Memorandum

Hygieia’s d-Nav Insulin Guidance Service lowers A1c 1.7%, saves $145 per patient per month from medication elimination in 90-day BCBS study – February 7, 2018

Executive Highlights

  • Hygieia recently announced and published very positive results from a demo project of its d-Nav Insulin Guidance Service (BGM + insulin titration + remote care) with Blue Cross Blue Shield of Michigan (BCBSM). The study found that after 90 days using the service, participants with type 2 diabetes on insulin (n=192) experienced an average A1c decrease of 1.7% (baseline: 9.4%).
  • At 90 days, those who saw A1c improvements received a medication review: ~83% of all “expensive” medication prescriptions (GLP-1 agonists, DPP-4 inhibitors, SGLT- 2 inhibitors) were eliminated. Among all patients, direct savings from medication discontinuation were estimated at $145 per patient per month, or $1,736 per patient per year. For those taking at least one expensive diabetes medication (GLP-1, DPP-4, SGLT-2), costs savings estimates were over three-fold higher: $514 saved per patient per month, or $6,172 saved per year – wow! For a health plan with 10,000 type 2 patients, the cost savings medication discontinuation alone would translate to annual reductions of nearly $20 million, or $62 million in the subgroup on expensive meds. Of course, A1c reductions would also likely contribute to further cost reductions.
  • In an exclusive interview with Hygieia management, we learned there are currently over 600 Hygieia d-Nav users globally. The company still hopes for a 2018 US commercialization, including with Amalgam’s iSage Rx insulin titration app integration (partnership announced last June). Hygiea would not comment on the status of an FDA submission – we assume a 510(k) clearance would be required, given the nature of the product. Given the strong EU outcomes (2%+ A1c reductions), we’re surprised the product has not scaled further. As of last September, the NHS does pays ~£150/patient/month for the d-Nav service.
  • The A1c and cost results show the power of smarter insulin titration in type 2 diabetes, especially in those taking expensive type 2 drugs. The outcomes are a nice win for Hygieia and will hopefully translate to strong reimbursement if/when it launches. The data are also a good sign for other companies that aim to automate insulin titration with data and devices (e.g., Lilly, Novo Nordisk/Glooko, Sanofi, Bigfoot, etc.).

Hygieia recently announced positive results published in the Journal of Health Economics and Outcomes Research from a Blue Cross Blue Shield of Michigan (BCBSM) demonstration project testing its d-Nav Insulin Guidance Service (BGM + insulin titration + remote care) in insulin users with type 2 diabetes. This project began in November 2016, and we have awaited these interim results ever since Hygieia’s original hope to release them last September.

For the study group of d-Nav users (n=192) after 90 days, A1c decreased a robust 1.7% from a baseline of 9.4% (p<0.001). In a “target” subgroup – the 54 users on at least one “expensive” medication at baseline (i.e., 50% on GLP-1 agonists, 32% on DPP-4 inhibitors, 24% on SGLT-2 inhibitors) – A1c similarly fell 1.4% from a 9.3% baseline. 89% of all participants achieved decreases in A1c.

Over half the participants (n=98) had a baseline A1c >9%, and in 84 of them, A1c dropped a mean 2.9% points from 10.5% to 7.6% (!); for the remaining 14, A1c dropped a mean 0.9% points, but did not go below 9% (11.1% to 10.2%). Overall, these are very strong A1c outcomes in quite a tough group of users.

The cost savings estimates from discontinued meds were equally strong. Of the 192 patients that completed the 90-day visit, 170 (89%) had improved A1c levels and were eligible for medication discontinuation. Researchers estimated direct savings from medication elimination in all users to be $145 per patient per month ($1,736 per patient per year). For a health plan with 10,000 type 2s, that could save over $17 million annually. In the target group using newer agents, direct savings were estimated to be far higher at $514 per patient per month ($6,172 per patient per year) – that projects to an impressive $62 million saved per year for a health plan with 10,000 type 2s on expensive diabetes medications. Of course, given the improvements in A1c, further decreases in healthcare expenditures would obviously be possible.

Interestingly, those taking GLP-1 agonists or DPP-4 inhibitors were more likely to be eligible for medication discontinuation than those on SGLT-2 inhibitors: 85% and 82% of those on GLP-1 agonists and DPP-4 inhibitors, respectively, achieved reductions in A1c by using the d-Nav service, while 69% of those on SGLT-2 inhibitors saw A1c decreases. Drug costs were calculated using the market price for each medication as of October 2017. The investigators excluded the costs of insulin due to price dependency on brand and volume, though presumably most users saw an increase in insulin usage at the same time their other meds decreased. We’re not sure how that nets out into overall treatment savings, but presumably still in Hygieia’s favor.

While this initial sub-analysis did not have a control group, but nonetheless, the strong A1c and medication discontinuation outcomes speak to the power of data-driven insulin titration – a win for Hygieia and a growing number of companies pursuing this field (including the major insulin players). As noted below, Hygieia actually sees its business model more like DaVita or Fresenius (dialysis service providers): “There are many tools in the market that are designed as ‘decision support’ or efficiency tools for physicians. However, we believe that the market doesn’t lack tools, it lacks providers’ capacity – which is what we offer.”

  • These data also remind us of how long it takes to get pilots off the ground. Originally, this was announced in April 2016 as a 1,000-patient, 12-month reimbursement study. The study then began seven months later (November 2016), with outcomes now out 14 months later. Presumably these 90-day results in 192 users are a sub-analysis, with more data to come from the full cohort. Hygieia hopes to share more information about BCBS’s response and further plans to collaborate with them or other payers in the near future.
  • Notably, BCBS also just commenced a pilot with Onduo in Arkansas, Georgia, and South Carolina last month. How will Hygieia’s outcomes and cost savings compare to Onduo’s, which also offers coaching, BGM, medication review, and also CGM for those who qualify? On a broader scale, how does the connected care/coaching market evolve in the coming years? There are many different  approaches – Livongo, mySugr, One Drop, Virta, Medtronic’s Turning Point Program, Dexcom/UHC, Glooko/Fit4D – and we imagine many will be needed to change the challenging type 2 diabetes care paradigm globally. Which will result in the best value proposition for payers/employers?

Further Study Details

  • The vast majority of participants rated the d-Nav service favorably in a follow-on mail survey. Questions pertained to confidence in the system, satisfaction with the decision to initiate the service and ability to manage diabetes, and desire to continue using the service. The majority of responses were either “strongly agree,” or “somewhat agree.” Impressively, from an initial cohort of 217 patients, only 12 (6%) withdrew consent, and 10 (5%) were lost to follow-up. We include key outcomes in tables from the paper below.
  • Study participants were fairly broad: those with type 2 diabetes on insulin with A1c ≥ 7.5%. It’s worth noting that the average baseline A1c of participants (9.4%) is quite high, though that is reflective of a group that needs serious help.
  • With d-Nav, we wonder how much of the benefit comes from the device vs. the coaching/remote care vs. synergy between the two – answering that question may not be necessary, as what matters is whether the whole package can deliver benefits and cost savings. That said, it would be fascinating to see how effective the product is without the remote human care – this has obvious implications for other companies pursuing insulin management tools. What would be possible with app/device-driven titration alone? Can the current Hygieia model scale into the thousands and tens of thousands of users?

Hygieia Business Model, Commercialization Timeline, and Pipeline

  • “Hygieia’s view of the market opportunity is different than that of other technology companies. Hygieia provides insulin management services, and the business model we follow is the one utilized very successfully by DaVita or Fresenius Medical Care [dialysis companies] in CKD. We are not aware of any other provider that offers insulin management services. There are many tools in the market that are designed as ‘decision support’ or efficiency tools for physicians. However, we believe that the market doesn’t lack tools, it lacks providers’ capacity - which is what we offer. We hope others will follow our footsteps and offer similar solutions directed at patients. There are over six million insulin users with type 2 diabetes in the US. We believe no one should take insulin without titration. There is plenty of room for others to come along and help us develop this market.” – Hygieia’s response to our question about expected market challenges and its business model
  • Hygieia told us that 600 patients are currently using the d-Nav Service globally. One clinic has been established in Michigan with plans for expansion. As of June, the company “will continue to pursue FDA clearance on all of the required tools,” but we have yet to receive further updates. The Hygieia device is CE marked, and as of last September, the NHS was paying about £150 per patient per month for the d-Nav service. Given that deal with Spirit Healthcare – and previous outcomes – we might have expected a larger user base at this time. Perhaps these BCBSM results will help in a big way as the company gears up for broader launches.
  • In June, Hygieia and Amalgam Rx announced plans to integrate the FDA-cleared iSage Rx app with d-Nav starting in 2018, offering titration for all major basal insulins, including Lantus, Levemir, Toujeo, Tresiba, and Basaglar. Hygieia expects iSage Rx will be available at the time of US commercialization. The Company has launched its cellular enabled d-Nav docking station, with a next-gen fully integrated cellular-enabled d-Nav device in the works. The current d-Nav device is not cutting-edge in terms of user experience, but it seems to get the job done nonetheless.

 

--by Maeve Serino, Brian Levine, Adam Brown, and Kelly Close