Dex Com announced approval this morning (March 27) for its STS (short-term sensor). We applaud the company for moving quickly through the regulatory landscape. We love the bold strategy of getting the product out to the marketplace and attempting to prompt reimbursement by ensuring sufficient market adoption - excellent! (We see this as trying to just go up against managed care - we hope it works. Although managed care is hard-core, we would also submit this is a difficult patient population to spurn. Who wants to say no?).
Although the company won't announce pricing, we would look for something around ~$4000 - $5000 annually all in (including system, sensors, calibration strips); while this is a big number, any hyperintensively managed patient is already spending well over half that on strips, wtihout nearly the same value. Just assume one fewer severe hypo a year, and the device has paid for itself multiple times over.
What we like best - the device sounds easy to teach and learn and sounds small. Biggest barriers to traditional pump use are healthcare providers and size of the pump - with this product, both issues may be, if not moot, not as important.
We like the fact that this approval comes at a time when advocacy groups are ever more important; we wouldn't want to be on the opposite side of JDRF right now. Would you?
Last, what was exciting was the approval for hospital use as well as home use. Potential in the hospital for what we've been calling VTGC (very [in italics] tight glycemic control) is exciting, since the evidence is overwhelming on what a difference this makes on morbidity and mortality - see our Feb/March DCU for more on this "Do hospitals really care about diabetes care?"
Onward and upward. Now, the big challenge is CMS and we hope the data can be created that will convince them to create a code and that will persuade payors to cover it. If that happens, we believe a thriving commercial market - and even more innovation - will come to pass. From a patient perspective, here's hoping ~ ...