NICE draft guidance recommends new "clot-busting" drug to treat acute coronary syndromes
Final draft guidance published today (16 September) by NICE confirms its previous positive draft recommendation for ticagrelor (Brilique, Astrazeneca). The draft guidance recommends ticagrelor within its licensed conditions (that is, in combination with aspirin and for up to 12 months) as an option to treat adults with acute coronary syndromes (ACS).
The term 'acute coronary syndromes' covers a range of conditions from unstable angina to myocardial infarction (heart attack). ACS are caused by thrombus (blood clot) formation following rupture of a plaque of fatty deposit (atheromatous plaque) in the coronary artery. This can cause the coronary artery to become progressively narrowed, affecting blood supply to the heart (ischaemia). ST-segment-elevation myocardial infarction (STEMI) and Non-ST-segment-elevation myocardial infarction (NSTEMI) - the names come from the pattern seen on an ECG, which measures the rhythm and electrical activity of the heart - happens when the ischaemia results in damage to the heart muscle. Where the blood supply to the heart is blocked but there is no evidence of actual damage to the heart muscle, the clinical syndrome is described as unstable angina. Every year around 200,000 people are diagnosed with ACS in England, of whom around three quarters have unstable angina or NSTEMI.
Ticagrelor belongs to a class of drugs called anti-platelets. These work by reducing or preventing the formation of blood clots. Ticagrelor is licensed for the treatment of people with ACS who are managed medically or who are having a procedure called a percutaneous coronary intervention to widen narrowed arteries in the heart.
The draft guidance recommends the use of ticagrelor, in combination with aspirin, as a treatment option in people with STEMI who are to undergo primary percutaneous coronary intervention (PCI) and in people with NSTEMI. It is also recommended as a treatment option for people with unstable angina, which is defined as changes on electrocardiogram suggestive of ischaemia plus one characteristic associated with cardiovascular diseasei.
Dr Carole Longson, NICE Health Technology Evaluation Centre Director, said: "Although mortality from MI and other cardiovascular causes has declined in recent years, an increasingly ageing population, coupled with worrying trends in the incidence of obesity and lifestyles that involve less exercise, make the management of ACS a continuing high priority. The independent Appraisal Committee concluded from the evidence that ticagrelor plus aspirin significantly reduces MI and death from cardiovascular causes - by 16% and 21% respectively - compared with clopidogrel plus aspirin. This draft guidance recognises the potential of ticagrelor in providing the NHS in England and Wales with another valuable tool to enable it to deal more effectively with the long-term management of ACS."
The proposed guidance is with consultees, who now have the opportunity to appeal. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
About the draft guidance
1. Please contact the press office for an embargoed copy of the draft guidance, which will be available on the NICE website at http://guidance.nice.org.uk/TA/Wave20/70 from Friday, 16 September. Registered consultees have until 30 September to appeal against the draft recommendations. If no appeals are received, final guidance is expected to be published on 26 October 2011.
2. Ticagrelor (Brilique, AstraZeneca) is an oral reversibly bound antagonist of the P2Y12 adenosine diphosphate (ADP) receptor which inhibits platelets aggregation and therefore thrombus formation in atherosclerotic disease. The summary of product characteristics (SPC) states that ticagrelor, co-administered with acetylsalicylic acid (aspirin, ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) defined as people with, ST-segment-elevation MI (STEMI), non-ST-segment-elevation MI (NSTEMI) or unstable angina. Patients may be managed medically or revascularised with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
3. According to the SPC, treatment should be initiated with a single 180 mg (2 tablets of 90 mg) loading dose of ticagrelor and then continued at 90 mg twice daily for up to 12 months. Patients taking ticagrelor should also take low-dose aspirin daily, unless specifically contraindicated. Following an initial dose of aspirin, ticagrelor should be taken daily with a maintenance dose of aspirin of 75-150 mg.
4. The manufacturer stated in its submission that the cost of 90 mg tablets of ticagrelor is £54.60 for a pack of 56 tablets (28 days). Costs may vary in different settings because of procurement discounts.
5. Current NICE guidance (TA182) recommends prasugrel as an option for preventing atherothrombotic events in people with ACS having PCI, only when immediate primary PCI for STEMI is necessary, or stent thrombosis has occurred during treatment with clopidogrel, or the patient has diabetes.
6. NICE clinical guideline 94 (Unstable angina and NSTEMI) recommends that aspirin should be offered as soon as possible to all patients and continued indefinitely unless contraindicated by bleeding risk or aspirin hypersensitivity. For patients with aspirin hypersensitivity, clopidogrel monotherapy should be considered as an alternative. For people with increased risk of mortality and no contraindications who may undergo PCI within 24 hours of admission to hospital, clopidogrel in combination with low-dose aspirin for 12 months after the most recent acute episode of NSTEMI ACS is recommended. Thereafter, standard care, including treatment with low-dose aspirin is recommended.
i. Age 60 years or older, previous MI or previous coronary artery bypass grafting (CABG), coronary artery disease with stenosis (narrowing) of 50% or more in at least two vessels, previous ischaemic stroke, previous transient ischaemic attack, carotid stenosis of at least 50%, or cerebral revascularisation, diabetes, peripheral arterial disease, or chronic renal dysfunction.
6. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health
7. NICE produces guidance in three areas of health:
public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sectorhealth technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHSclinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.8. NICE produces standards for patient care:
quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent servicesQuality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients9. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.
This page was last updated: 14 September 2011