Healthcare Blog

Astrazeneca's Brilique(R) (Ticagrelor) Accepted For Use By The Scottish Medicines Consortium (SMC)

April 05, 2017

AstraZeneca is pleased to announce that the Scottish Medicines Consortium (SMC) has today accepted Brilique® (ticagrelor) for use in combination with aspirin for the prevention of atherothrombotic events in adult patients who have had a myocardial infarction (STEMI/NSTEMI) or an episode of unstable angina. This includes patients managed medically, or those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG)1. Ticagrelor, the first in a new chemical class of oral antiplatelet medicine received authorisation from the European Medicines Agency (EMA) in December last year1.

Within Scotland there are an estimated 260,000 people who are suffering or have suffered from angina and 140,000 who have had a heart attack - with 15,500 admissions to Scottish hospitals for heart attack in 20082.

Dr Neal Uren, Cardiologist, Royal Infirmary of Edinburgh states, "Despite current treatment options, 1 in 7 patients (14.8%) will die within 12 months following a heart attack3. The SMC decision is a great step forward for improving the care of heart attack patients in Scotland. The decision means that patients in Scotland will now be the first in Britain to have widespread access to a new treatment which is superior to the existing standard of care in reducing the combined chance of repeat cardiovascular events such as heart attack, stroke or death from cardiovascular causes."

In the PLATO trial, ticagrelor was shown to reduce the risk of repeat cardiac events when given to adult patients after a heart attack or an episode of unstable angina, in comparison to the most commonly-used treatment, clopidogrel4. Ticagrelor demonstrated a 21% relative risk reduction in cardiovascular death (absolute risk reduction = 1.1%), and 16% of repeat cardiovascular events were avoided (absolute risk reduction = 5.8% vs 6.9% at 12 months), when patients were offered ticagrelor plus aspirin instead of clopidogrel plus aspirin after a heart attack or episode of unstable angina4. Treatment with ticagrelor is recommended for up to 12 months1. Premature discontinuation of any antiplatelet therapy, including ticagrelor, could result in an increased risk of cardiovascular death, or heart attack due to the patient's underlying disease1.

Guidance for England and Wales, from The National Institute for Health and Clinical Excellence (NICE) is expected later this year5, however healthcare professionals will be able to prescribe ticagrelor in the interim in accordance with local guidance. NICE guidance is also expected to be adopted in Northern Ireland6.

Other oral antiplatelet medicines currently available in Scotland include clopidogrel7 and prasugrel8.

Notes

The full guidance from the Scottish Medicines Consortium is detailed below:

ADVICE: following a full submission

Ticagrelor film-coated tablets are accepted for use within NHS Scotland.

Indication under review: co-administered with aspirin, for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non ST elevation myocardial infarction [NSTEMI] or ST elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).

As dual therapy with aspirin, ticagrelor demonstrated a significant reduction in ischaemic events compared with another antiplatelet drug without significantly increasing the incidence of study-defined major bleeding.

Alternative treatments are available at a lower drug acquisition cost.

About ticagrelor - for further information see separate media fast facts document

Discovered and developed by AstraZeneca, ticagrelor is the first in a new class of oral antiplatelet treatment for heart attack and unstable angina (Acute Coronary Syndromes). In 2009, ticagrelor became the first and only oral antiplatelet to demonstrate significant morbidity and mortality benefit in a broad ACS population when combined with aspirin versus clopidogrel with aspirin in patients who had a heart attack or episode of unstable angina.

PLATO is the largest clinical study completed to date by AstraZeneca and involved over 18,000 patients worldwide.

References:

1. Brilique Summary of Product Characteristics.

2. British Heart Foundation. Scotland Coronary Heart Disease Statistics 2009-2010.

3. Tang EW, Wong CK, Herbison P. Global Registry of Acute Coronary Events (GRACE) hospital discharge risk score accurately predicts long-term mortality post acute coronary syndrome. Am Heart J 2007;154:29-35

4. Wallentin et al. Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes. N Engl J Med 2009;361

5. National Institute for Health and Clinical Excellence (NICE). Acute coronary syndromes - ticagrelor.

6. DHSSPS. Implementation of National Institute for Health and Clinical Excellence Guidance in the HPSS. June 2006. HSS(PPMD)/(NICE)01/06

7. National Institute for Health and Clinical Excellence (NICE). Clopidogrel and modified release dipyridamole in the prevention of occlusive vascular events. May 2005. See here.

8. National Institute for Health and Clinical Excellence (NICE). Prasugrel for the treatment of acute coronary syndromes with percutaneous coronary intervention. October 2009. See here.

Source:
AstraZeneca