Bivalirudin: a pharmacoeconomic profile of its use in patients with acute coronary syndromes.
Bivalirudin (Angiox®; Angiomax®), a direct thrombin inhibitor, is an intravenous anticoagulant. The efficacy of bivalirudin in the management of patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) or ST-segment elevation myocardial infarction (STEMI) planned for invasive interventions has been shown in large, pivotal, open-label trials. Bivalirudin provided similar ischaemic protection to heparin plus a glycoprotein (GP) IIb/IIIa inhibitor, but with a significant reduction in bleeding events, in patients with NSTE-ACS planned for urgent or early intervention and those with STEMI planned for primary percutaneous coronary intervention (PCI). Mortality rates were also significantly lower in patients with STEMI receiving bivalirudin than in those receiving heparin plus a GP IIb/IIIa inhibitor in the key trial of patients with STEMI. Based on this clinical data, modelled cost-utility analyses from the perspective of various UK NHS providers have predicted that bivalirudin would be highly likely to be cost effective with regard to the cost per QALY gained relative to a heparin plus GP IIb/IIIa inhibitor-based strategy over a lifetime horizon in these patient populations. In patients with NSTE-ACS planned for urgent or early invasive intervention, a bivalirudin-based strategy was considered to be cost effective in the UK, Scotland and Wales. In patients with STEMI planned for primary PCI, a bivalirudin-based strategy was dominant in the UK and Scotland. Parallel and sensitivity analyses demonstrated that base-case conclusions were robust over a range of plausible changes in parameter estimates and assumptions, including changes made to more closely reflect current local clinical practice. In addition, budgetary impact analyses in several countries suggested that the implementation of a bivalirudin-based strategy, instead of a heparin plus GP IIb/IIIa inhibitor-based strategy, would be cost saving from a hospital perspective in patients with NSTE-ACS undergoing urgent or early PCI, as well as in patients with STEMI undergoing primary PCI. Likewise, prospective and retrospective treatment cost studies in the US indicated that treatment with bivalirudin was less costly than treatment with heparin plus a GP IIb/IIIa inhibitor in these indications. In conclusion, available pharmacoeconomic data from several countries, despite some inherent limitations, support the use of strategies based on bivalirudin over those based on heparin plus a GP IIb/IIIa inhibitor in patients with NSTE-ACS planned for urgent or early invasive intervention or STEMI planned for primary PCI. These pharmacoeconomic advantages primarily reflect that, relative to heparin plus a GP IIb/IIIa inhibitor, bivalirudin is associated with lower rates of bleeding over the short term, and is associated with lower rates of early mortality that are subsequently maintained over the longer term in patients with STEMI.