As discussed in sections 1 and 2, current American Diabetes Association guidelines recommend lowering A1C to less than 7.0% for most patients with diabetes.1 Although National Health and Nutrition Examination Survey data show a significant increase in glycemic goal achievement among adults with diagnosed diabetes, an alarming number (>40%) of patients were still not reaching the recommended goal.2
Adding to this, patients with diabetes commonly have other cardiovascular risk factors, including hypertension and dyslipidemia. In patients with type 2 diabetes, blood pressure (BP) and lipid goal achievement are also suboptimal. A 2001-2002 cross-sectional study examined achievement of A1C, BP, and low-density lipoprotein (LDL)-cholesterol goals and determined that only 7% of patients were meeting all 3 goals.3
The clinical consequences of not reaching clinical goals include faster disease progression, increased risk of microvascular and macrovascular complications, reduced quality of life (QOL), and premature mortality. Economic consequences include increased emergency department (ED) and hospital utilization, which account for the majority of observed excess costs.
The combination of increasing prevalence, an existing treatment gap, and poor outcomes associated with uncontrolled type 2 diabetes illustrate a true call-to-arms for managed care and other stakeholders to act. This section focuses on barriers to successful management of type 2 diabetes, including those derived from clinical, social, and administrative factors, as well as some examples where health plans and employers are utilizing innovative policies and practices to overcome these obstacles.
Barriers to Successful Management
Traditional therapy in type 2 diabetes involves a stepwise "treatment to failure" approach, whereby an oral diabetic treatment regimen is adjusted to achieve optimal glucose control.4 Over time, however, oral agents fail to maintain glucose at target levels, and the use of insulin should be considered. Although this approach can provide short-term glycemic control, it does not prevent progression of beta-cell failure. Furthermore, many antidiabetic agents are associated with adverse effects (eg, hypoglycemia, weight gain) that limit their use. Newer therapies, such as incretin-based agents, may address some of these issues; however, they are expensive and their exact role in therapy has not yet been established.
There is also lack of consensus regarding treatment goals and the best practices for achieving them. For example, treatment goals and algorithms recommended by the ADA and the European Association for the Study of Diabetes1,5 differ from those of the American Association of Clinical Endocrinologists/American College of Endocrinology (discussed in the previous section).6,7 These algorithms can cause confusion for both practitioners and those who shape medical policy because both the means and ends are not consistent.
The lack of consensus among major diabetes organizations may lead to confusion for practitioners (especially primary care) in treating patients, and for managed care organizations (MCOs) in developing new policies. Lack of consensus might also be a factor in physicians' underutilization of guidelines. In a national survey of generalists and diabetes specialists, fewer than half of either group cited expert guidelines or hospital algorithms as a major consideration in selecting initial or subsequent therapies.8
Clinical inertia-the failure to initiate or intensify treatment in a timely manner-is common in diabetes care. In the Diabetes Attitudes, Wishes, and Needs (DAWN) study, interview data from providers (physicians and nurses) in 13 countries revealed a high propensity to delay oral therapy, and an even stronger propensity to delay insulin, until "absolutely necessary" for patients with type 2 diabetes.9
More than half of nurses and primary care physicians reported delaying insulin therapy; specialists and opinion leaders were less likely to do so. The tendency to delay therapy was greater among US providers than in most other countries.
Underutilization of Team Support
Physicians cannot single-handedly do everything that is needed for aggressive, comprehensive diabetes management.10 Diabetes care can be improved by means of a team approach, providing support through nonphysician healthcare professionals such as diabetes educators either within or outside the physician's office.11 Benefits of multidisciplinary team care include improved glycemic control, increased follow-up, higher patient satisfaction, lower risk of complications, and better QOL.10 However, team support is not always readily available and, when available, is often not utilized.12,13
Diabetes education-also called diabetes self-management education (DSME) or diabetes self-management training (DSMT)-is a process by which people with (or at risk for) diabetes gain the knowledge and skills necessary to modify their behavior and successfully manage the disease.14 DSME/DSMT is considered the key to controlling diabetes14 and should be an integral component of care for all people with diabetes.13,15
Diabetes educators may come from a variety of healthcare disciplines including, but not limited to, registered nurses (RNs), registered dietitians, pharmacists, physicians, mental health professionals, podiatrists, optometrists, and exercise physiologists.16
Their services may be provided through hospitals, physician offices, pharmacies, MCOs, home healthcare agencies, or other settings. Many diabetes educators have earned a Certified Diabetes Educator (CDE) credential, and some are board certified in Advanced Diabetes Management (BC-ADM). BC-ADM requires an advanced academic degree and focuses on clinical management rather than education alone.
DSME/DSMT results in lower A1C levels and has also been shown to reduce healthcare utilization and costs.14 For example:
• In the Urban Diabetes Study, 18,404 diabetes patients were followed for a mean of 4.7 years.18 Patients who had any kind of educational visit(s) had 34% fewer hospitalizations, resulting in lower overall hospital charges, compared with those who had no educational visits (P <.001).
Despite evidence for its effectiveness and cost-effectiveness, diabetes education is underutilized. A 2005 national survey showed that slightly more than half (54.3%) of patients with diabetes had attended some type of DSME class. Analysis of Medicare reimbursement for DSMT revealed that only 1% of Medicare beneficiaries with diabetes received DSMT in 2004-2005. The 2007 Roper US Diabetes Patient Market Study found that 26% of patients had seen a diabetes educator in the previous year.13
Reasons for underutilization may include lack of access (eg, in rural areas), inadequate reimbursement, or physician unawareness of diabetes education resources. It is important to be aware that Medicare has specific coverage policies for individual and group DSMT, and that most private payers cover DSME/DSMT in the primary care setting.14 Many states require health plans to pay for diabetes education,20 although coverage and reimbursement policies may vary across states and geographic regions.14 Additionally, certain services may be separately reimbursable-eg, medical nutrition therapy provided by dietitians; counseling provided by qualified social workers, psychologists, or advanced practice RNs; and medication therapy management (MTM) provided by pharmacists or nurse practitioners.14,16
MTM is a partnership between the patient and a qualified healthcare professional, with the purpose of promoting safe and effective medication use.21 MTM helps patients resolve prescription drug problems-including side effects, drug interactions, cost and formulary issues-and is well suited for patients with type 2 diabetes, for whom treatment adherence is often problematic.22 Medicare guidelines require prescription plans to offer MTM services for certain beneficiaries who take multiple medications.22 Some employers have implemented innovative programs providing MTM through their health plans-eg, the Asheville Project and the Diabetes Ten City Challenge (DTCC), discussed later in this section.
Treatment adherence rates are generally lower in chronic disease than in acute disease11; and among chronic diseases, type 2 diabetes is particularly associated with low adherence. This may be related to a number of factors, including the difficulty of maintaining lifestyle changes and the use of complex, inconvenient medication regimens. Furthermore, patients may be undermotivated because treatment focuses on long-term complication prevention rather than symptom reduction.
The more you can engage a patient into understanding what's wrong with them, the better the outcome. It doesn't really matter what disease state we are talking about, education improves your outcome.
Studies differ in definitions of adherence, populations, and methods of ascertainment, making adherence rates difficult to determine accurately. In 2003, the World Health Organization (WHO) reported that 52% to 70% of US patients with type 2 diabetes adhere to diet; 26% to 52% follow a physical activity plan; and only about 33% self-monitor blood glucose as often as recommended.23 The WHO report also noted that, among US patients whose health insurance covers drugs, only 70% to 80% adhere to oral medication; while among Medicaid patients who were prescribed a single oral medication, merely 15% were still taking it regularly after 1 year.23
Adherence is not directly correlated with medication access, but may be more related to disease understanding. Diabetics who are informed and understand the long-term effects of the disease are more likely to be adherent.
A 2004 systematic review found that, in prospective studies, mean adherence rates (proportion of doses taken as prescribed) with oral medication ranged from 61% to 85% during up to 6 months' observation.24 In a retrospective 2-year analysis of 27,274 insulin users with type 2 diabetes, the mean adherence rate was approximately 63%.24 And in a retrospective study of 102 patients with type 2 diabetes initiating insulin, 79.6% persisted with treatment for 24 months.24
Impact of Nonadherence
In chronic disease in general, poor treatment adherence leads to poor clinical outcomes and increased medical costs.11 In type 2 diabetes, this is of particular concern because of the increasing prevalence of the disease (including among young people), coupled with the serious nature of its long-term complications.
In a population-based retrospective study involving 3260 patients with diabetes (type 1 or type 2 not specified), lower medication adherence was associated with higher diabetes-specific and all-cause medical costs, apparently driven by higher hospitalization rates.25 Adherence levels of 19% or less were associated with a 30% hospitalization risk during a 1-year period, compared with a 13% hospitalization risk among patients with 80% to 100% adherence (P <.05). The corresponding total (medical plus drug) costs per patient were $8867 versus $4570, respectively.
Factors Influencing Adherence
The following list describes several dynamics that may influence treatment adherence in type 2 diabetes. Considerations relating specifically or primarily to insulin therapy are discussed in a separate section below.
Adverse effects, or fear of adverse effects, can be a major barrier to medication adherence. In particular, fear of hypoglycemia and weight gain may discourage adherence to regimens involving insulin or insulin secretagogues (sulfonylureas and glinides).
THE ROLE OF DIABETES EDUCATORS. Diabetes educators can play a crucial role in overcoming adherence barriers. By asking open-ended questions, diabetes educators can elicit patient fears, concerns, and misconceptions about treatment, which can then be addressed.32 By teaching self-management skills, with ongoing follow-up and feedback, diabetes educators can encourage patients and help them develop confidence in their ability to successfully manage the disease.
The potential of diabetes education to improve treatment adherence has been demonstrated by innovative programs such as the Asheville Project and the DTCC, discussed later in this section.
Some resources for patient education and support can be found at:
While we have so many treatment options, why isn't treatment successful? I believe adherence is one of the biggest problems, and there are so many factors that feed into that. In my plan, one of the factors is economic; sometimes patients can't afford their copays or their coinsurance, so they just don't fill their prescription. They may opt to use their resources in other ways, unrelated to their health. Also, areas with lower socioeconomic levels are disaffected due to a lack of understanding their disease.
PRINCIPLES OF ADHERENCE INTERVENTIONS. The New England Healthcare Institute recommends that adherence interventions incorporate the following principles11:
What approaches can managed care take to promote these principles? Answers are being sought, and will evolve over time. A comprehensive review is beyond the scope of this discussion; however, some examples of successful programs are presented below in the section entitled The Impact of Managed Care.
Another barrier is associated with drug administration-the fear of injection. I think exenatide and the effect of weight loss have helped to eliminate some of that fear for a lot of people, because they see a positive benefit from using the injection. However, with insulin, there is no perceived advantage.
Barriers to Insulin Therapy
Insulin therapy is required for patients with type 2 diabetes once beta-cell failure reaches a critical threshold. Even before that stage, antidiabetes drugs (eg, insulin sensitizers, insulin secretagogues) require insulin to be effective, restating the importance of insulin to any effective diabetes therapy. Although beta-cell function cannot be assessed routinely in clinical practice, patients not achieving glycemic goals while adhering to combination noninsulin regimens are likely to reach that threshold.
Despite evidence for the efficacy and safety of early insulin use, both patients and clinicians often have considerable resistance to initiating insulin ("psychological insulin resistance").9,33,34 While the previous discussion about adherence barriers applies to insulin as well as to other therapies, there may be greater and/or additional barriers associated with initiating and adhering to insulin use. Some of the barriers are related to route of administration, and these considerations apply to other injectable medications as well (eg, pramlintide, exenatide). Others are related to patient and provider perceptions or misconceptions about insulin, or to lack of knowledge about newer insulins (eg, insulin analogs) and delivery devices (eg, insulin pens).
Clinician barriers to insulin use may include the perception that adding insulin is too complicated, or that it will require additional time and resources for monitoring34; the belief that patients will not accept or adhere to insulin therapy35; fear of hypoglycemia and/or weight gain34,35; and the belief that insulin is unnecessary or ineffective in type 2 diabetes.34
There are a number of patient-centric barriers to insulin therapy; these, as well as strategies to address each issue, are summarized in the.32-34,36
The Impact of Managed Care
MCOs, employers, and other organizations that administer or control health benefits have recognized the burden that diabetes places on the healthcare system. These groups have taken a variety of approaches to contain costs, either directly or by developing innovative programs to address the root of the problem: improving clinical status to improve economic outcomes.
Common Cost-Containment Approaches
Cost-sharing measures are among the most commonly used approaches to cost containment. Examples include tiered pharmacy copayments (used by most health plans), coinsurance (in which the patient pays a percentage of the cost), and benefit caps (as in Medicare Part D).37
Another commonly used cost-containment approach is formulary restriction. Examples include prior authorization (requiring permission to dispense certain drugs), step therapy (requiring that lower-cost drugs be tried first, before covering more expensive ones), closed formularies, and mandatory generic substitution.37
A review of 132 studies examining various drug cost-containment measures found that increased cost-sharing is generally associated with decreased drug treatment, lower adherence, and more frequent discontinuation of therapy.37 For patients with chronic conditions, including diabetes, higher drug cost-sharing is also associated with worse clinical outcomes, increased hospitalization rates, and increased use of emergency services.37
Most studies of prior authorization and step therapy suggest that these measures can decrease drug spending without increasing healthcare utilization or worsening clinical outcomes. However, closed formularies and mandatory generic substitution have been associated with adverse outcomes.37
These results suggest that benefit design can be an important factor in public health. The challenge for payers is to find ways of minimizing costs without discouraging cost-effective care.37
Value-Based Insurance Design
Value-based insurance design (VBID) is a benefit design that links cost-sharing to the therapeutic value of a service (ie, the more clinically beneficial a service is for the patient, the lower the patient's cost share).38,39 Approaches to VBID include reduction or elimination of copayments (1) for certain drugs or services for all patients, (2) for patients with specific diagnoses, (3) for high-risk patients with specific diagnoses, or (4) for patients with specific diagnoses who participate in disease management programs.39
Several examples of the latter approach are described below.
Pitney Bowes, a Fortune 500 company with 35,000 employees, offers a disease management program to employees with diabetes and other chronic diseases.40 In 2002, Pitney Bowes changed its drug benefit design for participants with diabetes, shifting tier 2 and 3 brand name diabetes medications and test strips to tier 1.
During the following 2 to 3 years, adherence rates for all shifted products improved significantly; in particular, the percentage of members with suboptimal insulin adherence decreased by two thirds.40 Also, the percentage of members using fixed-dose combinations of oral agents increased, with substantial improvement in adherence. Surprisingly, annual pharmacy costs for members with diabetes actually decreased 7%, possibly due to a reduction in complications that would have required more expensive drug treatment.
Furthermore, although there was a slight increase in hospitalizations (possibly related to aging of the workforce), the rate of ED visits decreased 26%, likely due to improved medication adherence. Overall per-patient cost of medical care for members with diabetes decreased 6% between 2001 and 2003.40
Diabetes Ten City Challenge
In the DTCC, employers at 10 geographic sites contracted with community pharmacies to provide diabetes disease management services.41 Participating pharmacists either were CDEs or had completed a diabetes training program offered by an accredited provider of continuing pharmacy education. Services were provided to patients at local pharmacies or at the workplace; pharmacists were compensated for their services via their networks by the employers. Patient incentives included waived copayments for medications and certain supplies; some employers added other incentives (eg, waived copayments for education classes and laboratory tests).
Among 573 patients who participated for at least 1 year, significant improvements in clinical outcomes occurred, including A1C, LDL cholesterol, systolic and diastolic BP, and body mass index.41 The participating patients also moved closer to Healthcare Effectiveness Data and Information Set targets for process measures such as A1C testing, lipid profiles, eye and foot examinations, and influenza vaccinations.
Compared with baseline, medical claims costs decreased 8.5%, pharmacy claims costs increased 36.5%, and overall healthcare costs increased 5.32% during the first year of the program.41 However, compared with projected costs, the mean annual total healthcare cost per patient decreased by 7.24%, resulting in estimated savings of $278,512 for employers during the first year of the program.
The Asheville Project began in 1997 as a diabetes disease management program offered by 2 large employers in Asheville, North Carolina.42 Pharmacists at 12 community pharmacies provided the services including self-management education and counseling, goal setting and monitoring, clinical assessment, and referral42,43-and were reimbursed on a fee-for-service basis.42 Participating pharmacists were not required to be CDEs, but did complete a rigorous diabetes certification program.42,43
Patients were offered the opportunity to meet with pharmacist providers at no out-of-pocket cost.42 Participating patients also received free glucose meters, and copayments for diabetes medications and supplies were waived. Initially, 85 patients were enrolled42 and were followed for up to 5 years.43 During the first 7 to 9 months, A1Cs were significantly reduced, and patient satisfaction improved. Costs for diabetes care increased by 87% ($52) per patient per month; however, there was a 16% ($82) decrease in all diagnosis costs.42
Long-term outcomes, among patients remaining in the program for up to 5 years, included sustained A1C reduction as well as increased A1C goal achievement. LDL-cholesterol and high-density lipoprotein-cholesterol levels also improved.43 Costs shifted from hospital, ED, and outpatient physician services to prescriptions. Although prescription claims increased, total claims decreased by $1622 to $3356 per patient per year compared with baseline. Additionally, 1 of the 2 employers reported decreased sick days; the value of the resulting productivity increase was estimated at $18,000 per year.
After controlling for confounding factors, the disease management services were not an independent, statistically significant factor in reducing A1C. However, the investigators noted that measurement of the services was not precise and did not capture the full range of services provided to patients.44
Other programs based on the Asheville model have been implemented-eg, the Lancaster County (Pennsylvania) BRiDGE Project for Improved Health Outcomes. The BRiDGE program is available to any employer in the area. Patients with diabetes agree to monthly visits with a certified local network pharmacist, who acts as a coach in face-to-face consultations. Participating patients receive incentives including reduced or waived deductibles and copays for lab tests, medication, and supplies.45,46
Type 2 diabetes is associated with a significant burden and consequences to both individual patients and society as we care for those with this disease. While treatment options are effective and available, there still remains a treatment gap. Addressing the needs of this gap not only includes improved clinical management of the disease, but also a review of the other factors affecting outcomes such as adherence to therapies and an improved understanding of the disease by both practitioners and patients.
The implications for managed care can be seen through the development and execution of innovative medical policies and practices which addresses the diabetes treatment gap. Availability of team-oriented diabetes care providers, financial incentives to healthcare providers and maintaining affordable access to pharmacologic therapies have demonstrated these approaches can improve clinical outcomes while reducing overall costs.
Author Affiliations: From Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (AJA); Sharp Rees-Stealy Medical Group, San Diego, CA (DCB); Outpatient Services, Monarch Healthcare, Irvine, CA (RB); Health Intelligence Partners, Chicago, IL (JEB); Division of Endocrinology, Cedars-Sinai Medical Center, Los Angeles, CA (MAB); Department of Family Medicine, Boston University School of Medicine, Boston (LC); Pharmacy Service, Arcadian Health Plan, San Dimas, CA (GSO); Brush, CO (MR ); Beth Israel Deaconess Medical Center, Boston, MA (FKW).
Funding Source: Financial support for this work was provided by Novo Nordisk.
Author Disclosures: Dr Ahmann reports being a consultant/advisory board member for Biodel, MannKind, and Novo Nordisk, grants from Amylin, Lilly, MannKind, and Medtronic, and receiving honoraria from and paid lectureship for Amylin, Lilly, Merck, and Sanofi. Dr Balfour reports being an advisory board member for GlaxoSmithKline, Lilly, Merck, Novartis, Novo Nordisk, Ortho-McNeil, Sanofi, Takeda, and Teva. Dr Bush reports being a consultant/advisory board member for Novo Nordisk and on the speakers' bureau for Lilly, Merck, and Novo Nordisk. Dr Culpepper served on the advisory board for AstraZeneca, Lilly, Pfizer, Sanofi, Takeda, and Wyeth. Drs Beltran, Berger, Ringel, and Welty and Ms Owens report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this supplement.
Authorship Information: Concept and design (DCB, MAB, LC, GSO, FKW); acquisition of data (DCB); analysis and interpretation of data (AJA, RB, MAB, LC); drafting of the manuscript (AJA, DCB, RB, MAB, LC, GSO, FKW); critical revision of the manuscript for important intellectual content (AJA, RB, MAB, LC, MR , GSO, FKW); and administrative, technical, or logistic support (JEB, GSO).
Address correspondence to: Jan E. Berger, MD, President & CEO, Health Intelligence Partners, 3842 Monticello Ave, Chicago, IL 60618. E-mail: firstname.lastname@example.org.
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