Bayer, J&J launch new stroke study to pump up payer-persuading Xarelto data

You can't accuse Bayer and Johnson & Johnson ($JNJ) of lacking ambitions for Xarelto. The development partners have plunked down hundreds of millions to study the anticoagulant for one use after another. So far, it's working. Armed with more indications than any of its warfarin-alternative rivals, Xarelto now has the biggest share of that market.

Johnson & Johnson CEO Alex Gorsky

And here's another one--another potential one, anyway. Bayer and J&J are enrolling for a 7,000-patient trial, testing Xarelto to see whether it can prevent a second stroke. It's part of an expanded list of studies on the clot-fighting drug the two companies unveiled last fall. The enrollment comes days after J&J CEO Alex Gorsky pooh-poohed questions about payer pressures on Xarelto pricing, crediting the drug's broad clinical development program for protecting the drug's spot in the market.

Dubbed NAVIGATE-ESUS, the newly announced study will focus on patients who've recently suffered an embolic stroke with an unknown source (ESUS). It will be a test of Xarelto vs. aspirin to see whether the brand-name drug can stave off another stroke better than the old remedy can.

According to Bayer, some 300,000 people have this type of stroke in North America and Europe every year. That's another big potential market for Xarelto, which most recently won approval to prevent clots in patients with acute coronary syndrome.

J&J, which books Xarelto sales in the U.S., captured $1.5 billion from the drug last year; for the fourth quarter, sales were up 58%. Market share-wise, Xarelto now has a 15% of the broader U.S. anticoagulant market, CEO Alex Gorsky said during a call with analysts. Bayer hasn't yet reported its full 2014 results.

During the fourth-quarter earnings call with analysts, Gorsky said he figures Xarelto has penetrated possibly one-third of the warfarin market, which means that the other two-thirds of patients now taking warfarin might be up for grabs. More proven uses, more opportunities to steal those patients away.

Plus, more data--provided it's positive--can only add to the case for Xarelto with payers. As drugmakers have rolled out their 2014 earnings and forecasts, executives from Eli Lilly ($LLY), J&J and Novartis ($NVS) have faced questions about the increasing pressure on U.S. pricing, and they've pointed out that the threat is most serious for drugs that aren't easily differentiated from their peers.

Asked about the payer threat to Xarelto, Gorsky quickly cited the broad clinical program--number of studies, number of patients, number of indications, and so on--as one reason J&J feels secure in the anticoagulant's positioning against rivals such as Pfizer and Bristol-Myers Squibb's ($BMY) Eliquis and Boehringer Ingelheim's Pradaxa.

"As part of our development program and the labeling, we had a very comprehensive approach," he noted during the fourth-quarter analyst call. "And we think that that clearly played a strong role. … As a result, not only have we seen strong acceptance, but we have seen good formulary uptake."

That's not to say that J&J and Bayer have won every new indication they've aspired to. One reason why its new raft of studies also includes research into ACS patients is that previous attempts to win FDA approval in that field have so far failed. Still, the more the merrier; the ESUS study and the others newly launched and planned could together help double Xarelto's stockpile of approved uses to at least a dozen.

And among the latest Xarelto research is one directly aimed at payer's pocketbooks: It showed that Xarelto actually saved money compared with cheap warfarin therapy, by doing a better job at keeping patients out of the hospital and preventing other costs. 

Xarelto is good for patients' pocketbooks, too, J&J points out. The drug already has impressive reimbursement stats in the U.S.; 93% of Medicare patients and 95% of commercially insured can get the drug at the lowest branded co-pay. And a co-pay card makes the drug essentially free for a full 12 months of treatment, for patients with private insurance. Overall, out-of-pocket costs for Xarelto are the lowest in the warfarin-alternative group, J&J says, citing IMS Health data.

- see the release from Bayer
- read the transcript of J&J's Q4 earnings call (reg. req.)

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Editor's note: This story was updated with Xarelto insurance coverage and cost information.