New diabetes guidelines imminent, Jardiance sales may surge

Two leading U.S. medical societies are poised in the coming weeks to issue new diabetes treatment guidelines reflecting the lifesaving cardiovascular effects of Eli Lilly's Jardiance in a move expected to drive up the drug's sales.

The forthcoming guidelines from the American Diabetes Association and the American Association of Clinical Endocrinologists follow last Friday's decision by U.S. regulators to expand the health benefits Lilly can claim for Jardiance to include preventing fatal heart attacks and strokes in type 2 diabetes patients.

The decision by the Food and Drug Administration on the once-daily pill that costs about $400 a month pushed Indianapolis-based Lilly's shares up 3 percent.

Ashtyn Evans, analyst with the Edward Jones investment company, expects annual Jardiance sales to approach $4 billion by the early 2020s, up from $200 million now, split with privately held German partner Boehringer Ingelheim.

Evans predicted that doctors would now favor Jardiance for new patients over other similar drugs called SGLT-2 inhibitors, including Johnson & Johnson's Invokana and AstraZeneca's Farxiga, until they complete their own heart-protection studies in the next two years.

The American Diabetes Association is expected to issue its guidelines next Thursday, including use of Jardiance and similar medicines, association spokeswoman Michelle Kirkwood said.

The endocrinologists' association in January will issue its updated guidelines mentioning Jardiance's cardiovascular effect, said Dr. Alan Garber, a professor of medicine at Baylor College of Medicine and a past president of the group.

Some 29 million Americans have diabetes. Type 2, closely linked to obesity, accounts for more than 90 percent of diabetes cases.

Jardiance was approved by regulators two years ago. The heart-protective data was released later.

Metformin, a generic drug that costs about $50 a year, is expected to remain the first treatment option for people with type 2 diabetes, but the guidelines are likely to make Jardiance a preferred secondary option, according to doctors and analysts.

With the FDA's Dec. 2 decision and the new guidelines, the treatment could become far more prescribed by primary care doctors, which would enable Lilly to access many more patients, Morningstar analyst Damien Conover said.

Typically, Jardiance is prescribed by specialists when blood sugar is not controlled by metformin alone.

"When you think of the overall patient population, getting it into the primary care users, that's going to be important," Conover said.

Insurers should be willing to pay for the drug now, Baylor's Garber said.

Insurer Anthem Inc said Jardiance is among the medium-cost drugs on its list of covered treatments as of April, reflecting the cardiovascular benefit. Express Scripts, the largest U.S. pharmacy benefit manager, said the drug is on its national list of preferred drugs.