Amid Uproar Over Term Artificial Pancreas, How Will Patients, Payers Respond?

When Time names a medical device one of the year’s top 25 innovations, patients generally have reason to celebrate.¹

But influential voices in the type 1 diabetes mellitus (T1DM) community scoff at claims that the MiniMed 530G system is a game-changer and see the fawning media coverage as proof that Medtronic has failed, perhaps intentionally, to explain its product clearly.

What should have been a major boost for both Medtronic’s sales and its reputation may, thus, prove a disappointment. Sites like DiabetesMine echo with harsh words for Medtronic officials who decided in September to apply the attention-grabbing label of “artificial pancreas device system”² to the 530G because of its 1 major innovation—integration between pump and sensor that allows the system to automatically pause insulin delivery if blood sugar readings fall too low.

Only time will tell whether such critiques fully offset flattering main-stream coverage, or what effect any media coverage has on the purchasing choices of patients who must also weigh insurance coverage, doctor recommendations and other factors.

“Time magazine still matters a lot, but DiabetesMine probably matters more these days from a commercial perspective. A huge percentage of the tech-lovingpump users who constitute the target market for any innovative product read these blogs and respect the knowledgeable people who write them,” said Kelly Close, editor-in-chief of the newsletter diaTribe and president of healthcare information firm Close Concerns.

“That said, it’s hard to imagine the anger over Medtronic’s marketing entirely negating the benefit it sees from this system, which has won rave reviews and sold extremely well in Europe. It’s possible to debate whether the 530G system really constitutes a major step toward an artificial pancreas, but there is absolutely no doubt that it constitutes an important step. And, you can’t dispute that it’s a huge improvement over the system it replaces.”

Among the roughly 26 million Americans with diabetes, fewer than 2 million have type 1 diabetes mellitus (T1DM),^3,4 and only a small fraction of them compensate for their lack of insulin-producing pancreatic cells with continuous subcutaneous insulin infusion delivered by pumps that have been paired with separately-purchased continuous glucose monitors (CGMs). Still, with new pumps costing roughly $7000 apiece⁵ and needing replacement every 5 years or so, roughly 300,000 American pump users (and their insurers) probably spend more than $400 million a year on such systems and then another $250 per month, per patient, on supplies.^5,6 (Exact numbers are not publicly available. Manufacturers do not break out sales of insulin pumps from other products, nor do they divulge the exact prices they negotiate with payers.)

Medtronic dominated the US pump market for many years, but observers say the competitors such as Tandem or Insulet or Animas seem to be building market share of late by touting innovations that range from less painful needles to more intuitive controls. On the sensor side, Close said that surveys conducted by dQ&A, a sister company to Close Concerns, likewise found Medtronic losing ground, in this case to its only main competitor, Dexcom.

The 530G system was designed to fend off this competition not just with better technology but also with its indivisible have mixed and matched pumps and sensors from different manufacturers as desired. The 530G, however, is the first integrated pump-and-sensor combo approved by the FDA as a combo rather than component parts (though the Animus Vibe system has been submitted for approval and others are under development). In most cases right now, patients report that those who want either component must buy both.⁷

Of course, the reason patients would want either component, or both, is improved technology. The 530G comes with a much improved glucose sensor dubbed the Enlite and “threshold suspend,” a first-in-class feature that many believe to be the first significant step toward the Holy Grail of T1DM treatment: a closed-loop treatment system that would perform automatically, just like a healthy pancreas.

Insulin pumps that are paired with CGMs typically use alarms to prod users to start pumping insulin when sugar levels get too high and stop when the insulin from the pump is pushing sugar levels too low. There’s always a risk, however, that the low-sugar alarm will fail to prompt users to switch off the machine before they suffer ill effects, which can range from short blackouts to diabetic comas. The biggest danger comes at night, when users often fail to hear the alarm because they have fallen into a deep sleep, either from normal causes or from the low blood sugar that triggers the alarm.

The 530G system seeks to minimize adverse events by pausing insulin delivery for up to 2 hours if the user doesn’t respond to low-sugar alarms. Trials undertaken to help win regulatory approval for the system in the United States and Europe have found significant benefits. The 247-patient ASPIRE trial, for example, found that the failure of the 121 patients in the threshold suspend group to heed nocturnal alarms triggered the automatic hiatus some 1438 times in just 3 months—a rate that exceeds 40 times per patient per year.⁸

As a result, nocturnal hypoglycemic events occurred 31.8% less frequently in the threshold-suspend group than in the control group. What’s more, the percentages of nocturnal sensor glucose values of <50 mg/dl, 50-60 mg/dl, and 60-70 mg/dl were all significantly reduced in the threshold-suspend group (P <.001 for each range).⁸

Even before Medtronic submitted the 530G system for approval, the FDA and diabetes research/advocacy groups had identified a 3-step progression from insulin pump to artificial pancreas: Threshold Suspend (automatically shutting insulin off), Control-to-Range (automatically keeping blood sugar from getting problematically high or low), and Control-to-Target (automatically keeping blood sugar at near optimal levels, just like a healthy pancreas).⁶

When it reviewed Medtronic’s system, the FDA felt the technology and its benefits merited a spot on the lowest rung of the ladder. Thus, when the FDA approved the 530G system, it labeled it not with pedestrian terms such as “integrated insulin pump and glucose sensor” but with language it had already devised for products that could automatically respond to low blood sugar: “OZO: Artificial Pancreas Device System, Threshold Suspend.”^6,9

Medtronic officials, in turn, believed the technology justified the FDA’s wording, so they used the same wording in their marketing materials and press releases.

“We in no way want the diabetes community to think that the MiniMed 530G with Enlite is a fully automated system,” wrote Amanda Sheldon, spokeswoman for Medtronic Diabetes, in an e-mail. “However, it is a critical first step along the path. It is the first system in the US to take action based on sensor glucose values in a particular situation.”

Medtronic’s decision to use the words “artificial pancreas device system” in its September 27, 2013, press release attracted attention from dozens of media outlets, though many of them seemed to miss all the caveats about the system’s limitations. A story posted by Detroit’s CBS affiliate begins thus: “It’s big news for millions of Americans with Type 1 diabetes. The FDA has approved the first artificial pancreas for those patients who can’t make their own insulin.”¹⁰

Another story, blogged at the website of Discover magazine, says, “Good news for diabetics: Last week the FDA approved an artificial pancreas device that could automate the arduous process of blood sugar regulation. … The gadget is wirelessly connected to a glucose monitor on the stomach that continually keeps track of a person’s blood sugar levels through a small needle.

Based on this data, the MiniMed’s automated insulin delivery system injects the appropriate doses to keep glucose levels stable.”¹¹

Similar stories still appear at reputable news sites across the Internet, though Medtronic says it has worked hard to find and correct erroneous reports. In other cases, such as the Time blurb that ranked the 530G among the 25 Best Inventions of 2013 (even though it won European approval in 2009), the brief story text is accurate, but the headline vastly oversells the device: “World Changing, The Artificial Pancreas.”¹

Backlash from many corners of the T1DM community appeared online almost immediately. Some criticism fell upon inept reporters and headline writers. Some fell upon the FDA for originating an easily misunderstood phrase like “artificial pancreas device system.” Even more, however, fell upon Medtronic for running with the FDA’s language.

“I don’t believe Medtronic was trying to mislead or make anyone think this is the artificial pancreas, but Medtronic’s use of the phrase ‘artificial pancreas device system’ was irresponsible and lazy,” said Mike Hoskins, a blogger for DiabetesMine and other sites, expressing his personal view. “Their excuse that it’s appropriate because of the FDA’s use of that language doesn’t hold water. They should know better. They should have known that language would be misinterpreted by media, the general public, and possibly even some in the D-Community who aren’t close to all this.”

Hoskins, who says the 530G’s marketing is one of several reasons he doubts he’ll ever use Medtronic products again, does believe that the 530G represents a genuine step forward and that the misleading marketing was accidental. Others aren’t so sure.

“The (Juvenile Diabetes Research Foundation) has divided the path to a real artificial pancreas into 6 steps¹² and this is, arguably, an imperfect implementation of the first step,” said Scott Hanselman, who has become an influential voice in the T1DM community despite blogging more about software than his disease.

“This device wouldn’t eliminate the need for me to do a single thing I have to do now with my older system, not a single thing. I’d still have to test my sugar frequently because the CGMs aren’t as accurate as finger sticks, which, frankly, aren’t all that accurate either. I’d still have to count carbs to calculate my insulin needs. I’d still have to pay constant attention to how my body felt for signs that my blood sugar was going awry.

“I’m not going to say there’s no value in the threshold suspend function, but to call it a major breakthrough seems like wild overstatement, and to use the words ‘artificial pancreas’ in any press release or marketing material associated with this product—well, I can’t really understand how any company could really be surprised when people assumed those words actually meant what a layman would expect them to mean.”

For all the reservations they have about Medtronic’s handling of the 530G’s launch, writers like Hoskins and Hanselman have never advised readers against the product. They merely advise potential customers to ignore misleading information and take all relevant factors into consideration before purchasing anything.

And there are many relevant factors beyond media stories, be they positive or negative. The most important for many users may be real-world reviews from fellow patients. Those reviews, when they begin to arrive in large quantities, will provide the clearest information on what type of patients see what level of benefit from threshold suspension. They’ll also reveal how the Enlite sensor compares with others.

Medical professionals will also exert influence over patient decisions, and they may provide a strong marketing service for the 530G. Medtronic has invested much in good relationships with doctors and it has also invested what is widely believed to be best-in-class software for doctors who want to upload and analyze data from CGMs. Public and private insurers, likewise,

will influence choices. Many insurers eventually provide some coverage for every pump approved by the FDA, but each one of them strikes a different deal with each provider and offers a different deal to members of each different plan they offer. For patients, even those whose plans are relatively generous, the costs can add up, so many go the cheapest route, even if it means foregoing their first choice device.

So far, Medtronic has been billing for the 530G exactly what it billed together for the predecessor insulin pump plus the previous sensor as it awaits a new HCPC for the system and begins the process of negotiating prices anew with payers.“Diabetes patients aren’t true consumers. We don’t necessarily buy the product we want. We buy the best product that makes sense, given our insurance,” said Kerri Sparling, who runs the blog Six Until Me. “You weigh all the factors, and you make the best choice available.”References

1. TIME Tech. The 25 Best Inventions of the Year 2013. November 13, 2013. http://techland.time.com/2013/11/14/the-25-bestinventions-of-the-year-2013/slide/the-artificialpancreas/. Accessed November 30, 2013.

2. Metronic gains approval of first artificial pancreas device system with threshold suspend automation [press release]. September 27, 2013. Medtronic Web site. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irolnewsArticle&ID=1859361&highlight=. Accessed November 30, 2013.

3. American Diabetes Association website. Diabetes statistics: data from the 2011 National Diabetes Fact Sheet. http://www.diabetes.org/diabetes-basics/diabetes-statistics/. Published January 26, 2011. Accessed November 30, 2013.

4. American Diabetes Association website. Diabetes Basics.Type 1. http://www.diabetes.org/diabetes-basics/type-1/ Accessed November 30.

5. Insulin pump therapy: guidelines for successful outcomes. American Association of Diabetes Educators 2008 Consensus Summit, September 18, 2008. http://www.diabeteseducator.org/export/sites/aade/_resources/pdf/Insulin_Pump_White_Paper.pdf. Accessed August 21, 2013.

6. Mehr SR. The next frontier for the artificial pancreas: payer coverage. Am J Manag Care. 2013;19(SP7):SPF235,SP257-259.

7. Hoskins M. Keeping it real on Medtronic’s 530G. DiabetesMine. http://www.diabetesmine.com/2013/10/keeping-it-real-on-medtronics-530g.html. Published October 8, 2013. Accessed December 2, 2013.

8. Klonoff DC, Bergenstal RM, Garg SK, et al. ASPIRE In-Home: rationale, design, and methods of a study to evaluate the safety and efficacy of automatic insulin suspension for nocturnal hypoglycemia. J Diabetes Sci Technol. 2013;7(4):1005-1010.

9. Caffrey MK. With MiniMed 530G, Medtronic seeks new CMS code. AJMC.com. October 1, 2013. http://www.ajmc.com/newsroom/With-MiniMed-530G-Medtronic-Seeks-New-CMSCode-.Accessed December 1, 2013.

10. CBS Detroit website. FDA approves first artificial pancreas for patients with diabetes. http://detroit.cbslocal.com/2013/09/27/fdaapproves-first-artificial-pancreas-for-patientswith-diabetes/. Published September 27, 2013. Accessed November 30, 2013.

11. Draxler B. First artificial pancreas approved to treat diabetes. Discover. http://blogs.discovermagazine.com/d-brief/2013/10/02/first-artificial-pancreas-approved-to-treat-diabetes/#.UpvzYmRDvxV. Published October 2, 2013. Accessed November 30, 2013.

12. Juvenile Diabetes Research Foundation. Artificial Pancreas Research Project. JRDF website. http://jdrf.org/research/treat/artificial-pancreas-project/. Accessed December 2, 2013.