Peer Exchange: As Trials Show CV Benefits in Therapy, Panelists Discuss "Exciting Time" in Diabetes Care

Evidence-Based Diabetes Management, September 2016, Volume 22, Issue SP13

Second of 2 Parts: See Part 1, in Evidence-Based Diabetes Management, coverage of Patient-Centered Diabetes Care 2016.

There are more therapeutic options than ever in diabetes care. However, the problem of getting patients to take part in them remains, according to a panel of experts who took part in a Peer Exchange convened by The American Journal of Managed Care.

During the first part of their discussion, the panelists addressed how professional societies, consulting endocrinologists, and smart software could help primary care providers treat patients with diabetes more effectively. They also spoke of strategies for enlisting and coordinating the sort of ancillary care providers—such as dietitians and educators—that have improved outcomes in research projects and pilot programs. Despite the challenges, trial results that show the possibility of preventing heart attacks and strokes, along with treating diabetes, make this “an exciting time” for the field, one expert said.

Joining the discussion, which took place ahead of Patient-Centered Diabetes Care 2016 in Teaneck, New Jersey, were panelists Zachary Bloomgarden, MD, professor at the Icahn School of Medicine at Mount Sinai; Michael Gardner, MD, medical director at the Cosmopolitan International Diabetes and Endocrinology Center at the University of Missouri; John A. Johnson, MD, MBA, senior medical director at WellCare Health Plans; and Robert A. Gabbay, MD, PhD, FACP, senior vice president and chief medical officer at Joslin Diabetes Center. Dennis P. Scanlon, PhD, professor of health policy and administration at Penn State, served as moderator.

Role of the Pharmacist

The second part of the discussion examined the role of another type of caregiver: the pharmacist. In an ideal world, physicians would have complete electronic health records from every patient, including a comprehensive account of pharmaceutical usage. In the real world, pharmacists are the only healthcare professionals who tend to see all patient prescriptions and know how frequently they get filled.

Trial programs have found that pharmacists can use that information to spot potential drug interactions and get more patients taking their medications on schedule. Now, some large pharmacies are working with payers and major care providers to do the same on a far larger scale. “Our pharmacists are a part of our interdisciplinary care teams because a lot of times, when you’re managing members with multiple comorbidities, there are drug-drug interactions and creatinine clearance issues that need to be factored in,” said Johnson. “There’s communication back with the primary care provider because he may not have a line of sight into the meds that were written by the specialists if it’s in a different health system.”

Unfortunately, such programs are not yet the norm, according to Gabbay. “Where there have been pilots, it’s been quite successful, and data is quite impressive,” he said. “But most of the chain pharmacies haven’t moved in that direction.”

Those that have, moreover, have sometimes struggled to provide physicians with truly useful information. “The reality is that we have so much feedback of meaningless interactions, and at a certain point, this really interferes with the ability to truly perceive what might be of concern,” Bloomgarden said. “Perhaps if we had a pharmacist who was really a member of the team and was involved in helping us to understand what medicines a person was taking and what were the clinically meaningful interactions, we could get around this. But it’s almost as though we’re at the earliest stage and we need to go up several levels to get these approaches to work.”

If pharmacists would also use their records to identify and assist patients who do not medicate themselves as instructed, that might improve outcomes even more. Patient adherence, the panelists all agreed, is a massive problem in diabetes care.

The Right Approach to Gauging Adherence

Over the long term, Bloomgarden noted, adherence rates to even the easiest drug regimens—like taking a single statin every day—rarely top 70%. Strict adherence to complex regimens, particularly those that include injections, is well below 50%.

Indeed, Bloomgarden said it took him years to convince one of his smartest and most rational patients to move from a single-injection regimen to a multiple-injection regimen, even though he presented a mountain of evidence that the multiple-injection regimen would make the patient feel dramatically better. (And it did end up doing so.)

Investigators have yet to find an easy way to fix such problems, but research consistently suggests that some approaches produce better patient adherence than others. Giving patients some choice in their treatment regimens seems to increase their investment in the process and boost adherence—as does the way healthcare providers discuss their subsequent behavior with them. Asking “Are you taking your insulin as prescribed?” prompts many patients to lie and forces others to make uncomfortable admissions.

Questions that make patients feel comfortable with their actual behavior before considering strategies for improvement can work better: “It’s very hard for most patients to take insulin as prescribed, particularly when they’re first starting out. What are the biggest barriers for you?” Once patients identify individual issues, caregivers can help them develop strategies to overcome those issues.

Such tactics can sig nificantly improve adherence—but only to a certain point. Even the most successful pilot programs have struggled to get long-term adherence near 50%, and there is little reason to expect any true breakthroughs in the field of patient compliance.

EMPA-REG OUTCOME Trial

There may be real breakthroughs, however, in cardiovascular care for patients with diabetes. The panelists expressed genuine hope (albeit tempered with caution) about a trio of trials that suggest that at least 3 diabetes treatments are cardio-protective.

The first of these trials, the EMPA-REG OUTCOME trial, reported that empagliflozin (Jardiance) reduced the risk of heart attacks, strokes, and death from heart disease by 14%, and reduced cardiovascular deaths by 38%.1 The second trial found that pioglitazone reduced the risk of subsequent heart attack and/or stroke by 24% among stroke victims with insulin resistance but no diabetes. It was also associated with a 50% reduction in the risk of incident diabetes.2 The last of the trials found that use of liraglutide reduced the risk of stroke, myocardial infarction, or cardiovascular death by 13%.3

“It sort of changes the way we think about choice of medications,” Gabbay said. “We have that list of [considerations]. Does it cause weight gain or not? Does it cause hypoglycemia or not? And now we have an expanded number of drugs that say, ‘Does it also lower cardiovascular risk beyond its glucose effects?’ And, obviously, that’s critically important because the number-one reason why people with diabetes die is heart disease. So, anything that’s going to lower that, particularly for people who are high risk, it’s hard not to consider that a really important factor in weighing the different factors in terms of choice.”

Bloomgarden agreed. “Absolutely. The findings of PROactive, which was a big trial of pioglitazone, showed a 50% reduction in stroke if you had a history of stroke, and that finding was actually the rationale for the IRIS trial,” he said. “That leads us to ask [questions]: people with diabetes who’ve had strokes, if we can be very careful about the known complications of these drugs, should they all have a thiazolidinedione? And then, what [is the right dose]? Should we aim for lower doses to avoid complications?”

Johnson added that payers, such as WellCare, had a responsibility to respond to such trial results quickly and, quite possibly, take some very expensive steps. Johnson had said earlier in the discussion that WellCare typically likes to make at least 1 drug from each class available to members by negotiating for all the drugs and taking the best deal. The new trial results might force payers to embrace particular medications, because empagliflozin and liraglutide are the only medications in their respective classes to show cardiovascular benefits. (Empagliflozin is a sodium glucose co-transporter 2 [SGLT2] inhibitor and liraglutide is a glucagon-like peptide-1 [GLP-1] receptor agonist.

That said, the panelists noted, physicians must carefully read actual studies to understand which patients would likely experience the benefits that trial populations experience. Trial populations rarely reflect the actual make-up of all real-world patients with a given disease. They typically reflect sub-sections of the patient population, and their findings may or may not hold true for other patient groups. “Rather than say, ‘Everybody should take empagliflozin,’ you might want to say, ‘Everybody who resembles those 6000 people [in the trial] who were carefully selected to have a certain level of risk factors [should consider empagliflozin].’”

Judging Quality in Diabetes Care

The session ended with a discussion about the challenges of judging caregiver performance and the potential impact of programs like the patient-centered medical home. Many types of specialists have argued that it’s hard to infer the quality of care they provide from patient outcomes because each individual patient and each individual condition is different. Worse outcomes can be a reflection of incompetence, sicker patients, or some other factors.

It is even harder to evaluate the quality of diabetes care because outcomes hinge so much on patient behavior. Patients who choose to eat well, exercise, and medicate themselves consistently usually fare very well, even with bad doctors. Patients who do the opposite will usually fare very poorly, even with good doctors. Caregivers can influence behavior, of course, but they cannot control it.

The panelists acknowledged the difficulty of inspiring compliance, but argued that people who treat patients with diabetes must hone their powers of persuasion and improve outcomes. “The other thing I’m always a little nervous about is the healthcare community saying, ‘Well, it’s all about patient adherence, and so that’s not my problem.’ No. We have an important role in that, and there’s certainly interventions that we know that can improve adherence and engagement of patients, and I think it’s part of our duty as providers to be able to guide people to do the things that will be better for their health,” Gabbay said.

Johnson added that the quality measurement tools employed by payers and the government—although certainly imperfect—evaluate caregivers in a number of different ways and have proven their value in predicting outcomes. “If you look at a Stars rating, the biggest components would be HEDIS (Healthcare Effectiveness Data and Information Set) and CAHPS (Consumer Assessment of Healthcare Providers and Systems),” Gabbay said, referring to the ratings used by Medicare Advantage plans. “CAHPS is the consumer survey that the general public, if they’re included in the sample, fill out and give an assessment of the care they receive from the health plan. HEDIS gives us more quality data on how the provider and the patient are performing. Controlling of blood pressure, controlling of [glycated hemoglobin], medication adherence: not just that the doctor did a great job of prescribing it, but is the person actually taking it and getting it filled.”

There was general agreement that physicians and other caregivers could influence patient behavior enough to judge them (partially) on their ability to inspire good behavior. There was also agreement that efforts to move from a fee-for-service model to a model that rewards doctors for reducing costs by improving outcomes would probably lead to better care.

< Indeed, the combination of innovative models for care delivery and steady progress in drug development make panel members optimistic about the future of diabetes care. “It is an extremely exciting time to be in the diabetes care space with all of the new things that we’re finding, all of the new things that we can do with medications in terms of, maybe finally, addressing cardiovascular disease and the comorbidities of diabetes,” said Gardner.

It will still be a challenge, however, to translate new discoveries into better outcomes for all patients. Part of that challenge lies in disseminating new discoveries about best practices from researchers and specialists to the primary care providers who treat most patients with diabetes, Gardner said.

Part of the challenge lies in making the commitment to personalize care. “In terms of individualizing our care, [we need to answer a lot of questions]: what do you do for a living? Is this really a meaningful plan for you? Does it get at what you need? Does it get at what your hopes and dreams, aspirations, etc are?”

References

1. Zinman B, Wanner C, Lachin JM, et al; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117-2126. doi: 10.1056/NEJMoa1504720.

2. Kernan WN, Viscoli CM, Furie, KL, et al; IRIS Trial Investigators. Pioglitazone after ischemic stroke or transient ischemic attack. N Engl J Med. 2016;374(14):1321-1331. doi: 10.1056/NEJMoa1506930.

3. Marso SP, Daniels GH, Brown-Frandsen K, et al; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311-322. doi: 10.1056/NEJMoa1603827.