FDA's convinced. Now, to persuade the payers

AstraZeneca's ($AZN) new anti-clotting drug Brilinta has become an object lesson in payer dynamics. The Wall Street Journal takes a look at Brilinta's market debut, detailing the challenges it faces in winning reimbursement from governments and insurers that are increasingly reluctant to fork over premiums for new meds. The point being that many debutante drugs are now confronting the same headwinds.

In Europe, where the clotbuster was first approved under the brand name Brilique, AstraZeneca has already had a few months to lobby state-run payers--with mixed results. France decided the evidence for Brilique's superiority over the standard drug Plavix was "insufficient," so AstraZeneca withdrew its reimbursement app, saying it would resubmit later. But the U.K.'s cost-effectiveness watchdog, often a thought leader in reimbursement decisions, made a preliminary recommendation in favor of the drug.

Next up is Germany, where the government has raised barriers to premium pricing on new drugs. Just to win the opportunity to negotiate a higher price, AstraZeneca essentially has to prove that Brilique is more beneficial than older drugs.

And here's where we see AstraZeneca's strategy, the WSJ reports. The company naturally submitted clinical data to support Brilique, including a study that showed patients using it had a 16% lower risk of heart attack, stroke or death than patients using Plavix. But AstraZeneca took that data a step further, analyzing the differences in treatment costs. More heart attacks equal more expensive treatments, so Brilique came out on top.

Now comes the fight in the U.S., where sales reps are undergoing training. Already adept at dealing with doctors, reps are now having to learn how to make their case to insurers and government payers. "Our people aren't as similarly well versed in all aspects of payer needs and how they look at value," AstraZeneca's global commercial chief Tony Zook told the Journal. And CEO David Brennan (photo) recognizes the uphill climb. "It will take a while before Brilinta becomes a major contributor to revenue," he said. At least they know their rivals have to scale the same hill.

- read the WSJ story

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