UK’s NICE backs another use for Bayer’s Xarelto

In draft guidance published today for consultation, the UK’s health costs watchdog the National Institute for Health and Care Excellence (NICE) has recommended German pharma major Bayer’s (BAYN: DE) Xarelto (rivaroxaban) as an option for preventing blood clots in people who have had a heart attack as a result of a blockage or narrowing in one of the blood vessels in the heart.

Bayer’s Xarelto, which has already generated sales of around $1.7 billion in the 12 months to end June 2014, 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 damaged.

The draft guidance considers the use of rivaroxaban to prevent further blood clots in adults who have had a heart attack – either STEMI or NSTEMI. 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is not severe enough to result in the release of biomarkers into the blood so this condition is not considered in the draft guidance. In 2009/10 there were 57,000 admissions for heart attacks in England, with 28,000 subsequent heart attacks.

Rivaroxaban offers an option for secondary prevention, says Bayer

“Patients with ACS remain at risk even though there have been a number of advances in treatment over the past few years, including newer antiplatelet agents. This is evidenced by the high incidence of cardiovascular death, myocardial infarction and stroke in patients following an ACS event. Rivaroxaban offers an option for secondary prevention in this patient group, and we hope that selected patients in the UK will be able to benefit from this advance in therapy” said Luis Felipe Graterol, medical director of Bayer UK subsidiary.

Carole Longson, NICE Health Technology Evaluation Centre Director, said: “People who have a heart attack are at higher risk of having further events. This can have a negative impact on the quality of life of the person and their family because of worries over their future health. Any additional treatments to reduce that risk are therefore to be welcomed. 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 of a higher risk of bleeding with rivaroxaban, the draft guidance also recommends that, before starting treatment clinicians should undertake 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 in combination with aspirin and clopidogrel or with aspirin alone, compared with aspirin and clopidogrel or aspirin alone, NICE noted.