March 5-8, 2015; San Diego, CA Day #1 Highlights – Draft

Executive Highlights

Hello from the 97th Annual Meeting of the Endocrine Society, where we are thrilled to be reporting from San Diego, “America’s Finest City” according to locals — we would certainly have a hard time disagreeing given the sunshine and warmth that greeted us today! The Convention Center was absolutely bustling, and though official numbers have not yet been released, we would not be surprised if find that attendance has topped 10,000 registrants yet again. Highlights from Thursday, the first full day of the formal scientific program, included new favorable hypoglycemia data from the SCALE Obesity and Prediabetes trial, an intense session on healthcare reform, and updates galore from an exciting day in the exhibit hall. Below, our top five highlights synthesize our biggest learnings from ENDO Day #1. To see what we are looking forward to tomorrow and over the weekend, please check out our preview.

1. It was an exciting day at the exhibit hall, with a slew of new products on display: Sanofi’s Toujeo (insulin glargine U300) and Afrezza, Lilly’s Trulicity (dulaglutide) and Glyxambi (empagliflozin/linagliptin), and Novo Nordisk’s Saxenda (liraglutide 3.0 mg).

2. Dr. Ofri Mosenzon (Hadassah University Hospital, Jerusalem, Israel) re-examined the results from the SCALE Diabetes trial for Novo Nordisk’s Saxenda (liraglutide 3.0 mg for obesity) through another lens, focusing on the 50% of patients who were responders (>5% weight loss); this group experienced greater improvements in glycemic control and fitness.

3. A safety analysis from another SCALE trial in patients without diabetes showed low rates of clinically significant hypoglycemia (≤56 mg/dl).

4. A solutions-oriented presentation from Mr. Harold Miller (Center for Healthcare Quality and Payment Reform, Pittsburgh, PA) on structural healthcare reform led to a heated debate on whether providers have enough control to effect big-picture policy change.  

5. Ms. Kellee Miller (Jaeb Center for Health Research, Tampa, FL) presented mixed results from a T1D Exchange study evaluating metformin as an adjunctive therapy in overweight adolescents with type 1 diabetes.

Top Five Highlights

1. It was an exciting day at the exhibit hall, with a slew of new products on display. The newly approved Toujeo (insulin glargine U300) and inhaled insulin Afrezza were the highlights of Sanofi’s booth – impressive given that Toujeo was approved by the FDA barely a week ago! It was certainly a change to see the juggernaut Lantus relegated to one corner of the booth. Signage on both Toujeo and Afrezza was understandably mostly label-based for now; we are looking forward to seeing future expanded exhibit hall offerings for Sanofi’s new insulin duo soon. We were intrigued to see the new GLP-1 agonist Trulicity (dulaglutide) displayed prominently in Lilly’s booth, with a display highlighting its comparable efficacy profile vs. Novo Nordisk’s Victoza (liraglutide) but with fewer injections – Lilly’s going head-to-head, that is for sure, against market leader Victoza, AZ’s new and improved Bydureon, and other GLP-1 compounds. The recently approved Glyxambi (empagliflozin/linagliptin) received one banner at the corner of the booth – we were a bit surprised not to see more and we expect we will see extensive displays for the first-in-class product at ADA in June. Novo Nordisk had not one but three booths across the exhibit hall, including a standalone (!) booth for obesity drug Saxenda (liraglutide 3.0 mg). The product’s exhibit hall debut appeared to be quite a success – a sales representative said the booth had gotten plenty of traffic throughout the day and that he was pleasantly surprised to find that most visitors were already aware of the product. On the tech front, we learned that Dexcom began shipping its Share receiver with built-in Bluetooth earlier this week – how cool. Insulet confirmed that the company’s next-gen, Bluetooth-enabled OmniPod PDM will be displayed for the first time at ADA 2015 (can’t wait to see this), while reps at Asante hinted that pipeline updates are coming in May. See the appendix for more detailed highlights from these and other exhibit hall displays.

2.  Dr. Ofri Mosenzon (Hadassah University Hospital, Jerusalem, Israel) presented a selective analysis of responders – those who achieved ≥5% weight loss – from SCALE Diabetes. As a matter of arithmetic the average weight loss was greater among responders, at around ~10% (relative to ~4% for the full liraglutide 3.0 mg group); while not surprising, this goes to show the importance of identifying responders and non-responders to obesity medications (we think of this as keys to the kingdom in many ways). A significantly higher percentage of those on Saxenda were defined as responders (≥5% weight loss) at 50%, compared to those on the 1.8 mg Victoza dose (36%) or placebo (14%). Not surprisingly, responders (by weight) experienced greater improvements in A1c, FPG, systolic blood pressure, as well as physical functioning compared to non-responders. Some might say you really need to see 10% weight loss to be a “responder” but we would beg to differ when you include all those other important parameters. There were no significant differences between responders and non-responders in terms of severe adverse events, GI adverse events, and hypoglycemic episodes. For more on the SCALE Diabetes trial, please see our coverage of the topline results as well as following presentations at ADA and EASD (which includes follow-up period data).

3. Dr. David Lau (University of Calgary, Calgary, Canada) presented generally reassuring hypoglycemia data from the SCALE Obesity and Prediabetes trial. This data seemed important to us from a safety standpoint given liraglutide’s glucose-lowering effects in type 2 diabetes. Results demonstrated that clinically relevant hypoglycemia events, defined as ≤56 mg/dl, were rare regardless of how they were assessed: hypoglycemia ascertained via FPG during study visits had an incidence of 0.1% on Saxenda vs. 0% on placebo; and the incidence of hypoglycemia during OGTT sessions was 2.3% on Saxenda vs. 0% on placebo. With hypoglycemia defined as ≤70 mg/dl, there were larger disparities, with the Saxenda group experiencing more events compared to the placebo group: spontaneously reported events were 1.3% vs. 1.0%; study visit measurements were 3.6% vs. 0.8%; and OGTT visit measurements were 8.3% vs. 1.4%. Importantly, Dr. Lau emphasized that no hypoglycemic events required third-party assistance. In addition, of events reported during FPG and OGTT visits, respectively, 31% and 42% on Saxenda vs. 30% and 33% on placebo were asymptomatic. Hypoglycemic events were less common in participants with prediabetes vs. those who were normoglycemic. Although we were not particularly surprised to see these results (hypoglycemia was not a major safety concern at Saxenda’s Advisory Committee meeting), this will likely serve as a reassurance for providers as Saxenda moves closer to its upcoming launch.

4. A solutions-oriented presentation from Mr. Harold Miller (Center for Healthcare Quality and Payment Reform, Pittsburgh, PA) on structural healthcare reform stimulated an energetic and somewhat contentious debate during Q&A. Mr. Miller’s presentation promoted “condition-based payment” as a solution to the problems with current reform efforts (fee-for-service, value-based purchasing, and shared savings). In his model, physicians would be provided more compensation up front (partial capitation) in order to provide the flexibility to redesign care without unnecessary (we’re not sure who defines that) tests and procedures; the system makes providers more accountable for care quality and cost containment. The key question, of course, is how to actually facilitate such a change in the system, and a few attendees commented that Mr. Miller’s optimistic mentality was a bit “pie-in-the-sky.” As one retired endocrinologist put it – “I don’t see any possibility that stakeholders are going to be willing to spend initial money up front to save money down the road.” Gosh that is depressing. Certainly, whenever we hear payers, we are always reminded that short-term cost-effectiveness drives decision-making and that little if anything less than outcome-based data will persuade payers to change tactics. That being said, for those looking for models of healthcare reform for better diabetes care, Mr. Miller makes a persuasive case for his hybrid capitation model – we also enjoyed hearing him speak at an ENDO workshop late last year on diabetes and the Affordable Care Act.

• The discussion reached a second level of intensity when Mr. Miller suggested that the responsibility for reform lies with physicians – “If physicians would organize themselves and take accountability for costs, we would establish more efficient patient care.” Whew! Mr. Miller’s point was that grassroots efforts are needed to drive changes in healthcare delivery, though this created another divide. Indeed, attendees were dismissive of the suggestion that they had any power at all, suggesting instead that the Affordable Care Act has incentivized unification with larger healthcare systems and has thereby taken their autonomy: “Endocrinologists don’t have control … It’s not as touchy feely as you make it sound.” In response, session speaker Dr. Daniel Einhorn (Scripps Health, La Jolla, CA) and chair Dr. Robert Vigersky (Medtronic Diabetes, Los Angeles, CA) joined the conversation, acknowledging the challenging environment but pointing out that physician-led efforts have been able to inspire new governmental legislation in the past (e.g., reimbursement of fingersticks). We were a bit surprised to hear physicians’ sense of fatalism – it struck us as disappointing though, in our eyes, reflects the underappreciated burden of caring for patients with diabetes and the emotional fatigue of navigating an increasingly physician-unfriendly system.
• Ultimately, we would agree that the barriers to healthcare reform are certainly steep, though not insurmountable. We do think that the Affordable Care Act presents unique opportunities to refocus the American healthcare system on chronic disease care. Don’t just take our word from it – at the recent ADA Postgraduate Course, Dr. Robert Gabbay (Joslin Diabetes Center, Boston, MA) delivered a to-do list on how endocrinologists and diabetes educators can be a part of the change and get into the patient-centered medical home (PCMH) game.

5. Ms. Kellee Miller (Jaeb Center for Health Research, Tampa, FL) presented mixed results from a T1D Exchange study evaluating metformin as an adjunctive therapy in overweight adolescents with type 1 diabetes. The double-blind trial enrolled 140 patients (baseline A1c = 8.8%; baseline BMI z-score = 1.65) who were randomized to receive up to 2000 mg/day of metformin or placebo for six months in addition to basal-bolus therapy. Disappointingly, there was no significant difference between the two groups in A1c change after six months (0.2% increase in both groups), or in the proportion of patients with an A1c <7.5% (3% with metformin vs. 4% with placebo). However, a greater percentage of patients on metformin experienced a reduction of at least 25% in their daily insulin requirement (23% with metformin vs. 1% with placebo; p=0.003), an effect that may have negated any glucose-lowering effect and which is still very meaningful (if for cost if not for other factors!). Additionally, a greater percentage saw a >10% reduction in BMI z-score (24% with metformin vs. 7% with placebo; p=0.01) – we also though that was notable. The rate of GI side effects was higher with metformin (70% vs. 35%; p<0.001), as was the rate of severe hypoglycemia (six events with metformin vs. none with placebo), though Ms. Miller noted that almost all events occurred in the first six weeks, when insulin was still being titrated (while this is slightly better than during “ongoing” use, the fact that any was seen at all is a disappointment). While the lack of efficacy in the primary A1c endpoint is ultimately disappointing, the significant reduction in insulin dose suggests to us that there was a benefit on glucose in addition to the weight benefit seen. Multiple ongoing studies are investigating metformin’s possible benefits in terms of insulin resistance. According to session chair Dr. Janet McGill (Washington University, St. Louis, MO), the use of metformin in type 1 diabetes is already relatively common in clinical practice.

Honorable Mentions

• Dr. Jovanna Dahlgren (University of Gothenberg, Gothenberg, Sweden) shared five-year outcomes data from the AMOS study, which demonstrated that bariatric surgery in youth appears to be similarly efficacious in weight loss and metabolic improvements as it is in adults. As background, the AMOS study included 81 obese youth aged 13-19 years old who had undergone roux-en-Y gastric bypass (RYGB), conducting follow-up visits at one, two, and five years post-surgery. This group was compared to a BMI and gender-matched adult group undergoing RYGB from the Swedish Obese Subjects (SOS) study. Findings demonstrated a similar weight trajectory with adolescents and adults, with ~27% weight loss at five years. Adolescents who had undergone surgery also demonstrated improved glucose control, normalized insulin, and reduced C-reactive protein (CRP) levels. This five-year data is especially notable as there is a dearth of long-term data for pediatric bariatric surgery, as we heard at the Cleveland Clinic Obesity Summit. However the most important data for bariatric surgery in youth may not be efficacy data, but rather safety data to allay concerns about nutritional deficiency during key developmental periods.  
• Dr. Donald Simonson (Brigham and Women’s Hospital, Boston, MA) presented data showing largely comparable results with gastric banding vs. intensive medical management in obese patients with type 2 diabetes. The 12-month trial randomized 40 patients (baseline BMI = 36.5 kg/m²; baseline A1c = 8.2%) to receive either laparoscopic gastric band surgery (n=18) or a 12-week intensive medical diabetes and weight management program (n=22). Twelve-month results showed greater weight loss in the surgical group (13.5 kg vs. 8.5 kg; p<0.05) but comparable A1c reductions between the two groups (1.2% vs. 1.0%). Dr. Simonson concluded that both treatments appear to be effective options for patients with obesity and type 2 diabetes that can improve weight, metabolic health, and quality of life. A three-year follow-up study is ongoing to see if any long-term differences emerge; as one attendee noted during Q&A, a cost-effectiveness comparison would also be useful in helping patients and providers assess the relative value of the two approaches.

Detailed Discussion and Commentary

Exhibit Hall

Below we summarize the exhibit hall offerings for a few companies with recent updates or new products on display. Coverage of a few other companies present at the ENDO Expo (including GSK and Merck) will be included in our ENDO full report.

Asante

Tucked away in the back of the exhibit hall, Asante’s booth highlighted the recent launch of its MySnap color-customizable insulin pump. As a reminder, the pump is cloud enabled, featuring a new screen and new look (e.g., the pump we were given to play with was a snazzy pink and black combination), while the app – creatively called the “SnapCoach” – allow users to bolus from the app itself and will eventually integrate data from Dexcom’s Gen 5 CGM. A rep told us that the majority of boothgoers were quite excited to play around with the pumps – that was a positive, we thought, and not particularly surprising considering Asante’s Silicon Valley approach to product development. Notably, we heard that Asante has big plans to reveal pipeline updates in May at the American Association of Clinical Endocrinologists (AACE) meeting in Nashville, TN. We also understand that the company continues to work on the closed-loop front though it sounds like progress is moving gradually. We’re staying tuned!

Astrazeneca

AZ’s entire diabetes portfolio was on display at the company’s fairly sizable booth, though SGLT-2 Farxiga (dapagliflozin) and the new Bydureon (GLP-1 - exenatide once weekly) pen received the most promotional attention. Eager sales reps circulated with demonstration models of the pen in hand; they contrasted it primarily with Byetta (exenatide twice daily) rather than the old Bydureon vial-syringe kit, emphasizing the advantages of the once-weekly dosing regimen as well as the convenience of the pen. As we have noted in the past, the “twist, tap, twist” procedure for the pen looked quite intuitive; the product does require some patient-end reconstitution (tapping the pen against the palm of their hand), but the representative suggested that the guide’s recommended 80 taps might not always be necessary – patients can judge based on the cloudiness of the solution. A very forthcoming presenter at AZ’s product theater for Bydureon acknowledged that the device is quite big, but noted that the size can be a positive for patients with dexterity problems.

Dexcom

Dexcom’s small, understated booth was lightly trafficked near the entrance of the exhibit hall. The G4 Platinum’s approval in children 2-17 years old was the major focus of a banner on the back wall. Reps shared excitement over the recent launch of the Animas Vibe integrated with Dexcom’s G4 Platinum CGM, though they seemed even more enthused to discuss the Share receiver with built-in Bluetooth that began shipping to patients earlier this week. Anecdotally, they suggested that uptake has been quick and driven by interest from caregivers looking for solutions to help pediatric and elderly populations. As a reminder, Dexcom has a particularly compelling pipeline; as a reminder, we believe that four other products are slated to launch this year alone: the G4AP algorithm in pediatrics, the Android version of Dexcom Share, the Apple Watch version of Dexcom Share, and the G5 mobile system (by end of year).

Insulet

Insulet sported a small booth, a bit tucked away in the back of the exhibit hall. In the company’s classic style, posters of patients tended to display the OmniPod on the tricep, putting a clear emphasis on the product’s small size and wearability. We received confirmation in speaking to reps that the next-gen, Bluetooth-enabled OmniPod PDM will be displayed for the first time at ADA 2015. The device will be a bit thicker than an iPhone 5 and will feature a color touchscreen and built-in blood glucose meter. We love to see that Insulet is thinking out of the box on this project, since getting Bluetooth, touchscreen, and the Dexcom integration are just a few of the innovations needed to stay ahead of the patient demand curve. On the sales front, we heard notable figures on adherence rates. Reps shared, as we have heard in company conference call since the original Omnipod launch that the overall attrition numbers (i.e., first time users who discontinue use) are only around 7-8%, while one sales rep noted that of the 400 units he saw go out last year (presumably under his watch), only three users discontinued use. We would not read to far into the anecdotal numbers, though Insulet’s marketing has long stressed the fact that those who try the Omnipod do not give it up.

J&J

As at most recent conferences, J&J’s booth was almost entirely devoted to Invokana (canagliflozin), with the company’s LifeScan/Animas divisions occupying only a small portion. We were interested to see the promotional materials for Invokana emphasizing access and insurance coverage – we wonder if this will be a way J&J hopes to distinguish the more established Invokana from newer entrants to the SGLT-2 inhibitor market and defend against the perception that the class is very costly. Certainly J&J is on it as far as access goes  - this has prompted a lot of price and co-pay competition. The canagliflozin/metformin combination Invokamet was more prominently featured than in the past; as J&J does not have plans for an SGLT-2 inhibitor/DPP-4 inhibitor fixed-dose combination that they have revealed, we would not be surprised to see a larger promotional push behind Invokamet as a lower-cost alternative in the future.

Lilly

Although Lilly had a number of its products on display we went straight to the two brand-new sections: the once-weekly GLP-1 agonist Trulicity (dulaglutide) and the BI-partnered SGLT-2 inhibitors/DPP-4 inhibitor fixed-dose combination (FDC) Glyxambi (empagliflozin/linagliptin). Glyxambi, which was approved barely one month ago, received only one banner at the corner of the booth with a link to the new product website Glyxambi.com. We expect to see a more detailed display at the ADA and perhaps at AACE, as Glyxambi is a first-in-class combination and is probably the most effective glucose-lowering pill out there over the long term. We were excited to see Trulicity displayed prominently in the front corner of the booth. The main purple display highlighted three factors: (i) once weekly dosing; (ii) proven glycemic control; and (iii) the Trulicity pen (which was on display). The adjacent display prominently featured the primary results from the AWARD-6 trial showcasing “comparable control to once-daily Victoza with fewer injections.” We also couldn’t help but notice that Humulin U-500 had a larger and more showy presence than we’ve seen at other recent meetings, with the tagline “for patients who need more” featuring a woman trapped inside a giant syringe. Hmm – we’re not sure about that imagery but surely the more concentrated insulin has a place in the market. That said, we’ve heard lots of complaints about the pricing for that particular drug.

Novo Nordisk

Novo Nordisk had not one but three (!) booths on display in the exhibit hall, including standalone booths for Saxenda (liraglutide 3.0 mg) and general obesity management along with the traditional diabetes exhibit. Obesity drug Saxenda’s exhibit hall debut appeared to be quite a success, as a sales representative said the booth had gotten plenty of traffic throughout the day and that he was pleasantly surprised to find that most visitors were already aware of the product. We also got to put our hands on the Saxenda pen for the first time and found it quite user-friendly, with a similar design as the Levemir (insulin detemir) FlexTouch pen. That was exciting to see and to be sure, with AZ’s better Bydureon pen and Lilly’s improvements with Trulicity – it’s exciting to see the improvements made on the GLP-1 front for diabetes and obesity. Over on the diabetes side, Novo Nordisk’s recent promotional push for Levemir was in full force, with sales reps highlighting the convenience of the new FlexTouch pen as well as some access advantages due to managed care. It will be interesting to see how Sanofi’s Toujeo will impact the basal insulin market – we are looking so forward to having the fixed dose GLP-1/insulin pens out in full force. Unsurprisingly, reps were attempting to draw as sharp a distinction as possible between Saxenda for obesity and Victoza (liraglutide 1.8 mg) for type 2 diabetes – they are on board with FDA’s goals for the respective compounds. A representative at the Saxenda booth did mention that several providers had inquired about the potential overlap between the two products’ targeted populations; he characterized the distinction as based on the patient’s “primary clinical goal.” We do expect the line between the two drugs to be blurry for many providers and will be curious to see how the situation plays out in clinical practice. We can imagine that not too many patients will “qualify” at first for covered Saxenda and wonder how many will try to get Victoza and use more of it. We think it’s pretty unimaginable that many diabetes patients will care “more” about weight vs. glycemic control – for so many, both are issues – but in the near-term, reimbursement will likely play a large role. We look forward to seeing what Novo Nordisk is able to do on this front!  

Sanofi

Impressively, Sanofi managed to include a significant presence for both the newly approved Toujeo (insulin glargine U300) and inhaled insulin Afrezza in its ENDO booth. Perhaps because of these brand new offerings, the booth managed to snag its fair share of passerby even though it was in a quieter part of the hall. Toujeo’s portion of the booth featured a five-foot mock-up of the Toujeo SoloStar pen, which is smaller than the Lantus SoloStar, has a higher capacity, and features other ergonomic improvements. There were not many claims on the signage beyond the label, which is understandable given how recent the approval was (barely a week ago!). It was quite strange (though certainly not unexpected) to see juggernaut Lantus off to one side of the booth – we are used to seeing it front and center, but such is the way of progress! Much of the interior of the booth was dedicated to Afrezza, which was proudly labeled as the only inhaled insulin. Here, too, most of the signage was dedicated to the label as well as dose recommendations. Reps were showing off the inhaler and the simplicity of the administration process. In the morning, Sanofi also ran a product theater on Afrezza hosted by Dr. Bruce Bode (Atlanta Diabetes Associates, Atlanta, GA). Dr. Bode presented key Afrezza data at last year’s ADA and we are heartened to see him firmly standing behind this exciting product.

Symposium: Implementation of the ACA and the Future of Diabetes Care

Introduction

Robert Vigersky, MD (Medtronic Diabetes, Los Angeles, CA)

Before introducing the session’s speakers, Dr. Robert Vigersky provided a compelling economic analysis of the current and future economic consequences of severe hypoglycemia in light of the growing number of insured patients with diabetes that are going to be covered under the Affordable Care Act: $14.7 billion in 2010, rising to $24.5 billion in 2020. As a reminder, we first saw this data at DTM 2014 though the numbers are so striking that we have reproduced the analysis below. We do not believe that the exploratory work has yet been published, though we will await news on this front.

• Dr. Vigersky’s model of the economic burden of severe hypoglycemia drew on statistics from the published literature and from actual hospitalizations. Assumptions utilized in 2010 were carried forward to 2020:
  
  • Assumptions for type 1 patients: (i) 100% of patients are on insulin; (ii) 20% of patients suffer from hypoglycemia unawareness; (iii) the rate of severe hypoglycemia is “8.1/yr” [this seemed high to us, perhaps because it’s only for patients with hypoglycemia unawareness – we continue to believe there should be more granularity within the definitions of severe hypoglycemia]; (iv) 21% of severe hypoglycemic events result in hospitalization (which translates to about 4% of patients being hospitalized, or a smaller percent being hospitalized multiple times); and (v) the average cost of severe hypoglycemia hospitalization is $17,564.
  • Assumptions for type 2 patients: (i) 22% of patients are insulin requiring; (ii) 9.8% of patients suffer from hypoglycemia unawareness; (iii) the rate of severe hypoglycemia is “5.9/yr”; (iv) 23% of severe hypoglycemic events result in hospitalization; and (v) the average cost of severe hypoglycemia hospitalization is $17, 564.
  • We are not entirely sure where the assumptions come from; we believe there would be pushback on the rate of type 2 patients on insulin that prompts severe hypoglycemia (overall, CDC reports closer to 30% of type 2 patients on insulin though the percentage on mealtime insulin has never been given of which we’re aware), as well as the rate of severe hypoglycemia that results in hospitalization and we are doing some work to define these sources.

Table 1: Economic Burden of Severe Hypoglycemia in the US

• Dr. Vigersky concluded the session by summarizing the Endocrine Society’s new policy recommendations to address the economic burden of diabetes: (i) establish urgency to recognize and rectify burden of frequent hypoglycemia; (ii) pilot new models of care for patient with diabetes especially those most burdened by hypoglycemia; (iii) use models that optimize ambulatory care to eliminate preventable complications; (iv) increase research funding that addresses gaps and promotes the development of therapy options; (v) accelerate FDA review and approval for treatments that address hypoglycemia burden; (vi) enlist the FDA-CMS parallel review process to improve access to innovative therapies; and (vii) establish coverage for CGM and telemedicine services in CMS population.
  
  • The recommendations stem from a symposium held in September 2014 that brought multiple stakeholders together to discuss the impact of the Affordable Care Act on diabetes and to answer the question of how the system might be redesigned to promote high quality, low cost care. The recommendations will inform a white paper to be published in the “next few months.”

The Clinical and Economic Burden of Diabetes

Daniel Einhorn, MD (Scripps Health, La Jolla, CA)

Dr. Daniel Einhorn provided a compelling lecture that had two major points – delivering guidelines-based care is a money loser for providers (estimated at $470,000-750,000/year for practices! Diabetes Care 2013) and there is a dramatic shortage of endocrinologists to care for all the people with diabetes (JCEM 2014). It was a “discouraging” message by his own admission and was made more striking when he shared that he has seen a number of physicians who do not accept new patients with diabetes any longer because of the financial and emotional burdens. Discouraging, indeed! We heard in Q&A from a retired endocrinologist who validated this perspective, noting that he ended his career in clinical practice for these reasons precisely and left behind only one endocrinologist for the entire city of Bakersfield, CA! Though we often hear of the caregiver burden in diabetes, we were particularly struck by these admissions that reminded us just how acute reimbursement issues continue to be. Even more concerning, Dr. Einhorn noted that no model has emerged as an adequate replacement, not even our value-based or cost-sharing models. In his eyes, there are a lot of unknowns and critical questions that remains to be answered, including: What will happen to outpatient care in a hospital driven system? How many new people with diabetes will have to be absorbed? How many physicians will leave practice? Can we run the system with mainly allied health providers (PA, NPs, etc.)?

• As a reminder, we have previously reported on both the 2013 Diabetes Care and 2014 JCEM papers.
  
  • We would highlight briefly that the Diabetes Care paper showed that the overall cost of CGM and pumps for providers (time + overheads associated with starting a patient on the technology) exceeded their reimbursement in all modeling scenarios. Indeed, the results suggested that physicians spend up to an extra $738 per additional patient on CGM per year and up to an extra $408 per additional patient on a pump per year. Scarily, these reimbursement gaps add up to estimated provider losses of $470,000-750,000 per year. In our view, it is not difficult to think that such daunting figures may not only dissuade providers from using the technology but also discourage young medical students from entering the fields of endocrinology and primary care.

-- by Melissa An, Varun Iyengar, Emily Regier, Manu Venkat, and Kelly Close