Payers want new guidelines, more data before easing access to diabetes' CV star Jardiance

Recently, Eli Lilly ($LLY) and Boehringer Ingelheim's Jardiance became the first diabetes drug to show it could reduce the combined risk of heart attack, stroke and death from cardiovascular causes--doing so by 14% in a study of high-risk Type 2 diabetes patients. But payers aren't exactly running to redo their formularies.

Aetna ($AET), CVS Health ($CVS) and Molina Healthcare ($MOH) all say they'll need further clinical data and an update to the guidelines from bodies like the American Diabetes Association (ADA) before they agree to make it any easier for patients to get their hands on the $4,800-per-year treatment, Reuters reports--and that process could take up to several years.

Others, like UnitedHealth ($UNH), Anthem ($ANTM), Express Scripts ($ESRX) and Cigna ($CI), told the news service they're sticking with traditional treatment courses right now, thanks to the availability of cheap generics. And they won't be switching things up before taking a hard look at the new Jardiance results.

That could put a dent in some of the bumped-up predictions analysts came out with when news of Jardiance's cardiovascular success hit. Many of them now expect bigger things, not only for the Lilly/BI med, but for the other drugs in its class as well.

Evercore ISI's Mark Schoenebaum, for one, said at the time that he expected to see the SGLT2 class overtake DPP-4s--a group led by Merck's ($MRK) Januvia--in the next three to 6 years. Before Lilly and BI released the new data, peak sales estimates for Jardiance sat below $2 billion--a number that "could invert" with Januvia's $6 billion yearly haul, he wrote in a note to investors.

But insurers may be waiting to see if fellow SGLT2s--Johnson & Johnson's ($JNJ) Invokana and AstraZeneca's ($AZN) Farxiga--produce similar CV benefits in trials. J&J expects results in 2017, while AZ's are due in 2019, Reuters notes. If they also turn out to pare down cardiac risk, it may open the door for payers to play the drugs against each other to negotiate discounts, a la the recent pricing war that Express Scripts touched off between next-gen hep C drugmakers Gilead ($GILD) and AbbVie ($ABBV).

Lilly and BI, of course, are hoping that doesn't happen. David Kendall, VP of medical affairs for Lilly's diabetes franchise, told the news service he'd like to see insurers back greater Jardiance use ASAP. "We would hope undue delay isn't an outcome; we would hope for timely decision-making," he said.

But the way Carol Wysham, head of the diabetes and endocrinology department at Washington's Rockwood Clinic, sees it, they shouldn't hold their breath.

"It could be 2017 before insurance companies will advocate this as a preferred agent," she told Reuters. "They aren't going to do anything until they have to."

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