Objective To assess the cost-effectiveness of bivalirudin versus heparin and glycoprotein IIb/IIIa inhibitor (H-GPI) in patients undergoing primary percutaneous coronary intervention (PPCI) for acute ST-segment elevation myocardial infarction (STEMI), from a UK health service perspective.
Design Cost-utility analysis with life-long time horizon.
Main outcome measures Costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness.
Methods Event risks and medical resource use data derived from the HORIZONS-AMI trial were entered into a decision analytic model. Clinical events until the end of year 1 (main model) or year 3 (alternative model) were modelled in detail. Adjustments were applied to approximate UK routine practice characteristics. Life expectancy of 1-year or 3-year survivors, health-state utilities, initial hospitalisation length of stay in the comparator strategy and unit costs were based on UK sources. Costs and effects were discounted at 3.5%.
Results The main model predicted bivalirudin and H-GPI patients to survive 11.52 and 11.35 (undiscounted) years on average, respectively, and to accrue 6.26 and 6.17 QALYs. Patient lifetime costs were £267 lower in the bivalirudin strategy (£12 843 vs £13 110). Extensive sensitivity and scenario analyses confirmed these results to be robust. In probabilistic analysis, quality-adjusted survival was higher and costs were lower with bivalirudin in 95.0% of simulation runs. In 99.2%, cost-effectiveness was better than £20 000 per QALY gained. Results from the alternative model were fully consistent.
Conclusion The use of bivalirudin instead of H-GPI in STEMI patients undergoing PPCI is cost-effective, and offers a high probability of dominance. Background treatment with aspirin and clopidogrel is assumed.
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Funding This research was funded by The Medicines Company, Parsippany, NJ, USA. It was performed to inform a Single Technology Appraisal by the National Institute for Health and Clinical Excellence.
Competing interests MS received consultancy fees and research funding from The Medicines Company via employment institution. TT and SP were employees of The Medicines Company at the time of study conduct. TDS has no conflict of interest. DB and AB received speaker's fees and research grants from The Medicines Company.
Ethics approval This health economic study did not involve human subjects but underlying data sources did. This is also true for the HORIZONS-AMI trial (ClinicalTrials.gov number, NCT00433966) that formed the main clinical basis of the analysis. Ethical approval for the HORIZONS-AMI trial was obtained as reported in the clinical publications referenced in the article.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement A substantial amount of additional data and details relating to the clinical and economic aspects of the study are contained in the evaluation report underlying NICE guidance TA230. They are available to the general public from the NICE website (http://guidance.nice.org.uk/TA/Wave23/27/FAD/EvaluationReport).
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