Denmark-based news site MedWatch published a new article announcing the official launch of Novo Nordisk’s connected insulin pens in Sweden. According to the article, the launch officially began in “early March,” and will “soon be expanded to Western Europe and many other countries.” Per a Swedish press release published earlier this month, the official launch kicked off on March 9th. The initial launch in Sweden makes sense, given Novo Nordisk’s previous work in the country (see pilot results presented at ADA 2019), as well as the country’s high adoption of data-generating and digital technologies (84% of adult type 1s and 94% of pediatric type 1s use CGM).
The long-awaited Novo Nordisk connected insulin pens have been CE-Marked since 2018, with original expectations to launch in early 2019. Following the initial small-scale launch in Sweden, Novo Nordisk chose to recall the pens due to “rare instances” of a memory function issue. At DTM 2019, we heard that the company aimed to launch the pens again in 2Q20, but heard few updates until the most recent launch in March 2021. Regardless, Novo Nordisk has clearly invested a considerable amount of time and effort into getting these pens right and, if things go to plan, should have a head start over its insulin manufacturer competitors in entering the connected pen space.
NovoPen 6 and NovoPen Echo Plus are reusable (durable) insulin pens compatible with all Novo Nordisk’s insulin cartridges. The pens display the dose of the last injection and time since the last injection on the end of the pen (see images below), which supports users in determining their insulin on board and in making dosing decisions. The pens have an 800-dose memory and NFC connectivity, which enables integration with other companies’ apps and platforms, although notably, Novo Nordisk does not have a designated app for its connected pens. It took us a little while to figure this out.
What’s next for Novo Nordisk? As far as we know, Novo Nordisk has not yet submitted either connected pen to the FDA. Of course, executing on the launch for NovoPen 6 and NovoPen Echo Plus in Europe is priority for Novo Nordisk right now and should provide valuable learnings for the company when it ultimately launches in the US. To support disposable pen users, Novo Nordisk has a connected pen attachment in its pipeline. Finally, at DTM 2019, Novo Nordisk displayed a roadmap slide seeming to suggest three “digital therapeutic” projects in the pipeline. Given Novo’s wide-ranging data partners (e.g., Roche/mySugr, Dexcom, Glooko, Abbott, and Medtronic), Novo Nordisk seems well-positioned to bolster its strong insulin portfolio by providing further support around insulin initiation and titration through software.
NovoPen 6 and NovoPen Echo Plus are reusable (durable) insulin pens compatible with all Novo Nordisk insulin cartridges (both basal and bolus). The pens display the dose of the last injection and time since the last injection on the end of the pen (see images below), which supports users in determining their insulin on board and in making dosing decisions. With an 800-dose memory and NFC connectivity to the platforms of companies connected to Novo’s digital health ecosystem, NovoPen 6 and NovoPen Echo Plus also make it easier for patients to log data and to keep track of their long-term insulin injection patterns. The only notable difference between NovoPen 6 and NovoPen Echo Plus is that while NovoPen 6 has dose adjustments down to 1U of insulin with a 60U maximum dose, NovoPen Echo Plus offers 0.5U dose adjustment increments and a 30U max dose, which makes it better suited to those with low insulin needs or low body weights (e.g., young children). Both pens have a “guaranteed lifespan” of 3+ years without charging.
NovoPen 6 and NovoPen Echo Plus are integrated with “patient-facing apps” including Glooko’s DiaSend app to which data is sent via NFC connectivity, but do not have their own designated Novo Nordisk apps. Later, the pens’ data will also be integrated into Roche’s mySugar and Abbott’s Freestyle Libre applications, although the timeline was undisclosed. Novo Nordisk has also launched a new developer site, which will allow additional app and solution developers to integrate its connected pen data into their platforms. This is a very welcome follow-up from Novo Nordisk’s plan in 2018 in that it allows patients to access their data both on the pen (as was planned) and in mobile apps, in addition to transferring data to Glooko for provider access via an NFC-enabled pad (Glooko Kiosk). However, we were surprised to learn that Novo Nordisk will not at this stage have a designated app for its smart pens, although we can appreciate that data integration into existing apps and platforms reduces the number of platforms a patient needs to go to for data access. Given that NovoPen 6 and NovoPen Echo Plus are NFC-enabled (rather than Bluetooth-enabled), we would speculate that users may scan their pen a la FreeStyle Libre, although with the 800-injection memory, users will likely not scan as frequently as with FreeStyle Libre.
With this spring’s launch, Novo Nordisk is actualizing its data sharing partnership with Glooko and eventually, Roche. While it is unclear what these partnerships will look like exactly, Novo Nordisk has had a long-standing agreement with Glooko to integrate NovoPen 6 and Echo Plus data into Glooko’s data management platform since 2017 and shared plans to integrate NovoPen 6 and Echo Plus data into Roche’s mySugr app and Accu-Chek SmartPix software in 2018. At the time, Novo Nordisk suggested that the companies may use the insulin dose data to drive decision support down the line, although we haven’t heard updates of that potential since then and that opportunity went unmentioned in the launch announcement. As a reminder, Novo Nordisk also has data integration agreements with the three major CGM companies (i.e., Abbott as of February 2019, Dexcom as of October 2018, Medtronic as of September 2019). Today’s article mentioned that the company’s partnership with Abbott “will come into force at a later time,” and did not allude to its agreements with Medtronic and Dexcom. When we connected with Novo Nordisk VP of Commercial Innovation Dr. Andres Dyhr Toft, he did not offer any commentary on these two partnerships. We will report back on other partnerships if we learn anything official.
The Swedish real-world study (n=94 type 1s) presented at ADA 2019 and published in DT&T showed that use of NovoPen 6 significantly increased Time in Range by +1.9 hours/day from 38% at baseline to 46% at two weeks, reduced time in hypoglycemia (-18 min/day), and decreased missed bolus injections from 25% to 14% two weeks after baseline, which are impressive results particularly if Novo Nordisk can provide data showing a more long-term improvement in Time in Range, hypoglycemia, and bolus dosing. As an aside, we’re very impressed by Sweden’s National Diabetes Register and its inclusion of CGM metrics like Time in Range, time in hypoglycemia, mean glucose, and standard deviation of mean glucose – this is so important to drive CGM uptake and use by providers. We hope that one day, EMR integration in the US will allow all endocrinologists to easily know their clinic’s average Time in Range, as they do with A1c.
The European launch of Novo Nordisk’s NovoPen 6 and NovoPen Echo Pen Plus smart pens makes Novo Nordisk the first major insulin manufacturer to offer its own connected pen technology, lending it a unique position in the competitive landscape. The opportunity for connected insulin pens is certainly there: estimates from Medtronic suggest that the total addressable MDI market for connected pens is at least 12X that of Medtronic's insulin pump business; from both a financial and public health perspective, we expect numerous players to be involved long-term. Presumably, having more MDI users using Novo’s smart pens will also give Novo Nordisk more insight into how its patients are using insulin in real-world settings. Combined with glucose data, these smart pen devices should generate a valuable set of real-world data for Novo Nordisk to learn from and drive better patient and provider satisfaction and outcomes.
Currently, the smart pen market is led by Companion’s InPen which was acquired by Medtronic in August 2020, but in addition to Novo Nordisk, Lilly has also made recent public announcements about its efforts in the area. Sanofi also appears to be working to develop smart pen systems of their own. There are also a number of smaller players in the European smart pen market including most notably, Biocorp and Common Sensing who both have partnership agreements with Sanofi.
While popular wisdom may suggest that Medtronic’s InPen is likely to face increased market pressure as Novo Nordisk expands the launch of its smart pen technology outside Sweden, we’d certainly say that there is more than enough room for everyone – particularly for two giants! Medtronic’s current smart pen efforts, which have mainly been centered on expanding InPen uptake in the US, include data integration with Medtronic’s Guardian CGM as well as concerted efforts to “close the loop” for MDI patients by leveraging AI algorithms, InPen, and future CGM technologies. Specifically, Medtronic has plans to integrate InPen with its AI-based food and activity tracking algorithms Nutrino and Klue. While Novo Nordisk does boast data sharing partnerships with Abbott and Dexcom, it’s very likely that a fair number of Abbott and Dexcom’s customers already use closed loop technology. Figuring out how many patients will welcome “opening the door for CGM integration” in the near future will be key – the number of people with diabetes not on pumps or closed loop already is one number to calculate, as is the number of current insulin users on MDI as well as future users. As a reminder, in September 2019, Medtronic partnered with Novo Nordisk to integrate its own CGM data with Novo Nordisk’s smart pen systems. Presumably, this will still go forward. To date, Medtronic hasn’t shared any public timelines on OUS launch of InPen; while Medtronic’s global footprint might suggest such a launch is inevitable, we also wonder whether Medtronic might keep the focus on the US. Ultimately, we’re unsure how Novo Nordisk will be collecting and analyzing food data and exercise data. We see them behind Medtronic and Companion on this front, given Medtronic’s previously mentioned AI-based food and activity tracking algorithms Nutrino and Klue. That said, given Medtronic’s jump on integrating CGM and food and exercise data, it also may decide to focus more on the US due to higher margins in the US – we doubt it, but anything could be possible.
Eli Lilly and Sanofi have both shared plans to develop and commercialize smart pen technology. Last month brought substantive updates on Lilly’s smart pen efforts when the company announced a collaboration and licensing agreement with Welldoc. Lilly aims to submit a pen attachment and insulin management app to the FDA “later this year,” with Welldoc’s help in building out the custom smartphone app solution. At the time, we also confirmed that the Lilly/Welldoc solution will also support automatic integration with Dexcom CGMs. Sanofi has been a bit less open about its smart pen strategy, but given the company’s remarks at JPM 2021, some sort of digital health strategy seems certain, such as building its own connected pens and titration apps as suggested in September 2019. Sanofi already has data sharing partnerships with Abbott, and the company’s December 2019 announcement that it would discontinue diabetes therapy R&D did not reflect its approach to digital, though we don’t know the exact specifics.
Biocorp’s Mallya smart insulin cap launched in Europe in November 2020. Biocorp is currently backed by Sanofi, and Sanofi has worldwide non-exclusive distribution rights to Mallya. Currently Mallya is only commercially available in Romania, but is expecting to launch in France with partner Roche Diabetes Care in “early 2021.” As a smart cap, Mallya is compatible with disposable insulin pens including Novo Nordisk’s FlexPen.
What’s next for Novo Nordisk?
Looking ahead, there are a number of related efforts in Novo Nordisk’s pipeline that went unmentioned in today’s article.
As far as we know, Novo Nordisk has not yet submitted either connected pen to the FDA. Of course, executing on the launch for NovoPen 6 and Echo Plus in Europe is priority for Novo Nordisk right now and should provide valuable learnings for the company when it ultimately launches in the US. It’s also worth noting that durable insulin pens are less popular in the US, where more MDI users opt for disposable pens. (This could be informing Lilly’s strategy of working on its connected pen attachment first – see above.) Still, the reusable form factor did not seem to affect the growth of InPen, the first and only FDA-cleared connected pen available in the US.
To support disposable pen users, Novo Nordisk has a connected pen attachment in its pipeline. Like the timing for the durable pens, the timing for the connected pen attachment has changed over time. To our understanding, the attachment resembles a pen cap and will be compatible with Novo’s FlexTouch. When we got a look at a prototype device at EASD 2019, the device had Bluetooth connectivity and could detect the type of insulin being delivered by the color of an exposed plunger. The device has no on-body viewing, meaning data viewing takes place on a smartphone app.
At DTM 2019, Novo Nordisk displayed a roadmap slide seeming to suggest three “digital therapeutic” projects in the pipeline. Back then, Novo Nordisk’s Corporate Vice President of Commercial Innovation Dr. Anders Toft didn’t share many details, but suggested the projects were being worked on “very actively.” During our Q&A with Dr. Toft, he shared that Novo Nordisk is working on a digital solution to support those starting on basal insulin in “self-titrating” their insulin dosage. Per Dr. Toft, Novo Nordisk will share more on the solution “later this year.” Given Novo’s wide-ranging data partners (i.e., Roche/mySugr, Dexcom, Glooko, Abbott, and Medtronic), Novo Nordisk seems well-positioned to bolster its strong insulin portfolio by providing further support around insulin initiation and titration through software.
Close Concerns’ Q&A with Novo Nordisk VP of Commercial Innovation Anders Dyhr Toft
Q: Was there any official announcement from Novo Nordisk about the Sweden launch? When did it officially commence?
A: Yes indeed, on March 9th, the launch was announced in a press release in Sweden, which shared that our connected insulin pens were now available to people with diabetes across Sweden as the first country.
Q: What is the scale of the launch in Sweden (e.g., pilot at a few hospitals, etc.)? What are the key metrics Novo Nordisk is monitoring in the Sweden launch? Are there any timelines for rollout to other countries in Europe?
A: NovoPen 6 and NovoPen Echo Plus are generally available for everyone who gets a prescription to them in Sweden. People with diabetes in Sweden, who would like a connected insulin pen, should speak with their HCP.
Following the launch in Sweden, NovoPen 6 and NovoPen Echo Plus will become available in select European countries. Time frames will vary according to device, insulin brand and unique market regulations.
Q: What is the current manufacturing capacity for Echo Plus and NovoPen 6?
A: We are building up capacity to supply a range of markets.
Q: Have there been any changes in the feature set for either pen since the most recent update? Are the pens already integrated with Abbott, Dexcom, and Medtronic CGMs?
A: As shown on NovoPen 6 (novonordisk.com), NovoPen 6 and NovoPen Echo Plus are or will soon be integrated with the solutions from Glooko, Roche and Abbott. For further details regarding the plans with Dexcom and Medtronic, please reach out to the companies for a statement.
Q: Does the pen data go to Glooko, exclusively? Is there, or will there be, a Novo Nordisk-created software data management solution for providers?
A: In our strategic partnership with Glooko, we aim to more closely connect with how people with diabetes and HCPs manage the complexities of diabetes in the real world through digital solutions, including apps and HCP platforms like Glooko’s in-clinic solution. Glooko’s in-clinic upload box (labelled as Diasend or Glooko in the USA) consolidates data from more than 170 glucose meters, continuous glucose monitors, insulin pumps and activity trackers into one single dashboard that is visible to both HCPs and users at diasend.com.
In order to further facilitate the leverage of the NovoPen 6 and NovoPen Echo Plus data in different diabetes management solutions to the benefit for people living with diabetes and providers, we launched the Novo Nordisk Developer Portal in November 2020. The developer portal offers developers of apps, software systems and devices to connect their solutions to the Novo Nordisk’s connected insulin pens.
There are already 15+ companies connecting their solutions with our connected insulin pens besides our five global partners.
Q: Is there any timeline for FDA submission and launch of the smart pens in the US?
A: Following the launch in Sweden, our connected insulin connected pens will first become available in select European countries, and with regards to North America, we do not reveal any specific launch plans.
Q: What is the status of Novo’s re-usable pen attachment device?
A: We are developing a smart add-on device for pre-filled insulin pens which is now in the final development phase.
Q: Does Novo Nordisk still have plans to build out its own digital therapeutics (see DTM 2019)?
A: We are working on a digital therapeutics solution to help when people are starting on basal insulin. The solution aims to extend the advice and guidance of HCPs, as their patients adjust or ‘self-titrate’ their insulin dosage. We are looking forward to sharing more information about it later this year!
--by Hanna Gutow, Katie Mahoney, Albert Cai, and Kelly Close