Memorandum

Lilly partners with Rimidi to develop provider-focused tools for integrated insulin management system (smart pen, CGM or BGM, apps) – December 15, 2017

Executive Highlights

  • Yesterday, Lilly and Rimidi announced a non-exclusive partnership to develop provider-focused tools for Lilly’s integrated insulin management system. This will include a connected insulin pen, BGM or CGM, patient-facing apps, and clinician software. As we understand it, Rimidi will drive the HCP-facing piece.
  • Rimidi’s software will integrate into clinicians’ workflows on top of electronic medical records (EMRs), providing therapeutic guidance and identifying optimal treatment plans. The system will use device data, patient-generated health data, and clinical history – wow! Rimidi’s platform also gives providers and health systems a population-based, risk-stratified view, flagging patients in trouble or in need of contact. We assume Lilly will handle the patient-facing aspects of this system.
  • Lilly now has multiple clinical trials in its “Connected Diabetes Ecosystem,” and still plans to launch both pen- and pump-based insulin automation systems in 2-3 years (pending FDA clearance/approval). We assume Lilly has a clear line of sight to market at this point, as multiple press releases have shared this timing. The two products, as a reminder, are the connected pen + insulin titration and an AID hybrid closed loop system. Both will use Dexcom CGM.
  • We noticed a few slight changes to this press release’s language, confirming that: (i) BGM and CGM will both be used in the integrated insulin management system; (ii) Lilly’s portfolio may contain both PMA and 510(k) products (e.g., perhaps a standalone connected pen or pump could be sold?); and (iii) there is now more than one clinical trial underway in the Connected Diabetes Ecosystem. Nice!

Yesterday, Lilly and Rimidi announced a non-exclusive agreement to integrate a version of Rimidi’s diabetes management software platform (Diabetes+Me) with Lilly’s integrated insulin management system (connected insulin pen+glucose-monitoring+software to deliver personalized insulin dose recommendations).

According to Rimidi CEO Dr. Lucienne Ide, her company will provide software to help clinicians identify patients who could benefit from Lilly’s insulin management tools and prescribing the best treatment plan (including configuring apps and devices) seamlessly within the clinic workflow. Data will also flow back from patient devices into Rimidi’s platform, which can provide insights about blood glucose, insulin dosing, engagement, etc. – in Dr. Ide’s words, the “roadmap is to identify the best approach for each patient through patient phenotyping and advanced analytics.”

Patients using Lilly’s connected pen or apps will receive insights on dosing, as well as reminders about taking fingersticks (for BGM). Exactly how the software development duties will be split between Lilly and Rimidi are not entirely clear. No financial terms were shared either.

In a big advantage, Rimidi’s platform runs on top of EMRs, pulling patient-generated health data and clinical data (comorbidities, history, medication, labs, vitals, etc.) to “identify individuals who may benefit from specific management approaches.” In the context of Lilly’s system, we assume Rimidi’s platform will indicate to providers when a therapy adjustment is needed, allow for population management and risk stratification, and help flag patients who are at need of extra follow-up. This decision support could be transformative – we imagine the software might recommend different therapeutic approaches based on a particular patient (e.g., “This patient is likely to benefit from a “GLP-1+basal,”), giving providers highly actionable decision support for prescribing and titration. Dr. Ide also told us that Rimidi will suggest to providers which individuals would qualify/benefit from CGM – that would be a clear positive for Dexcom and could drive greater adoption of CGM. Of course, the population approach could also drive new reimbursement/service models for Lilly, changing its drug-focused business model meaningfully.

Dr. Ide noted that her team is excited that this sort of EMR data is much more accessible via SMART on FHIR integrations – the 2018 meaningful use 3 requirement around APIs has forced all of the major EMR vendors to make an API available, and most have chosen to comply with FHIR standards. Dr. Ide echoed the enthusiasm we’ve heard from others in the software and data sectors, calling it a game-changer in terms of interoperability and scalability. Seamless integration into clinical workflow and easing physician burden will be critical for driving digital health in primary care and busy endocrinology offices. It’s outstanding to see Lilly already thinking about this, even though launch is 2-3 years out – to date, diabetes tech has had fairly limited integration with EMRs.

With the debut WSJ article, a Dexcom press release shortly thereafter, Lilly’s own press release, and a ClinicalTrials.gov posting for the AID feasibility trial (n=30, 12-18 days), we’ve heard quite a bit about Lilly’s “Connected Diabetes Ecosystem” in less than a month. The company continues to reiterate timing too –both the AID hybrid closed loop and integrated insulin management systems should be available to patients within two to three years, pending FDA clearance/approval. Lilly is clearly going to be a meaningful connected diabetes technology provider/integrator, and the timeline suggests a high degree of confidence about the path ahead.

Lilly Connected Diabetes Ecosystem – Changes From Prior Press Release

  • We noticed a few meaningful changes in this Lilly press release relative to previous updates (debut WSJ article, Dexcom announcement, Lilly AID press release):
    • This Rimidi announcement specifies that the “glucose-sensing technologies” leveraged by the integrated insulin management system – previously not characterized – will be both CGM and BGM. We had always assumed this would be the case, as it will expand access to more type 2s and offer a greater portfolio of devices/services at different price points. We wonder who Lilly will choose as its BGM partner, if anyone. AgaMatrix is certainly one option – it supplies One Drop’s Chrome BGM and is partnered with Companion Medical to ship a BGM with each InPen.
    • The release concludes by saying that the automated insulin delivery and integrated insulin management systems will be available to patients within two to three years, “pending FDA approval or clearance.” The previous press releases have just said “approval,” omitting clearance. It’s possible the prior announcements should have included both words, but it is also possible to read further – perhaps Lilly intends on putting together a portfolio of PMA and 510(k) products. For instance, PMA would encompass the automated insulin delivery system and the connected pen + CGM + dosing guidance products, while 510(k) product could insinuate a standalone pen, pump, or BGM-driven dose titration app (i.e., like Voluntis’ Insulia).
    • This release also shares that “some clinical trials have started.” We only know of the one AID feasibility study and are not sure which other systems are under investigation – the previous announcement only said that “more clinical trials will be initiated in the coming months.”

Rimidi Background

  • The Rimidi website explains that Diabetes+Me offers (i) patient-facing self-management software (logbook; portal for feedback/coaching from healthcare team); (ii) physician-facing decision support (visualize the impact of therapy adjustments; individualize therapy; remote monitoring; and (iii) health system-facing population management software (risk stratification; real-time monitoring; tracking of key metrics). Exactly how much of the functionality will be used in the Lilly system is unclear at this point. Rimidi will take on risk with clients around outcomes or engagement. Our assumption is that Lilly will handle the patient-facing aspects, while Rimidi will focus on the backend platform, population views, EMR integration, etc.
  • Rimidi is one of Dexcom’s initial data API partners, which may have contributed to this Lilly agreement (since Dexcom is providing CGM for both of Lilly’s tech-enabled insulin delivery systems). Through Rimidi, Dexcom users can share their data with their healthcare provider, which then becomes available within the clinician’s workflow.
  • In one clinical trial, Rimidi impressively doubled the patient load that an individual clinician could manage. Dr. Ide expects numbers may be even higher now that full EMR integration is coming on line. Rimidi’s platform led to fewer inpatient admissions and outpatient visits in the year following the study.

Close Concerns’ Questions

Q: Why was Rimidi chosen over others? We imagine Glooko also could have provided this service, but presumably there was a compelling reason to go with Rimidi.

Q: What are the financial terms of the deal? Is Rimidi paid a licensing fee + a percentage of revenue once the system is commercialized?

Q: What is the spectrum of clinical decision support providers will receive? How specific will the recommendations be? How open will PCPs and busy endocrinologists be?

Q: What are the data displays in the EMR?

Q: Will Lilly launch standalone smart pens and its pump, outside of the two automated insulin-dosing systems?

Q: For pen users receiving insulin titration, how much value will CGM add over BGM? Will the difference in outcomes cover the additional cost of CGM? What kind of portfolio will Lilly offer in smart pens + titration?

 

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