The overall cost of drugs for type 2 diabetes almost doubled between 2001 and 2007, yet whether these newer drugs improve care and outcomes isn’t known, a new study finds.
In that time period, total spending went from $6.7 billion to $12.5 billion, say researchers from the University of Chicago and Stanford University.

In 2002, diabetes accounted for more than 10 percent of U.S. health-care expenditures, and that number is expected to increase as the number of people with type 2 diabetes grows, the researchers noted.

“We found dramatic changes in the treatment patterns for diabetes during the past decade,” said study author Dr. G. Caleb Alexander, an assistant professor of medicine at the University of Chicago. “This includes a remarkable change in drugs, as well as significant increases in costs.”
Whether these changes in diabetic care positively impact outcomes isn’t known, Alexander said.

“The jury is still out as to whether these changes are worth it,” he said. “The million dollar question is: Are these changes going to lead to overall significant improvement in the outcomes that matter to patients and their doctors?”

The report was published in the Oct. 27 issue of the Archives of Internal Medicine.

The dramatic increase in cost is due to the high cost of commonly prescribed newer drugs. For example, sitagliptin (Januvia) costs $160 per prescription and exenatide (Byetta) costs $210 per prescription. That’s eight to 11 times higher than older, generic drugs such as metformin, Alexander said.

These drugs are marketed as being more convenient and offering better control of blood sugar than the older medications. In addition, doctors are using these new drugs as an alternative to insulin, Alexander said. In fact, insulin use dropped from 38 percent in 1994 to 28 percent in 2007.

Another factor fueling higher costs of diabetes care is that an increasing number of people are being diagnosed. In 2004, 4 percent of the U.S. population were diabetics; that number is expected to increase to 7 percent by 2050, the researchers said.

In addition, diabetic patients are receiving more aggressive treatment. Diabetic patients are often prescribed more than one medication. In 1994, 82 percent of diabetics received one drug; by 2007, only 47 percent of patients were receiving just one drug, the researchers found.

Alexander admitted that many of the new drugs target different pathways of disease. “There are some real innovations here,” he said. “But we don’t know enough about the comparative effectiveness of these medicines compared with older medicines to make a final verdict.”

One of the concerns is that drugs are approved by the U.S. Food and Drug Administration before they have been tested on thousands of people, Alexander said. “All too often, physicians and patients may tend to adopt newer therapies without sufficient evidence of their superiority or benefits over older, less expensive, more time-tested alternatives,” he said.

Recently, the diabetes drug Avandia has been linked to an increased risk for heart attack resulting in the FDA’s adding a “black box” warning to the label.

Dr. Stuart Weiss, an endocrinologist at New York University Medical Center, thinks newer medications are more effective than the older ones, but they don’t replace the need for a healthful diet and exercise.

“Spending money is bad, and diet and exercise is the best thing we can do for our diabetic patients, but they are not very comfortable accepting diet and exercise as the treatment for diabetes,” Weiss said.

Using the older, generic medications is “good enough if your expectations are very low,” Weiss said. Diabetes is a progressive disease, and drugs such as metformin fail over time, he said. “The cheap drugs are not so good,” he said.

“The newer drugs have a very nice effect on the progression of disease in diabetes, and they don’t lose efficacy after a few years,” Weiss added. “I don’t know whether they are going to fail over time. There is no medication that can’t be overwhelmed by a bad diet.”

Saving money by not using the newer drugs is not the answer to the growing diabetes epidemic. Even the most expensive drugs are cheaper than untreated diabetes, Weiss said. “If people think that giving cheap drugs will be the solution to the growing problem — I think they are making a huge mistake.”

Representatives of the drug industry were unavailable for comment on Monday.

(Source: G. Caleb Alexander, M.D., assistant professor, medicine, University of Chicago; Stuart Weiss, M.D., endocrinologist, New York University Medical Center, and clinical assistant professor, NYU School of Medicine, New York City; Oct. 27, 2008, Archives of Internal Medicine)