Just a matter of time

Just a matter of time

This morning Novo Nordisk (NYSE: NVO) released results from their SCALE study, according to a company issued press release;

“Results from a post hoc analysis of the three-year part of the phase 3a SCALE (Satiety and Clinical Adiposity – Liraglutide Evidence) Obesity and Prediabetes trial show that people treated with Saxenda® (liraglutide 3 mg) experienced consistent weight loss and improved blood glucose control across baseline body mass index (BMI) categories over three years as compared to placebo treatment. These data were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) 2016.”

What’s noteworthy about the results is the use of the phrase Prediabetes. It’s well known that diabetes continues to grow at epidemic rates. But it is also true that prediabetes is not recognized as a disease state, hence physicians cannot prescribe therapy options to treat it. Herein lies the problem for drug companies like Novo, how do they market and get reimbursed for a therapy option for prediabetes.

Years ago when the term prediabetes began appearing more regularly Diabetic Investor speculated that given the size of this market it was only a matter of time before drug companies began targeting this market. That the number of patients with “prediabetes” was just too large to ignore. Even though not officially recognized as a disease state there is near universal agreement that preventing patients with “prediabetes” from developing full blown diabetes has many benefits.

Fast forward to today with the diabetes drug market commoditizing and what better way to sell more drugs than by targeting a huge market. Perhaps the best way to think about this is think of the oil industry. Back in the 70’s during the oil crisis when everyone thought the world was running out of oil the industry reinvented itself coming with new drilling techniques. The price of oil was skyrocketing making these new techniques economically feasible. Today the world is once again awash in oil with prices coming down from the stratosphere.

Don’t get us wrong here we see nothing nefarious about drug companies targeting patients with “prediabetes”. There is no question there are benefits from preventing patients with “prediabetes” from developing full blown diabetes. However as large as this market is it will have the same issues as the market for diabetes drugs. Novo may be ahead of curve by officially studying the impact of their therapy options on “prediabetes” but that will change in a hurry. Soon everyone in diabetes drugs will do so.

To Diabetic Investor this is just the continuation of a trend we noted some time ago. When it comes to getting favorable formulary placement drug companies are looking for any edge they can get. In the old days it was good enough to show that patients using a drug experienced improvements in HbA1c. Today drugs must also show no adverse cardiovascular events, be weight neutral and soon show improvements to glycemic variability. Big data has come to the diabetes drug world.

This reminds us of when Red Auerbach, the famous coach of the Boston Celtics lobbied for rule changes that favored his style of play.  Changes which ultimately help create the Celtics dominance. In many respects this is what Novo and others are trying to do, change the rules of the game by targeting their therapy options at a larger market. Even though “prediabetes” may not be a disease today we suspect it’s just a matter of time before it becomes one.

The bottom line here is the bottom line. There is just too much money to be made by going after this market official disease or not.