2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
FDA Comment Number : EC36
Submitter : Dr. Claudia Graham Date & Time: 06/07/2004 07:06:07
Organization : Medtronic MiniMed
Device Industry
Category :
Issue Areas/Comments
The Opportunity in Type 1 Diabetes:

One area that meets the criteria as an opportunity for improved quality and cost savings is the treatment of Type 1 diabetes. According to the American Diabetes Association, 1 million people currently are diagnosed with Type 1 diabetes, and 30,000 new cases of Type 1 diabetes are diagnosed annually. Type 1 diabetes can occur at any age, but is one of the most frequent chronic diseases among children in the US. Type 1 diabetes is a chronic illness, and it is a disproportionately expensive disease. According to a 2002 study published in Diabetes Care and endorsed by the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC), direct medical and indirect expenditures attributable to diabetes in 2002 were estimated at $132 billion. Direct medical expenditures alone totaled $91.8 billion with $23.2 billion attributable to diabetes care and $24.6 billion for chronic complications related to diabetes. Approximately $44 billion was for excess prevalence of general medical conditions. Overall, 57.4 percent of individuals with Type 1 and 2 diabetes are covered by government-financed health insurance programs. This includes children and low-income adults covered under Medicaid, as well as the elderly and disabled covered by Medicare. In addition, according to data from the Centers for Medicare and Medicaid Services (CMS), diabetes is the primary cause of end-stage renal disease (ESRD) for one-third of all Medicare ESRD beneficiaries.

The high cost of diabetes in part underscores an unmet need for improved treatment of this population. Specifically, diabetes can be managed to prevent many of the costs and long-term complications that are currently prevalent. Intensive therapy has been shown to be cost-effective in both Type 1 and Type 2 diabetes because two-thirds of the costs of diabetes management currently are related to inpatient care and associated complications. , Since publication of results from the landmark Diabetes Control and Complications Trial (DCCT) in 2003, many published studies have confirmed the importance of intensive diabetes self-management for individuals with Type 1 diabetes. Evidence continues to accumulate in support of the importance of a decrease in glycosylated hemoglobin (HbA1C) levels to 7.0 percent (normal is 3.8 to 6 percent), or lower if possible. , , , ,

Research Needs

Unfortunately, less than half of patients with Type I diabetes are treated to clinically accepted targets, such as those established by American Academy of Clinical Endocrinologists (AACE). Recent data suggests that the average HbA1c of US diabetes patients is 8.6%. and up to 1/3rd of the patients exceed 9.5%. It is critical to understand why so many patients with diabetes are not being treated to clinically established quality targets. Hypotheses include lack of patient and provider education, under-use of state-of-the-art diabetes technologies, and public payer policies that create disincentives for optimal management.

In addition to identifying barriers to optimal diabetes care, the research should identify mechanisms to overcome these barriers. Solutions should
focus on those that are appropriate in the context of government-funded health care programs, particularly Medicaid and Medicare. For example, it is important to understand the types of programs states are implementing to control costs of care for diabetes and the implications of such programs in terms of long-term costs and patient outcomes. Additional analysis should be conducted on how such programs could best be designed to improve outcomes and control costs in both the short and long-term. Similarly, research should explore innovative ways in which intensive insulin management can reduce Medicare costs by preventing complications such as ESRD.