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Abciximab

A Pharmacoeconomic Review of its Use in Percutaneous Coronary Revascularisation

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Summary

Abstract

Abciximab is a monoclonal antibody fragment that inhibits platelet aggregation through antagonism of glycoprotein IIb/IIIa. The drug is used in conjunction with heparin and aspirin to prevent ischaemic complications associated with percutaneous coronary revascularisation in patients with coronary heart disease

Large and well designed clinical studies have shown abciximab, as an adjunct to aspirin and heparin, to reduce by around one-third to one-half the incidence of ischaemic complications within 30 days of percutaneous coronary revascularisation. Use of the drug appears advantageous in patients at high risk, and abciximab also reduces complications in patients undergoing coronary stenting, although the drug does not appear to inhibit restenotic tissue volume within stents. Longer term benefit has also been reported, with emerging 1-year data from a study in patients at all levels of risk showing reductions in a composite end-point of death, myocardial infarction (MI) or urgent repeat revascularisation. Three-year benefit has been reported in high risk patients. Meta-analysis results, and 1-year data from patients receiving stents, have shown reduced mortality with abciximab.

Abciximab therapy had an incremental cost over standard therapy from a hospital perspective of $US293 per patient (1991/1992 values) over 6 months in a prospective economic substudy from a major US clinical trial of the drug in high risk patients. Abciximab was cost saving in patients with unstable angina. A mean net cost of hospitalisation of $US476 per patients (1995 costs) has been shown in a further study in patients with a broad range of levels of risk, and observational data indicate reduced duration of hospitalisation with abciximab.

Cost-effectiveness data favoured abciximab with aspirin and heparin over a 6-month period in Spanish and Dutch analyses in which data from the above trial were combined with local cost data, but not in an Australian analysis. Subgroup analyses have indicated enhanced cost effectiveness in high risk patients. Available data also show clinical benefit and cost effectiveness of abciximab therapy in conjunction with coronary stent placement.

Conclusions: Data indicate intravenous bolus plus 12-hour infusion regimens of abciximab to be economically viable in patients at high or low risk of ischaemic complications after percutaneous coronary revascularisation. The drug has been shown to be cost effective in patients receiving the drug in conjunction with coronary stents, and subgroup analyses indicate additional cost effectiveness in certain groups of patients at high risk of ischaemic complications (notably those with acute MI and unstable angina).

Cost of Illness

The main pharmacoeconomic value of abciximab is in reducing or eliminating the costs associated with the complications of percutaneous coronary revascularisation. By the mid-1990s, at least 800 000 percutaneous coronary revascularisation procedures were being performed worldwide each year. According to 1993/1994 US data, the average total per-patient charge incurred during initial hospitalisation for percutaneous transluminal coronary angioplasty is $US27 100 for patients with a primary diagnosis of acute myocardial infarction (MI) and $US19 300 for patients without such a diagnosis. In the year following the procedure, the average per-patient hospital costs or charges are approximately $US2000 to $US5000

In general, the strongest influencing factor on total initial hospitalisation costs for patients undergoing percutaneous coronary procedures is the development of ischaemic complications. Acute ischaemic complications can increase initial inhospital costs 1.5- to 4-fold, compared with an uncomplicated procedure. Late complications related to restenosis may substantially increase total costs by necessitating repeat revascularisation procedures.

A recently introduced strategy to reduce the complications of percutaneous coronary revascularisation is elective coronary stenting, now used in more than 50% of coronary revascularisation procedures in the US. The increased initial hospitalisation costs associated with stenting are largely offset by lower follow-up costs resulting from reduced complication rates.

Clinical Profile

Abciximab, as an adjunct to heparin and aspirin, reduces by about one-third to one-half the incidence of ischaemic complications (death, MI or urgent coronary intervention) occurring within 30 days of percutaneous coronary revascularisation, according to large, placebo-controlled trials. The need for urgent coronary intervention (percutaneous coronary revascularisation or coronary artery bypass surgery) and the incidence of MI are reduced. Abciximab appears to be particularly effective in patients at the highest risk for ischaemic complications, i.e. those undergoing percutaneous coronary revascularisation for the treatment of unstable angina or acute MI, although benefit is also attained in patients with lower risk levels. The drug reduces acute ischaemic complications in patients undergoing elective coronary stenting. Reduced mortality risk has been shown bymeta-analysis of major studies in which abciximab was administered as an intravenous bolus followed by 12-hour infusion, and by 1-year data from patients receiving abciximab in conjunction with stenting

Long term (3-year) benefit in terms of reduced need for repeat revascularisation with abciximab was evident in a major trial (EPIC: Evaluation of Platelet IIb/IIIa Inhibition for Prevention of Ischemic Complications of High Risk Angioplasty study) involving high risk patients. The incidence of ischaemic complications was lower at 6 months in patients undergoing elective coronary stenting with abciximab than in those who received stents plus placebo in another major trial (EPISTENT: Evaluation of Platelet IIb/IIIa Inhibitor for Stenting study). Recent 6-month data from another study (ERASER: Evaluation of ReoPro and Stenting to Eliminate Restenosis) have shown no effect of abciximab on neointimal tissue proliferation measured by intravascular ultrasound in patients receiving stents, however. Emerging 1-year data from a study in patients at all levels of risk (EPILOG: Evaluation in PTCA to Improve Long-Term Outcome with Abciximab GPIIb/IIIa Blockade study) also show long term benefit in terms of a composite end-point of death, MI or urgent repeat revascularisation. Abciximab had no significant effect on the incidence of ischaemic complications or repeat revascularisation overall at 6 months in the CAPTURE (c7E3 Fab Antiplatelet Therapy in Unstable Refractory Angina) or RAPPORT (ReoPro and Primary PTCA Organization and Randomized Trial) studies, although the cumulative need for urgent repeat revascularisation was significantly reduced in the latter, and a post-procedure infusion of only 1 hour’s duration, which is no longer recommended, was used in the former. Additional benefit was obtained with abciximab in patients enrolled in EPILOG who required unplanned stent placement.

In line with its antiplatelet activity, the most significant adverse effects associated with abciximab when used in combination with heparin and aspirin are bleeding complications and thrombocytopenia. Although bleeding complications were a significant concern with the first major trial of abciximab to be conducted (EPIC), bleeding can be minimised by adherence to the recommended protocol for abciximab administration. With this protocol, the rate of major bleeding complications in abciximab recipients in clinical trials was ≤2% and was not significantly different than that in placebo recipients. Careful patient selection, meticulous femoral artery access site care, use of a low dose, bodyweight-adjusted heparin regimen, and early removal of the arterial sheath are recommended.

The incidence of thrombocytopenia (platelet count <100 000/μl) in patients treated with abciximab was approximately 2.5 to 5.6%, compared with 1.3 to 3.3% in placebo recipients, in major trials. Severe thrombocytopenia (platelet count <50 000/μl) has been noted in up to 1.6 and 0.7% of abciximab and placebo recipients, respectively.

Pharmacoeconomic Considerations

Pharmacoeconomic investigations of abciximab have been driven by the need to identify net resource gains that may be made through the avoidance or reduction of costs associated with ischaemic complications after index percutaneous coronary revascularisation. Such resource savings may partly or fully offset the acquisition cost of the drug

Results of a prospective economic substudy (in which hospital costs, inpatient physician fees and drug acquisition costs were considered) carried out in conjunction with the major clinical trial of abciximab in high risk patients (EPIC) showed use of the drug (bolus plus infusion) to result in an incremental cost compared with standard care of $US293 per patient over 6 months (1991/1992 values). Abciximab was cost saving in patients with unstable angina in a subgroup analysis.

Prospective economic data from EPILOG (patients at all levels of risk of ischaemic complications) collected over the 6 months after the index procedure have shown a mean net cost of hospitalisation of $US476 per patient (1995 costs). Almost 65% of the cost of the drug was offset by avoidance of additional procedures. Favourable cost data have also been shown in modelled analyses, and the adoption of the widespread use of abciximab and coronary stents in 1 institution has been associated with a 28% reduction in the mean total per patient hospital cost. Statistically significant reductions in length of hospital stay have also been demonstrated with abciximab by retrospective analyses of hospital billing data from a US managed-care organisation.

Cost issues associated with the use of abciximab have also been investigated in institution-specific analyses carried out in the US. A proportional hazards model applied in a retrospective study in patients with unstable coronary syndromes showed abciximab treatment to be associated with reduced need for revascularisation within 2 weeks of the index procedure, with a corresponding reduction in costs per case over 6 months.

Six-month efficacy and safety data from EPIC have been applied in a number of local cost-effectiveness analyses. The average cost per patient free from a serious ischaemic event or repeat revascularisation favoured abciximab with aspirin and heparin over aspirin and heparin alone in Spanish and Dutch studies, but not in an Australian analysis. Incremental cost-effectiveness estimates from these studies as well as a Canadian analysis were $US5804 (Spanish study; year of costing not stated), NLG5235 (Dutch guilders; 1992 to 1994 values), $A13 012 (Australian dollars; 1996 values) and $Can8840 (Canadian dollars; year of costing not stated). In a 10-year Australian Markov projection (5% annual discount rate and 1996 prices) the incremental cost per year of life gained (YLG) with abciximab versus standard therapy was $A5547. Other modelled scenarios produced estimates of cost per YLG of NLG8311 for all patients and NLG4156 for patients with unstable angina (1994 Dutch estimate) or $Can24 556 (year of costing not stated).

A combination of 6-month efficacy results from an analysis of 4 major clinical trials in patients from all risk groups undergoing percutaneous coronary revascularisation with hospital costs in a Canadian analysis yielded a net cost per event (MI or repeat revascularisation) prevented of $Can 27 000. Overall, subgroup analyses have indicated that abciximab is likely to prove most cost effective in high risk patients, particularly those with unstable angina or acute MI.

Abciximab reduces the incidence of ischaemic complications in patients undergoing elective coronary stenting and may have favourable pharmacoeconomics when used in this setting. Six-month data from the EPISTENT study in patients receiving coronary stents with or without abciximab have shown the drug to be cost effective from a payer perspective. The absolute reduction in mortality at 6 months in patients who received abciximab was 0.74%. The cost per YLG with abciximab was estimated to be $US17 318 (based on an incremental drug cost of abciximab of $US1472 and a gain of 0.85 life years with the drug); when the incremental cost of abciximab was set at its acquisition cost (3 vials: $US1350) in a sensitivity analysis, the cost per YLG was $US15 882 (year of costing not stated). Data from the 1-year analysis show reduction of the cost per YLG to $US9316.

On the basis of hospital billing data from the EPILOG study and an overall reduced relative risk of mortality, data from a meta-analysis of 6 major trials in which abciximab therapy was given as a bolus plus 12-hour infusion showed a cost per YLG of $US4664 in patients who received the drug. Despite the caution required in the interpretation of results of this type, the cost effectiveness of abciximab was favourable on the basis of commonly used thresholds of $US40 000 to $US50 000 per YLG. Preliminary observational data also indicate cost effectiveness of abciximab in ‘real-world’ practice settings.

Although available data show abciximab therapy to be economically attractive in broad populations of patients undergoing percutaneous coronary revascularisation, enhancement of cost effectiveness in high risk patients (notably those with acute MI or unstable angina) has been demonstrated by subgroup analyses.

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    Christopher J. Dunn & Rachel H. Foster

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Dunn, C.J., Foster, R.H. Abciximab. Pharmacoeconomics 16, 711–741 (1999). https://doi.org/10.2165/00019053-199916060-00009

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