NICE wants more data on Bayer's Xarelto

U.K. cost-effectiveness watchdogs aren't quite convinced about Bayer's anti-clotting drug Xarelto. The National Institute for Health and Clinical Excellence says it's asking Bayer for more data on the new drug, provided the company wants to prove it's worth using to prevent strokes and clots in patients with atrial fibrillation. That indication is key to new-generation clotting drugs because it covers a much larger potential market compared with other uses in surgery patients.

So, for now, Xarelto won't get NICE's coveted recommendation for use on the country's National Health Service. The recommendation is important because it not only affects use in the U.K., but in other countries that closely follow NICE's advice. The agency said Bayer's submitted data covered trial participants at higher risk of stroke and systemic embolism than run-of-the-mill AF patients eligible for treatment, Reuters notes.

"Evidence of [Xarelto's] cost-effectiveness was not reflective of all the people with atrial fibrillation ... who would be eligible for treatment," NICE said in a statement, noting that the population difference might have made Xarelto's efficacy appear greater than it would be in a broader group.

In the market for so-called warfarin alternatives, Xarelto is competing with Boehringer Ingelheim's Pradaxa and Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) Eliquis. Boehringer was also asked for additional data by NICE, which ended up backing Pradaxa for stroke prevention in November. Eliquis so far only has NICE's recommendation for clot prevention in patients undergoing hip and knee surgery.

- get the NICE release
- see the draft from NICE
- read the Reuters story