Memorandum
- Novo Nordisk made a splash on day #1 of EASD with the news that it will launch an already-CE-marked, NFC-enabled, reusable smart pens – NovoPen 6 and Echo Plus – in early 2019. Both devices support cartridges of basal and bolus insulin and have displays of insulin on board and time since last injection, an 800-injection dose memory, and a truly remarkable five-year battery life (with no recharging necessary!). These devices are ideal for clinic upload via Glooko/Diasend, but Bluetooth connectivity is almost certainly on the roadmap. For now, this is a first step into smart pens intended to enhance the patient-clinician conversation. It does not seem that patients will initially have their own app to download the pens via NFC on their own phone – a different approach from Companion, Lilly, Bigfoot, and Common Sensing (who all use Bluetooth). Of course, Novo Nordisk or partners could build NFC capture into an app (speculation).
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“Key markets” will begin to launch in 1Q19, presumably starting with various countries in Europe. Novo Nordisk reps framed the rollout as an expansion of the n=~700 Swedish connected pen pilot, so we would expect that Sweden will be one of the first markets with broad access.
- Also in major new news, Novo Nordisk will launch a reusable, Bluetooth pen attachment (cap, clip, sleeve?) for disposable, pre-filled FlexTouch pens later in 2019. This device will relay dose size and timing to an app(s), as well as have a safety mechanism for recognizing the type of insulin being injected.
- Novo Nordisk continues to take a partnership approach to connectivity, announcing the first smart pen data partnerships today with Dexcom, Glooko, and Roche. These partners, along with more to come, will integrate Novo Nordisk insulin injection data into their platforms, and in some cases, build out decision support based on it. We look forward to seeing products materialize from these deals.
- With this announcement, Novo Nordisk has drawn a clear line in the sand as a major insulin company developing smart pens, bringing a near-term answer to Lilly’s smart pen efforts. Lilly has not given launch timing on standalone smart pens, other than saying its injection titration system – smart pen, G6 CGM, app – is expected to launch in late 2019-late 2020. Sanofi is working with Common Sensing’s Gocap in a pilot, but has not officially committed to a commercial launch like NN or Lilly. Of course, Companion Medical's first-to-market InPen is available now in the US, with sales continuing to ramp (per AADE).
This morning, Novo Nordisk announced that it plans to commence launches of its connected insulin pens beginning in early 2019, along with new/expanded partnerships with Dexcom, Glooko, and Roche (who also trumpeted the news). The CE-marked, durable, NFC-enabled NovoPen 6 and NovoPen Echo Plus will roll out in “key markets” beginning in 1Q19, and eventually more than 50 countries in the coming years, replacing the NovoPen 5 and NovoPen Echo, respectively. A 2019 US launch seems possible to us, though that would depend on regulatory path with FDA as NovoPen 5, sans connectivity, is not in the US (Echo is). Regardless of exact launch cadence, Novo Nordisk is clearly committed to connected devices and partnering in digital health– a great sign to improve the safety and efficacy of insulin and make injection dose capture standard of care.
Both NovoPen 6 and Echo Plus have displays of insulin-on-board and time since last injection on their dial-ends (picture below), a three-month dose log (retaining the last ~800 injections), a remarkable five-year lifetime (with no battery change or recharging!). The difference between them is in the dosing: The pediatric-oriented Echo Plus allows for half-unit dosing and a maximum 30-unit injection, whereas the NovoPen 6 has a minimum dose of one unit and a maximum dose of 60 units. Both devices are compatible with both basal (Levemir, Tresiba) and prandial (NovoLog, Fiasp) insulin cartridges, which are prescribed separately and inserted into the reusable pen. Cartridge availability varies by geography.
The durable pens with NFC are ideal for clinic upload via Glooko/Diasend and enhancing the clinician-patient conversation, as in the Swedish pilot that inspired this initial launch (more on that below). However, Novo Nordisk could theoretically launch other means of capturing the data (i.e., smartphone NFC), as could data integration partners.
The press release also notes that connectivity for disposable, pre-filled injection pens will come to market “later in 2019” – a very big deal that Novo Nordisk will have both durable and disposable smart pen options. We’ve confirmed with Novo Nordisk that this dose capture intelligence will take the form of a Bluetooth-enabled smart device (cap, clip, sleeve?) that is appended to the disposable FlexTouch pen, transmitting the type of insulin being injected (a safety precaution to avoid mix-ups), the quantity of insulin injected, and the time since the last injection. We learned that the device is being developed in-house but manufactured with an unnamed external partner. The idea for the device is five-to-six years old, with meaningful progress on it in the last 2-3 years – though this is long by device standards, it is reasonably fast for an insulin giant moving into the connected arena. 2019 will be a big year for Novo Nordisk’s connected efforts!
Novo Nordisk does not seem to be building a dedicated app for the nearer term NFC durable pens, though it may when Bluetooth products come to market so that patients who don’t use CGM or BGM apps can benefit – this feature could also theoretically be woven into the Glooko or Cornerstones4Care apps. In our conversation today, the company told us it’s focused on integrating into existing solutions, and only building something new if it’s truly and meaningfully different.
See below for more background on Novo Nordisk’s Swedish connected pen pilot with NovoPen 5, as well as its diabetes tech partners and general partnering philosophy.
NovoPen 6 and Echo Plus Pictures
From the ADA 2018 Exhibit Hall:
An image shared in mySugr’s update email:
Novo Nordisk Swedish Connected Pen Pilot
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In today’s press release, EVP Ms. Camilla Sylvest alluded to an ongoing Swedish pilot with the connected NovoPen 5 Plus (~10 sites, 700 patients, 1,000 pens). She cited improved patient dialogue without additional time investment on providers’ parts in the pilot, and a Novo Nordisk rep simply added in EASD hallway chatter: “Lots of coaching moments.” Two side notes: (i) All members of the pilot wore CGM, so we may eventually see outcomes published; and (ii) NovoPen 5 Plus was a transition product between the non-connected NovoPen 5 and connected NovoPen 6 that will launch next year.
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Novo Nordisk reps framed the launch as an expansion of the Sweden pilot. That is, the pens will be NFC-enabled, positioning them for HCP downloading in the clinic, rather than real-time, patient-facing data collection (we got to upload the NovoPen 6 to Glooko through the Glooko/Diasend NFC pad in Novo Nordisk’s ADA booth); of course, Novo Nordisk or partner companies may build NFC communication into their apps. This active approach of data upload is not quite as seamless as Bluetooth for the end user, but the big payoff is realized in the five-year battery life – compare to the one-year life of Companion Medical’s Bluetooth-enabled InPen. Still, reps told us that 6 and Echo Plus are the first links in a step-by-step pipeline, which we take to mean that Bluetooth will come since that would allow for in-the-moment patient decision support, more passive upload in the background, and potentially greater engagement.
Non-Exclusive Development and Collaboration Agreements with Roche, Dexcom, and Glooko
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These connected pens will enter the market within Novo Nordisk’s non-exclusive partnering philosophy – we were assured there are more partners to come! Novo Nordisk insulin data will be integrated into partners’ ecosystems, allowing dose data to be displayed in “easy, automated, and reliable way,” a rep said, to enable more meaningful coaching conversations. They added that the company “wants to integrate with solutions on the market instead of developing our own copies of what’s already available. We will develop patient decision support, but it won’t just be copying what’s already out there.” These “solutions for personalized treatment guidance” (language from the press release), will presumably go beyond insulin titration, bolus calculators, and logging modules – even basic titration would be meaningful. Our speculation? This is a prime opportunity for the company’s IBM Watson partnership to deliver tailored insulin dosing advice based on exercise, food intake, past personal data, and population trends (“people like you tend to do X in a situation like this”). Regarding the specific partners:
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Roche: According to a Roche press release, Novo Nordisk insulin data will be synced into Roche’s mySugr app and Accu-Chek SmartPix software (enabling “more efficient and targeted decision support”). mySugr included the news in an industry update email; mySugr MDI users (and their CDE coaches, if applicable) will certainly be happy to have injection history. As a reminder, Roche already distributes smart pens made by smart pen manufacturer Pendiq, and we learned today that the data flows into SmartPix already.
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Dexcom: Dexcom SVP Mr. Jake Leach said today in an EASD symposia that the planned Dexcom/Novo Nordisk solution will combine CGM with connected insulin pen data and “guidance information” to “give advice” that makes diabetes easier. The press release notes that this will happen “in the coming years.” Dexcom’s TypeZero acquisition gives it decision support algorithms for MDI, which may be tapped for this partnership; notably, TypeZero algorithms are already being evaluated in a UVA/Stanford/Mt. Sinai study with connected Novo Nordisk pens and Dexcom CGM. Dexcom already has a partnership with Lilly for the latter’s Integrated Insulin Management system, and has sensors being distributed through Onduo (the Sanofi-Verily joint venture).
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Glooko: This agreement presumably extends the existing partnership to co-develop digital tools. Glooko has the inside track to begin using Novo Nordisk insulin delivery data first, since it has an NFC pad facilitating clinic upload to its data management platform.
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Close Concerns Questions
Q: Will the cost of NovoPen 6 and Echo Plus be similar to current durable pens?
Q: What competitive impact will Novo Nordisk’s connected devices have on smaller companies designing dose capture devices (Companion Medical, Common Sensing, Bigfoot)? Will Novo Nordisk allow its cartridges to be used in other connected durable pens (e.g., Companion Medical, Pendiq)?
Q: How will the market segment develop between NFC-enabled pens optimized for clinic-upload vs. Bluetooth-enabled, patient-upload smart pens? Which will drive better outcomes? Which will patients prefer? Which will healthcare providers prefer?
Q: How long will it take for connected pens to get to 5% penetration globally? Will connected pens see higher uptake than insulin pumps? How soon will the majority of MDI users have connectivity in their injection/pump devices?
Q: How will Novo Nordisk progress into the realms of diabetes bundles, coaching, and outcomes-based contracting in the coming years?
Q: How will Novo Nordisk’s smart pen offerings compete with Lilly? What will Sanofi do on the connected pen front? Which company will add the most digital value to insulin?
Q: What kind of outcomes can smart pens/decision support deliver vs. automated insulin delivery with pumps? What will payers reimburse for? Will great smart pens/decision support put pricing pressure on the pump/AID market?
-- by Brian Levine, Adam Brown, and Kelly Close