The Intersection of Cost and Efficacy in Allografts

David Armstrong, PhD, DPM, expands on a recent study looking at the cost effectiveness of DHACM in treating lower extremity diabetic ulcers, and how the results might translate in the clinic and for payers.

This is the second of 2 videos with Dr. Armstrong as part of an Advances campaign. For additional content, read more here.

Transcript

I'm David Armstrong. I'm Professor of Surgery at the Keck School of Medicine at the University of Southern California. It's a pleasure to be here today with you.

There's really two studies that kind of go together that sort of fascinated us and fascinated me personally to try to get a broad based overview of really the effect of so-called skin substitutes on lower extremity diabetic ulcers specifically, but really in general, across the United States. And one of the ways we could potentially do that was by looking at the Medicare database. And initially this last year, we did that in a study looking at the database over from I think 2015 to 2018, give or take.

And what we saw in that evaluation, when we looked at people that received skin substitutes versus those that did not, all else being equal, there was a really significant reduction in major amputation and even minor amputation and emergency department use and hospital readmission, compared to lower extremity diabetic ulcers that did not receive skin substitutes. And what we saw as well, is that when folks were using the product as best as we could derive, according to the best available instructions for use or applying it in a certain amount of time and a certain spacing, we saw an even bigger net protective effect in that patient population.

That was followed by more specific one that was led by Bill Tettelbach and coworkers. And in that study, we looked at one brand, one specific form factor of skin substitute, which was dehydrated human amnion chorion membrane or DHACM, I think we need to buy a vowel with that acronym, in lower extremity diabetic ulcers. And in that study, we added a year onto there, we went from 2015 to 2019. And in that study, we applied relatively similar analysis plan. But in that one, what we found was out of initially I think more than 10 million folks with diabetes, I think a million and maybe 1.2 million or so, by memory, had a lower extremity diabetic ulcer. And then we developed these propensity matched groups with between 19 and 20,000 in each of those groups. What we found in that study, fascinatingly, was that those patients that had that specific form factor had significantly reduced costs and improved clinical benefits compared to just good quality therapy, or at least the therapy that we could measure in the other arms that did not receive that.

And we saw it as well there, reduction in major amputations, emergency department visits, inpatient admissions and readmissions, and those clinical gains were seen remarkably at a lower cost over a five year period, which was, to me, I guess you'd say, I was really pleasantly surprised because typically, what we see with many products is the less you need them, the better they work. And when you start looking at cost effectiveness and cost efficacy across a large patient population, well sometimes it's hard to sort of divine that.

Here, I think what we're seeing, writ large, is significant promise coming out of this space, especially as we're moving from kind of a widgetized, kind of per patient sort of regime, to where companies are getting paid based on the number of products that they sell and people are doing more and more procedures. I think that's fine, but I think it's a little crass. I think as we start to see some of this cost efficacy, we're starting to see that for as we move into maybe a pay for performance kind of regime, not only in the United States, but around the world, that we're going to start to see maybe real promise coming from using some of these therapies earlier and in the right patient population. And I think some of these data from these two studies, that is to me, some of the first kernels of evidence to support some of the randomized controlled trials that we've already seen.

This one specifically was focusing on cost. Well, in general, was focusing on some of the other data that we looked at, but specifically looking at cost effectiveness and it was focusing on one specific form factor of skin substitute. In this case, it was the dehydrated, the human chorion, amnion membrane allograft, versus in the last study, we looked at all coded skin substitutes, and we also added on one extra year of analysis for this one because we had it in the data set when we were analyzing it. One was 2015 to 2018, the other was 2015, I think, to 2019.