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NICE heart attack recommendation for Xarelto

Bayer drug on course for another blood clot indication in England and Wales
Bayer Xarelto rivaroxaban

The market for Bayer's anticoagulant Xarelto in the UK is set to expand after it was recommended for NHS reimbursement in yet another blood clot indication.

The National Institute for Health and Care Excellence (NICE) issued final draft guidance that says Xarelto (rivaroxaban) should be available in England and Wales if used in combination with clopidogrel and aspirin, or with aspirin alone, to prevent blood clots in people who have had a heart attack.

It follows previous draft guidance issued by NICE that backed the cost-effectiveness of the drug in these patients who have experienced an acute coronary syndrome (ACS). ACS is a range of serious conditions, including heart attack, caused by a blockage in the blood flow in the coronary arteries.

According to NICE people who have a heart attack are at higher risk of having further events, noting that of the 57,000 admissions for heart attacks in England in 2009/10 there were 28,000 subsequent heart attacks.

Heart attack patients are usually managed with generic bloodthinners such as aspirin and/or clopidogrel to reduce the risk of blood clot. Xarelto, one of several next generation oral anticoagulants, has demonstrated it is more effective than these options and can help prevent further cardiovascular deaths and heart attacks.

The drug works by stopping a substance called Factor Xa from working. Factor Xa is necessary in the formation of thrombin and fibrin, key components in the formation of blood clots.

Despite its improvement in efficacy the drug is associated with a higher risk of causing bleeding, however, and NICE's guidance notes that doctors carry out an assessment of a person's bleeding risk before starting treatment.

Since its launch Xarelto has emerged as one of Bayer's leading products, reaching sales of more than $2bn for 2013, according to PMLiVE's Top Pharma List.

This has been helped by its wide range of blood clot indications, several of which NICE has previously recommended. These include the treatment and prevention of deep vein thrombosis and pulmonary embolism, the prevention of stroke in people with atrial fibrillation and the prevention of venous thromboembolism after total hip or total knee replacement in adults.

The new guidance allows Bayer to retain an edge over rival anticoagulants from Boehringer Ingelheim and Bristol-Myers Squibb/Pfizer, whose own respective oral medicines Pradaxa (dabigatran etexilate) and Eliquis (apixaban) are yet to be approved in an ACS indication in Europe.

Article by
Thomas Meek

23rd January 2015

From: Sales, Healthcare

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