As Comorbidities Pile Up, True Diabetes Cost Measured by More Than Insulin, Panel Says

The cost of insulin has offered a steady drumbeat in the public eye, with at least 2 hearings dedicated to diabetes alone in Congress so far in 2019, along with separate hearings with other drugmakers and pharmacy benefit managers giving testimony to lawmakers.

At a recent meeting in Dallas, Texas, bringing together endocrinologists, a cardiologist, a diabetes educator, and a room full of fellow diabetes educators and health workers, there was another cost on everyone's mind: the cost of doing nothing. That is especially true in Texas, where diabetes prevalence is skyrocketing, and social determinants of health and which ZIP code you live in can impact your outcome.

Everything from how it is treated, who treats it, the lifestyle changes that are required, and which services are paid (or not paid for) makes diabetes complicated, and the cost is exorbitant due to unwanted and preventable complications, according to the presenters at the inaugural meeting of the Institute for Value Based Medicine (IVBM) in Diabetes, an initiative of The American Journal of Managed Care^®.

“Diabetes is not letting go,” said Jaime A. Davidson, MD, FACP, MACE. “Diabetes is getting worse every day.” Davidson, who was also the moderator of the April 4 event, kicked off the meeting indicating the scope of the problem not just in the United States but also in Texas.

For Davidson, one of the most worrisome trends in type 2 diabetes (T2D) is the fact that there was a 76% increase in prevalence among adults aged 30-39 years between 1990 to 1999, according to National Institutes of Health statistics. “They’re younger people,” he said. “If we don’t take care of them, in 20 years they’re going to be in trouble.”

A picture of diabetes in Texas

In the United States overall, diabetes is the 7th leading cause of death, and there are 1.5 million cases each year, Davidson said.

Racial disparities are evident, with Hispanic women and men having the highest lifetime risk of developing diabetes (about 50% and 45%, respectively), followed by black women and men (nearly 50% and 40%, respectively).

In Texas in 2016, 14% of the population, or nearly 3 million people, had diabetes, compared with 1.4 million people, or 8% of the state's population, in 2006.

He said in recent years, El Paso has had a 74% increase in T2D prevalence, followed by Houston (41%), Austin (34%), and Dallas (31%).

Texas residents fare worse than the general US population, for the most part, when looking at different subgroups. For instance, by education and age, the prevalence of diabetes for an individual with some college is 12.3% nationwide, but 14% in Texas. By age, adults aged 45-64 or over 65 in Texas also suffer from diabetes at rates higher than the US population (17.5% vs 14.5% and 22.7% vs 22.6%).

Showing slides of the number of emergency department visits for every 100 patients with diabetes among different Dallas area zip codes in 2014, Davidson showed very high rates for many groups —70, 80, 90 visits.

In addition, 38.1% of Texans with T2D have 2 or more comorbidities versus 29.5% nationally; 13.1% of Texans have 2 or more complications compared with 9.9% nationally.

“Isn’t that staggering?” he asked the audience.

He also listed problems that demand action in Texas: patients are not getting glycated hemoglobin (A1C) tests, and many have poor refill rates for insulin, as high as 68% in El Paso, as well as for oral agents.

Challenges for both patients and physicians

Diabetes is not an easy disease for either patients or clinicians, said Philip Raskin, MD, FACP, FACE, CDE, professor of medicine at the University of Texas Southwestern Medical Center. It is one that is getting more complicated to manage, even as there are more and more treatments.

In addition, constraints from insurers in the form of prior authorizations, step therapy, formulary switches, and time pressures from healthcare systems to see an increased number of patients in a shorter amount of time drive him crazy, said Raskin, an endocrinologist who limits his practice to the care of people with diabetes.

“Sometimes I want to yank my hair out," he said. "I spend more time dealing with the hassles trying to practice good, evidence-based medicine."

Raskin said he thought about getting up and presenting what he called a “free ranging rant” but then realized he probably had to make his presentation more formal. So he focused his talk on the nitty-gritty details of challenges that plague both patients and physicians; for both groups, the struggles of time and money are paramount.

Caring for a patient with diabetes takes multiple, repeated and persistent interventions to keep the condition under control, he said. Mentioning a few, he noted that lipids, kidney function and feet should be checked annually, and other aspects should be checked at each visit, such as diet, exercise, and smoking cessation.

Challenges faced by doctors include a lack of time and money, evolving therapeutic choices and technology, and having appropriate knowledge and experience, such as the ability to teach patients to use continuous glucose monitors; and knowledgeable staff.

“Doctors don’t examine anymore,” he said. “It drives me crazy … they just talk and type,” he added, referring to the demands of an electronic health record.

Patient challenges include time and knowledge, insurance issues, complicated pathophysiology, money, and access.

There are perhaps 3000 endocrinologists in the US and many do not accept patients with diabetes, Raskin said.

From patient-centric to person-centric care

Similar to Raskin, Kellie Rodriguez, RN, MSN, MBA, CDE, director of the Global Diabetes Program at the Parkland Health and Hospital System, talked about the “unrelenting daily expectations” that people with diabetes must manage.

She noted that there are plenty of guidelines and knowledge about diabetes for the medical community— but we still aren’t getting the outcomes we are looking for. In addition, besides the direct healthcare costs for people with diabetes, she pointed out the toll of indirect costs, borne by families and employers.

“We spend a lot of money, there is a lot of cost, do we still get the results that we need?” she asked.

While the proportion of patients who achieve recommended A1C, blood pressure, and low-density lipoprotein (LDL) cholesterol levels has increased, many—33% to 49%—still did not meet targets recommended in guidelines, according to 2013 data. And only 14% met targets for all 3 measures while also avoiding smoking.

These outcomes are vital for value-based care, she noted, since it impacts payment, and the cost of diabetes care impacts everyone, from the patient to the healthcare system. “This is an expensive disease and it’s unrelenting,” Rodriguez said.

She showed numbers, though, not of costs, but of hours, and to her, she said, it is one of the most important slides she shows at every presentation. While there are 8760 in a year, only 6 might be spent in a healthcare setting, leaving this complex disease to be managed by patients. “As important as we are, we do not manage diabetes,” she said. “People manage diabetes in between our visits.”

She said she insists on using language that focuses on the person, rather than the "patient," and with that shift, maybe clinicians can impact what she calls the “lived world” experience of diabetes.

The 7 self-care behaviors that people with diabetes must exhibit—healthy coping, health eating, monitoring, risk reduction, exercise, medication, problem solving—are why she does not like to see the words “non-adherent” in documentation, given their all-consuming nature and the fact that diabetes does not exist in a vaccum, separate from all other aspects of life.

As an example, she presented a case of a young woman who is hospitalized at least monthly for diabetes. She then adds additional information about the woman’s history of mental disorders and traumatic events.

“Tell me, where diabetes self-management fits into this equation?” Rodriguez asked.

It is difficult to motivate someone towards self-care when they have nothing to smile about, she said, and unless healthcare systems pay attention to social determinants of health (SDOH), outcomes like glycemic control and lower blood pressure won’t be improved.

SDOH “drives 80% of outcomes,” she said.

Managing patients with diabetes and cardiovascular disease risk

With heart disease the leading cause of sickness and death for people with diabetes, there is a bigger treatment role for cardiologists, especially with the release of last year’s American College of Cardiology (ACC) Expert Consensus Decision Pathway.

Ian J. Neeland, MD, assistant professor of medicine, University of Texas Southwestern Medical Center, gave the perspective of a cardiologist using the ACC pathway.

The new ACC document said that empagliflozin is the preferred therapy among sodium glucose co-transporter 2 (SGLT2) inhibitors for patients with T2D and atherosclerotic cardiovascular disease (ASCVD). The consensus document also said that that liraglutide is the preferred treatment among a second novel class of T2D treatments, the glucagon-like peptide-1 (GLP-1) receptor agonists. Empagliflozin is sold as Jardiance by Boehringer Ingelheim and Eli Lilly; liraglutide is sold as Victoza by Novo Nordisk.

Neeland said a cardiologist is positioned to address 3 key elements of managing T2D:

• Screening for T2D in patients with or at risk for cardiovascular disease (CVD)
• Aggressive treatment of CVD risk factors
• Recommending or initiating new T2D medications

The reason Neeland said he included the word “initiating” when it comes to beginning newer medications is because there is still some debate over whose role it is to oversee them.

“Is it a diabetes medication, or is it cardiovascular medication? Or is it both, and whose really in charge?” he said.

When it comes to screening, only 13% of outpatients with CVD are screened for T2D by a cardiologist, and patients with diabetes are more like to see a cardiologist than an endocrinologist, since there are more cardiologists in the United States.

Highlighting the risk factors for diabetes that may be screened for in a cardiologist’s office—healthy diet/weight, physical activity, blood pressure,

lipids, and antiplatelet agent(s)—Neeland noted that there was 1 risk factor he did not include: glucose.

Why? Because while tighter glucose control has shown benefits for microvascular disease—about a 20% relative risk reduction—it has not shown benefit for macrovascular disease. In 2 studies, there was no difference in CV death, heart attack, stroke (the ADVANCE study) and in another (ACCORD) there was higher mortality in the intensive group and no difference in CV.

This is why historically cardiologists have not been involved in diabetes care from the perspective of glucose control, he said.

Neeland recapped how in 2008, the FDA began requiring that makers of T2D therapies conduct large cardiovascular outcomes trials (CVOTs) to demonstrate that there would not be any “unacceptable” cardiovascular risk.

There are over a dozen current CVOT trials examining dipeptidyl peptidase 4 (DPP-4) inhibitors, GLP-1 receptor agonists and SGLT2 inhibitors, he said. Providers have to be aware of, understand, and incorporate the dizzying amounts of data emerging from trials, Neeland said. This is a huge challenge, he said, and a lot of work.

He reviewed the results from randomized outcomes trials for empagliflozin, canagliflozin, and dapagliflozin, but noted that people in clinical trials are usually healthier than those seen in every day clinical practice. Real-world trials, though, showed much of the same benefit for all preventing all-cause deaths and hospitalization for heart failure.

CVD-REAL, therefore, was important because it showed a 51% lower risk of death and a 39% lowerrisk of hospitalization for heart failure for those beginning an SGLT2 compared with those initiating another glucose-lowering drug.

This is creating new discussion about the underlying cause of deaths. “That’s important because heart failure is probably going to dwarf myocardial infarctions or ischemic heart disease in the next 10 years,” he said.

“People are having less heart attacks but they’re having a lot more heart failure,” he said, stemming from rising rates of obesity and diabetes.

The cardiovascular benefit is independent of the improvement in glucose, which raises the question, if it is not glucose, then what is it? The class of drugs affects so many different areas that have an impact on CV events including blood pressure, weight loss and kidney function, that there is still not a precise answer.

After taking the audience through the ACC pathway for patient and medication selection, Neeland noted that there are unresolved questions and topics up for debate:

• Which clinician takes “ownership” of SGLT2/GLP-1: the primary care doctor, the endocrinologist, or the cardiologist?
• Who adds and adjusts the other T2D therapies?
• What does “control” mean in T2D for people whose A1C is <7% but they may still potentially be at risk?
• Is there a use in primary prevention patients
• Should SLGT2 and GLP-1 be used together?

Overall, he said, there is an increasing role for cardiologists in diabetes, Neeland said.

More challenges

After listening to his co-presenters, Davidson offered more thoughts.

“We talk about cost, and we talk about money, and we talk about being so expensive,” he said. “But remember most of the cost of taking care of patients with diabetes is not the cost of the medications. It’s not the cost of the cardiologist, or the endocrinologist, or the diabetes educator. It’s the cost that I showed you it’s getting into the emergency room, getting into the hospital, it’s getting complications because we don’t feed them well, and that’s what the cost is.”