AbbVie Price Boost of Drug Slammed in Studies Criticized

AbbVie Inc. (ABBV) boosted the price of its Niaspan heart pill by 37 percent to offset prescription losses after studies panned the drug, drawing criticism from doctors amid a national debate over the high cost of health care.

The findings from two studies, in almost 30,000 people, were reported in 2011 and last year. Neither showed benefit from the drug, which is also sold as a generic called niacin, and the 2011 research was stopped early after the National Institutes of Health said patients on the medicine had strokes at double the rate of those just taking a companion drug.

Yet revenue from AbbVie’s sixth-best-selling product has remained steady at about $120 million a month since before the research was published, according to prescription sales data compiled by Bloomberg. That’s because from the time the first negative study was published through this month, the North Chicago, Illinois-based drugmaker increased its per-pill price to $4.78 from $3.50.

“I don’t know how you can justify it,” Robert Giugliano, a cardiologist at Brigham and Women’s Hospital in Boston and an associate professor of medicine at Harvard. “The balance of the data suggests that niacin has little if any role in” treating patients with cholesterol problems, he said in a telephone interview.

AbbVie declined less than 1 percent to $46.59 at the close in New York. The company has gained 36 percent this year.

Curtail Spending

Niaspan is an example of the difficulty faced by the U.S. in its attempt to curtail the almost $3 billion spent on health care each year.

“The way our market works it’s not surprising the company would do that,” said Dee Mahan, a drug-pricing expert with the Washington-based consumer group Families USA. “It does point to some failures of our system.

‘‘We’re relying on insurance companies and pharmacy benefit managers to negotiate prices and put pressure on manufacturers,’’ Mahan said. ‘‘As a consumer advocate you wish the market could be regulated in a better way so consumers don’t get hurt.’’

Niaspan raises so-called good cholesterol, or HDL, which scientists say may help away dangerous excess fats in the blood. It’s often prescribed along with a statin such as Pfizer Inc.’s Lipitor or Merck & Co.’s Zocor, which lower bad cholesterol, or LDL. Approved for sale in the U.S. in 1997, Niaspan generated $5.11 billion in sales through 2012.

Since the 2011 study, monthly prescriptions for the drug have fallen by about 33 percent as of last month, to 382,000, according to data compiled by Bloomberg.

AbbVie Reaction

Greg Miley, a spokesman for AbbVie, declined to comment on the drug’s pricing, the effect of the studies or the number of prescriptions. ‘‘Niaspan remains an important treatment option to help patients with abnormal cholesterol levels,” and the drug’s safety profile is made clear on its label, Miley said in an e-mail response to questions.

Abbott Laboratories (ABT), AbbVie’s former parent company, said after the 2011 study was published that the “relevance” of the results “to patients outside the study population is currently unknown and it would be premature to extrapolate these results to a broader patient population.”

Drugmakers frequently raise prices on their products, depending on the response of the marketplace, said Chris Bowe, an industry analyst with Informa-Scrip Intelligence in New York.

“You’re seeing some sales leak away, and any business is going to try and raise prices to make up for that,” Bowe said in a telephone interview. Niaspan’s patent protection ends next year, and it’s especially common for a company to raise the price toward the end of its exclusivity to capture every last dollar from a product, he said.

Less Understandable

What’s less understandable is why insurers and pharmacy benefit managers go along with AbbVie’s action after the studies were released, Bowe said. “You’d think they’d say, ‘Come on!’” he said.

Express Scripts Holding Co., the largest U.S. processor of drug prescriptions, has seen a similar drop in the use of the Niaspan, which is on the St. Louis-based company’s list of covered medicines.

“Individual plan sponsors ultimately make the final decisions about what adjustments they’d like to make to our recommended formulary,” David Whitrap, an Express Scripts spokesman, said in an e-mail.

Niaspan was approved by U.S. regulators as an extended-release version of niacin, or form of vitamin B3 that’s been around since 1956 as a treatment for patients whose bad cholesterol is too high. Side effects to the drug, noted on its label, include red skin rashes and itching.

AIM-HIGH

The 2011 study, dubbed AIM-HIGH, was funded by the U.S. National Institutes of Health and Abbott, and published in the New England Journal of Medicine.

Released in May of that year, the 3,414-patient trial found that Niaspan didn’t prevent heart attacks in patients whose cholesterol was controlled with a statin, such as Merck & Co.’s Zocor. It was stopped early after the National Institutes of Health said the rate of strokes in patients on the drug was more than double those taking a statin alone.

The 2012 study, sponsored by Merck and called HPS2-THRIVE, combined niacin with a Merck drug laropiprant meant to lower its flushing side effects. Released in December, the trial in 25,673 patients also failed to find a benefit and may have raised side effects such as muscle pain or infections.

The drug’s performance “did not translate into clinical benefit,” said William Boden, chief of medicine at the Samuel S. Stratton VA Medical Center in Albany, New York, who was a principal investigator in the 2011 study. Even so, the drug still has a role for about 25 percent to 30 percent of patients who have the highest risk for heart attacks, he said.

“There’s a group of individuals -- probably in the minority, and I’d include myself -- who feel there continues to be a role for niacin,” Boden said in an interview. He takes the drug himself, and said he has for about a decade. He still prescribes it for patients with very low HDL levels, he said.

To contact the reporter on this story: Drew Armstrong in New York at darmstrong17@bloomberg.net;

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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