In Therapy highlights, a type 2 pharmacotherapy session noted the upcoming completion of the VERTIS CV outcomes trial for Merck/Pfizer’s SGLT-2 inhibitor Steglatro (ertugliflozin) of late 2019 and commented with confidence that positive results should be expected here, further cementing a class-wide cardioprotective effect. Closer Look readers are well aware of this timing due to inclusion in Merck’s earnings reports (2Q19) and our CVOT competitive landscape.
In Tech highlights, Senseonics’ CMO Dr. Fran Kauffman reviewed several key Eversense CGM milestones as a follow up to what was presented at ADA, including outstanding patient satisfaction in the US launch, with the news that the real-world US data has been published in DT&T, non-adjunctive approval in June, and ongoing enrollment in the 180-day PROMISE trial to support iCGM labeling for both 90-day and 180-day. It’s a very different audience at AADE than ADA and we were struck by the even more intense interest in CGM (it’s only going on direction at all professional meetings – up!)
We’ve added three technology exhibits below from Companion Medical (very busy booth), mySugr, and One Drop. Combined, mySugr and One Drop now report more than three million users!
Big Picture highlights include commentary on operational crises in managing Diabetes Prevention Programs; two talks on hypoglycemia (Dr. Mark Heyman on fear; reducing risk with education); population health; and how a PBM is using text messaging.
Greetings from Houston! We bring you our final eight highlights installment from AADE 2019 below.
- Top Two Highlights – Therapy and Tech
- 1. Type 2 Pharmacotherapy Session Touches on Optimism about Positive VERTIS CV Results for Steglatro; Advocates for Simply Getting Patients on Any GLP-1 That’s Covered
- 2. Senseonics Eversense: US Real-World Data Published in DT&T; Outstanding Patient Satisfaction; 180-Day Trial Enrolling to Support iCGM
- Exhibit Hall Additions – Diabetes Technology
- Big Picture Highlights
- Operational Crises in Managing Diabetes Prevention Programs (DPPs): Tools for Improving Patient and Business Outcomes
- New Systematic Review Highlights a Need for Further Studies on Effect of DSMES on Reducing Hypoglycemia Risk
- Expanding Access to Diabetes Self-Management Training Act Could Lead to $9.4 Billion in Medicare Savings over 10 Years, According to Microsimulation Modelling Results
- Dr. Mark Heyman on Strategies for Overcoming Hypoglycemia Fear: Educate, Challenge Thoughts and Beliefs, Expose, and Refer
- Population Health: The Future of Diabetes Care?
- A Role for Technology for PBMs: Using Text Messages to Improve Medication Persistence and Patient Engagement
Top Two Highlights – Therapy and Tech
In a wide-spanning talk on applying the vast armamentarium of type 2 diabetes pharmacotherapies to specific case studies, UCSD’s Dr. Nathan Painter commented on the soon-to-read-out VERTIS CV trial for Merck/Pfizer’s SGLT-2 inhibitor Steglatro (ertugliflozin), noting that he’s “willing to put money on Steglatro showing benefit” in the trial. We share Dr. Painter’s enthusiasm for Steglatro in this trial, and expect to see results further cementing SGLT inhibitors’ class effect on improving cardiovascular outcomes. As a reminder, VERTIS CV is now set to complete in December 2019 (up until about a month ago, the estimate was for slightly earlier in the year) and we’re hoping for a release of topline results not too soon after. VERTIS CV is notable in a few ways: (i) it’s the only SGLT CVOT, to our knowledge, to collect baseline heart failure status in all participants, further bolstering the study’s ability to examine the increasingly apparent link between SGLT inhibition and heart failure outcomes; (ii) we learned last year at EASD 2018 that 22% of VERTIS’ patients have a history of heart failure, which is nearly twice the number enrolled in EMPA-REG OUTCOME; and (iii) the trial is strongly a secondary prevention study, enrolling nearly 100% of participants with established CVD. We’re thrilled to see Dr. Painter and other KOLs start to discuss potential forthcoming results for VERTIS CV to the broader diabetes community; we’re similarly optimistic about what it could mean for patients to have another cardioprotective SGLT inhibitor on the market (and perhaps at a lower cost as well). Commercially, it’s unclear how successful Merck/Pfizer have been in getting Steglatro to patients – we’ve yet to hear any updates on this end on either of the company’s quarterly updates since the product’s approval and launch in late 2017/early 2018. We’re hoping to see increased focus on the product from the two companies after results from VERTIS CV reads out – could it be that Merck/Pfizer view it as essential for Steglatro to garner its own CV indication before competing in the crowded SGLT inhibitor class (where Lilly/BI’s Jardiance, J&J’s Invokana, and AZ’s Farxiga already boast positive CVOT data)? There is certainly investment in marketing at the major scientific meetings, which we are very happy to see. Intra-class competition aside, we still see tremendous potential for the whole SGLT class to improve outcomes for patients: recent analyses show that only a tiny fraction (<10%) of second-line diabetes prescriptions go to SGLT inhibitors, leaving tremendous opportunity for growth.
Dr. Painter also had an important message when it comes to prescribing GLP-1s: Just get patients on any one that’s possible to get them on! Dr. Painter explained that it’s extremely rare for a patient’s insurance (this was a US-oriented talk and he was referring to patients that have insurance) to cover all (or most) of the available GLP-1s on the market. As a result, it’s crucial to advocate for a patient to get on whatever GLP-1 may be covered for them—regardless of intra-class differences between agents. We’re glad to see Dr. Painter emphasize this point, especially in light of growing consensus among thought leaders regarding a class-wide cardioprotective effect for GLP-1s. When it comes to differences within the GLP-1 class in regard to CVOT data, Dr. Painter underscored that these agents are still worth it even if you don’t consider the cardioprotective effects that they might have – the benefits on glucose, weight loss, and more are just too much to pass up. We completely agree.
Before AADE officially began, Senseonics CMO Dr. Francine Kauffman reviewed very positive real-world data from 90 days of Eversense wear – the same data presented at ADA, and Dr. Kaufman excitedly reported that full results have been published in DT&T. Users spent an average of ~15 hours/day time-in-range, had a mean GMI of 7.2%, with time below 70 mg/dl of ~4% and time spent >180 mg/dl at ~34%. These values compare favorably to similar real-world CGM trials and are fairly close to the just-published time-in-range consensus goals. Patients wore the Eversense 20 hours/day, one-third were CGM-naïve, and 80% had type 1 diabetes. MARD for Eversense against home BGM was 11.2% over the 90-day period, which is very strong relative to fingersticks.
Patient satisfaction metrics have been outstanding in early US users, with ~79% of patients (n=143) opting to receive another sensor after 90 days. In a survey, mean satisfaction was 4.2/5, with both training and customer support at 4.5. 84% of respondents were likely to recommend Eversense . The 21% of users who discontinued Eversense were not asked about their reasons, but insurance coverage “may well have been an issue.” We certainly agree about that. We’re excited about as many differentiated CGM options possible – a rising tide lifts all boats.
Eversense now has ~500 US prescribers and ~250 healthcare providers trained on insertion. A series of slides emphasized the importance of choice in CGM, noting some of the advantages of Eversense: no need for frequent self-insertions, on-body vibration alerts without a phone, gentle adhesive patch, and high transmitter wear time.
The 180-day Eversense XL PROMISE pivotal study (n=180) is still recruiting. 90-day data from this trial (ClinicalTrials.gov page) will be used to obtain an initial iCGM indication, with launch for the 180-day wear and reduced calibrations Eversense XL expected in 2020 (as of 1Q19).
In line with recent updates, one slide shared pipeline plans – including calibration reduction, pediatric labeling, interoperability, 365-day wear, and on-demand swiping to obtain a real-time glucose value without the transmitter (a fully implantable form factor!). These will be exciting advances for Senseonics and make the value proposition even more compelling.
Exhibit Hall Additions – Diabetes Technology
See the main exhibit hall report in our Day #3 coverage for full exhibit hall coverage.
Wow, was Companion Medical’s booth busy when we walked by! After a talk from Gary Scheiner highlighting Companion’s InPen, educators flocked to the booth to learn about the only smart pen currently on the US market. Companion’s new data integrations were a big topic of discussion, with Dexcom, Glooko, and Rimidi all added on just a couple months ago. Company representatives also seemed particularly excited about the ability to pair multiple InPens with users’ smartphones – e.g., to have one at work and another at home. The Companion app is available on iOS and Android, with a notably strong 4.3/5 rating on iPhone (41 reviews) – paired Bluetooth apps for diabetes tech rarely have ratings this high. Educator extraordinaire Gary Scheiner was a huge fan, saying, "Trying to help patients to better manage their diabetes starts with an accurate assessment. Without knowing exactly when and how much insulin a person has taken, it is virtually impossible (and potentially dangerous) to fine-tune their management program. The Companion app lets me see this information clearly and quickly."
The trademark bright green of mySugr was seen throughout AADE as exhibitors handed out tote bags with the memorable tagline “Make Diabetes Suck Less” and mySugr’s logo. The booth featured the mySugr subscription bundle, which comes with the Accu-Chek Guide BGM, 250 strips, lancets, and of course, a subscription to mySugr Pro – a $213 value in the starter kit alone. The subscription is now $49/month, up about 20% from $40/month last year, but still an incredibly great deal for unlimited strips (automatically mailed to the user) for those that use a high number of strips and access to on-demand coaching through mySugr. Currently, coaching is only offered to bundle subscribers, but one representative commented that the company is looking into adding coaching as a separate add-on available for individual purchase. The program is available in the US and Germany, and we’d be interested to know how many subscribe to it. According to mySugr’s website, the app now has 1.8 million downloads and is the “most downloaded diabetes app in the world.” Wow! We’d love to know more about engagement and will be looking to gather more data on this front.
In One Drop’s bright, sleek, and modern-looking booth, the marketing team proudly discussed the new eight-hour glucose prediction capabilities for people with type 2 diabetes on basal insulin, which launched at ADA. The feature uses machine learning to assess limited fingerstick data, food logging, exercise data, and other contextual inputs (e.g., demographics, weight, A1c) to give forward-looking trend analysis and lifestyle tips – e.g., taking a 15-minute walk. It launched for type 2s not on insulin last fall, and has now expanded to basal insulin users. One Drop’s Dr. Mark Heyman presented to a packed audience on machine learning during AADE – see the slides here and screenshot below. We appreciated the focus on the value of machine learning for educators – e.g., scheduling and triage, data analysis and interpretation, and intervention recommendations. (We’ll return with more on this session in our full report.) Representatives were also excited about the new data integration with MannKind’s BluHale, highlighting that insulin dose data capture would only result in better predictions and support from the app. The One Drop app has over 1.3 million users globally and impressive ratings on both Apple iOS (4.5/5 stars, n=8,900 ratings) and Android (4.2/5 stars, n=1,585 ratings, 500,000+ installs).
One Drop continues to offer a variety of direct-to-consumer BGM strips subscription and coaching options, including unlimited strips for $49.99 per month – including a new meter every year.
Big Picture Highlights
In a presentation for DPP program organizers, several speakers outlined the “operational crisis” of low funding and low referrals to DPP programs, before three DPP leaders shared their success stories in improving business and operational outcomes. Alarmingly, only 5% of Medicare beneficiaries and only 6.8% of privately insured patients used DSME services, and a 2017 national practice survey found that only 12% of enrolled patients completed more than 75% of DSMES sessions. (See a self-assessment tool for improving DSMES business outcomes here).
Often, the speakers noted, doctors will frame DSMES and similar programs as soft suggestions, leading patients to only consider them as an afterthought. When doctors emphasize the value of these programs and strongly recommend them, however, patients are far more likely to attend and will often see significant improvement in their diabetes awareness and outcomes. Increased collaboration between physicians and educators, including inviting physicians to witness a class in person, were cited as valuable tools for addressing gaps in referral.
In an especially illuminating moment, a number of diabetes educators during Q&A expressed frustration over insurance and reimbursement barriers that prevented them from reaching more patients. One audience member noted that Medicare does not reimburse for a class that is offered for free, another explained that she could not convince HMOs to send at-risk patients to her program due to the costs associated with referring out of network, and a third lamented that, once her program received Medicare reimbursement and her patients were given transparent pricing information, her class size reduced from 150 to 17. Likewise, from our view, we remain frustrated that the US insurance structure often forces educators to choose between gaining adequate funding or reaching a wider range of patients, especially given that these insurance-related cost barriers disproportionally affect low-resource patients who are often in most need of this valuable care. While a move toward universal, single-payer systems such as Medicare for All may significantly improve this system by empowering providers to focus solely on patient needs without being hindered by out-of-network costs and by allowing educators to receive reimbursement for classes that are cost-free for all patients, there are other potential barriers associated with this approach.
Drs. Jacqueline LaManna, Jan Kavookjian, Michelle Litchman, and Jane Dickinson presented findings from their systematic review of studies (n=14) examining the impact of DSMES on hypoglycemia outcomes, highlighting the need for (i) more studies in this area; (ii) better descriptions of DSMES; and (iii) more consistent terminology in the literature. The review was published in The Diabetes Educator in August 2019 and used a modified Cochrane method to systematically search and review articles published between 2001-2017 that included DSMES by itself or as a key component of interventions impacting hypoglycemia outcomes. Primary outcomes in the study centered on changes in hypoglycemia events and symptoms, the only two hypoglycemia outcomes targeted in the retained studies; secondary target outcomes included knowledge gain and behavior change, clinical outcomes, humanistic outcomes, and economic and utilization outcomes after diabetes education.
These results highlight that more studies examining outcomes of diabetes education are needed, along with better descriptions of the DSMES content and structure that was delivered; more standardized terminology will also help in being able to compare findings across studies. For example, some studies examined “hypoglycemia events”, and others, the more subjective “hypoglycemia symptoms” which challenges comparison of study results. “Glycemic control” is also judgement-based and can be perceived as stigmatizing in persons with diabetes. Studies also need to include more diverse participants (across the age spectrum, ethnicity, and socioeconomic status), as well as looking at the role of caregivers in reducing risk for hypoglycemia outcomes. Moving forward, we’re curious to see how initiatives such as the Endocrine Society’s recently announced HypoPrevent program will address these points
Significant improvements in psychosocial and humanistic measures were reported in several studies. Decreases in diabetes distress (PAID), health distress, or depressive symptoms (PHQ) were seen in seven of eight studies measuring these, and increases in self-efficacy were reported in the three studies that measured it.
As background, AADE worked with the Diabetes Advocacy Alliance and our congressional champions on the introduction of the Expanded Access to Diabetes Self-Management Training (DSMT) Act in the 116th Congress. Senators Jean Shaheen (D-NH) and Susan Collins (R-ME) introduced S. 814, the Senate version of this legislation. Representatives Tom Reed (R-NY) and Diana DeGette (D-CO) introduced H.R. 1840 in the House of Representatives.
Ms. Kate Thomas (AADE Director of Advocacy) and Mr. Tim Dall (HIS Markit Health economist and Executive Director) presented modelled results on the impacts of the Expanding Access to Diabetes Self- Management Training (DSMT) Act on access and utilization of DSMT, along with potential Medicare savings. As a reminder, the recently introduced Expanding Access to DSMT Act aims to greatly increase Medicare beneficiaries accessing DSMT. Importantly, the bill introduces modifications to existing DSMT benefits in order to promote patient enrollment. Under this bill, the initial 10 hours of DSMT available to beneficiaries during the first year would remain available in subsequent years until fully utilized. The original two hours of DSMT in subsequent years would also be increased to six. Moreover, DSMT services would be excluded from Medicare Part B cost-sharing and deductible requirements, and Medical Nutrition Therapy (MNT) and DSMT would be allowed to be provided on the same day. Physicians and qualified non-physician practitioners not directly involved in managing a patient’s diabetes would be able to refer them for DSMT services. Furthermore, DSMT services could be provided in a community-based location as well as be demonstrated virtually.
A Disease Prevention Microsimulation Model (DPMM) was developed to test three scenarios with and without the cost share provision (full bill vs. partial bill): (i) status quo of utilization of DSMT; (ii) moderate improvement scenario; and (iii) aggressive improvement scenario. The DPMM was designed to model the likelihood and timing of disease onset and severity and the projected medical costs, employment levels, productivity levels, mortality risk and quality of life. The DPMM projected more than 50 clinical and economic outcomes, and medical expenditures were estimated using multivariate regression from the Medical Expenditure Panel Survey and modeled by medical setting and diagnosis category. The model was validated through expert review.
Improving DSMT access was projected to save Medicare $4.9 and $9.4 billion over 10 years in the modest and aggressive utilization scenarios, respectively. Medicare spending was found to decrease across all care settings. Both the modest and aggressive improvement scenarios are conservative estimates of the increase in DSMT utilization over 10 years, with the former projecting 7% of beneficiaries attending and the latter estimating attendance from 17%. However, the model has some limitations. Although clinical benefits from existing studies on DSMT were incorporated, there are relatively few studies in this area generally. At the same time, this study only modeled health benefits from improvements in glycemic levels and body weight, even though DMST is known to have other short- and long-term impacts on health expenses. The savings estimates presented might therefore be on the conservative side.
DSMT has been a Medicare benefit since 1997 and is known to lower A1c, improve the quality of life, reduce complications, and enhance self-efficacy etc. However, less than 5% of newly diagnosed Medicare patients access this service.
Dr. Mark Heyman outlined four strategies that can be used to help people overcome fear of hypoglycemia: educate, challenge thoughts and beliefs, expose (in a safe and controlled environment) to hypoglycemia, and refer to a mental health professional. Fear of hypoglycemia (FOH) can either be event-based (stemming from a personal experience with severe hypoglycemia) or agency-based (stemming from lack of confidence in one’s ability to be able to effectively deal with hypoglycemia if it were to occur). Fear of hypoglycemia can have a big impact on both quality of life and diabetes self-management, with patients avoiding activities and keeping their blood sugar levels high in order to avoid even a chance of experiencing hypoglycemia. Health professionals can assess for FOH by asking open-ended questions during clinical visits, actively listening to patients, and being curious during their interactions. Though Dr. Heyman does not believe that it is not always practical to use formal assessment tools (i.e. HFS-II, HFS-PYC, FH-15, CHFS) to diagnose FOH in a clinic-setting, they may be helpful to assess progress in patients being treated for FOH.
Though it may feel uncomfortable, exposing people to hypoglycemia in a safe, controlled, and comfortable environment with clinicians on hand can ease fears. Exposure can be graduated (decreasing blood sugar levels X amount per week) or flooded (going directly into hypoglycemia from an in-range blood sugar). A first-hand experience with hypoglycemia shows people what it’s like and “makes the unknown known”. It also gives people evidence that they can handle the symptoms of hypoglycemia and treat them effectively.
Referral to a mental health provider with expertise in diabetes may be required if other strategies are not effective. Referral is especially recommended if a patient has an impaired ability to provide self-care or if their fear of hypoglycemia severely impact quality of life or daily functioning. The ADA’s Mental Health Provider Directory is a good resource for finding professionals to refer patients to.
Population Health: The Future of Diabetes Care?
A powerhouse group of DCESs, including MedStar Health’s Ms. Joan Bardsley and Ms. Gretchen Youseff and Innovative Healthcare Designs’ Ms. Teresa Pearson, presented a dynamic lesson on the evolving role of diabetes educators in a field increasingly focused on population health. The idea of population health – health outcomes of an entire group of individuals – has taken off within diabetes care, as often certain barriers to health collectively affect an entire population. Ms. Bardsley noted that although population health can help guide treatment, diabetes care remains person-centered. Person-centered care is one of the central tenets of Project VISION – a new set of values crafted by the AADE that will shape the organization’s future, which Ms. Bardsley also discussed. Out of Project VISION’s six principles – (i) promote person-centered care; (ii) achieve the “quadruple aim” – quality, cost, patient experience, provider experience; (iii) promote behavioral health; (iv) leverage technology; (v) incorporate cardiometabolic and related conditions; and (vi) integrate diabetes management, self-management education, prevention, and support – she seemed particularly passionate about the utilization of technology, urging DCESs in the audience to strive to become experts in tech, as patients now have that expectation. This new responsibility is a clear example of the numerous shifts within diabetes care, on the systems-level, educator-level, and person with diabetes-level, which make up the new “emerging model of care.”
Ms. Pearson (Innovative Healthcare Designs, Minneapolis, MN) taught a lesson on how to actually create population health initiatives by walking the audience through a step-by-step protocol. In particular, the procedure was designed to produce organized, risk-based outcomes, allowing providers to communicate the value of a certain initiative to management. Risk stratification of populations was a key feature of the system, and Ms. Pearson explained that often health initiatives will be implemented in a gradient fashion, prioritizing those most at risk. Ms. Pearson has previously spoken on population health care models, presenting a virtual patient-centered medical home model used in 12 counties in Minnesota at AADE 2013.
Ms. Gretchen Youssef also shared her experience with MedStar Health’s Diabetes Pathway Boot Camp as a case study for new care models. In terms of population stratification, individuals from the overall pool with diabetes were selected based on being type 2 outpatients and then having an A1c ≥9%. In the first visit, participants have a detailed conversation with a DCES, focusing on barriers to medication adherence and taking fingersticks, eating patterns and access to food, and self-care behaviors. At visit one, patients are also given a cellular connected BGM (Telcare) that automatically uploads data to a provider dashboard, and Diabetes to Go, a series of booklets on understanding hypoglycemia, hyperglycemia, meal planning, various diabetes medications, and taking fingersticks. MedStar Health also developed a medication algorithm (with input from endocrinologists, DCESs, and primary care physicians) to allow nurse practitioners to make medication changes. For subsequent weeks, the participant receives ongoing DSMES at least once a week. After 12 weeks, the patient is “graduated” from the program and returns to their normal primary care physician or endocrinologist. Overall, mean A1c dropped 11.2% to 8.1% in the intervention group (n=366) after 12 weeks and created an estimated $3,090/year in savings from averted hospitalization costs.
Dr. Jennifer Banks and Dr. Patty Taddei-Allen from WellDyneRx, an independent Florida-based PBM, presented promising results from a pilot study of their text message-based intervention, WellConnect. Patients who opted into WellConnect received reminders to take their medication, refill prescriptions, and make doctor’s appointments. Patients also received messages about medication-specific potential side effects (e.g., nausea when starting metformin), links to demonstration videos, and potential cost saving opportunities, such as moving to an equivalent, but preferred formulary agent, or enrolling in patient assistance programs. Lastly, through WellConnect, patients could also have direct access to diabetes educators. In the pilot study of WellConnect (n=216), member engagement (not defined) was 50% across many ages and net promoter score for the program was 49. On a five-point satisfaction Likert scale, nearly 90% gave WellConnect a score of 4 or 5. Unfortunately, neither clinical, financial, nor quality of life outcomes were shared. We like the idea here of using a highly scalable platform – text messages – to offer more on-demand support. It’s also positive to see this from a PBM, given their wide reach in the US healthcare system. How might these interventions be used to help with CGM and pump use, especially in the pharmacy channel?
- In their presentation, Drs. Banks and Taddei-Allen also pointed to two similar programs, Sempre Health and RxSavingSolutions. Sempre Health forms partnerships with manufacturers and payers, then uses text messages to encourage patients to perform positive behaviors (e.g., fill a prescription on time), enabling individuals to lower their own copay at the pharmacy counter. Sempre inked a deal with Novo Nordisk and had plans to enroll 10,000 patients in 2018; we haven’t heard updates on this collaboration since then. Kansas-based RxSavingSolutions parses prescription data to identify potential cost-savings opportunities for patients. According to their website, the company covers 3.5 million members and analyzed 19 million pharmacy claims in 2018.
--by Ammara Aqeel, William Newton, Ursula Biba, Albert Cai, Rhea Teng, Peter Rentzepis, Martin Kurian, Adam Brown, and Kelly Close