FDAnews
www.fdanews.com/articles/168124-nice-recommends-coverage-for-xarelto-for-heart-attack-patients

NICE Recommends Coverage for Xarelto for Heart Attack Patients

October 29, 2014

The UK’s cost-effectiveness watchdog has recommended coverage of Bayer’s blood thinner Xarelto for preventing blood clots in people who have had a heart attack based on evidence the drug can decrease the cardiovascular risk by up to 20 percent.

In a draft guidance last week, the National Institute for Health and Care Excellence (NICE) endorsed the drug in combination with either aspirin or aspirin and Bristol-Myers Squibb/Sanofi’s Plavix (clopidogrel). The announcement comes four months after the NICE recommended the same drug to reduce the risk of blood clots in patients with atrial fibrillation.

NICE evaluators looking at Xarelto’s (rivaroxaban) clinical effectiveness said they initially were concerned that Bayer had studied patients who were younger than the average UK heart attack patient, with fewer comorbidities. But experts convinced them that the average difference in age was unlikely to be statistically significant, they added.

NICE also looked at multiple ways of determining the drug’s cost-effectiveness and concluded that Xarelto would cost no more than $16,000 for every year of quality of life gained. A 56-tablet pack of 2.5-mg Xarelto costs $94.25 in the UK. Using that price, a year’s treatment of Xarelto would cost roughly $1,227.

Comments on the recommendation are due by Nov. 13. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.