Troy Trygstad, PharmD, MBA, PhD; Dhiren Patel, PharmD; Javier Morales, MD, FACP, FACE; and Tripp Logan, PharmD, recognize current diabetes treatment guidelines and consider the role of newer options, such as sodium-glucose cotransporter 2 inhibitors.
Troy Trygstad, PharmD, MBA, PhD: We’ve come all of this way with all of these new therapies. We continue to learn more and more about the pathophysiology. We have guidelines that evolve as we learn more about the pathophysiology and continue to produce more and more novel, effective drugs. Dhiren, can you describe the ADA and AACE guideline developments and explain how the sodium-glucose cotransporter 2 inhibitors relate to the new guidelines?
Dhiren Patel, PharmD: Sure. This year, in the beginning of 2018, the ADA did a pretty decent revamp of their guidelines. Previously, they had recommended using metformin in the first-line setting. Then, after that, you had 5 or 6 options that you could use, but there was a drastic move from that traditional frame that they had. Now, because of a lot of these additional, newer trials, which are specifically based on the cardiovascular outcomes trials that we now have, you can ask yourself—as the clinician—the question of, does this patient have established cardiovascular disease? If so, you should be using one of the agents that demonstrates this positive cardiovascular data, and so that was a big shift.
It is getting a little bit more prescriptive or is giving us a little bit more of a push in terms of knowing that you need to kind of go where the data are. But if a patient doesn’t have established cardiovascular disease, then you’re obviously kind of free to pick from what is best for that patient.
If you compare that to the AACE guidelines, they’ve traditionally had this hierarchy model based off of the strength of evidence that was out there. And so, up until after first line, which both guidelines agree with, it was just metformin. The AACE guidelines support adding a GLP-1 receptor agonist, but right underneath that are the SGLT2 inhibitors. So, you can kind of see that they elevated that over the years, specifically relating things to the more recent trials that have come out.
Javier Morales, MD, FACP, FACE: It used to be that the DPP-4 inhibitors were below GLP-1. As you mentioned, on the body of this new evidence, the SGLT2s actually came up.
Troy Trygstad, PharmD, MBA, PhD: So, we have increased knowledge and pathophysiology, which leads to new and better drugs to treat, which leads to new guidelines that are based on evidence. But then that final mile is, how does it change practice? Tripp, with all of these new therapies out there and new guideline evolutions, let’s use this example of urine glucose present. For the average practitioner who is keeping up with all of the new pathophysiology, drug developments, and the new guidelines and evidence, how does that translate to practice? Do you have any advice for practitioners out there, to keep abreast of all of this new information?
Tripp Logan, PharmD: A lot of times, in our community practice, we’ll see multiple providers with varying levels of understanding of current guidelines. Half of our patients are being treated with 3 or 4 iterations of the current guidelines. Then we’ve got some really aggressive prescribers, who are on top of it, that are working. So, it’s job security for us because we’ve got a lot of education to do—not only guideline-based but also with these patients who are coming in. Maybe they’re somewhat stable, but this cardiovascular indication is a benefit. So: “Why is my medicine changing? It’s more expensive than it was” or “Hold on—sugar in the urine is bad. We’re supposed to protect my kidneys, but now there’s sugar in my kidneys. I’m really nervous. They’re telling me to worry about my kidneys.”
And so, these are all things that we’re working through in the field. We are not only trying to stay on top of the guidelines to make sure that we’re understanding what’s going on, but we also are relaying this message: “Something new has come out, and it’s for your benefit.”
Then there’s the whole factor—new typically equals a more costly out-of-pocket expense for a lot of people. In some situations, you’ve got people with nonformulary drugs with high deductible insurance. That’s another piece for us to navigate. It may be the best possible option for this patient, but if coverage is an issue, then it’s a problem, so that’s another piece of the navigation.
If somebody is used to metformin and the co-pay on metformin, and then one of these new products is a better option for them, but it’s costing them an extra $50 out of pocket a month, we’re in this cost-versus-benefit analysis. “What’s better for you? Is this going to get in the way of you having dinner this weekend? Is this going to impact your lifestyle at home?” Then we have to decide, is it really worth going down this path or not? So, we have a complex issue when these things come up.