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ACTIVE A Health Economic Analysis of ACTIVE-A Andre Lamy Wesley Tong Peggy Gao Susan Chrolavicius Salim Yusuf Stuart J Connolly.

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Presentation on theme: "ACTIVE A Health Economic Analysis of ACTIVE-A Andre Lamy Wesley Tong Peggy Gao Susan Chrolavicius Salim Yusuf Stuart J Connolly."— Presentation transcript:

1 ACTIVE A Health Economic Analysis of ACTIVE-A Andre Lamy Wesley Tong Peggy Gao Susan Chrolavicius Salim Yusuf Stuart J Connolly

2 ACTIVE Role of the Sponsor The ACTIVE A trial and this economic analysis were funded by grants from sanofi-aventis and Bristol- Myers Squibb. The authors had free access to the complete study data and performed all of the analyses independently.

3 ACTIVE The ACTIVE A trial The Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events – Aspirin trial Clopidogrel with aspirin (C+A) vs aspirin alone For patients with atrial fibrillation unsuitable for vitamin K antagonist 7554 patients in 33 countries AF patients at high risk of stroke N Eng J Med 2009; 360:

4 ACTIVE Stroke Graph courtesy of the ACTIVE group

5 ACTIVE Outcome Clopidogrel + Aspirin AspirinClopidogrel + Aspirin versus Aspirin #rate/ year #rate/ year RR95% CIP Ischemic/Uncertain <0.001 Hemorrhagic Non-disabling (mod. Rankin 0-2) Disabling or fatal (mod. Rankin 3-6) Stroke Types and Severity Table courtesy of the ACTIVE group

6 ACTIVE Summary of Clinical Findings The risk of stroke was reduced by 28% However the risk of major bleeding increased by 57% Most common site was the GI tract. In 1000 patients treated for 3 years, clopidogrel with aspirin will: Prevent 28 strokes (17 fatal/disabling) Prevent 6 Myocardial Infarctions Result in 20 major bleeds (3 fatal)

7 ACTIVE ACTIVE-A Economic Analysis Clopidogrel + aspirin shown to reduce stroke risk but increase risk of bleeding Objective: To determine the economic impact of adding clopidogrel to aspirin in the ACTIVE-A population

8 ACTIVE Design In-trial analysis Study time horizon used (average follow-up: 3.6 years) Only direct medical costs Based on utilization data from CRFs Canadian healthcare perspective All costs in 2008 CAD Discounted at 3% per year Hypothesis: Clopidogrel + aspirin is cost neutral compared to aspirin alone.

9 ACTIVE Cost Components Average Cost Per Patient Procedures Non-study drugs EventsStudy drug Treatments Length of Stay Investigations Drugs HHS OCCP List PriceODB Formulary

10 ACTIVE Cost of Stroke Cost (2008 CAD) Ischemic Stroke$58,277 Hemorrhagic Stroke$61,537 TIA$8,104 Stroke costs include: Hospital Ambulatory care Physician fees Tests and procedures All medications Assistive devices Allied health professionals Home modifications Caregiver expenses Goeree R, Blackhouse G, Petrovic R, Salama S. J Med Econ 2005;8:147-67

11 ACTIVE Unit Costs Cost Myocardial Infarction$9,405PCI with Stent$19,002 CHF$11,262 Catheter/coronary angiography $5,544 non-CNS systemic embolism$10,162CABG$17,951 Unstable angina$4,814Pulmonary embolism$7,006 Minor bleed requiring at least 1 unit of blood $7,235Atrial fibrillation$5,526 GI bleeding with transfusion$7,235

12 ACTIVE Statistical Analysis Bootstrap method (5000 samples) for SE and 95% CI. Bias corrected and accelerated method for confidence intervals Sensitivity Analyses Clopidogrel cost ($2.52/day 2008 CAD) 50% of base 200% of base

13 ACTIVE Results Placebo + Aspirin Mean Cost (CI) Clopidogrel + Aspirin Mean Cost (CI) Incremental Cost Mean Cost (CI) Events $11,464$9,839$1,625 Procedures $815$729$86 Non-study Medication $1,478$1,450$28 Study Medication $0$2,114 Total $13,756 ($13,032, $14,544)$14,132 ($13,445, $14,842)$376 ($645, $1,397) Total, discounted $12,961 ($12,274, $13,697)$13,308 ($12,664, $13,978)$347 ($613, $1,307)

14 ACTIVE Results $13,756 $14,132

15 ACTIVE $13,756$14,132 $16,289 $13,054

16 ACTIVE Limitations Only direct health care costs (mostly hospitalizations) Indirect costs for C+A vs A alone presumably lower due to fewer strokes Wide Confidence Intervals (CI) Due to large standard error in event cost Bootstrapping and jackknife showed similar results Absolute difference in cost is within predefined margins for cost neutrality (+/- 5%)

17 ACTIVE Applicable to the United States? Resource Utilization No likely significant difference as treatments of AF patients are similar. Unit costs Canadian costs are comparable to Medicare costs. Cost of clopidogrel will be the determinant factor between cost-saving, cost-neutral or cost-effective

18 ACTIVE Conclusion Cost of clopidogrel + aspirin not significantly different from aspirin alone Supports the use of clopidogrel + aspirin in patients unsuitable for Vitamin K antagonist therapy in the ACTIVE-A trial

19 ACTIVE

20 Results with CIs Base CaseClopidogrel Cost 50% of Base Clopidogrel Cost 200% of Base Events-$1,625 (-$2,614 - $637) -$1,625 (-$2,613 - $637) Procedures-$86 (-$28 - $109) Non-study medications -$28 (-$80 - $24)-$27 (-$77 - $23)-$31 (-$88 - $26) Study medications $2,114 ($2,073 - $2,155) $1,057 ($1,036 - $1,078)$4,228 ($4,146 – $4,311) Total$376 (-$645 - $1,397)-$680 (-$1,702 - $342)$2,488 ($1,467 – $3,509)

21 ACTIVE Sensitvity Analysis – Drug Cost Base CaseClopidogrel Cost 50% of Base Clopidogrel Cost 200% of Base Events-$1,625 (-$2,613, -$637) Procedures-$86 (-$281, $109) Non-study medications -$28 (-$281, $109)-$27 (-$77, $23)-$31 (-$88, $26) Study medications $2,114 ($2,073, $2,155)$1,057 ($1,036, $1,078)$4,228 ($4,146, $4,310) Total$376 (-$645, $1,397)-$680 (-$1,702, $342)$2,488 ($1,467, $3,509) Total, discounted $347 (-$613, $1,307)-$645 (-$1,606, $312)$2,332 ($1,372, $3,292)

22 ACTIVE Outcome Clopidogrel + Aspirin AspirinClopidogrel + Aspirin versus Aspirin #rate/ year #rate/ year RR95% CIP Major <0.001 Severe <0.001 Fatal Intra-cranial Extra-cranial <0.001 Bleeding Table courtesy of the ACTIVE group

23 ACTIVE Benefits and Risks: Compared to Warfarin Effects Warfarin versus Aspirin Clopidogrel & Aspirin versus Aspirin Meta-analysis* (RRR) ACTIVE A (RRR) Reduction in stroke- 38%-28% Increase in intra-cranial bleed+128%+87% Increase in extra-cranial bleed+70%+51% *Hart RC et al. Meta-analysis: Antithrombotic therapy to prevent stroke in patients who have non-valvular AF. Ann Intern Med 2007: 146: Table courtesy of the ACTIVE group


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