The last battleground

The last battleground

“Currently more than 30 million people in the European Union have diabetes. Many of these individuals manage the disease by taking multiple, daily insulin injections. According to a recent publication, half of all patients requiring multiple daily injections intentionally skip doses because they consider the injections embarrassing, inconvenient, painful and/or disruptive to their daily activities. Adhering to prescribed insulin therapy regimens is important, because tight glucose control is vital to reducing the risk of long-term type 2 diabetes complications. Studies indicate that simple, continuous insulin-infusion regimens may improve glycemic control and quality of life among individuals with type 2 diabetes.”

The above statement comes from a press release put out today by CeQur, who received a CE mark for their PaQ® Insulin Delivery Device. The PaQ® is yet another in a series of what Diabetic Investor likes to call dumb pumps. Like the V-Go from Valeritas the PaQ delivers a constant amount of insulin while allowing the patient to administer additional insulin by the press of a button. As their press release indicates the PaQ, like the V-Go, is targeted at type 2 patients following multiple daily injection therapy (MDI).

While Diabetic Investor does not dispute that patients following MDI sometimes skip injections or that it’s important for these patients to follow their prescribed therapy regimen, we remain unconvinced that using a dumb pump will improve therapy compliance and ultimately lead to better overall patient outcomes. Nor do we believe that using a dumb pump is the simplest method for improving therapy compliance.  As we noted when Valeritas announced study results indicating that patients using their V-Go insulin delivery system achieved better outcomes, dumb pumps are just the latest in series of products that do the exact opposite of what they are intended to do; making the patient’s life easier.

Yet, what products like the PaQ and V-Go do indicate is the last battleground for diabetes devices are patients following MDI. As we have noted on previously nearly every glucose monitoring company either has or is working on glucose monitors that either contain a bolus calculator or seamlessly integrate with a smart phone which has a bolus calculator app. Sanofi (NYSE:SNY) is even going one step further and is developing an insulin pen that communicates with a smart phone. The goal here is admirable as the theory is armed with this information MDI patients will more effectively manage their diabetes and ultimately achieve better outcomes.

The fact is glucose monitoring companies know that it’s next to impossible to get a non-insulin using patient to regularly monitor their glucose levels. The same can be said of patients who use both insulin and oral medications. On the other end of the spectrum they see insulin pump patients, the most frequent testers of all, gravitating towards continuous glucose monitoring systems (CGM); which basically leaves MDI patients the most coveted patient of all. These same companies also see the future and know with the competitive bidding, decreasing usage and a growing sense that payors will no longer reimburse for patients not following insulin therapy that MDI patients are their last hope at making any money.

The same can be said for the many companies who are developing alternate insulin delivery systems. The common thread among all these companies is patients currently following MDI want simpler, more patient friendly systems which will make their lives easier, when in reality what these patients really want is not to be on insulin therapy at all. The fact is MDI patients already have a simple and easy delivery system, namely an insulin pen; a delivery system which is not only simple and easy but also discreet.  We’ve said it before and we’ll say it again the problem with insulin therapy, MDI in particular, is not the how the insulin is delivered rather the complexity and work involved.

This is the reason Lantus has become the world’s number one selling insulin and why Novo Nordisk (NYSE:NVO) will aggressively promote Tresiba ® and Ryzodeg®, when it comes to insulin therapy the less frequently the patient needs to administer their insulin the better. It is also the reason why there are so many companies working on faster acting insulin’s, insulin’s which could actually be taken after a patient eats and could possible limit hypoglycemic events. With these new faster acting insulin’s the motto is simple, get in fast, do the job and get out.

Still with all these new insulin’s and fancy devices the battle over MDI patients will likely come down to how quickly physicians embrace GLP-1’s. Again as we have noted on more than one occasion GLP-1’s have many benefits not the least of which is they are not insulin and don’t carry the baggage that insulin carries. The real question to Diabetic Investor isn’t whether physicians will convert their existing MDI patients to products like Bydureon, but how many they will convert. For those who doubt this will occur think of the choices a physician has when adding a therapy for a Type 2 patient who is failing using orals alone.

Before GLP-1’s, Lantus was the logical add-on therapy for much the same reasons GLP-1’s will continue to grow in popularity, it could be dosed simply and only needed to be dosed once a day.  Should Lantus fail to get the patient under control, the choice came down to adding an insulin blend or fasting acting insulin. Here’s where things get a little dicey for the patient and the physician, once beyond using Lantus alone more patient education and intervention is needed. All of a sudden things like regular glucose monitoring, carb counting, and the threat of hypoglycemia and weight gain all come into play. Largely ignored but also a huge factor is the psychological impact moving down this path has on a patient, far too many patients see the move towards insulin therapy as a personal failure or as an admission they have a serious disease. A belief that has been reinforced by their physician who has constantly warned them that if they didn’t follow their therapy regimen they would be forced to put them on the needle.

Although not perfect GLP-1 therapy takes away many of the issues with insulin therapy, simple dosing, and no need for glucose monitoring, weight loss not weight gain and little threat of hypoglycemia.  Now go back to our original question and think of the choices a physician has when moving from oral therapies alone to the additional of an injectable therapy, which injectable will they choose; the one which requires patient education or the one which can be taught in about 15 minutes?

This is just one more reason why existing MDI patients have become the last battleground for diabetes device companies as they are perhaps the last bastion of hope for these companies to make a living. We’ve said it before and we’ll say it again, the Type 1 population (patients who must follow some form of insulin therapy) is not large enough nor is it growing fast enough to support all the players in the diabetes device world let alone the many in the alternate insulin delivery arena.  There’s a reason Diabetic Investor calls these systems dumb pumps, because anyone with a working brain cell understands that it’s not how insulin is delivered that’s the problem, it’s the complexity of insulin therapy and lack of patient education that is. Dumb pumps are just the latest example of how some device companies have become enamored with technology, have failed to see the true needs of the patients while also ignoring the realities of the market.  It’s been said before but it’s worth repeating; there is no cure for stupid. RIBIT!!!!!