6 mos 4 - 48 108 hrs hrs

  5. Cardiac Events at 6 Months CONS (%) INV (%) OR P value No. Pts 1o Endpoint Death/MI Death MI Rehosp ACS 1106 19.4 9.5 3.5 6.9 13.7 1114 15.9 7.3 3.3 4.8 11.0 0.78 0.74 0.93 0.67 0.78 0.025 0.0498 0.74 0.029 0.054

  6. Hypothesis: Costs over a six month period will be similar with an invasive or conservative approach to UA/NSTEMI Economic Study

  7. 1o Endpoint:Total6 month costs(hospital, professional, meds, ER, ER, outpatient procedures, nursing home, rehab, visiting nurse, indirect) Power: Equivalence design with 80% power: the treatments will be judged equivalent if the 90% CI for the true cost difference lies within the equivalence region (-$1200, $1200) C-E Analysis : If one strategy is found to be both more costly and more effective than another, determine the incremental cost-effectiveness 2o Endpoints: Initial hospitalization costs(hospital plus professional) 30-day costs Quality of Life Economic Methods

  8. Economic Methods Cost • Hospital Costs: UB92 formulation of hospital bill (93% complete for initial hospitalization) • Physician Costs: Model based on share of hospital bill by DRG • Outpatient Costs: Medicare Fee Schedule • Medication Costs: Average Wholesale Price • Indirect Costs: Lost wages estimated Quality of Life • Angina: Seattle Angina Questionnaire • Utility: Health Utilities Index

  9. Cost of Initial Hospitalization Difference between groups = $1,994 (95% C.I. $688, $3329) 16,000 $14,660 14,000 $12,667 $3,372 12,000 $3,047 10,000 Professional Cost ($) 8,000 Costs 6,000 Hospital $11,288 $9,619 Costs 4,000 2,000 0 Invasive Conservative

  10. 8000 $7,203 7000 $6,063 $2,187 6000 $2,033 5000 Indirect $1,125 Cost ($) 4000 Other Direct $1,120 3000 Rehosp 2000 $3,891 $2,910 1000 0 Invasive Conservative 6 Month Follow-Up Costs Difference -$1,140 (95% C.I. -$2165, -$50)

  11. 25,000 $20,616 $19,987 20,000 $6,063 $7,203 15,000 Cost ($) Follow-up 10,000 $14,553 $12,784 Initial Hosp 5,000 0 Invasive Conservative Primary Endpoint: Total Costs 6 Months  Events = -35/1000 patients  Cost = $629 (95% CI: -$1273, $2465) (90% CI: -$912, $2162)

  12. Effect of Troponin Status on 6 Month Primary Events & Costs Troponin + Troponin - Events = +24/1000 pts Events = -99/1000 pts Cost = $924 (95% CI: -$2043, $3654) Cost = $605 (95% CI: -$2466, $3466) $24,260 $23,655 $6,737 $8,128 $16,506 $15,582 Total Cost ($) $5,410 $6,179 $17,523 $15,527 $11,096 $9,403 Invasive Conservative Invasive Conservative Initial Hosp Follow-up

  13. Effect of ST Segment Status on 6 Month Primary Events & Costs ST Segment + ST Segment - Events = -99/1000 pts Events = +3/1000 pts Cost = $42 (95% CI: -4801, 4050) Cost = $1070 (95% CI: -772, 2887) $25,178 $25,135 $18,938 $17,868 $7,039 $8,533 Total Cost ($) $5,704 $6,656 $18,139 $16,602 $13,234 $11,212 Invasive Conservative Invasive Conservative Initial Hosp Follow-up

  14. Effect of Gender on 6 Month Primary Events & Costs Male Female Events = -41/1000 pts Events = -26/1000 pts Cost = $21 (95% CI: -2105, 2073) Cost = $1,748 (95% CI: -2163, 4760) $20,708 $20,729 $20,463 $18,715 $6,074 $6,045 $7,620 $6,489 Total Cost ($) $14,634 $14,418 $13,109 $12,226 Invasive Conservative Invasive Conservative Initial Hosp Follow-up

  15. Effect of Age on 6 Month Primary Events & Costs Age > 65 Age < 65 Events = -46/1000 pts Events = -29/1000 pts Cost = $772 (95% C.I. -2377, 3668) Cost = $518 (95% C.I. -1976, 2596) $21,327 $20,555 $20,033 $19,515 $4,377 Total Cost ($) $5,829 $7,444 $8,343 $16,950 $14,726 $12,589 $11,172 Invasive Conservative Invasive Conservative Initial Hosp Follow-up

  16. Effect of Diabetes on 6 Month Primary Events & Costs Diabetes No Diabetes Events = -76/1000 pts Events = -22/1000 pts Cost = $3,232 (95% CI: -676, 6573) Cost = -$406(95% CI: -2458, 1746) $24,205 $20,973 $19,186 $19,592 $7,514 Total Cost ($) $7,492 $5,485 $7,088 $16,691 $13,481 $13,701 $12,504 Invasive Conservative Invasive Conservative Initial Hosp Follow-up

  17. Multivariate Predictors of Total Six Month Costs R2 = 0.070

  18. Utility, Life Years andQuality-Adjusted Life Years (QALYs) Invasive Conservative  0.022 0.006 0.006 -0.002 -0.006 p-value 0.20 0.71 0.70 0.56 0.48 Utility: Baseline 30 Day 6 Month Life Years QALYs 0.664 0.746 0.761 0.486 0.358 0.642 0.740 0.755 0.488 0.364

  19. Utility 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

  20. Seattle Angina Scores Invasive Conservative BL 6M BL 6M Physical Functioning Angina Stability Angina Frequency Treatment Satisfaction Quality of Life 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

  21. Summary • Total 6 month costs are similar in the two treatment arms • Initial hospital costs are higher with an invasive strategy • Follow-up costs are higher with a conservative strategy • ST+ & Troponin+ subgroups show greater benefit at similar six month cost

  22. Conclusion In UA/NSTEMI treated with GPIIb/IIIa blockade: The benefit of the invasive strategy is achieved without an economically relevant increase in cost

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