Managed Care - October 2008 - (Page 45) vented. Better yet, the natural history of diabetes may be altered. For this to occur, however, clinical decision making must become more dynamic and fluid, with rapid, real-time responses that include changing therapy or adding agents to achieve the goals listed in table 3. EFFECT ON MANAGED CARE: IT’S NOT ALL ABOUT DRUG COSTS Traditionally, managed care organizations have focused primarily on drug costs in analyzing treatment choices. However, with a disease such as diabetes, which is commonly only one component in a constellation of pathologic conditions, an economic analysis must be broader and more wide ranging. Numerous factors are involved in evaluating the true costs of a disease, including expenditures for treating complications of the disease itself and for the side effects of treatment. Sophisticated analyses go beyond cost per pill and should include an examination of the potential costs/benefits to using multiple drugs or more expensive unit-cost agents, given an understanding that benefits accrue not only to enhanced glycemic control but to improvements in blood pressure, weight, and lipids. The economic impact of preventing complications — for example, a potential reduction in macrovascular events or forestalling the onset of renal failure necessitating dialysis — could be significant. Furthermore, such investigations should likely include the costs due to side effects of treatment. Some, such as the edema and mild CHF seen with thiazolidinediones, may be minimal, especially with adequate provider education to mitigate their impact. However, the potential costs of others, such as hypoglycemia associated with insulin use, may be significant. Representing a new perspective in managed care, value-based insurance design seeks to eliminate or minimize barriers to treatment for certain chronic diseases, recognizing that such barriers ultimately increase costs and worsen patient outcomes. For some plans, this may mean discontinuing co-payments for high-value medications and/or physician appointments. The objective is to optimize disease management, with the goal of interrupting the typical path of disease progression. Several large employers, such as Proctor & Gamble and the University of Michigan, have implemented such a program with success (New York Times 2007). However, employer groups or businesses that contract with managed care organizations may not appreciate the long-term benefit inherent in this approach. A conflict may arise as they are responsible for the immediate expenditure to provide coverage, yet the time frame of their responsibility to individual subscribers is uncertain. Employer groups, managed care organizations, and health care providers all need motivation to treat aggressively. To encourage such an approach, the short-term payoff of intensive treatment of the pathophysiology of diabetes with regard to potential minimization of cardiovascular outcomes and the advantages of β-cell preservation should be convincingly demonstrated. One can logically argue that early and aggressive treatment of type 2 diabetes using combination therapy, with the goals of achieving improvements in blood pressure and dyslipidemia, decreasing insulin resistance, and enhancing β-cell function while providing excellent glycemic control, will improve patient outcomes and minimize the impact of macro- and microvascular complications, thereby decreasing the economic implications of caring for people with diabetes. To more rigorously examine this premise statistical models such as CORE can be employed. Modeling is especially useful for patient segmentation, to identify populations for whom a specific drug or intervention is likely to have the most impact. CORE is a peer-reviewed, validated diabetes model that takes into account baseline characteristics, past history of complications, current and future diabetes management, and concomitant medications (Palmer 2004, Palmer 2004). CORE utilizes simple, widely used mathematics and is based on submodels that simulate important complications of diabetes. Country-specific costs can be incorporated to calculate the development of complications, life expectancy, qualityadjusted life-years, total costs to a population, and cost-effectiveness. CORE is internet-based and includes a variety of user-defined and standard values. It represents a useful tool for evaluating potential outcomes and the budgetary impact of different diabetes treatments. Several leading managed care organizations, including Premera Blue Cross/Blue Shield and Humana, have utilized CORE models as one component of their decision-making processes. To test the impact of some of the approaches described in this paper, a CORE analysis could be performed to include costs of agents in combination therapy and expenditures due to management of drug side effects. It would also take into account savings accrued as a consequence of prevention of myocardial infarction and stroke. Changing the focus of health care from treating disease to a wellness model is a radical departure from current thinking. However, for chronic diseases characterized by numerous complications and associated conditions that amplify disease effects, worsen outcomes, and vastly increase health care-related expenditures, such a change may be necessary. As the pathophysiology of diabetes becomes better understood, and novel therapeutic approaches target different defects, an argument can be made for early, effective treatment to preserve β-cell function, diminish insulin resistance, and improve dyslipidemia and hypertension, ultimately OCTOBER 2008 / MANAGED CARE 45
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