National Institute for Health and Clinical Excellence (NICE)
NICE recommends rivaroxaban (Xarelto) to prevent blood clots in people who have had a heart attack in final draft guidance
In final draft guidance published recently NICE has confirmed its earlier positive draft decision recommending rivaroxaban (Xarelto, Bayer Healthcare), in combination with clopidogrel and aspirin, or with aspirin alone, as an option
An acute coronary syndrome happens when one or more of the blood vessels in the heart become narrowed or blocked. Where the blood supply to the heart is blocked, this can lead to heart attacks (ST-segment-elevation myocardial infarction (STEMI) and non-ST-segment myocardial infarction (NSTEMI)) where there is damage to the heart muscle.
People who have a heart attack are at higher risk of having further events. In 2009/10 there were 57,000 admissions for heart attacks in England, with 28,000 subsequent heart attacks.
Rivaroxaban is licensed for the prevention of blood clots in adults who have an acute coronary syndrome severe enough to result in the release of cardiac biomarkers into the blood that show heart muscle has been damaged1. It is given with aspirin and clopidogrel, another drug that helps to prevent the blood from clotting, or with aspirin alone.
Rivaroxaban is given as a tablet. It prevents the formation of blood clots by stopping a substance called Factor Xa from working. Factor Xa is necessary in the formation of thrombin and fibrin, the key components in blood clot formation. Rivaroxaban helps to maintain blood flow to the heart muscle to prevent further damage to the heart.
Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “Based on the evidence considered, the independent Appraisal Committee concluded that rivaroxaban, in combination with aspirin plus clopidogrel or with aspirin alone, was more effective than aspirin plus clopidogrel or aspirin alone for preventing further cardiovascular deaths and heart attacks in people with acute coronary syndrome and raised cardiac biomarkers. The Committee therefore recommended rivaroxaban as a cost-effective use of NHS resources.
“Because rivaroxaban is associated with a higher risk of causing bleeding than clopidogrel in combination with aspirin or aspirin alone, the draft guidance recommends that before starting treatment doctors should carry out a careful assessment of a person’s bleeding risk. The decision to start treatment should be made after an informed discussion between the doctor and patient about the benefits and risks of rivaroxaban. Also, because there is limited experience of treatment with rivaroxaban up to 24 months, the draft guidance recommends careful consideration should be given to whether treatment is continued beyond 12 months.”
The draft guidance is now with consultees, who have the opportunity to appeal against it. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.
Notes to Editors
- The draft guidance considers the use of rivaroxaban to prevent further blood clots in adults who have had a heart attack. In unstable angina, damage to the heart is not severe enough to result in the release of biomarkers into the blood so this condition is not considered in the draft guidance.
About the draft guidance
- The draft guidance on rivaroxaban for acute coronary syndrome can be found on the NICE website
- The Committee concluded that rivaroxaban 2.5 mg twice daily in combination with aspirin plus clopidogrel or with aspirin alone was more effective than aspirin plus clopidogrel or aspirin alone for preventing further cardiovascular deaths and myocardial infarction in people with acute coronary syndrome and raised cardiac biomarkers.
- The Committee noted that the company’s base case ICER was £6,203 per QALY gained, and the ERG’s preferred base case estimate was £5,622 per QALY gained. It accepted that there is uncertainty about the validity of the results based on ATLAS-ACS 2-TIMI 51 because of the risk of bias resulting from missing data and informative censoring. However, The Committee considered that the ICERs presented were all within the range which could be considered cost effective and that adjusting for the various types of bias that might have occurred was unlikely to increase the ICER to the extent that it would become unacceptable.
- The list price of rivaroxaban is £58.88 per 2.5 mg, 56‑capsule pack (excluding VAT, company submission) The license dose is 2.5 mg twice daily which equates to a price of £2.10 per day. Total acquisition costs depend on the duration of therapy. Assuming a treatment duration of 12 months, total acquisition costs are £766.50. Costs may vary in different settings because of negotiated procurement discounts.
About acute coronary syndrome
- The presence of ST segment elevation on an electrocardiogram usually indicates total occlusion of the affected artery, resulting in necrosis of the tissue supplied by that artery acute myocardial infarction (MI)). This condition (STEMI) is treated immediately with reperfusion therapy (thrombolysis or percutaneous coronary intervention [PCI]).
- ACS without STEMI is classified as either unstable angina or non ST segment elevation myocardial infarction (NSTEMI). NSTEMI differs from unstable angina primarily in the severity of myocardial ischaemia. In NSTEMI, the ischaemia is severe enough to result in the release of biochemical markers of myocardial injury into the blood. Immediate treatment for these conditions aims to prevent progression to total occlusion of the artery and, for people at high risk of myocardial infarction, may include coronary revascularisation, either by means of PCI or coronary artery bypass graft.
- Long term management of ACS includes the use of aspirin and another antiplatelet agent (clopidogrel, prasugrel or ticagrelor).
- NICE has produced a clinical guideline on secondary prevention in primary and secondary care for patients following a myocardial infarction (Clinical Guideline No. 172). For people with NSTEMI clopidogrel with aspirin or ticagrelor with aspirin are treatment options. For people with STEMI, who have received a bare-metal or drug eluting stent or who received medical management with or without reperfusion treatment with a fibrinolytic agent, clopidogrel with aspirin is recommended.
- For people with STEMI who cardiologists intend to treat with PCI, ticagrelor with aspirin is a treatment option.
- For people with ACS (STEMI, NSTEMI or unstable angina) prasugrel with aspirin is a treatment option for people who require immediate PCI for STEMI, people who have had stent thrombosis while taking clopidogrel or people with diabetes (technology appraisal No. 317).
- For all indications the dual antiplatelet treatment is recommended to be continued for up to 12 months following the acute event after which aspirin is recommended to be taken indefinitely in people for whom aspirin is suitable.
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.
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