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Cost-effectiveness of prasugrel versus clopidogrel in patients with acute coronary syndromes and planned percutaneous coronary intervention: results from the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel - Thrombolysis in Myocardial Infarction TRITON-TIMI 38 |
Mahoney EM, Wang K, Arnold SV, Proskorovsky I, Wiviott S, Antman E, Braunwald E, Cohen DJ |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study evaluated the cost-effectiveness and cost-utility of prasugrel and clopidogrel for people with acute coronary syndrome, who were undergoing a percutaneous coronary intervention. The authors concluded that prasugrel for up to 15 months was cost-effective. The choice of clinical outcome from which to extrapolate (non-fatal events), the lack of clear reporting of some methods, and the uncertainty that this brings, mean that the conclusions should be considered cautiously. Type of economic evaluation Cost-effectiveness analysis, cost-utility analysis Study objective To evaluate the cost-effectiveness and cost-utility of prasugrel versus clopidogrel in people with acute coronary syndrome, who were undergoing a percutaneous coronary intervention. Interventions The two comparators were prasugrel 60mg loading dose then 10mg daily and clopidogrel 300mg loading dose then 75mg daily. Location/setting USA/secondary prevention. Methods Analytical approach:An individual patient analysis of a pre-specified subsample of the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel - Thrombolysis in Myocardial Infarction (TRITON-TIMI) 38 (Wiviott, et al. 2007, see 'Other Publications of Related Interest' below for bibliographic details) was used to assess the costs and effects. Life expectancy projections were used to extend the clinical trial data to a lifetime horizon. The authors reported a US health care system perspective (Medicare).
Effectiveness data:The effectiveness of the comparators was measured by the cardiovascular deaths, non-fatal myocardial infarctions, and strokes avoided. The data were from an economic study of a subset of eight countries in the TRITON-TIMI 38, an international multicentre randomised controlled trial. The limited time horizon of the trial, with a mean follow-up of 14.7 months, meant that the life expectancy for survivors was estimated using a Canadian public health database, and using the non-fatal events recorded during the trial follow-up.
Monetary benefit and utility valuations:Age- and sex-specific utility values were obtained from the Beaver Dam Health Outcome Study.
Measure of benefit:The measure of benefit for the main analysis was life-years lost or gained. Quality-adjusted life-years (QALYs) were the measure of benefit for a secondary analysis. Life-years were discounted at a 3% annual rate, in the base case.
Cost data:A micro-costing approach was used. The resource use was from the subsample of eight countries in the TRITON-TIMI 38. These countries were the USA, Australia, Canada, Germany, Italy, Spain, UK, and France. Hospitalisation costs were estimated using diagnosis-related group data and in-house complications. All costs were assessed in 2005 US dollars ($), except for the two drugs, which were based on their 2009 wholesale prices. The costs for after the trial follow-up were from a US registry. A 3% annual discount rate was applied.
Analysis of uncertainty:Bootstrapping was used to estimate the distribution of lifetime costs versus effectiveness, which was presented, and the data were used to produce cost-effectiveness acceptability curves. Different scenarios were analysed to assess the impact of variations in the key model inputs. Subgroup analyses were performed. Results In the base case, the lifetime costs were $26,067 for prasugrel and $26,288 for clopidogrel; a mean difference favouring prasugrel of $221 (95% CI -759 to 299). The life expectancy lost was 0.428 for prasugrel and 0.530 for clopidogrel; a mean difference favouring prasugrel of 0.102 (95% CI 0.030 to 0.180). These results suggested that prasugrel dominated clopidogrel, as it was less costly and more effective.
The bootstrapped sensitivity analysis found that prasugrel dominated clopidogrel in 79.7% of replications, and it had an incremental cost-effectiveness ratio (ICER) below $50,000 per life-year gained in 99.8% of replications. Prasugrel remained dominant in the cost-utility analysis, with a mean gain of 0.095 QALYs.
Under a broad range of assumptions, in most of the subgroups analysed, and when the cost of clopidogrel was reduced to $1 per day, this dominance remained. Authors' conclusions The authors concluded that for patients with acute coronary syndrome, who were undergoing a planned percutaneous coronary intervention, treatment with prasugrel rather than clopidogrel for up to 15 months was cost-effective. CRD commentary Interventions:The interventions were adequately described, and seem to have been relevant for the health problem, but it was not clear what role aspirin played in this analysis. The authors clearly stated that dual antiplatelet therapy with aspirin and clopidogrel was the usual care, but clopidogrel alone seems to have been analysed. If this is the case, the exclusion of dual therapy made this a partial analysis.
Note: since this abstract was published the authors have clarified the situiation egarding aspirin therapy as follows, "Patients in both treatment arms were treated with dual antiplatelet therapy; aspirin therapy was assumed not to differ between groups and was therefore not included in the analysis"
Effectiveness/benefits:The main clinical data were from a international multicentre trial and its details were very briefly outlined. A subset of eight countries was used for this analysis. Due to the short follow-up, a longitudinal database was used for the clinical event rates over a lifetime, based on the non-fatal clinical events that occurred within the trial period. The methods used were not presented, but were referenced and validated in the literature. This database was Canadian. The validity of the clinical data is difficult to assess based on the information presented. The extensive sensitivity analysis helped to demonstrate that the results were robust, but it could not eliminate all doubt. The authors suggested that prasugrel might be associated with reduced overall cardiovascular death, non-fatal myocardial infarctions, and non-fatal strokes, but this could be at the expense of an increased risk of major bleeding.
Costs:The costs were relevant to the selected perspective and they included hospitalisations, physician services, procedures, and medications. The unit costs and resource use were not fully presented, but the differences in some mean costs, the frequency of hospitalisation, and a summary of the cost results were presented. The authors acknowledged the limitations of using US diagnosis-related group costs for hospitalisations in other countries and that this could over or under estimate the costs.
Analysis and results:An appropriate cost-effectiveness analysis was outlined and performed. Extensive sensitivity analyses were conducted and all of them suggested that the conclusion was robust, but insufficient information was presented to allow the methods to be validated. The reporting suggested that a comprehensive analysis was undertaken and its limitations were clearly outlined, but a full assessment would require the reading of the relevant sources of evidence.
Concluding remarks:The choice of clinical outcome from which to extrapolate (non-fatal events), the lack of clear reporting of some methods, and the uncertainty that this brings, mean that the conclusions should be considered cautiously. Funding Supported by a grant from Eli Lilly & Co, Inc. Bibliographic details Mahoney EM, Wang K, Arnold SV, Proskorovsky I, Wiviott S, Antman E, Braunwald E, Cohen DJ. Cost-effectiveness of prasugrel versus clopidogrel in patients with acute coronary syndromes and planned percutaneous coronary intervention: results from the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel - Thrombolysis in Myocardial Infarction TRITON-TIMI 38. Circulation 2010; 121(1): 71-79 Other publications of related interest Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM. Prasugrel versus clopidogrel in patients with acute coronary syndromes. New England Journal of Medicine 2007; 357(20): 2001-2015. Indexing Status Subject indexing assigned by NLM MeSH Acute Coronary Syndrome /drug therapy /economics /mortality; Angioplasty, Balloon, Coronary; Combined Modality Therapy; Cost-Benefit Analysis; Databases, Factual; Drug Costs /statistics & Follow-Up Studies; Hemorrhage /mortality; Hospitalization /economics; Humans; Life Expectancy; Multicenter Studies as Topic /statistics & Myocardial Infarction /drug therapy /economics /mortality; Outcome and Process Assessment (Health Care) /economics; Piperazines /economics /therapeutic use; Platelet Aggregation Inhibitors /economics /therapeutic use; Prasugrel Hydrochloride; Randomized Controlled Trials as Topic /statistics & Stroke /mortality; Thiophenes /economics /therapeutic use; Thrombolytic Therapy /economics; Ticlopidine /analogs & United States /epidemiology; derivatives /economics /therapeutic use; numerical data; numerical data; numerical data AccessionNumber 22010000434 Date bibliographic record published 04/08/2010 Date abstract record published 25/05/2011 |
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