Bayer’s Xarelto makes grade in NICE final draft guidance


In final draft guidance UK health watchdog NICE has confirmed its earlier positive draft decision recommending Bayer's Xarelto (rivaroxaban) as an option for preventing blood clots in people who have had an acute coronary syndrome (ACS).

It can be used in combination with clopidogrel and aspirin, or with aspirin alone and is licensed for the prevention of blood clots in adults who have an ACS severe enough to result in the release of cardiac biomarkers into the blood that show heart muscle has been damaged.

The NICE Final Appraisal Determination (FAD) is the last step in the review process and recommends Xarelto 2.5mg twice daily as an effective treatment option for preventing secondary events – such as death, heart attack or stroke.

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."

Professor Carlo di Mario, Professor of Cardiology, Imperial College London, stated that the addition of Xarelto to standard antiplatelet therapy represented a "significant advance" in the management of ACS.

"We're delighted with this FAD as it expands the clinical utility of Xarelto across different settings and patient populations, providing even more patients with access and improved outcomes," said Dr Luis Felipe Graterol, medical director, Bayer HealthCare UK.

The draft guidance now moves to review by consultees, with final guidance expected in the first quarter of 2015.

With this latest positive review, Xarelto looks set to extend its use in the growing armoury in the anticoagulant drugs sector, where Boehringer Ingelheim's Pradaxa (dabigatran), Lilly's Efient (prasugrel) and AstraZeneca's Brilique/Brilinta (ticagrelor) are gaining traction.


NICE draft guidance recommends Bayer's Xarelto post heart attack

Linda Banks

23 January, 2015