NICE Advisors Recommend Rivaroxaban for Secondary Prevention in ACS Patients

October 23, 2014

LONDON, UK — An independent appraisal committee for the UK's National Institute for Health and Care Excellence (NICE) is supporting the use of rivaroxaban (Xarelto, Bayer/Janssen Pharmaceuticals) as part of a secondary-prevention strategy in acute coronary syndrome (ACS) patients[1].

In its review of the data, the NICE appraisal committee states that rivaroxaban 2.5 mg twice daily with aspirin alone or aspirin plus clopidogrel or ticlopidine is an option for biomarker-confirmed ACS patients without a prior history of stroke or transient ischemic attack. Before starting treatment, clinicians should carefully assess the patient's risk of bleeding, according to the review.

In their conclusions, the committee states that rivaroxaban is a "cost-effective" use of the National Health Service (NHS) resources. The NICE decision is not yet final—it is only the opinion of the independent committee—but a final appraisal determination is expected soon. In the UK, the department of health asks NICE for guidance on using drugs, treatments, and technologies within the NHS.

Rivaroxaban, an oral factor Xa inhibitor, was approved for the ACS indication throughout Europe after the European Commission gave its approval in May 2013. The approval was based on the ATLAS ACS 2-TIMI 51 study, a trial reported by heartwire .

In the US, the pursuit of an ACS indication with rivaroxaban has been futile so far. Three times the US FDA has said no to the expanded indication. In the latest tangle before an FDA advisory committee, 10 panel members voted against approving rivaroxaban as a short-term treatment in ACS patients, leading the FDA to follow their recommendation and say no to the expanded indication.

Rivaroxaban is approved in the US and Europe to reduce the risk of stroke in nonvalvular atrial fibrillation. It is also approved to reduce the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) following knee- or hip-replacement surgery, for the treatment of DVT or PE, and to reduce the risk of recurrent DVT and PE following initial treatment.


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