Section 7 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires integrated care boards, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this evaluation within 3 months of its date of publication.
The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal guidance recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the
When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has acute coronary syndromes and the healthcare professional responsible for their care thinks that glycoprotein (GP) IIb or IIIa inhibitors is the right treatment, they should be available for use, in line with NICE's recommendations.
All clinicians who treat people with an acute coronary syndrome (ACS) should review their current policies and practice in line with the guidance set out in section 1.
Local guidelines or care pathways, particularly those on the management of patients with unstable angina or myocardial infarction (MI), should incorporate the guidance in section 1.
To measure compliance locally with the guidance, the following criteria could be used. Further details of suggestions for audit are in the section on detail on criteria for audit.
The following groups of patients receive an intravenous small-molecule GP IIb/IIIa inhibitor (eptifibatide or tirofiban) as part of their initial medical management (together with aspirin and unfractionated heparin):
patients with unstable angina who are at high risk of subsequent MI or death
patients with NSTEMI who are at high risk of subsequent MI or death.
Patients who are at high risk and for whom percutaneous coronary intervention (PCI) is recommended but delayed beyond the initial medical management phase receive a GP IIb/IIIa inhibitor (abciximab) as an adjunct to PCI.
A GP IIb/IIIa inhibitor (abciximab) is considered as an adjunct to PCI for all patients with diabetes who are undergoing elective PCI or for those patients undergoing complex procedures.
A GP IIb/IIIa inhibitor is not used for patients who are undergoing procedurally uncomplicated, elective single-vessel PCI, unless unexpected immediate complications occur.
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.
Replacement of the September 2000 guidance with this revised guidance is not anticipated to increase costs to the NHS. Fewer patients undergoing elective percutaneous coronary intervention (PCI) will receive glycoprotein (GP) IIb/IIIa inhibitors, which may result in some cost savings. Under the previous guidance it was assumed that a positive troponin test would be used to identify high risk and that therefore approximately one-third of people admitted with acute coronary syndrome (ACS) would receive a GP IIb/IIIa inhibitor. The prevalence of the risk factors described in 1.4 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 this section of the guidance remains unchanged.
The British Cardiovascular Intervention Society audit recorded 30,916 PCIs in NHS centres during 2000. However, since there are only limited data as to the case-mix of patients undergoing these procedures estimation of budget impact cannot be made.
An audit on the appropriateness of the use of glycoprotein (GP) IIb/IIIa inhibitors could be carried out to ensure the following:
Small-molecule GP IIb/IIIa inhibitors are provided as part of initial medical management for patients with unstable angina or with NSTEMI who are at high risk of subsequent myocardial infarction (MI) or death.
A GP IIb/IIIa inhibitor (abciximab) is provided as an adjunct for patients at high risk for whom percutaneous coronary intervention (PCI) is recommended but delayed beyond the initial medical management phase.
A GP IIb/IIIa inhibitor (abciximab) is considered as an adjunct to PCI for all patients with diabetes who are undergoing elective PCI or for those patients undergoing complex procedures.
A GP IIb/IIIa inhibitor (abciximab) is not provided for patients who are undergoing procedurally uncomplicated, elective PCI.
An audit on the first objective above could be carried out on all patients presenting with unstable angina or NSTEMI over a suitable time period given the total number of patients with these conditions treated in 6 months or 1 year. If clinical coding is reliable, the patients can be identified through clinical or procedure codes. If clinical coding for these conditions is not entirely reliable, it may be necessary to retrieve cases of patients who are coded as unstable angina and those coded as myocardial infarction and screen these cases to find patients with NSTEMI.
An audit on the other objectives could be carried out using all patients booked and on the waiting list for PCI over a suitable time period given the total number of PCIs carried out in 6 months or 1 year.
| Criterion | Standard | Exception | Definition of terms |
|---|---|---|---|
|
A patient in any 1 of the following groups receives a glycoprotein (GP) IIb/IIIa inhibitor:
|
100% of patients with unstable angina or NSTEMI who are at high risk. |
None. |
Clinicians will have to agree locally how the initial medical management phase is identified for audit purposes. High risk is of subsequent MI or death as determined by clinician judgement based on risk factors such as:
Clinicians will have to agree locally on how high risk is documented for audit purposes. |
In this approach, the audit involves finding the patients in the audit group who are at high risk and determining if all those patients had a GP IIb/IIIa inhibitor.
Another way to audit appropriateness of the use of GP IIb/IIIa inhibitors in initial medical management is first to find patients in the audit group who have had small-molecule GP IIb/IIIa inhibitors in the initial medical management phase, then to screen those cases to see if the patient was at high risk.
The measures that could be used in an audit of appropriateness of the use of a GP IIb/IIIa inhibitor (abciximab) as an adjunct to PCI are as set out below.
| Criterion | Standard | Exception | Definition of terms |
|---|---|---|---|
|
A glycoprotein (GP) IIb/IIIa inhibitor (abciximab) is provided for the patient who is at high risk and is recommended for percutaneous coronary intervention (PCI) but the PCI is delayed beyond the initial medical management phase. |
100% of patients who are at high risk and are scheduled for a PCI but the PCI is delayed beyond the initial medical management phase. |
None. |
See above for a definition of high risk. |
|
A GP IIb/IIIa inhibitor (abciximab) is considered for the patient who has diabetes and is undergoing an elective PCI. |
100% of patients who have diabetes and are undergoing an elective PCI. |
None. |
Clinicians will have to agree locally on what constitutes evidence that the treatment was considered for audit purposes. |
|
A GP IIb/IIIa inhibitor (abciximab) is considered for the patient who is undergoing a complex procedure. |
100% of patients who are undergoing a complex procedure. |
None. |
Examples of complex procedures = multi-vessel PCI, insertion of multiple stents, vein graft PCI, PCI for bifurcation lesions Clinicians will have to agree locally on what constitutes evidence that the treatment was considered for audit purposes. |
|
A GP IIb/IIIa inhibitor (abciximab) is not provided for a patient who is undergoing a procedurally uncomplicated, routine elective PCI. |
100% of patients who are undergoing an uncomplicated routine elective PCI. |
An unexpected immediate complication occurs. |
– |
Another way to audit the appropriateness of the use of a GP IIb/IIIa inhibitor (abciximab) as an adjunct to PCI is to screen all patients scheduled for or who have undergone PCI to find out whether, if a GP IIb/IIIa inhibitor (abciximab) was administered, the patient met the criteria listed in the first 3 measures above.
Compliance with each measure described in the table is calculated as follows:
Numerator divided by the denominator, multiplied by 100.
Numerator: Number of patients whose care is consistent with the criterion plus the number of patients who meet any exception.
Denominator: Number of patients to whom the measure applies.
Clinicians should review the findings of measurement, identify if practice can be improved, agree on a plan to achieve any desired improvement and repeat the measurement of actual practice to confirm that the desired improvement is being achieved.