Appraisal Consultation Document: Glycoprotein IIb/IIIa Inhibitors
NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE
Appraisal consultation document
The use of glycoprotein IIb/IIIa inhibitors in the treatment of acute coronary syndromes
(Review of existing guidance)
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The National Institute for Clinical Excellence (NICE, or the Institute) is reviewing its guidance on the use of glycoprotein IIb/IIIa inhibitors in the treatment of acute coronary syndromes, which was issued in September 2000. When the review has been completed, the Institute will provide guidance to the Department of Health and the Welsh Assembly Government on the use of this technology in the NHS in England and Wales. The Appraisal Committee has had its first meeting to consider both the evidence submitted and the views put forward by the representatives nominated for by professional organisations and patient/carer and service user organisations. This document has been prepared for consultation with the formal consultees. It summarises the evidence and views that have been considered and sets out the preliminary recommendations developed by the Committee. The Institute is now inviting comments from the formal consultees in the appraisal process (the consultees for this appraisal are listed on the NICE website). Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation. The process the Institute will follow after the consultation period is summarised below. (For further details, see the Guide to the Technology Appraisal Process on the Institute's website).
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The key dates for this appraisal are: Details of membership of the Appraisal Committee are given in Appendix A and a list of the sources of evidence used in the preparation of this document is given in Appendix B. |
| Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation. |
| 1 | Appraisal Committee's preliminary recommendations |
| 1.1 | The intravenous use of the small-molecule glycoprotein IIb/IIIa (GP IIb/IIIa) inhibitors (eptifibatide and tirofiban), in addition to aspirin and unfractionated heparin, is recommended as part of the initial medical management of patients with unstable angina or non-ST-segment-elevation myocardial infarction (NSTEMI) who are at high risk of subsequent non-fatal myocardial infarction (MI) or death, irrespective of whether angiography with a view to percutaneous coronary intervention (PCI) is planned. |
| 1.2 | The clinician should determine who is at high risk, taking into account combinations of risk indicators such as: age; ethnicity; clinical risk markers, such as previous MI, PCI or coronary artery bypass graft (CABG); co-morbidities, especially diabetes; acute ECG changes; and raised cardiac troponin level, if available (see 1.3). |
| 1.3 | Treatment with a GP IIb/IIIa inhibitor should be initiated as soon as high-risk status has been determined, which will usually be before the result of a troponin test is known. |
| 1.4 | If PCI is recommended but is delayed beyond the initial medical management phase, then a GP IIb/IIIa inhibitor licensed for use in this indication (currently only abciximab), as an adjunct to PCI, is recommended for patients at high risk only. |
| 1.5 | For patients not at high risk who are to undergo procedurally uncomplicated, routine, elective PCI, the use of intravenous GP IIb/IIIa inhibitors is not recommended. |
| 1.6 | GP IIb/IIIa inhibitors are not currently licensed in the UK for use as an adjunct to thrombolytic therapy in ST-segment-elevation MI. |
| 2 | Clinical need and practice |
| 2.1 |
Coronary heart disease (CHD) is the most common cause of death in the UK. It is a progressive disease. The first presenting symptom is often stable angina (pain in the chest on exertion), which may progress to an acute coronary syndrome (ACS). Acute coronary syndromes encompass a range of symptoms with broadly similar underlying causes. They include ischaemic cardiac chest pain of recent origin in the categories:
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| 2.2 | Unstable angina covers a range of clinical states falling between stable angina and acute MI, including angina at rest lasting more than 20 minutes, increasing angina and angina occurring more than 24 hours after an acute MI. |
| 2.3 | NSTEMI (also known as non-Q-wave MI) is the term used when the cardiac enzymes (troponins or creatinine phosphokinase) are elevated to the ranges indicating that MI has occurred, but a Q-wave does not develop on ECG tracings. This is thought to indicate damage to the heart muscle that does not extend through the full thickness of the myocardium. NSTEMI therefore represents the most severe end of the spectrum of non-ST-elevation ACS. |
| 2.4 | In 1998 the overall prevalence of CHD in England was estimated to be 7.1% in men and 4.6% in women. Prevalence increases with age. It is difficult to estimate the incidence of ACS in England and Wales. The Hospital Episode Statistics for 2000/01 detail 148,000 episodes of angina pectoris in England, with 83,000 of these specified as unstable angina. However, there are variations for the coding of this condition, and it has been suggested that these figures are conservative. Recently, the incidence of unstable angina has been estimated at 226 cases per 100,000 population, which equates to approximately 120,000 cases in England and Wales per annum. |
| 2.5 | In 1999 in England and Wales, there were over 115,000 deaths caused by CHD. Although CHD-associated mortality rates are falling by about 4% per year in the UK, this does not reflect a fall in incidence of the disease. In addition, improvements in rates of death from CHD have not been uniform across all social classes; death rates amongst unskilled men are three times greater than those among professional men. |
| 2.6 | The main aim in the short-term management of non-ST-segment-elevation ACS is to control pain and prevent progression to full-thickness MI (STEMI) and/or death. The first measures (conservative) involve bed rest and medical treatment including antiplatelet therapy (aspirin), anticoagulants (heparin and low-molecular-weight heparin [LMWH]), vasodilators (nitrates), calcium-channel blockers and beta-blockers. Revascularisation, when necessary, is usually by means of PCI; stents are increasingly being used during these procedures. |
| 2.7 | Certain patients with unstable angina are at high risk of progression to MI or death. The British Cardiac Society guidelines say that certain circumstances are associated with an increased risk of early adverse outcome - these include: age above 65 years; co-morbidity, especially diabetes; prolonged (> 15 minutes) cardiac pain at rest; ischaemic ECG ST-segment depression on admission or during symptoms; ECG T?wave inversion (associated with a intermediate risk, lying between that associated with ST-segment depression and normal ECG); evidence of impairment of left ventricular function (either pre-existing or during MI); and elevated c-reactive protein. In addition, those with raised levels of cardiac troponin are considered to be at high risk of an event. |
| 2.8 | Despite the use of standard therapy (antiplatelets and anticoagulants), the rate of adverse outcomes (such as death, non-fatal re-infarction, refractory angina or readmission for unstable angina) at 6 months after presenting with unstable angina is about 30%. |
| 2.9 | In guidance issued in September 2000, the National Institute for Clinical Excellence recommended the intravenous use of glycoprotein IIb/IIIa (GP IIb/IIIa) inhibitors, in addition to aspirin and low (adjusted) dose unfractionated heparin, for patients with unstable angina who are at high risk of death or further MI. The Institute's guidance recommended intravenous administration of GP IIb/IIIa inhibitors to patients undergoing acute or elective PCI. |
| 3 | The technology |
| 3.1 | Abciximab (ReoPro) |
| 3.1.1 | Abciximab is a monoclonal antibody that targets the GP IIb/IIIa receptor on the surface of platelets. |
| 3.1.2 | Abciximab is indicated as an adjunct to aspirin and heparin for the prevention of ischaemic complications in patients undergoing PCI. It is also indicated for the short-term (1 month) reduction of risk of MI in patients who have unstable angina that is not responding to full conventional therapy and who are to undergo PCI. Abciximab is administered intravenously at an initial bolus dose of 0.25 mg/kg body weight followed by a maintenance dose of 0.125 µg/kg/min (maximum 10 µg/min) over 12 to 36 hours. |
| 3.1.3.. | As with the other GP IIb/IIIa inhibitors, the side effects of abciximab (including bleeding and thrombocytopenia) are related to its pharmacological effects. For full details of side effects and contraindications, see the Summary of Product Characteristics. |
| 3.1.4 | The cost of abciximab is £280.00 for a 10-mg vial (British National Formulary, 42nd edition). For a 70-kg person, the cost per course ranges from £840.00 to £1120.00, depending on the duration of treatment (costs rounded to full vials). |
| 3.2 | Eptifibatide (Integrilin) |
| 3.2.1 | Eptifibatide is a synthetic cyclic heptapeptide and is one of the small-molecule GP IIb/IIIa inhibitors. It reversibly inhibits platelet aggregation by preventing the binding of fibrinogen and other adhesive ligands to the GP IIb/IIIa receptors. |
| 3.2.2 | Eptifibatide is indicated for the prevention of early MI in patients presenting with unstable angina or non-Q-wave MI who have had chest pain within the last 24 hours and who have ECG changes and/or elevated cardiac enzymes. It is administered intravenously, at an initial bolus dose of 180 µg/kg, followed by a maintenance dose of 2.0 µg/kg/min over 72 to 96 hours. |
| 3.2.3 | As with the other GP IIb/IIIa inhibitors, the side effects of eptifibatide (including bleeding and thrombocytopenia) are related to its pharmacological effects. For full details of side effects and contraindications, see the Summary of Product Characteristics. |
| 3.2.4 | The cost of eptifibatide is £15.54 for a 20-mg vial and £48.84 for a 75-mg vial (British National Formulary, 42nd edition). For a 70-kg person, the cost per course ranges from £455.10 to £552.78, depending on the duration of treatment (costs rounded to full vials). |
| 3.3 | Tirofiban (Aggrastat) |
| 3.3.1 | Tirofiban is a non-peptidal antagonist of the GP IIb/IIIa receptor and is one of the small-molecule GP IIb/IIIa inhibitors. It prevents fibrinogen from binding to the GP IIb/IIIa receptor, thus blocking platelet aggregation. |
| 3.3.2 | Tirofiban is indicated for the prevention of early MI in patients presenting with unstable angina or non-Q-wave MI who have had chest pain within the last 12 hours and who have ECG changes and/or elevated cardiac enzymes. It is administered intravenously at an initial dose of 0.4 µg/kg/min for 30 minutes, followed by a maintenance dose of 0.1 µg/kg/min for at least 48 hours, and up to 108 hours. |
| 3.3.3 | As with the other GP IIb/IIIa inhibitors, the side effects of tirofiban (including bleeding and thrombocytopenia) are related to its pharmacological effects. For full details of side effects and contraindications, see the Summary of Product Characteristics. |
| 3.3.4 | The cost of tirofiban is £146.11 for a 12.5-mg vial (British National Formulary, 42nd edition). For a 70-kg person, the cost per course ranges from £292.22 to £584.44, depending on the duration of treatment (costs rounded to full vials). |
| 4 | Evidence and interpretation |
| The Appraisal Committee considered evidence from a number of sources (see Appendix B). Each indication was considered separately. | |
| 4.1 | Clinical effectiveness |
| 4.1.1 | GP IIb/IIIa inhibitors for the medical management of acute coronary syndromes. |
| 4.1.1.1 | The Assessment Group found five studies, one of which had become available since the last appraisal of GP IIb/IIIa inhibitors. All were classified as randomised controlled trials (RCTs) that included patients with unstable angina or non-Q-wave MI, but the definitions of the participants varied between trials. Two studies looked at eptifibatide, two at tirofiban and one at abciximab; all these studies compared treatment with placebo or no treatment. On the whole, the studies were well conducted. Outcome measures included death, MI, need for revascularisations and adverse events associated with use of the drugs. Differences between trials precluded pooling results in the Assessment Report. |
| 4.1.1.2 | For the small-molecule GP IIb/IIIa inhibitors (eptifibatide and tirofiban), in nearly all studies the rates of death and MI were reduced in the treatment groups compared with the comparator group, but the difference was not always statistically significant. In all of the trials the risk of bleeding was greater in the groups receiving a GP IIb/IIIa inhibitor than in the comparator group, but the difference was not always statistically significant. |
| 4.1.1.3 | In the GUSTO-IV trial of abciximab the results demonstrated neither benefit nor trends of benefit in the primary outcomes of death and MI at 30 days. |
| 4.1.1.4 | The Assessment Group concluded that the effects of GP IIb/IIIa inhibitors were small compared with those of other interventions in ACS, for example aspirin. Subgroup analyses showed that GP IIb/IIIa inhibitors may be particularly effective in troponin-positive patients. A recently published meta-analysis seen by the Committee (the Boersma study) analysed the data for various subgroups and suggested a small benefit to patients not going on to have a PCI. |
| 4.1.1.5 | The submissions for this appraisal from consultees (manufacturers/sponsors and professional and patient/carer groups) contained no clinical evidence on the use of GP IIb/IIIa inhibitors for the medical management of ACS that had not already been included in the Assessment Report. |
| 4.1.1.6 | The experts were asked about the evidence for medical management in those not going on to have a PCI during GP IIb/IIIa inhibitor administration, which is frequently the scenario in current UK practice. They acknowledged that there was some benefit in this strategy, but thought that, ideally, patients at high risk should get GP IIb/IIIa inhibitors and then proceed to angiography, with a view to PCI. They were also asked to comment on the importance of various risk factors used to identify high-risk patients; they believed that the troponin result often confirms that ainfarction has taken place, but that increased troponin is not the only indicator of high risk. They were asked to comment on the importance of the timing of GP IIb/IIIa inhibitor administration, as suggested by sub-analyses of the PURSUIT trial demonstrating increased benefit if administered early |
| 4.1.2 | GP IIb/IIIa inhibitors as an adjunct to PCI |
| 4.1.2.1 | The Assessment Group found 17 trials, five of which had become available since the last appraisal of GP IIb/IIIa inhibitors. Fourteen trials compared treatment with placebo or no treatment - ten of these involved abciximab, three involved eptifibatide and one involved tirofiban. There were two head-to-head trials, one of abciximab and eptifibatide and one of abciximab and tirofiban. One further trial compared invasive and conservative treatment, with all participants receiving tirofiban. The definition of participants both within and between trials was broad, from patients undergoing elective PCI to those who had acute PCI after MI. All trials were classified as RCTs, and many of them were large (at least 1000 participants). Outcomes measured included death, non-fatal MI, the need for PCI or CABG after the current procedure, and adverse events. |
| 4.1.2.2 | Again the results of the trials were not pooled for the Assessment Report because of heterogeneity, which included differences between studies in the inclusion criteria for patients undergoing the procedure. Only one trial showed a significant benefit on mortality at 30 days; another trial showed significant benefit on mortality at 6 months. There was a reduction in the rate of revascularisation at 30 days and at 6 months in studies in which this was measured, but the difference was statistically significant in one trial only. |
| 4.1.2.3 | However, with composite outcomes (usually a combination of death, subsequent MI and revascularisation), the great majority of trials showed a statistically significant benefit of treatment with GP IIb/IIIa inhibitors. There were more minor and major bleeds in the treatment groups in all studies, but the increased rates were not always statistically significant. There was little evidence of benefit for subgroups. |
| 4.1.2.4 | The only new data submitted on the use of GP IIb/IIIa inhibitors during PCI were longer-term data from two trials (ESPRIT and EPIC) and data from a recent UK audit presented by the British Cardiac Society and Royal College of Physicians (London). |
| 4.1.2.5 | The experts were asked about the use of GP IIb/IIIa inhibitors as an adjunct during PCIs. Their view was that they were being used during acute PCIs, technically complicated PCIs and during PCIs for people at high risk, but not during routine, elective PCI procedures. They emphasised the low risk of adverse events occurring during procedures, as demonstrated by the UK audit data. |
| 4.2 | Cost effectiveness |
| 4.2.1 | GP IIb/IIIa inhibitors for the medical management of acute coronary syndromes |
| 4.2.1.1 | The Assessment Group found no additional cost-effectiveness studies beyond the seven included in the previous appraisal of GP IIb/IIIa inhibitors. None of these studies were UK-based. Since management of ACS in the UK differs from that in other developed countries, particularly in regard to the rate of PCI, the results were not considered to be applicable to the UK. Economic models for tirofiban and eptifibatide were submitted by the manufacturers for the original appraisal. |
| 4.2.1.2 | The eptifibatide manufacturer model was based on a prospective economic evaluation conducted as part of the PURSUIT trial. Based on the subgroup of patients from Western Europe (12% of the total patients), the cost per life year gained for eptifibatide was estimated as £8,179 to £11,079. Although lifetime survival duration was modelled, no extrapolation of costs over the patients' lifetime was attempted and it is not clear how this would impact on the results. |
| 4.2.1.3 | The tirofiban manufacturer model reported that 22% of the cost of tirofiban is offset by savings due to the reduction in events. The lack of a standardised outcome measure makes it difficult to interpret these results in relation to other treatments. The absolute reduction in event rates associated with tirofiban was not adjusted for UK-specific baseline event rates. |
| 4.2.2 | Use as an adjunct to PCI |
| 4.2.2.1 | A further six economic studies in the literature were identified in addition to the 17 studies included in the original appraisal, but none of these fully reflects current UK practice and the long-term costs and consequences. The original appraisal also considered the manufacturer submission for abciximab. |
| 4.2.2.2 | In the manufacturer's model for abciximab, for patients undergoing urgent and elective PCIs in a UK setting, estimates of cost per quality-adjusted life year (QALY) ranged from £6,941 to £9,053 based on the EPILOG trial and from £3,949 to £5,151 based on the EPISTENT trial. These estimates must be interpreted with caution for the following reasons: the baseline risk of events is different in the UK from that in the trials; the assumption that patients surviving the first year will live for a further 15 years ignores variability of prognosis; and it may not be valid to assume that costs do not differ between treatment options over a period of 2-15 years. |
| 4.2.3 | Assessment Group model |
| 4.2.3.1 |
The Assessment Group developed a UK-specific model to look at the optimal use and timing of use of GP IIb/IIIa inhibitors in ACS patients. The model estimated health outcomes in terms of QALYs and had a lifetime time horizon. Four treatment strategies for GP IIb/IIIa inhibitors were compared:
An additional analysis looked at initial management in high-risk ACS patients only (defined as those with at least one of three factors: age > 70 years, diabetes, ST-depression). Initially baseline event rates were calculated based on PRAIS-UK/Leeds audit data. Since PCI rates here may be lower than in current practice, an alternative analysis using the Boersma meta-analysis was performed. The model applied relative risks from all available trials and from the Boersma data. All analyses showed that use of GP IIb/IIIa inhibitors in initial management was the preferred strategy. Depending on the assumptions used, estimates of cost per QALY ranged from £4,605 to £11,671. However, the most cost-effective option was initial medical management in the subgroup of high-risk patients only, with cost per QALY estimated at £3,966. The additional benefit of use in all patients compared to use in high-risk patients alone was gained at a cost per QALY of £91,000. When using GP IIb/IIIa inhibitors as an adjunct to PCI was compared with not using them, the base case cost per QALY was £25,811 and this was reduced to £11,160 if baseline event rates based on Boersma data were applied. |
| 4.2.3.2 | In summary, the Assessment Report model, which is the closest representation of current UK practice, indicates that the most cost-effective strategy is for GP IIb/IIIa inhibitors to be used as part of the initial medical management of high-risk ACS patients irrespective of whether angiography with a view to PCI is performed. (It should be noted that early PCI itself was not assessed by the model.) Although early angiography with a view to PCI is an option for the initial management of high-risk ACS patients, this is not within the scope of the present guidance. The model suggests that the cost effectiveness of GP IIb/IIIa inhibitors is not dependent on the concurrent use of PCI, so their administration does not need to be delayed until a decision is made to carry out PCI. The use of GP IIb/IIIa inhibitors as an adjunct during PCI only is also less cost effective than their use in initial medical management. |
| 4.3 | Consideration of the evidence |
| 4.3.1 | The Committee considered the evidence available and the viewpoints expressed by the experts on the current management of ACS patients in the UK. It was emphasised that this appraisal was on the use of the GP IIb/IIIa inhibitors in the management of ACS, not on the role of PCI nor the management of ACS in general. |
| 4.3.2 | Historically, PCI rates have been lower in the UK than in the countries where the majority of the published trials of the GP IIb/IIIa inhibitors in ACS have been carried out. The Committee took this into account when considering the validity of these trials in relation to current UK practice, together with evidence from the experts suggesting that PCI rates in the UK are now rising by approximately 20% per annum. |
| 4.3.3 | The Committee considered that the Assessment Group model provided the best estimates of cost effectiveness for the UK, and on the balance of clinical and cost effectiveness, the Committee concluded that use of GP IIb/IIIa inhibitors for initial medical management in high-risk patients was the preferred treatment strategy. |
| 4.3.4 | The current licensed indications for the GP IIb/IIIa inhibitors are for use with aspirin and unfractionated heparin. However, the Committee recognised that LMWH is used widely in the management of ACS in place of unfractionated heparin. |
| 4.3.5 | If GP IIb/IIIa inhibitors are to be used as part of medical management in high-risk patients, the Committee thought that it was important that treatment should be initiated as soon as possible. This proves problematic if raised troponin alone is used to identify high-risk status, as the earliest that raised troponin levels can be accurately detected is 6 hours after the onset of chest pain. For this reason, the use of other risk indicators to identify high-risk patients was considered to be appropriate. |
| 4.3.6 | The Committee considered that while undergoing PCI, high-risk ACS patients should receive a GP IIb/IIIa inhibitor. In instances where this was not covered by initial medical management, the Committee thought that the administration of a GP IIb/IIIa inhibitor would still be appropriate. No clinical trial evidence is available on a strategy that involves a second administration of a GP IIb/IIIa inhibitor (i.e. after initial medical management) for a delayed PCI. |
| 4.3.7 | At the same time the Committee considered that, for patients undergoing procedurally uncomplicated, routine, elective PCI, GP IIb/IIIa inhibitors should not be recommended, because of the low risk of adverse events during PCI procedures, as demonstrated by UK audit data submitted by the British Cardiac Society and Royal College of Physicians (London). |
| 5 | Proposed recommendations for further research |
| 5.1 |
All of the currently available trials look at the GP IIb/IIIa inhibitors in conjunction with heparin, in line with their licensed indications. There is an ongoing trial (A-Z trial) looking at the use of tirofiban in conjunction with LMWH; INTERACT, another ongoing trial, is looking at a combination of eptifibatide with a LMWH (enoxaparin). As LMWH is widely used instead of standard heparin, the results of these trials are awaited with interest. |
| 5.2 | The effects of GP IIb/IIIa inhibitors in current UK practice should be investigated in carefully designed research to assess their benefits in non-ST-segment-elevation ACS in patients who are not scheduled for PCI. |
| 5.3 | Research should be carried out to investigate the efficacy of GP IIb/IIIa inhibitors in subgroups such as women. A recently published meta-analysis of patient-level data has suggested that GP IIb/IIIa inhibitors may have no benefit in the medical management of ACS in women. |
| 5.4 | The results of the CURE trial may lead to a consideration of the use of clopidogrel for the management of patients with ACS. Research to assess the relative benefits of GP IIb/IIIa inhibitors as an adjunct to PCI when clopidogrel is already being used would help to establish the relative roles of these antiplatelet agents in the short-term management of patients with ACS. |
| 5.5 | Research is need to establish the statistical relationship between clinical risk factors and troponin levels, so as to assess the value added by the troponin result in the determination of risk level. |
| 6 |
Preliminary views on the resource impact for the NHS |
| 6.1 | This section outlines the Appraisal Committee's preliminary assessment concerning the likely impact on NHS resources if the recommendations in Section 1 were to be implemented. When guidance is issued, this section is intended to assist NHS planners and managers in its implementation. Therefore the Institute particularly welcomes comments and information from those who would be involved in the implementation of the guidance so that this section can be made as helpful and robust as possible. |
| 6.2 |
In September 2000 the Institute's guidance indicated that the additional cost of providing GP IIb/IIIa inhibitors for medical management of unstable angina and non-Q-wave MI (NSTEMI) would be approximately £17 million per annum. This assumed that a positive troponin test would be used to identify high risk and that therefore approximately one-third of people admitted with ACS would receive a GP IIb/IIIa inhibitor. The prevalence of the risk factors described in 1.2 among people admitted with ACS is unknown, but assuming a similar proportion will be identified as being at high risk as would have been identified using the troponin result, the impact of the guidance remains unchanged. |
| 6.3 | The British Cardiovascular Intervention Society audit recorded the rate of PCI at 590 per million population in the year 2000. Based on mid-2000 population estimates for England and Wales of 52.9 million, this would mean approximately 31,000 procedures per year. However, there are no estimates as to the case-mix of patients undergoing these procedures. |
| 7 | Proposals for implementation and audit |
| This section presents proposals for implementation and audit based on the preliminary recommendations for guidance in Section 1. | |
| 7.1 | All clinicians who treat people with an ACS should review their current policies and practice in line with the guidance set out in Section 1. |
| 7.2 | Local guidelines or care pathways, particularly those on the treatment of patients with unstable angina or MI, should incorporate the guidance set out in Section 1. |
| 7.3 | To measure compliance locally with the guidance set out in Section 1, the following criteria could be used. Further details of suggestions for audit are presented in Appendix C. |
| 7.3.1 |
The following groups of patients receive small-molecule GP IIb/IIIa inhibitors as part of their initial medical management (along with aspirin and unfractionated heparin):
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| 7.3.2 | Treatment with GP IIb/IIIa inhibitors is initiated as soon as high-risk status is determined by the clinician. |
| 7.3.3 |
Patients who are high risk, and for whom PCI is recommended but delayed beyond the initial medical management phase receive abciximab as an adjunct to PCI.
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| 7.3.4 | GP IIb/IIIa inhibitors are not used for patients who are not at high risk and are undergoing procedurally uncomplicated, routine, elective PCI. |
| 7.4 | Local clinical audits on the care of patients with ACS also could include criteria on other aspects of care referred to in the National Service Framework for Coronary Heart Disease. |
| 8 | Related guidance |
| 8.1 | The Institute issued the original guidance on the use of GP IIb/IIIa inhibitors in September 2000: National Institute for Clinical Excellence (2000) The use of glycoprotein IIb/IIIa inhibitors in the treatment of acute coronary syndromes. NICE Technology Appraisal Guidance No. 12. London: National Institute for Clinical Excellence. All documents and further details available from: www.nice.org.uk |
| 8.2 | The Institute issued guidance on the use of coronary artery stents in April 2000: National Institute for Clinical Excellence (2000) The use of coronary artery stents in ischaemic heart disease. NICE Technology Appraisal Guidance No. 4. London: National Institute for Clinical Excellence. All documents and further details available from: www.nice.org.uk |
| 8.3 |
An appraisal of early thrombolytic therapy is ongoing.
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| 9 | Proposed date for review of guidance |
| 9.1 |
The review date for a technology appraisal refers to the month and year in which the Guidance Executive will consider any new evidence on the technology, in the form of an updated assessment report, and decide whether the technology should be referred to the Appraisal Committee for review. |
| 9.2 |
It is proposed that the guidance on this technology is reviewed in May 2005. |
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Professor David Barnett |
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Chairman, Appraisal Committee |
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April 2002 |
| Appendix A. Appraisal Committee members |
| NOTE
The Appraisal Committee is a standing advisory committee of the Institute. Its members are appointed for a 3-year term. A list of the Committee members appears below. The Appraisal Committee meets twice a month other than in December, when there are no meetings. The Committee membership is split into two branches, with the chairman, vice-chairman and a number of other members attending meetings of both branches. Each branch considers its own list of technologies and topics are not moved between the branches. |
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Committee members are asked to declare any interests in the technology to be appraised. If there is a conflict of interest, the member is excluded from participating further in that appraisal. |
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The minutes of each Appraisal Committee meeting, which include the names of the members who attended and their declaration of interests, are posted on the NICE website. |
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Dr Jane Adam |
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Radiologist, St. George's Hospital, London |
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Professor R L Akehurst |
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Dean, School of Health Related Research, Sheffield University |
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Dr Sunil Angris |
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General Practitioner, Waterhouses Medical Practice |
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Professor David Barnett (Chairman) |
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Professor of Clinical Pharmacology, University of Leicester |
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Professor Sir Colin Berry |
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Professor of Morbid Anatomy, St Bartholomew's and Royal London School of Medicine |
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Dr Sheila Bird |
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MRC Biostatistics Unit, Cambridge |
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Professor Carol Black |
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Consultant Physician, Royal Free Hospital & UCL, London |
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Professor John Brazier |
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Health Economist, University of Sheffield |
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Professor Martin Buxton |
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Director of Health Economics Research Group, Brunel University |
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Professor Bruce Campbell |
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Consultant Surgeon, Royal Devon & Exeter Hospital |
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Professor Mike Campbell |
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Statistician, Institute of General Practice & Primary Care, Sheffield |
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Dr Karl Claxton |
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Health Economist, University of York |
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Professor Sarah Cowley |
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Professor of Community Practice Development, Kings College, London |
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Dr Nicky Cullum |
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Reader in Health Studies, University of York |
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Professor Jack Dowie |
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Health Economist, London School of Hygiene & Tropical Medicine, London |
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Mr Chris Evennett |
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Chief Executive, Mid-Hampshire Primary Care Group |
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Dr Paul Ewings |
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Statistician, Taunton & Somerset NHS Trust |
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Professor Terry Feest |
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Clinical Director and Consultant Nephrologist, Richard Bright Renal Unit, and Chairman of the UK Renal Registry |
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Ms Jean Gaffin |
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Formerly Executive Director, National Council for Hospice and Specialist Palliative Care Service |
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Mrs Sue Gallagher |
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Chief Executive, Merton, Sutton and Wandsworth Health Authority |
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Dr Trevor Gibbs |
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Head, Global Clinical Safety & Pharmacovigilance, GlaxoSmithKline |
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Sally Gooch |
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Director of Nursing, Mid-Essex Hospital Services Trust |
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Mr John Goulston |
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Director of Finance, The Royal Free Hampstead NHS Trust |
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Professor Trisha Greenhalgh |
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Professor of Primary Health Care, University College London |
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Miss Linda Hands |
| Consultant Vascular Surgeon, John Radcliffe Hospital, Oxford |
| Liz Heyer |
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Chief Executive, Barnet & Chase Farm Hospitals NHS Trust |
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Professor Philip Home |
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Professor of Diabetes Medicine, University of Newcastle |
|
Dr Terry John |
|
General Practitioner, The Firs, London |
|
Dr Diane Ketley |
|
Research into Practice Programme Leader, NHS Modernisation Agency |
|
Dr Mayur Lakhani |
|
General Practitioner, Highgate Surgery, Leicester, and Lecturer, University of Leicester |
|
Ruth Lesirge |
|
Lay Representative; Director, Mental Health Foundation |
|
Dr George Levvy |
|
Lay Representative; Chief Executive, Motor Neurone Disease Association |
|
Dr Gill Morgan |
|
CEO, North & East Devon Health Authority |
|
Professor Miranda Mugford |
|
Health Economist, University of East Anglia |
|
Mr M Mughal |
|
Consultant Surgeon, Chorley and South Ribble NHS Trust |
|
Mr James Partridge |
|
Chief Executive, Changing Faces |
|
Siân Richards |
|
General Manager, Cardiff Local Health Group |
|
Professor Philip Routledge |
|
Professor of Clinical Pharmacology, University of Wales |
|
Dr Rhiannon Rowsell |
|
Pharmaceutical Physician, AstraZeneca UK Ltd |
|
Dr Stephen Saltissi |
|
Consultant Cardiologist, Royal Liverpool University Hospital |
|
Professor Andrew Stevens (Vice-Chairman) |
|
Professor of Public Health, University of Birmingham |
|
Professor Ray Tallis |
|
Consultant Physician, Hope Hospital, Salford |
|
Dr Cathryn Thomas |
|
General Practitioner, and Senior Lecturer, Department of Primary Care and General Practice, University of Birmingham |
|
Professor Mary Watkins |
|
Head of Institute of Health Studies, University of Plymouth |
|
Dr Norman Waugh |
|
Public Health Consultant, University of Southampton |
| Appendix B. Sources of evidence considered by the Committee | |
|
The following documentation and opinion was made available to the Committee: | |
|
A. |
Assessment Report prepared by NHS Centre for Reviews & Dissemination and Centre for Health Economics: A Systematic Review Update of the Clinical Effectiveness and Cost Effectiveness of Glycoprotein IIb/IIIa Antagonists and A Cost-effectiveness Model Comparing Alternative Management Strategies for the Use of Glycoprotein IIb/IIIa Antagonists in Non-ST Elevation Acute Coronary Syndromes. |
| B. |
Manufacturer/sponsor submissions from:
|
| C. |
Professional/specialist group submissions from:
|
| D. |
Patient/carer group submissions from:
|
| E. |
Expert perspectives from:
|
| Appendix C. Detail on criteria for audit of the use of glycoprotein IIb/IIIa inhibitors in the treatment of acute coronary syndromes | |||
| Possible objectives for an audit | |||
|
An audit could be carried out to ensure that patients in accelerated phase of CML receive imatinib | |||
| Patients to be included in an audit | |||
|
An audit on the appropriateness and timeliness of use of GP IIb/IIIa inhibitors could be carried out to ensure the following.
|