Table 1.
Cost effectiveness studies based on CURE and PCI-CURE trials for efficacy estimates.
| Author | Study | Comparators | Funding | Health Care System |
Year | Description | Findings |
|---|---|---|---|---|---|---|---|
| Pignone et al18 | Published literature | Aspirin vs no aspirin for primary prevention | Bayer and CDC | US | 2003 | Markov model in men, lifetime time horizon | Aspirin is a dominant strategy compared to no aspirin |
| Greving et al19 | Published literature | Aspirin vs no aspirin for primary prevention | Netherlands Organization for Health Research and Development | Holland | 2005 | Markov model, 10 year time horizon | ICER depended on age and gender and overall risk profile, with lower ICER in higher risk populations |
| Earnshaw et al20 | Published literature | Aspirin vs no aspirin for primary prevention | Bayer and NCI | US | 2009 | Markov model in men, lifetime time horizon | Aspirin dominates no treatment in men older than 45 years with 10 year CHD risk >10% |
| Gaspoz et al21 | Published literature | Aspirin +/− Clopidogrel vs no therapy for secondary prevention | AHRQ and NHLBI | US | 2000 | Coronary Heart Disease Policy Model, 25 year time horizon | The ICER for aspirin from current use to all eligible patients is $11,000/QALY gained. The ICER for clopidogrel in aspirin intolerant is $31,000/QALY gained. Routine clopidogrel is not favorable, although the ICER is sensitive to the cost of clopidogrel. |
| Latour-Pérez et al33 | CURE | Clopidogrel + Aspirin vs Aspirin in ACS | Sanofi | Spain | 1999 | Markov model; treated for 1 year; societal perspective; lifetime event horizon | ICER €12,000/QALY gained Range €5,000 to €30,000 based on risk |
| Badia et al34 | CURE | Clopidogrel + Aspirin vs Aspirin in ACS | Sanofi-Aventis + Bristol-Myers Squibb | Spain | 2003 | Patient-level outcomes and Markov model; treated 1 year; short and long term analyses | ICER €17190 per event avoided short term ICER €8132/LYG long term |
| Lindgren et al35 | CURE | Clopidogrel + Aspirin vs Aspirin in ACS | Sanofi | Sweden | 2000 | Markov model; treated x 1 year; payer perspective; lifetime time horizon | ICER € 1365/LYG (study patients) ICER € 1009/LYG (registry patients) |
| Lindgren et al36 | PCI-CURE + literature | Clopidogrel for up to 1 year + Aspirin vs Clopidogrel up 4 weeks + Aspirin in ACS | Sanofi-Aventis | Sweden | 2004 | Markov model; treated x 1 year; societal perspective; lifetime event-horizon | ICER € 10,993LYG (direct cost only) ICER € 8,127/LYG (with indirect cost) |
| Weintraub et al37 | CURE | Clopidogrel + Aspirin vs Aspirin in ACS | Sanofi-Aventis | US | 2001 | Patient-level outcomes; life expectancy estimates; event horizon 1 year; | ICER $6,318/LYG (Framingham estimate) ICER $6,475/LYG (Saskatchewan estimate) |
| Mahoney et al38 | PCI CURE | Clopidogrel for up to 1 year + Aspirin vs Clopidogrel up 4 weeks + Aspirin in ACS | Sanofi-Aventis | US | 2001 | Patient-level outcomes; US based; life expectancy estimates; event horizon 1 year; | ICER $2856-$4775LYG (Overall) ICER dominant-$935/LYG (Early PCI) |
| Lamy et al39 | CURE | Clopidogrel + Aspirin vs Aspirin in ACS | Sanofi-Aventis | UK, US, Sweden, France, Canada | 2001 | Patient-level outcomes; societal perspective; treated for 9 moths; event horizon 9 months; | ICER per primary event: £10,366 UK, $22,484 USA, SKr 127,951 Sweden, €16,186 France, and C$7973 Canada |
| Schleinitz et al40 | CURE | Clopidogrel + Aspirin vs Aspirin in ACS | NIH + VA | US | 2002 | Markov model; US based; treated for 1 year; societal perspective; lifetime event horizon | ICER $15,400/QALY gained |
| Bruggenjurgen41 | CURE | Clopidogrel + Aspirin vs Aspirin in ACS | Sanofi-Aventis | Germany | 2005 | Markov model; German based; treated x 1 year; payer perspective; | ICER €3,113/LYG |
| Kolm et al42 | CURE & PCI CURE | Clopidogrel + Aspirin vs Aspirin in ACS | Sanofi-Aventis | Canada | 2003 | Patient-level outcomes; treated for 1 year; event horizon 1 year; | ICER <$10,000 per event prevented ICER <$4,000LYG |
| Gibler et al44 | CLARITY | Clopidogrel vs Placebo load in STEMI | NA | US | NA | Patient-level data alongside clinical trial for short term. Simulation lifetime | Short term clopidogrel is dominant. Lifetime <$6000/LYG |
| Berg et al45 | CLARITY and COMMIT | Clopidogrel vs Placebo in STEMI | NA | Sweden, Germany, France | 2005 | Markov model. | CLARITY: clopidogrel for up to 1 year dominant in Sweden and France, ICER of € 92/LYG in Germany. COMMIT: ICERs were € 2772, 4144, and 2786/LYG in Sweden Germany and France |
| Zhang46 | COMMIT | Clopidogrel + aspirin vs Placebo + aspirin in medically managed STEMI | Sanofi-Aventis + Bristol-Myers Squibb | US | 2002 | Patient level data alongside clinical trial short term. Lifetime model | Short term clopidogrel is a dominate strategy. Lifetime ICER clopidogrel is $7806/LYG |
| Beinart49 | CREDO | Clopidogrel loading plus 1 year vs clopidogrel for 28 days in PCI | Sanofi-Aventis | US | NA | Patient level data alongside clinical trial, lifetime time horizon | Clopidogrel loading is dominant short term. ICER 3000–5000/LYG over a lifetime. |
| Cowper50 | CREDO + Duke database | Extending clopidogrel for 1 year after PCI vs not extending clopidogrel | AHRQ | US | 2000 | Simulation | The ICER for extending clopidogrel from one month to one year after PCI was $15,696/LYG. |
| Ringborg et al51 | CREDO | Clopidogrel loading plus 1 year vs clopidogrel for 28 days in PCI | Sanofi-Aventis | Sweden | 2004 | Markov model | The ICER was € 3022/LYG for clopidogrel loading plus 1 year of therapy. |
| Berg et al52 | PCI-CURE, CREDO, CLARITY, Swedish registries | Prolonged treatment with clopidogrel after PCI vs no prolonged treatment | NA | Sweden, Germany, France | 2006 | Meta-analysis, Markov model | Pre-treatment with clopidogrel compared with aspirin alone is dominant. Long-term clopidogrel compared with 1-month treatment years ICERs of € 4225/QALY to 7871/QALY. |
| Mahoney et al54 | TRITON | Prasugrel vs Clopidogrel in ACS | Eli Lilly | US | 2005 | Patient level data alongside clinical trial, lifetime time horizon | The ICER was $9727/LYG for prasugrel compared to clopidogrel. |
| Mauskopf et al55 | TRITON/administrative database | Prasugrel vs Clopidogrel in ACS | Eli Lilly | US managed care | 2009 | Simulation | Prasugrel is dominant in ACS patients, results sensitive to drug prices. |
| Nikolic et al57 | PLATO | Ticagrelor vs Clopidogrel in ACS | AstraZeneca | Sweden | 2010 | Markov model, lifetime time horizon | Over a lifetime, the ICER was € 2753/QALY gained for ticagrelor compared to clopidogrel. |
| Cohen et al77 | REPLACE-2 | Bivalirudin with provisional GP IIb/IIIa inhibitor vs UFH GP IIb/IIIa in non-emergent PCI | NA | US | 2002 | Patient level data alongside clinical trial, 30 day time horizon | Bivalirudin with provisional GP IIb/IIIa inhibitor costs less with no difference in clinical outcome compared to UFH GP IIb/IIIa |
| Summers et al78 | REPLACE-2 plus literature | Bivalirudin with provisional GP IIb/IIIa inhibitor vs UFH GP IIb/IIIa in non-emergent PCI | NA | US | NA | Simulation | Bivalirudin with provisional GP IIb/IIIa inhibitor dominates UFH GP IIb/IIIa inhibitor. The results are sensitive to how much bivalirudin is given |
| Schwenkelenks et al80 | HORIZONS-AMI | Bivalirudin vs heparin and GP IIb/IIIa inhibitor in primary PCI for STEMI | The Medicines Company | United Kingdom | 2009–2010 | Markov model, lifetime time horizon. | Bivalirudin dominated UFH with GP IIb-IIa inhibitor |
| Schwenkelenks et al81 | ACUITY and GRACE UK dataset | Bivalirudin vs heparin and GP IIb/IIIa inhibitor for invasive management of non-STEMI ACS | The Medicines Company | United Kingdom | 2008 | Markov model, lifetime time horizon. | The ICER for Bivalirudin vs UFH with GP IIb-IIa inhibitor was £9,906/QALY gained |
| Crespin et al82 | PLATO plus claims database | Ticagrelor vs Genotype-Driven Antiplatelet Therapy for Secondary Prevention after ACS | NIA and NIGMS | US | 2009 | Markov model, 5 year time horizon | The ICER for ticagrelor compared to genotype-driven treatment was $10,059/QALY gained, and was sensitive to the price of ticagrelor |
Abbreviations: ACS: acute coronary syndrome, AHRQ: Agency for Health Research and Quality, CDC: Centers for Disease Control and Prevention, ICER: incremental cost effectiveness ratio, LYG: Life year gained, NA: not available, NCI: National Cancer Institute, NHLBI: National Heart Lung and Blood Institute, NIA: National Institute of Aging, NIGMS: National Institute of General Medical Sciences, PCI: percutaneous coronary intervention, QALY: quality adjusted life year, STEMI: ST elevation myocardial infarction, UFH: unfractionated heparin