WellDoc launches BlueStar, FDA-cleared, mobile, personalized prescription therapy for type 2 diabetes with insurance reimbursement – June 13, 2013

This morning, WellDoc announced the launch of BlueStar (“the first FDA-cleared, mobile prescription therapy for type 2 diabetes with insurance reimbursement”) at the 2nd annual Digital Health Summit in San Diego. Using patients’ own inputted data (e.g., medications, blood sugar readings, diet, and exercise), the BlueStar software provides real-time coaching, educational content, and motivational support to people with type 2 diabetes. We especially like that it offers personalized messaging to patients, which dovetails incredibly well with the field’s increasing focus on individualized therapy. BlueStar is FDA cleared (over a year between 510(k) submission and clearance), works on smartphone platforms (e.g. iPhone and Android), feature phones, tablets, and desktops (nice to see broad device compatibility), and requires a prescription from a licensed HCP. The product is based on WellDoc’s Automated Expert Analytics System, the same system that powered an earlier version of BlueStar used in the company’s randomized controlled trials (Quinn et al., Diabetes Care 2011; Quinn et al., DT&T 2008). Notably, the BlueStar product also provides HCPs with medication and other care plan suggestions based on ADA and AADE clinical guidelines. Speakers at diabetes technology conferences have been increasingly begging and pleading for clinical decision support software that works, that saves them time, and improves patient outcomes. We will be interested to see how quickly clinicians and patients embrace BlueStar, and more broadly, which side of the table drives more of the demand.

We were very encouraged to see that BlueStar will launch with reimbursement similar to other prescription products (adjudicated as a pharmacy benefit; i.e., copays that vary by insurance plan). This is a major win for patients and a testament to WellDoc’s strong management team and focus on publishing solid clinical data. A controlled launch in “select areas” will occur this summer (we assume major cities and areas near large diabetes centers) followed by a nationwide launch later this year. We applaud the efforts of Ford, Rite Aid, Dexcom, and “other Fortune 500 companies” that are adding BlueStar to their health insurance coverage under their prescription benefit plans.

Given the amount of self-care diabetes requires, the lack of time and patient contact with HCPs (four times per year at best), the fraction of patients at goal, and the challenges of staying motivated to manage an “invisible” disease, we see holistic, mobile, personalized, patient-centered solutions like WellDoc’s BlueStar as playing a hugely important role in the future. We think it’s key that WellDoc has a business model in place (somewhat of a novelty in mHealth!); a focus on translating data into actionable knowledge; and a system that comprehensively addresses the psychological, medical, AND adherence aspects of diabetes. We believe BlueStar’s success will depend on many factors, especially: 1) Will patients stay engaged and motivated to use it, particularly because BlueStar relies on patient data logging (it’s a plus that BlueStar gives patients dynamic and personalized real-time and longitudinal feedback, which improves the cost-benefit ratio in our view); and 2) Will providers embrace the system, will it save them time, and will they be comfortable relying on its recommendations?

• BlueStar provides real-time motivational, behavioral, and education support for patients with type 2 diabetes. The mobile prescription therapy is powered by the proprietary WellDoc Automated Expert Analytics System, which analyzes trends in users’ data (i.e., blood glucose and A1c levels, diet, exercise, blood pressure, lipids, and foot exams) and makes recommendations based on behavioral patterns. Everything is highly personalized from the initial setup and the feedback and messaging adapts over time – each patient’s BlueStar is completely different. The algorithms are based on expert feedback from diabetes clinicians, and as we understand it, every single message maps directly to standards of care.
• In our view, patient engagement will be a key factor in BlueStar’s success, since the system’s algorithms rely on patients inputting blood glucose, diet, exercise, and other data. Of course, engagement and adherence plays a critical factor in the success of any diabetes therapy, whether it’s oral therapies, injectables, pump therapy, or glucose monitoring. Historically, it has been difficult for patients to consistently manually log data. We think of this as a cost-benefit analysis that patients are doing – it’s understandably difficult to put energy and information into a process that doesn’t result in meaningful clinical benefits. Increasing the clinical benefits of a device will improve the ratio, and ideally, motivate patients to stay engaged over the long term.
  • ​WellDoc’s approach provides educational and motivational feedback on every patient input – we believe that’s critical to helping patients feel like their efforts are worthwhile (i.e., real-time feedback is so much better than slaving away for three months manually logging glucose values, only to see a provider for 30 minutes (at best), get feedback at that point, and then return 90 days later). Of course, if patients actively use BlueStar, the collected data and resulting decision support analysis should also result in more engaging office visits with providers. We’ll be interested to see how things play out on this front.
• We like that BlueStar empowers patients to self-manage their diabetes – certainly, many patients do have the raw motivation to improve their diabetes, though many lack the education or real-time feedback to know what to do at the precise moment. This empowerment is a critical element of successful long-term diabetes control and something we feel can move the needle and help reduce the economic burden of diabetes on our healthcare system. The fact that BlueStar will be reimbursed from the get-go will make patient access less of an issue. On the clinician side, the FDA clearance and prior clinical data are confidence inspiring as well.
• WellDoc has also thought very strategically about minimizing the time providers will need to spend on BlueStar. There is no set-up required by a patient’s healthcare providers – that part is all handled by WellDoc trainers. HCPs can choose to just prescribe BlueStar like a drug, or they can also choose to use WellDoc’s clinical decision support. The clinical decision support aspect of BlueStar is intended to make HCPs’ work flow more efficient; in a quick glance of WellDoc’s SMARTVisit report, providers can understand what has been going on with a patient and make smarter treatment decisions. WellDoc has found that putting the analyzed data in the doctors’ hands makes them twice as likely to make treatment changes (e.g., getting patients to the right therapies and doses faster).
  • Chief Strategy & Commercial Officer Chris Bergstrom noted in a recent conversation that WellDoc was founded by endocrinologists and that clinicians (endocrinologists, PCPs, dietitians, CDE’s and behaviorists) built the product – he emphasized that it’s really designed from the ground up to make HCPs’ jobs easier and more efficient, not harder. We admire this approach – we continue to hear HCPs at conferences stand up and describe how challenging and daunting their jobs are. Most importantly, they have little time and don’t have reimbursement for the activities that their patients need; this in turn prompts even less interest in the field. We will be interested to see if BlueStar can start to move things forward on this front.
• We found it particularly striking that BlueStar will be reimbursed similar to other prescription drugs – it’s a rarity to hear an mHealth solution has reimbursement at all, let alone one with a model similar to existing drugs. We look forward to better understanding patients’ out-of-pocket costs for BlueStar, especially for those without insurance.
• Similar to an insulin pump company, a national network of trainers will work with patients to introduce them to BlueStar and make sure they understand how it works. Once HCPs prescribe the product, WellDoc sends a face-to-face CDE trainer who is certified to conduct new BlueStar starts. The trainer meets with each patient and conducts a 30- minute training session. This involves setting up all the devices the patient wants to use, configuring the algorithms to the patient, and teaching them how to use the product. After that, patients can call WellDoc Customer Care if they need further support.
• As we understand it, WellDoc had to establish a pharmacy network that was licensed in all 50 states. From a patient and clinician perspective, we think this is a great way to commercialize the system – while it makes distribution more controlled, it will ensure the safety of patients using BlueStar. We understand that the FDA required the prescription-only distribution approach because BlueStar essentially helps patients adhere to their physician’s care and treatment plan – one could certainly imagine a scary scenario of a less controlled distribution scenario (e.g., open for download on the App store without the oversight and determination of medical necessity of a physician) would result in many patients using a product that might contradict his or her physician’s care plan.
• BlueStar is FDA cleared for and designed for all patients with type 2, regardless of their medication regimen. Given the progressive nature of type 2, it’s a big plus that the product is smart enough to grow with a patient over time. For example, if a patient has been on Lantus for a short period of time, the messaging will be different than if he or she has been on Lantus for a long period of time.
• As we understand it, WellDoc has plans to develop a BlueStar-like product for type 1 diabetes – this is fantastic in our view, given the greater attention, coaching, education, and motivation needed to manage type 1.
• We note that BlueStar is different from WellDoc’s DiabetesManager. The DiabetesManager was a call center-based product for disease management companies, and one of its primary features was enterprise tools that made nurse case managers more efficient. BlueStar is significantly different in that it requires a prescription, has clinical decision support for HCPs, enhanced algorithms, increased levels of personalization, and incorporates standards of care and co-morbidities.
  • ​As a reminder, WellDoc’s original DiabetesManager system received 510(k) clearance from the FDA in August 2010. BlueStar uses a similar expert analytics system to the DiabetesManager. To read our report on the 2010 clearance, see http://www.closeconcerns.com/knowledgebase/r/773866ce.
• To date, WellDoc has published two RCTs showing significant 1.2-1.4% reductions in A1c levels with its software – Quinn et al., Diabetes Care 2011 (1.9% in the WellDoc intervention group vs. 0.7% in the usual care group; p <0.001 over 12 months) and Quinn et al., DT&T 2008 (2% in the WellDoc group vs. 0.7% in the usual care group; p <0.02 over three months). We look forward to seeing how the real-world reductions in A1c will map on to these randomized controlled trial results.
• WellDoc’s DC HealthConnect project demonstrated a 58% reduction in ER visits and hospitalizations in 32 type 2 diabetes patients on Medicaid. Participants used their own cell phones (the phones were web-enabled, though analog phones were allowed) and were offered a $20 monthly discount on their cell phone plans. Over an average follow-up period of 12 months, those using WellDoc reduced their hospital visits from five to zero (!) and their ER visits from 21 to 11. Exit surveys indicated satisfaction on many fronts, with: 1) 100% reporting that the instant coaching feedback was helpful; 2) 100% agreeing that the system increased the frequency of their blood glucose testing; 3) 6% (two out of 32) finding it bothersome to enter their blood glucose testing information into the program; and 4) 6% (two out of 32) reporting concerns regarding data privacy. Although a small study, and technically too small to apply statistical significance testing, we found the results quite notable given their potential implications for both patient health and healthcare costs. For more details, see our report at http://www.closeconcerns.com/knowledgebase/r/66bc2c96. We’ve learned that WellDoc also saw similar results in a six-month demonstration (n=202) with a Medicaid population in Ohio – ER visits dropped 16% and hospital admissions dropped by 55%.

​INTERVIEW WITH WELLDOC CHIEF STRATEGY & COMMERCIAL OFFICER CHRIS BERGSTROM

Q: Patients have to manually log their glucose values and information. How confident are you that engagement will remain high? Are there plans to integrate with meters and make the data transfer seamless?

A: Our philosophy is that patients should be able to use WellDoc from whatever device makes the most sense for them at any particular moment. So today, they can use their smartphone, feature phone, tablet, or PC. Tomorrow, their meter, their car, their ‘???’ So, yes we've begun work on integrating into other devices like meters. However, we haven't found the manual entry of blood glucose values is an issue. If glucose was the only component of type 2 management, then perhaps it would be more important; however, BlueStar helps with the management of medications, symptoms, diet, exercise, glucose, standards of care (e.g., foot exams, etc.), so patients are engaging and entering info of all types. Adding a two- or three-digit number along with the other info is not much trouble.

Q: How will BlueStar motivate patients to continue to enter information? We’ve heard that patients typically fatigue from entering data after a few days. Will the system provide rewards or challenges to engage patients?

Historically, products that have asked patients for data are essentially digital log-books and/or digital encyclopedias. Thus, they haven't provided much value in return for entering data. The result is that they sometimes rely upon extrinsic rewards (e.g., a bribe or a game). These types of rewards have been shown to change behavior only in the short term – for example, you'll likely do anything I say for $100 right now.

At WellDoc, we take a completely different approach – we believe in intrinsic rewards and motivation. So, unlike other products that ask for your inputs and provide you nothing in return (except for perhaps a pie chart), BlueStar provides rich education, coaching, motivation, and feedback every time you enter information. Everything is personalized to you and relevant to your contextual, real-time situation. Patients learn quickly that the more they invest in BlueStar the more they are rewarded with knowledge and support. Further, because the product has clinical decision support, the patient receives an additional positive feedback loop when they visit their doctor. They are suddenly having a more robust and productive conversation during the office visit. With analyzed data in the doctors’ hands and treatment recommendations at their finger tips, we've found that doctors are twice as likely to make treatment changes (e.g. getting patients to the right therapies and doses faster). We are changing both patient and provider behavior for the better and they mutually feed off of each other in a meaningful way.

Q: What is the minimum amount of logging someone can do and still get benefits from BlueStar?

A: There is no minimum amount – the product is customized to each patient based on their medication regime, medical history, duration of time on therapies, behavioral readiness, context at any particular moment in time, etc. Literally, everyone gets their own version. It's different for each patient and different each day (just like real life) based on how much a patient may need or want to interact. The product is designed to constantly learn and follows a patient through their diabetes journey and knows when certain times are more critical, such as when starting and titrating a new medication.

Q: Did WellDoc do any feasibility studies to better characterize patient engagement or the clinical benefits of BlueStar?

A: Yes, we did extensive human factors, clinical, and real-world testing. We don't share this proprietary data, but the majority of patients persistently and consistently used the product for extended periods of time (we currently have data on file up to 12 months). There were a minority of patients who did not consistently use the product and we are researching to understand what barriers those patients faced.

Q: At launch, what payers are reimbursing BlueStar?

A: We are launching with coverage for millions of Americans and will be working on behalf of all type 2s to increase coverage over time. It’s a never ending process, but so far, demand from employers (e.g., Ford, a Fortune 10 employer with ~500,000 lives) and PBMs has been strong.

Q: How long did FDA clearance take? What was FDA’s biggest concern?

A: 510(k) clearance took over a year. FDA’s biggest concern was probably around our messaging related to prescription drugs – that is one of the primary reasons BlueStar is a prescription-only product. The FDA wanted to ensure that we were supporting a patient in adhering to their physicians’ orders, not the orders that WellDoc or any other party made-up.

Q: How will WellDoc market the system to HCPs?

A: Direct to physician detailing, trade and science conferences, etc.

Q: What do you see as the biggest challenge to commercializing?

A: Investing in a national sales force.

-- by Marissa Lynn, Adam Brown, and Kelly Close