November 28, 2018; Arlington, VA; Full Report – Draft

ADA recently hosted a Summit on Therapeutic Inertia, bringing together ~125 representatives from patient advocacy groups, HCPs, health systems, payers, and industry with the goal of discussing the impact of and solutions to therapeutic inertia in type 2 diabetes. See the agenda and slides here.

ADA CEO Ms. Tracey Brown and Chief Scientific, Medical, and Mission Officer Dr. Will Cefalu opened the meeting, emphasizing a theme of disruption for the initiative. We thought Ms. Brown put it especially well in saying, “therapeutic inertia has been inhibiting our ability to bend the curve of the diabetes epidemic… Since this has been a longstanding issue, we have to disrupt the status quo. We have the best and brightest in this room, so let’s push ourselves to that uncomfortable place and challenge conventional thinking… We have to start changing behavior and thinking about collaboration in a different way.” Dr. Cefalu’s opening was incredibly strong as well – when he speaks, you can kind of hear a pin drop.

Thematically, an interesting debate on prescriptive vs. individualized guidelines emerged, leading Dr. Cefalu to wonder aloud, “for years we have been going to more individualized approaches. What we’ve heard today is that we need to be more prescriptive. I find this challenging. I think that to address therapeutic inertia, you might be right – we might need to be more forceful, especially after years of doing the opposite of being more individualized.” We recalled Dr. Cefalu’s remarks from Keystone 2017, when he highlighted that “no algorithm is going to tell you how to treat your patient. There’s still something called the art of medicine.” This is undoubtedly still true, and is another obstacle to developing prescriptive guidelines (type 2 diabetes is a highly heterogeneous disease, hence the “art of medicine” in treating it).

We also heard ample discussion on the need for more therapeutic touch points between visits, better utilization of technology (e.g. telehealth), and “meeting patients where they are” in the community.

A few comments on rationale and language were also very interesting. Dr. Cefalu drew a distinction between “clinical inertia” and “therapeutic inertia.” He articulated that the former seems to “point the finger” at the clinician, while the latter refers to a problem with the larger medical system. We think this framing is fundamentally important to this discussion. While “therapeutic inertia” may sound like it is associated with therapy only, we believe this is much more broadly defined in participants’ minds.

In summarizing the day’s discussion, Dr. Bill Polonsky was frank in sharing that he felt overwhelmed, pinpointing three broad areas of action to emerge over the nine-hour day:

• (i) better support physicians;

• (ii) better support patients; and

• (iii) fix the healthcare system.

Dr. Polonsky spoke to the struggle of identifying the real problem behind therapeutic inertia, perhaps more than anything to illustrate the true complexity of the issue and the need for a multifactorial solution. He closed on two strong points: (i) patients are more comfortable getting on board if they perceive their disease as urgent; and (ii) HCPs are more likely to take action and prescribe medications if they have enough time in a visit devoted to diabetes. These conclusions offered some guidance on where future initiatives might head (not that this is particularly new or easy).

Dr. Cefalu noted that ADA’s Overcoming Therapeutic Inertia campaign is set to last at least three years. He emphasized the role of collaboration and partnership. Today’s meeting is phase I of the initiative, to be followed by phase II (advocate for impact, determine priorities, and build the campaign) and then phase III (deliver campaign, measure results, and accelerate diabetes management globally through practice of ADA Standards of Care).

We’re glad to note broad industry support of this undertaking, with founding sponsorship from Abbott, AstraZeneca, Merck, Novo Nordisk, and Sanofi, as well as additional sponsorship from Dexcom, Janssen, Lilly, and Medtronic.

Below, we’ve included a series of highly quotable quotes followed by a brief summary of each section from the meeting – stay tuned for more on this important Summit, coming soon!

Quotable Quotes

• “I knew going in how complex this issue is: It’s not just lifestyle, insurance, patient, or community – it’s all kinds of complexity. I hope the writing group captures that. There is not a single solution to make big jump forward…I live in southeast Arizona, where you see a lot of weird stuff, but diabetes is clearly the #1 public health issue. It smokes cancer and cardiovascular disease. If you think we’re in trouble, let’s double the population with diabetes in 30 years, and we’ll get hammered. We need to make people aware that this is a really serious problem, and I’d be happy just to slow it down. We have to be thoughtful and multi-disciplinary. One thing is for absolute sure: If it doesn’t get better where I live, it’s going to implode my state.” – Dr. David Marrero (University of Arizona Health Sciences, Tucson, AZ)

• “I applaud the focus on primary care. I think the challenge for all of us today is how do we take all of these great pockets of work and scale them up. That seems fundamental. I think we all have examples of where things are working nicely [in smaller settings]. From the ADA’s perspective, the question is how we scale these up.” – Dr. Robert Gabbay (Joslin Diabetes Center, Boston, MA)

• “We’ve tried to individualize [guidelines], but this has ended up with every single group doing [treatment] differently. No question, this is [one of the main] challenges.” – Dr. Bob Rizza (Mayo Clinic, Rochester, MN)

• “We need to change society’s perception on what diabetes really means.” – Dr. Karen Talmadge (Nabu Strategic Advisors, Los Altos Hills, CA)

• “I don’t think CGM is for upscaling in terms of primary care [of type 2 diabetes]. It’s very complex and I don’t think we can use CGM to upscale therapy.” – Dr. Kamlesh Khunti (University of Leicester, Leicester, United Kingdom)

• "The next iteration of the AACE diabetes guidelines will likely encourage the use of CGM in certain individuals with type 2. This refers mainly to intermittent use of CGM, professional or personal, to help get to goal, help with adherence, and help with hypoglycemia avoidance. If one looks at many of the barriers discussed today regarding therapeutic inertia, CGM addresses these: getting to goal quickly, taking advantage of urgency, the enjoyment of problem solving together, adherence, etc. We believe intermittent CGM will prove cost-effective, perhaps more so than A1c, because it tells a story, and people remember stories. Even cultural humility is addressed; for example, "let's see what happens with that bowl of rice and then objectively decide together what to do with the results". We recognize there are few clinical trials to prove efficacy, but anyone with experience knows that the value of CGM is obvious and profound. So I believe we can use clinical guidelines to move the field forward, not just reflect already common or proven practice. Let's have the courage to do so."  – Dr. Daniel Einhorn (Diabetes and Endocrine Associates, La Jolla, CA)

• “How do we scale all of these successful interventions? I think this is where digital health comes in. Someone asked earlier – ‘how are we going to train all primary care providers to interpret CGM data?’ – Why can’t we interpret it for them using digital health?” – Dr. Andrew Rhinehart (Glytec, Marco Island, FL)

• “This message is not different from 5 to 10 to 15 years ago. We can invest more in behavior and all of the systems challenges, and recognize that there are a lot of new effective technologies and digital health solutions. We also have to realize that we need to reduce cardiovascular and kidney disease, because these complications are really driving the cost.” – Kelly Close (The diaTribe Foundation, San Francisco, CA)

• “I think we can learn a lot from smoking. We’ve broadly convinced people that it’s probably not good for you and that the negative impacts are really big, and we’ve made it way less convenient and less cool to be a smoker.” – Dr. Bill Polonsky (Behavioral Diabetes Institute, San Diego, CA)

• “We really do need to think about how to engage in policy, systems, and environmental change work. People live their lives outside of the clinical setting. We need to link clinics with communities.” – Dr. Ann Albright (CDC, Atlanta, GA)
• “Diabetes should be the next opioids. There was [in the past a focus on] HIV, now there’s [a focus on] opioids, and now it’s our turn. These issues are addressed because of the social view. Diabetes needs to become a social issue, not just a health issue in our country.” – Dr. Ann Albright (CDC, Atlanta, GA)

•  “If we’re thinking about prevention, the white paper may need to think beyond type 2 diabetes and to prevention of type 2 diabetes in people at risk. How do you change behavior to make people eat better and exercise?” – Dr. Robert Eckel (University of Colorado, Denver, CO)

• “One thing, when I think about inertia, is how we can stop patients from even progressing to diabetes. We define it as this set point in time, but you’ve already had beta cell destruction at diagnosis. If we can incentivize doctors to have that discussion early, how transformative would that be? How do we get the patient and clinician activated to talk about lifestyle early on and bend that curve so that many don’t even develop diabetes? To me that’s theoretical inertia. As we look at the trajectory of this disease, that to me would make a sizable dent in diabetes.”

• “What would really be disruptive would be to have less patients. Back when the Standards of Care were four pages, there were only five million diagnosed patients with type 2 diabetes, and we didn’t think it would become this problem. It used to be that 140 mg/dl was diabetes, and now it’s 126 mg/dl. We know microvascular changes occur before 126 mg/dl. We need to rethink how we tell people you get diabetes: It doesn’t happen overnight. And maybe then we can get people to recognize the relation to other diseases like cancer.” – Michael Duenas, DO (American Optometric Association, St. Louis, MO)

• “We need to change how we talk about diabetes, and remind people both that they did not cause the disease and that it’s an urgent matter. If we don’t take it urgently, what’s going to happen to society? A meeting like this is how we can bend the curve, but let’s get out there and talk about the urgency – we have a national crisis and people just don’t know it.” – Karen Talmadge, PhD (Nabu Strategic Advisors, Los Altos, CA)

• “I don’t love the word ‘target because it’s a single number. I prefer ‘milestone’ or some equivalent – it’s a number with a time attached to it. If you’re not down toward that goal in three months with an SGLT-2 inhibitor, you’re never going to get there. Maybe the target should be in three or six months, if you have not fallen by 0.5%, don’t continue with that protocol.” – Barry Ginsburg, MD, PhD (University of Iowa, Iowa City, IA)

• “We try to make visits, in a word, fun, and make it something that patients and families look forward to. We work with staff on that, and it doesn’t work for everyone, but that aspect of enjoyability makes it more pleasant for me. People miss visits less often.” – Dr. Daniel Einhorn (Diabetes and Endocrine Associates, La Jolla, CA)

• “Several of us have mentioned that payment strategies need to change. It’s fine to say, ‘Oh we’ve got telehealth, data, CGM – they can share that with us.’ When I’m not in clinic, I’m doing other things. The payments and incentives do need to be changed if we do all these things between visits, in the community. To the extent that bundled payments would do that, bring them on.” – Dr. Sue Kirkman (University of North Carolina, Chapel Hill, NC)

• “I wouldn’t go to a PCP for metastatic breast cancer. Diabetes is a complex disease. My son is radiation oncologist – he doesn’t even understand what a no-show rate is. Treatment is going to be complex. It’s not going to be that easy, but we need plans on who is going to see what segment of the population. There will be serious therapeutics but with different levels of treatment.” – Dr. George King (Joslin Diabetes Center, Boston, MA)

Themes

The Criticality of Primary and Team-Based Care and the Role of EMRs in Promoting Care Coordination

In a world where most diabetes diagnosis/treatment occurs in primary care offices, PCPs and other HCPs are a key component of the conversation on therapeutic inertia, and significant discussion was devoted to the role and education of PCPs. Multiple attendees decried the near absence of diabetes-specific education during medical school and residency. Very early on, Primary Care Education Consortium’s Dr. Steven Brunton explained that, while diabetes education is inadequate, his organization hosts a weekend conference for Chief Residents, who leave with greater confidence intervening in diabetes care. The same thing, he says, should be done with PCPs: Doctors are more likely to do something if they feel like have the skills, so concentrated but brief education on diabetes could be hugely impactful. How can ADA more effectively penetrate primary care through its Diabetes is Primary initiative? Another commented that PCPs have their own guidelines for insulin initiation – but it’s a 40-page document – and suggested more digestible resources for PCPs, such as a short video about GLP-1 initiation and titration. Mount Sinai’s Dr. Deena Adimoolam similarly suggested specific algorithms for PCPs (more on that below), and emphasized the need to more effectively utilize team-based care, specifically from CDEs and PharmDs, to whom patients who need more care can be referred. The criticality of non-physician and especially non-endocrinologist HCPs, as well as coordinated, team-based care, became increasingly apparent over the course of the day.

• Attendees also highlighted the benefits and shortcomings of EMRs in making diabetes and team-based care easier to deliver. Multiple speakers and attendees offered helpful components of their EMRs, including dashboards and items that make it easier to tell when/if patients are refilling prescriptions, up to date on screenings and tests, or meeting therapeutic targets. Tools also allow HCPs, in some health systems, to check if a prescription drug is on a patient’s formulary – though sometimes these only tell you if something isn’t covered without providing an alternative in the class, a big pain point. Oftentimes, these data points can help guide conversations between the patient and clinician and support clinician decision making – some programs even offer bona fide decision support software, making treatment recommendations based on family history, lab values, and medication regimens. However, there is significant room for improvement on multiple aspects on EMRs. For one, Dr. Hope Feldman explained that as a PCP she doesn’t get much feedback on patients – when patients go to specialists, she doesn’t know what happens, and that patient doesn’t get coordinated care. Moreover, she said, “Patients expect that our computers are talking” and don’t understand that physicians aren’t all looking at the same chart, leading to frustration on the part of the patient and redundant work for PCPs. How can technology be improved to enable more coordinated care?

The Need for More Patient Touch-Points and Meeting Patients Where They Are: Roles for Community Outreach and Telehealth

There was strong consensus in the room that there need to be more ways to stay in touch with patients between quarterly office visits (if you’re lucky enough to even see patients every three months on-schedule), but that consensus was balanced against frustration over reimbursement issues and the difficulty of finding effective means of community engagement. As Dexcom’s Dr. David Price aptly outlined, “We have a problem with the routine three-month follow up. A patient comes in with a high A1c, they get a medication change, the resident presents it to them and says come back in three months. What is the message to the patient?” The question becomes, then, how do you reach patients between those three-month visits? Dr. Cefalu posed this question to the clinician panel, specifically asking about the most impactful change – the low hanging fruit – that their practices have made. Both Dr. Sue Kirkman and Ms. Gretchen Youssef extolled incentive restructuring to promote the use of telehealth and remote visits, which increase patient satisfaction and let providers track blood glucose in real time. Ms. Sandra Leal emphasized the benefits of leveraging pharmacist relationships, as patients see their pharmacist more often than physicians, allowing for more consistent communication. This enthusiasm aside, there was also considerable frustration with the challenge of accessing communities of people with diabetes. To this end, Ms. Leal and Ms. Youssef emphasized the need to go where people are – don’t expect them to show up, but go into the community yourself, be it in a park, library, recreation center, church, or barber shop. That said, Ms. Youssef did admit that, while people show up to these programs, Medicare doesn’t allow for billing in a building that her practice does not own – in our view, a needless restriction. She added that Medicare reimbursement for diabetes education covers only one individual hour but nine additional hours of classes – unfortunately, many people in her community aren’t able to travel for classes. For many patients, diabetes may comprise one of five or six medical appointments, and it’s not that diabetes education isn’t valuable – it’s that it’s not convenient when it takes three buses to attend.

• We were excited to hear Dr. Price also make a plug for outcomes beyond A1c: “We hear about the need for more touch points, and those aren’t based on A1c. We need to move away from A1c and look at blood glucose on the meter or CGM, and then those touch points are based on those values. We need time-in-range goals or other metrics that are meaningful to patients so we can set follow-up goals to look at after the visit, whether that’s two or four weeks afterward.” Indeed, it makes sense to have continuous care and outcomes beyond A1c go hand in hand – here, here!

Debate Emerges Over Prescriptive Guidelines vs. Disease Heterogeneity: Can Diabetes Management be Made Simple?

The ability of more “prescriptive” guidelines to address therapeutic inertia became a central point of discussion during the Summit. Mayo Clinic’s Dr. Bob Rizza introduced this idea during a moderated discussion, explaining that despite the wealth of resources that the Mayo Clinic has, “we still don’t get it right.” He argued for the need to create a system of incentives and consequences for not achieving goals and emphasized that “the ADA is going to have to do something difficult, which is come up with explicit statements on what must be done.” As he put it, diabetes now has an avalanche of available drugs and treatment options that can cause confusion and debate, making it paramount that ADA simply tell HCPs, prescriptively and explicitly, what to do. Other participants, including Leicester’s Dr. Kamlesh Khunti and Dallas Diabetes Research Center’s Dr. Julio Rosenstock bolstered the call for a more prescriptive approach. Dr. Rosenstock boldly called out guidelines as a key problem: “They’re much longer and nobody reads them. Fundamentally, guidelines have been a variation of the same thing, just changing the flow chart and graphics. It’s step-up, sequential therapy as opposed to simultaneous therapy. There are too many options for PCPs, and it’s highly confusing even for practicing endos when there are issues with the formulary. We need to come back to the basics of prescriptive guidelines, in a simultaneous fashion for PCPs and avoid the step-up therapy that does not actually happen. Let’s train PCPs’ medical assistants.” He suggested testing, in smaller systems, the administration of more prescriptive guidelines, and Dr. Khunti expressed his agreement, referencing hypertension as a well-managed disease area following the development of more direct management recommendations. Medtronic’s Dr. Bob Vigersky suggested that guidelines could be embedded within the EMR, so that HCPs can see them at the time of visit and even have treatment choices suggested to them directly.

Joslin’s Dr. Robert Gabbay tempered this sentiment, explaining the tension between the individualized vs. system-based approaches being discussed. Taking a step back, Dr. Gabbay asserted that “we want to be prescriptive for the 80%-90% of people that these approaches will be effective for, but also leave room for individuals where these approaches may not be effective.” Others pushed back more strongly, arguing that such an approach doesn’t account for the heterogeneity of diabetes, in both biologic and sociologic aspects: “If we think this is only an implementation problem, we’re mistaken. We don’t have behavioral modification tools and we need discovery of new ways and approaches to modify behavior.” Joslin’s Dr. George King furthered this point, comparing diabetes to cancer: “I wouldn’t go to a PCP for metastatic breast cancer. Diabetes is a complex disease […] Treatment is going to be complex. It’s not going to be that easy, but we need plans on who is going to see what segment of the population. There will be serious therapeutics but with different levels of treatment.”

• Dr. Cefalu generally agreed with the idea of a more prescriptive approach, but expressed concern over how this message might contradict with past messaging from the ADA that emphasized more individualized approaches to treatment. Dr. Cefalu wondered, “How will we handle this from the writing group? For years we have been going to more individualized approaches. What we’ve heard today is that we need to be more prescriptive. I find this challenging. I think that to address therapeutic inertia, you might be right – we might need to be more forceful, especially after years of doing the opposite of being more individualized.” For our part, we think there is merit to both sides, and we would be very interested to see more data on specific prescribing practices within specialties. One possible solution could be to produce more prescriptive guidelines for PCPs, to reduce over-reliance on metformin or unnecessary use of insulin rather than GLP-1s, for example – but first, it’s critical to know whether this is a disproportionate problem in the first place.

Audience Weighs in on Drivers, Impact, and Solutions, Identifying Cost as Critical Driver and Impact of Therapeutic Inertia

Audience-generated word clouds, displayed below, addressed three questions on the drivers, impact, and solutions to therapeutic inertia. We were intrigued but unsurprised to note that “cost” was prominently displayed in all three clouds, but more interesting – and dramatic – was that therapeutic inertia seriously impacted cost. We think this is an important point, and one that arose throughout the meeting: Inertia drives increased long-term costs. Other answers focused on patient and provider attitudes, knowledge and education, and access and reimbursement – see below! We note that these questions were asked at the very beginning of the day.

• What is the top contributor to therapeutic inertia?

• What are the top three words describing the impact of therapeutic inertia on your practice?

• What are the top three words describing solutions to therapeutic inertia?

Presentation Highlights

Magnitude and Assessment of Therapeutic Inertia

Kamlesh Khunti, MD, PhD (Leicester Diabetes Center, UK)

As one of the foremost scholars in the field, Dr. Kamlesh Khunti provided a comprehensive overview of research on therapeutic inertia, focusing on the extent of the issue, its drivers, and potential solutions to the problem. He pointed toward data from the European GUIDANCE study to illuminate the divide between efficacious diabetes therapies currently available and the disappointingly low proportion of patients meeting A1c goals. Dr. Khunti identified therapeutic inertia as one of the key factors contributing to this efficacy gap and defined therapeutic inertia as “the failure to advance therapy or to de-intensify therapy when appropriate to do so.” While insulin initiation is the most commonly-used example of therapeutic inertia, Dr. Khunti stressed that it can affect each component of diabetes management: diet and exercise, oral monotherapy, oral combination therapy, adding insulin to oral therapy, and intensifying insulin therapy. However, therapeutic inertia can also apply to the failure to de-intensify therapy, a somewhat counterintuitive point. Dr. Khunti lamented this fact, noting that “in medical school, we are taught to add therapies but not take therapies off” when they are not needed.

• Therapeutic inertia can also apply to the failure to de-intensify therapy. Dr. Khunti emphasized this somewhat surprising point, lamenting that “in medical school we are taught to add therapies but not take therapies off” when they are not needed. He presented data on the potential for overtreatment of type 2 diabetes, especially in older adults, and cited this as a potential explanatory factor for the increased risk of hypoglycemia in this population. Further, he introduced the idea of “quaternary prevention,” which involves undertaking interventions to protect a group at risk of over-medicalization. To be sure, the key issue here remains the same – individualizing appropriate therapies for each patient – and it’s important to remember that polypharmacy is also an issue in the discussion on therapeutic inertia. It’s also worth noting that polypharmacy – and improving the issue – can have a big impact on patient satisfaction and quality of life.  

• Contributing to therapeutic inertia is the significant disconnect in applying data from randomized controlled trials to patient care. Dr. Khunti explained that it’s often difficult for HCPs to determine if data from RCTs is applicable to the patients that they are seeing in clinic. As a result, utilization of more efficacious drug classes remains alarmingly low: One analysis has shown that only 5% of patients who met the inclusion criteria for EMPA-REG OUTCOME were on an SGLT-2 inhibitor, and only 6% of those who met LEADER inclusion criteria were on a GLP-1 (other factors are certainly also at play). We recently heard Dr. Mikhail Kosiborod cite this same data at AHA 2018 in advocating for cardiologists to play a more active role in type 2 diabetes management.

• Dr. Khunti closed his remarks by offering a visualization of the current treatment paradigm – riddled with therapeutic inertia – and what the ideal intervention would look like. In the current paradigm, patients undergo wild fluctuations: They start a treatment, meet a goal, gradually see their A1c creep up above targets, then have to initiate another therapy late. In contrast, Dr. Khunti envisions a future in which patients are empowered with earlier and appropriate interventions that improve their chances of reaching goals in the long term.

Patient Mission Moment

Felicia Hill-Briggs, PhD (Johns Hopkins University, Baltimore, MD)

In a remarkable speech, ADA President of Health Care and Education Dr. Felicia Hill-Briggs shared her personal story of living with type 1 diabetes and urged the audience to consider patient and family circumstances and perspectives throughout the day and going forward. In her words, “As we move forward in thinking about recommendations, I want to ensure that thought and planning also consider the various life circumstances and needs of patients and families.” Dr. Hill-Briggs drew on her own experiences to illustrate the importance of individual patient factors: As the first person ever diagnosed with type 1 diabetes in a segregated, west Baltimore hospital in the 1970s, she grew up without a diabetes community or formal diabetes education. Describing a lengthy quest by her parents to find a physician to treat her diabetes – she saw an adult endocrinologist at age 9 – Dr. Hill-Briggs outlined how bi-monthly issues of ADA’s Diabetes Forecast offered virtually all of her diabetes education and began her 42-year relationship with ADA. Adulthood presented new challenges: In the pre-ACA era, Dr. Hill-Brings was ineligible for her own health insurance. While working toward her PhD in clinical psychology at NYU, Dr. Hill-Briggs took to enrolling in studies throughout the city to access free medical care (she cheekily called herself an “early adopter of research”). These experiences informed Dr. Hill-Briggs’ future work with underserved and high-risk populations, both individually and on a system-wide level, and led her to urge the audience to keep contextual factors in mind as the group moves forward with planning. This sentiment strongly echoed introductory remarks from Dr. Cefalu on the new ADA/EASD consensus algorithm, which literally puts the patient at the center of treatment and talks more comprehensively about patient characteristics and lifestyle, and we’re impressed by this consistent messaging from ADA. As she described, patients and their families often feel lost in medical decision making, but providers also need more support, knowledge, and assistance to provide the highest quality care. Dr. Hill-Briggs concluded with two challenges to the audience: (i) how can we communicate learnings from this room to patients and families in the way that a white paper will communicate to professionals; and (ii) how can we engage patients and families with specific tools in the process of moving forward with clear initiatives and recommendations?

Primary Care + Specialist Perspective

Sue Kirkman, MD (University of North Carolina, Chapel Hill, NC); Sandra Leal, PharmD (SinfoniaRx, Tucson, AZ); Gretchen Youssef (MedStar Health, Washington, DC; President-Elect, AHA, Health Care and Education)

Dr. Sue Kirkman, Ms. Sandra Leal, and Ms. Gretchen Youssef provided the perspective of primary care providers and endocrinologists, detailing approaches that have and have not been successful in addressing therapeutic inertia.

• What has been successful? Presenting the endocrinologist’s perspective, Dr. Kirkman noted that integrating data – including point-of-care A1c measurements and downloads from pumps, CGMs, and meters by triage staff in the clinic – has been especially helpful in addressing inertia. Holistic care that includes CDEs and PharmD’s with prescribing privileges in the practice have also been essential in mitigating therapeutic inertia. Reinforcing this point, Ms. Leal advocated for increased use of pharmacists as part of the overall care team for patients with diabetes, pointing toward higher rates of adherence, closure of care gaps, increased safety of medication use, and decreased cost associated with pharmacists more closely working in these situations. Ms. Leal envisions a more proactive role for the pharmacist in reaching out and applying personalized care for patients at the population level. Speaking on behalf of CDEs, Ms. Youssef highlighted how risk stratifying patients with A1c levels over 9% and offering “boot camps” for education can increase efficiency of treatment as well.

• What has not been successful? Dr. Kirkman has found that group classes have not been successful in her practice; these classes are offered but often underused, presumably because of transportation issues and dispersed populations in her area. We do wonder whether vide0-based peer support classes could garner higher uptake in situations like these, and this statement reinforced the importance of considering specific communities in designing interventions. Dr. Kirkman also noted that, although CDEs have been helpful, their focus in her system has tended to be on type 1 patients and technology, and less on DSMES and type 2 diabetes. More work is needed to develop the same level of expertise in type 2 diabetes, at least in Dr. Kirkman’s experience. Broadly speaking, Dr. Kirkman also noted the general underutilization of diabetes self-management and advocated for its increased implementation and reimbursement.

  • Significant barriers still exist: Dr. Kirkman noted a lack of time that endocrinologists have in patient visits, silo-ization of primary and specialized care, the difficult to keep chronicity in mind with intermittent visits, social determinants of health, and formulary confusion that patients may have.

Health System Perspective

Beth Averbeck, MD (HealthPartners Medical Group, Minneapolis, MD); Luigi Meneghini, MD (Parkland Health and Hospital System, Dallas, TX)

Offering perspectives on health-system-level changes that can improve therapeutic inertia and patient outcomes, Drs. Beth Averbeck (Senior Medical Director of Primary Care at HealthPartners) and Luigi Meneghini (Director of the Global Diabetes Program at Parkland) detailed what has and hasn’t worked in their respective organizations. Dr. Averbeck opened by explaining that HealthPartners  offers integrated health plans and healthcare, striving to provide coordinated care that considers each patient as a whole person. In her words, they offer “all care, for all patients, at all visits” using a team-based approach, a practice that has enabled the system to beat the HEDIS 90^th percentile score on both proportion of patients achieving an A1c <8.0% (70% vs. 65%) and blood pressure <140/90 (84% vs. 77%). Both Drs. Averbeck and Meneghini highlighted intuitive, user-friendly dashboards that guide clinical focus and decision making: HealthPartners uses a “CV Wizard” to identify modifiable risk factors and give clinical recommendations on which areas to target (there’s also a patient view to track progress and engage patients); Parkland’s diabetes overview snapshot offers easy tracking of diabetes-relevant measures, guiding patient-provider conversations on medications, screening, and education. Similar to the clinicians speaking earlier in the day, Dr. Averbeck also highlighted that pharmacists can be critical team members: They adjust medications, order labs, help with formulary issues and overall regimens, and can – at least in HealthPartners – take visits for 60 minutes. CDEs complement pharmacists, as some patients are more apt to see one or the other, and both are embedded in the system’s diabetes clinics. Dr. Meneghini also noted the importance of mental health care and integrated screening for people with diabetes. Serving as a foil to all of these positives, however, Dr. Meneghini outlined some initiatives that haven’t worked at Parkland, including community engagement (he cited a disconnect between the community and the workers), efforts to address social determinants of health, and attempts to gain more efficient or transparent access to therapies/drug formularies – of course, all of these are quite ambitious and point to many of the issues ADA could work on moving forward.

Payor Perspective

Sanford Cohen, MD (United Healthcare, Islandia, NY)

Dr. Sanford Cohen, CMO Employer & Individual for United Healthcare, offered a rundown of what the payer is doing in diabetes and emphasized the company’s commitment to the triple aim of healthcare. We imagine most payers have similar programs and initiatives in place – and we were quite impressed with United Healthcare’s efforts on diabetes prevention – but we were also most struck by the apparent disconnect between what HCPs knew was available to them and what the payer thought HCPs knew was available. Moreover, we heard chatter that was not optimistic about the prospect of payers significantly changing the way they do things to the end of reducing therapeutic inertia anytime soon. Dr. Cohen’s presentation was followed by a steady stream of questions from the audience, leading Dr. Cohen to affirm United’s focus on long-term outcomes but ultimately lending little insight on the payer’s openness to future changes. We would like to express our appreciation for Dr. Cohen’s willingness to speak and answer questions at the Summit, given what can be a tense relationship between payers/PBMs and HCPs/patients. Our understanding is that an employee from Aetna was also in attendance, representing the only other major payer presence. Framing United’s initiatives within the triple aim (improving population health, patient satisfaction, and cost effectiveness), Dr. Cohen outlined five areas of effort from the company relevant to type 2 diabetes:

• Value-based care and performance-based payment: Dr. Cohen identified payment models as United’s foremost strategy in diabetes, identifying these as an opportunity to collaborate with physicians and explain how value-based contracting is changing healthcare delivery. In his explanation, this shift in reimbursement is changing healthcare delivery by increasing risk sharing, aligning incentives among physicians and payers, and enabling United to help with care coordination. He further emphasized that data and information are critical to these schemes: When a physician enters into a value-based contract, they gain access to a member’s longitudinal history from United (we’re not sure why this can’t always be available).

• Delivery system transformation: Most interesting on this front was PreCheck MyScript, a tool that enables HCPs to check formulary coverage for United members (both commercial and Medicaid) at POC, with the goal of preventing the need to repeat visits or re-write scripts. Additionally, prior authorizations can be completed in the app if necessary, and Dr. Cohen cited strong feedback about the tool – which United is working to embed in EHR. However, few (if any) physicians in the room were familiar with the tool, and Dr. Cohen acknowledged the company needs to do more to improve utilization. Additionally, United has been working with Accountable Care Organizations (ACOs) to improve daily operations and communication; United informs an ACO is a patient is admitted to the ER or discharged, enabling post-hospital follow up and an 11% reduction in readmissions. 

• Population health management: Most notably, United offers eligible members a free, online weight loss and diabetes prevention program called Real Appeal, which includes online coaching, is modeled on the DPP (and has just achieved CDC preliminary recognition making it part of the National DPP), and is associated with ~7-10 pounds of weight loss and reduced progression to diabetes. Dr. Cohen also outlined the predictive analytics and summative interfaces available to physicians, which can show both (i) whether a physician is on track to meet reimbursement targets and (ii) which patients are at risk for certain conditions. Physicians can examine care gaps on a patient level – for example, did a patient receive their eye exam or renal screening – and Dr. Sanford asserted that United has seen an improvement in diabetes measures when physicians can access that info. Transparency extends to the patient, who can see which physicians are designated “premium” providers due to their ability to give high-quality outcomes at a low cost (albeit, a low cost to the system rather than the patient). Dr. Cohen revealed that the “premium” network achieves an 18% cost reduction with better outcomes and fewer admissions (though few specifics were given, and we’re not sure what this metric was controlled for).

• Data exchange with advanced analytics: United is utilizing historical data, modeling, and other strategies to examine which patients under its purview are at risk for diabetes progression or CV events. Dr. Cohen cited a controlled trial, in which the company prompted medical action to avoid hospital admissions among at-risk patients, actually demonstrating a decrease in hospitalizations by taking such action. 

• Consumer engagement: Dr. Cohen explained that United is beginning work examining the social determinants of health and the use of “non-traditional data.”

Industry Perspective

Rachele Berria, MD, PhD (Sanofi, Bridgewater, NJ); Karmeen Kulkarni (Abbott, Salt Lake City, UT); Swapnil Rajpathak, MD, DrPH (Merck, Kenilworth, NJ)

Representatives from Sanofi, Abbott, and Merck took the stage post-lunch to provide industry’s perspective on therapeutic inertia and detail measures that they are taking to address this barrier.

• Sanofi Diabetes Medical Head Dr. Rachele Berria highlighted the persistent gap between patient and HCP perspectives. Citing survey data completed in collaboration with AACE, Dr. Berria revealed a disconnect between how engaged patients are and how engaged HCPs believe patients to be: While three in five patients with type 2 diabetes indicate that they are willing to do more to achieve their A1c targets more quickly, only one in five HCPs believe that their patients are willing to do so. This divide extends to other measures, including the percentage willing to visit their HCPs more often (57% vs. 19%) and willing to make multiple medication changes (52% vs. 16%). She presented research from dQ&A further highlighting this apparent disconnect: While patients identify their top three treatment priorities as long-term A1c goals, staying healthy, and avoiding weight gain, HCPs identify their top three priorities as avoiding side effects, affordability, and long-term A1c goals. She spoke very highly of dQ&A, which now has a much broader panel of type 2 and type 1 patients – we always look forward to their new data.

• Director of Abbott Diabetes Care Scientific Affairs Dr. Karmeen Kulkarni identified four factors contributing to therapeutic inertia relating to CGM usage. Dr. Kulkarni pointed to a lack of awareness, limited clinical experience, difficulties integrating into clinic workflow, and restricted access as key factors contributing to a relatively low penetration of CGM (~10%) despite noted clinical benefits (including A1c reductions without increase in hypoglycemia and improved quality of life). To address lack of awareness, Abbott is undertaking an ongoing peer-to-peer outreach program to help educate HCPs and investing in DTC marketing, which has apparently worked very well to date in increasing awareness among patients. Regarding improving clinic workflow, Dr. Kulkarni emphasized the potential of newer CGMs inasmuch as they are much easier to use than previous generations ­– a fact that we think has held back penetration in some ways, given poor patient satisfaction with earlier-generation products. Dr. Kulkarni also pointed toward the International Consensus on CGM as an important step in addressing limited clinical experience. Finally, concerning restricted access to CGM, Dr. Kulkarni advocated for better Medicare coverage, and lamented the fact that coverage here is still restricted (e.g. Medicare requires patients test four times per day).

• Merck’s Dr. Swapnil Rajpathak (Executive Director, Center for Observational and Real World Evidence) highlighted the importance of evidence generation. Dr. Rajpathak underscored that Merck’s focus in this space has been on generating evidence to support sound decision-making processes. On this front, he cited a 2011 study published in Diabetes, Obesity and Metabolism demonstrating that the median time to receive additional diabetes pharmacotherapy after not meeting glycemic targets with metformin alone is more than one year. As part of its effort to support clinically sound and timely treatment intensification, Merck is currently partnering with Cleveland Clinic to develop an EMR based tool to reduce inertia, and hopes to have this tool submitted before ADA 2019. During the subsequent Q&A, Cleveland Clinic’s Dr. Kevin Pantalone provided more details on this tool, explaining that it will include three components, including a “smart form” that will enable HCPs to view diabetes drugs based on what is most important to the patient (e.g. cost, A1c lowering). While we have heard some criticism that these types of algorithms are a bit misguided – issues like cost, efficacy, and hypoglycemia risk are relevant to nearly all patients – we’re optimistic that they may be helpful in guiding PCP prescribing practice.

-- by Ann Carracher, Martin Kurian, and Kelly Close