U.K.'s NICE Backs J&J And Bayer's Blood Thinner Xarelto

In a draft guidance published for consultation, UK’s National Institute for Health and Care Excellence (NICE) announced that it has given a positive opinion for coverage of Xarelto (rivaroxaban) for patients who have had a heart attack.

Xarelto is an oral anticoagulant discovered by Bayer and co-developed with Johnson & Johnson’s subsidiary Janssen Research & Development. The drug is approved for a number of indications, including the prevention of stroke and systemic embolism in patients with atrial fibrillation, treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism after an acute DVT. In the U.K., Xarelto is approved for the prevention of blood clots in adult patients who have an acute coronary syndrome and who are confirmed to have heart muscle damage.

NICE recommended Xarelto as an optional treatment for the prevention of blood clots in patients who have had a heart attack resulting from a heart blood vessel narrowing or blockage. The draft guidance considers coverage of Xarelto specifically for patients who have had either (ST-segment-elevation myocardial infarction (STEMI) or non-ST-segment myocardial infarction (NSTEMI).

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.”

The U.K. regulatory authority also recommends proper assessment of a patient’s bleeding risk prior to starting treatment with Xarelto. This should include a discussion between patient and physician about the risks and benefits of rivaroxaban therapy with aspirin and clopidogrel or with aspirin alone compared to the same treatment without rivaroxaban.

The U.S. Food and Drug Administration (FDA) reports that NICE is looking at several ways of making Xarelto cost-effective, preferably at no more than $16,000 for every year of quality of life gained. A year’s treatment of Xarelto would come at a price tag of approximately $1,227.

Feedback on the draft guidance is expected by November 13.