This really is a game changer

This really is a game changer

Today’s news that Novo Nordisk (NYSE:NVO) is moving their oral GLP-1 into phase 3 trials has broader implications than just how this drug could impact the oral diabetes drug market. Should this drug gain approval its impact would spread into the insulin market and adoption of interconnected diabetes management (IDM). Let’s take a look at how it would impact the insulin market first.

Given that the majority of physicians follow a treatment to failure approach the normal pattern is to add insulin when a patient is failing on oral meds alone. This is one reason Lantus became the world’s number one selling insulin as it was the first insulin added after orals failed. Lantus also had the unique advantage of being dosed just once per day.

Yet adding insulin to the patient’s treatment regimen also carried with it some new risk factors, the possibility of hypoglycemic events plus weight gain. Yes when used as intend insulin therapy is very effective there is no disputing this fact. However insulin therapy besides coming with some additional risk factors also required greater patient education. In an attempt to offset this education requirement many physicians dumbed down insulin therapy basically instructing patients to inject X amount of insulin each time they eat or in the case of Lantus before they went to sleep each night.

Physicians understood that while it would be great if patients actually tested their glucose levels regularly, counted crabs correctly or understood concepts such as time to action or duration of action, this was just too much for the majority of patients to grasp. Physicians wanted insulin therapy to be as simple as possible. Many physicians felt it was bad enough these people would be injecting themselves each day, sometimes multiple times per day, and did not want to burden them with education even though it would be beneficial. It also didn’t help any that physicians didn’t have the time for education nor were they reimbursed for it. Keep in mind that over 80% of the patients with diabetes are treated by a primary care physician and NOT a diabetes specialist.

Another hidden issue with adding insulin to a patient’s treatment regimen is patients viewed this as a personal failure. That adding insulin even though beneficial was seen as they had failed at properly managing their diabetes. This is one reason the GLP-1 market has gained traction besides the many benefits we have outlined patients did not see adding this injectable as a failure because it wasn’t insulin. As crazy as this may seem it’s true.

With an oral GLP-1 at their disposal physicians who have become more comfortable with GLP-1’s will have one more tool in their toolbox before adding insulin. Basically an oral GLP-1 will replace injected insulin as the next drug added to the patient’s treatment regimen after the other orals have failed. There is no question, if approved, this drug will adversely impact the insulin market.

Another market impacted will be IDM. The premise behind IDM is that data will be transformed into patient relevant actionable information. That patients will achieve better outcomes because they are getting help. As we have noted in the past for IDM to be truly impactful and relevant it must apply to patients who aren’t using insulin. As we have stated in the past insulin using patients can take immediate action based on the information IDM provides. Non-insulin patients however don’t have this luxury, as they cannot take immediate and impactful action.

Let’s face some facts as everyone knows IDM as impactful as it could be was a tough sell for patients who don’t use insulin or those who aren’t following multiple daily injection (MDI) therapy. The simple fact is outside of insulin pump or MDI the majority of patients don’t test their glucose regularly. Heck many fail to test at all, a sad but very true fact. Well IDM is data dependent and with no data to analyze IDM is nothing more than another whiz bang technology that goes unused in the real world.

The presence of an oral GLP-1 or a system like the Intarcia exenatide pump makes IDM useless.  The reality is using a GLP-1 whether it’s injected as it is now or swallowed or pumped in as it will likely be in the future takes away the need for glucose monitoring. And without glucose monitor the cornerstone on which IDM is built IDM becomes useless.

Now this does not mean IDM does not have a place in diabetes management, there is no question it can be a valuable tool. However what it means is that IDM will be limited mostly to insulin using patients a large market for sure but nowhere near as large as the non-insulin market. In effect IDM will have the same problem as the conventional glucose monitoring market, too many companies chasing a finite group of patients.

This is another reason we see this news by Novo as game changing as it has the potential to impact the entire diabetes market. Yes things are getting very interesting indeed.