Study: Physicians do not consistently follow ADA-recommended prescribing guidelines for newly diagnosed diabetics

WOONSOCKET, R.I. — Physicians in 35% of cases involving more than 250,000 newly diagnosed diabetes patients did not follow the American Diabetes Association/European Association for the Study of Diabetes consensus guidelines for recommended treatment, according to a new CVS Caremark study.

In addition to the quality of care implications, because those guidelines recommend use of generic medications rather than more expensive branded medications, patients, payers and the healthcare system could be paying an additional $420 million annually for the newly initiated treatment, the researchers stated.

The study was conducted by researchers from CVS Caremark, Harvard University and Brigham and Women's Hospital, and was published this week in the American Journal of Medicine. The review looked at pharmacy claims of 254,000 patients who were newly started on a diabetes medication between Jan. 1, 2006, and Dec. 31, 2008. The research found more than one-third of initial treatment regimens for diabetes did not include the ADA's recommended first-line drug, which is a generic.

"While 65% of the patients we studied received care consistent with the ADA consensus statements, our results highlight remaining gaps between practice recommendations and contemporary pharmacotherapy for diabetes mellitus (Type 2)," researchers wrote in the study.

"We felt it was important to look at how the guidelines were being followed to review the quality of care for patients with diabetes who were newly initiating drug therapy. However, because the guidelines recommend generics as a way to provide cost-effective quality care, the economics of this review were impossible to ignore. That makes this study the first, to our knowledge, to define the fiscal implications of therapeutic choices in a large population of patients with diabetes," stated Niteesh K. Choudhry, associate physician in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, associate professor at Harvard Medical School and senior author of the study.

Choudhry added, "With approximately 2 million new cases of diabetes each year, if the medication patterns and insurance coverage for our cohort is representative of the U.S. population, an excess expenditure of $1,120 per patient per year would translate to more than $420 million in additional direct medication costs for diabetes therapy outside the established consensus guideline recommendations. Because the prevalence of diabetes is increasing quite dramatically, the potential savings from improved adherence to these recommendations could far exceed these estimates."

"We found significant variability in clinical practice for treating patients with diabetes," added Troyen A. Brenan, CVS Caremark EVP and chief medical officer, and head of the research initiative with Harvard and Brigham and Women's. "As we look for ways to rein in the cost of health care, we need to look at how physicians apply practices such as the ADA-recommended consensus guidelines because they align clinical effectiveness with cost-effective prescribing."

Type-2 diabetes has emerged as one of the most significant health issues worldwide. In the United States, more than 20 million people have diabetes, and the number of Americans with the disease is expected to increase by 165% by 2050. In the United States, treatment of the disease is estimated to cost $200 billion annually.

The researchers reviewed how doctors are treating newly diagnosed patients through a review of CVS Caremark's claims data to learn more about the clinical practices for those patients who are prescribed oral medications as part of their treatment. Because there is a substantial price difference between generic and branded medications, the researchers said a look at the economics of treatment was in order. The pharmacy claims they reviewed showed those being treated with generics spent an average of $116.10 over six months, compared with $677.20 for the more expensive therapies. That is a difference of $560 per patient for six months, or $1,120 per patient per year.

CVS Caremark has been working with Harvard and Brigham and Women's to assist in the research of ways to improve pharmacy care. The collaboration, which has been in place for the past three years, has resulted in more than 20 published peer-reviewed articles about patient medication-taking behavior and issues of adherence.


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