Hot Topic: U Pharmacy Researchers Asked to Present Study On How Well Diabetes Drug Works in 'Real World'

Hot Topic: U Pharmacy Researchers Asked to Present Study On How Well Diabetes Drug Works in 'Real World'

May 2, 2008 12:00 PM

Should reimbursement for drug therapies be based on showing that medications work in real health-care settings and not just clinical trials?

Managed care organizations, insurers, and governments that reimburse for costly drug therapies are becoming increasingly interested in that question. In the next few days, faculty from the University of Utah Pharmacotherapy Outcomes Research Center (PORC) will present a case study addressing the issue at the annual conference of the International Society of Phamacoeconomic Outcomes Research (ISPOR) in Toronto.

“Limiting reimbursement based on showing that drugs work in the real world is a hot topic,” said Diana I. Brixner, R.Ph., Ph.D., executive director of PORC and professor and chair of the Department of Pharmacotherapy in the College of Pharmacy. “U.S. insurance companies are looking more and more to this kind of information for their formulary decisions.”

PORC researchers wanted to study the issue with exenatide, a drug for people with type 2 diabetes. Randomized clinical trials had shown exenatide helped people with the disease control their glucose levels and lose weight. Clinical trials are controlled to ensure patients follow strict regimens for taking drugs and adhere to other protocols. PORC researchers wanted to see if exenatide worked in a larger population in a real-world setting where a number of variables can affect the outcome of drug therapies, such as which patients are prescribed the drug and whether patients take medications as prescribed.
Type 2 diabetes, which affects nearly 21 million Americans, occurs when the body cannot produce enough insulin or the body’s cells cannot use it. Insulin is the hormone that breaks down sugars and starches into the glucose that provides the energy for cells to live. When cells become starved of glucose and the insulin hormone builds up in the body, it can seriously harm the eyes, kidneys, nerves, and heart.

PORC researchers examined more than 12,000 electronic medical records of patients taking exenatide from January 2000 through June 2007. The patients had taken one or more other diabetes drugs in combination with exenatide for at least six months. The researchers looked at two key measures for people with type 2 diabetes: A1C level (a running average of blood glucose) and patient weight. 

The study confirmed the results of the clinical trial, showing a marked drop in their A1C levels at six months. Further, 70 percent of patients taking exenatide lost weight. “This drug is a real benefit in those with type 2 diabetes, especially because nearly 90 percent of people with type 2 diabetes are overweight,” said Brixner, who’s the current president of ISPOR.”

The exenatide study was selected for a highly competitive podium presentation at the ISPOR conference, and is part of a strong presence PORC will have at the meeting. Researchers from the center will give another podium presentation on a study that looks at the association between antipsychotic drugs and weight gain in adolescents and also will present 10 research posters.

The exenatide study was conducted with an unrestricted grant from the companies that make the medication—Amylin Pharmaceuticals and Eli Lilly and Company. Brixner believes more pharmaceutical companies should be undertaking studies to show their drugs actually work in real-world settings. “It needs to be a standard,” she said.

Many experts believe, however, that the government should fund a center to compare clinical trial and real-world results of drugs. A government center would function as more of an objective third party. “That’s where the real debate is now,” Brixner said.

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