The diabetes/weight loss drug is be evaluated in trials for pediatric patients who are at least 10 years of age.
Mary Taylor, PharmD, BCACP, CDCES, CPP, a clinical pharmacist and diabetes educator at Cone Health Medical Group Pediatric Specialists in Greensboro, NC, joins Pharmacy Times to speak on the impact of having access to different providers for patients. Taylor also speaks on the landscape of semaglutide and other medications indicated for weight loss and diabetes, including discussion on access barriers, regulations, and their use in pediatric patients. This is a conversation that is not to be missed.
PT Staff: How can diabetes care become less siloed?
Mary Taylor, PharmD, BCACP, CDCES, CPP: I honestly wish that somehow, some way, when you see primary care (because it's going to have to happen at the primary care level; patients with diabetes, they can't just go to endocrinologist, there's not enough room and there's not enough space for them) to [also], if possible, get a diabetes care and education specialist, dietitian, and pharmacist on the health care team— it’s putting these referrals in when patients get diagnosed so that they're being seen and followed up with.
For this to change, there will have to be advocating to our legislators about this change about how to do it, , there's probably going to have to be data to show that this is beneficial and can eventually save money in the long run because, if you get these patients controlled, there's going to be less hospitalization and less different disease states that they're going to have. So you're going to have to show that it's eventually worth it in the long term.
But being able to talk to your team and just put in referrals, I guess, is all you can really do right now. And I also think (and a referral that I didn't say that I feel strongly that we should also include as a mental health specialist) it's just going to be a lot of lobbying and advocating for patients and just trying different models. Hopefully, with insurance changing for fee-for-service to quality metrics, that they'll do more of these things.
PT Staff: There's been a surge in the use of semaglutide (Ozempic; Novo Nordisk) for diabetes, and it's also indicated for weight loss, so you don't have to have diabetes to use it. Is this having any impact on the care of patients with diabetes?
Mary Taylor, PharmD, BCACP, CDCES, CPP: It definitely is impacting both of our patients, and it's unfortunate because both populations need this medication, right, whether they are using it for weight management or for diabetes. The differences though is, if someone [weren’t able to] use it if for weight management, they're going to have to try diet and exercise. But if our patients with diabetes can't use it, you have to modify [treatment] with another therapies.
There's been a ton of backorders going on; I don't think the companies anticipated this much of a demand for the agents. So sometimes they'll have to go back on insulin until we can go up on their dose because they can't get it from the pharmacy. Some patients completely can't get it from the pharmacy and don't get in touch with their doctor—then they are at increased risk of going to the hospital because they're not taking anything. So there is huge concerns with that as well.
I [also] think insurance is a huge barrier too. With insurance—it depends on when you filled it, what strength you're on, and what it's being used for—you can't just switch back and forth all the time between like Ozempic and semaglutide (Wegovy; Novo Nordisk), even though they both [have] the same generic, semaglutide. I wish that these manufacturers could keep up with the demand or put stricter regulations on who's using it so it doesn't get misused. It does require prior authorization for weight and diabetes management, which I think helps, in some sort, [since] it is putting some sort of restriction that you can't get it. But it's [generally] just really sad because [not having access is] hurting patients, both who use it for weight [management] and for diabetes.
PT Staff: When it comes to what you were saying earlier with younger populations, are these medications being studied?
Mary Taylor, PharmD, BCACP, CDCES, CPP: Dulaglutide (Trulicity), which is made by Eli Lilly, exenatide (Bydureon) which is made by AstraZeneca, and liraglutide (Victoza; Novo Nordisk) are all FDA-indicated for the pediatric population. Now Wegovy, which is semaglutide, FDA-indicated for weight loss in [children aged] 12 and older. But Ozempic hasn't been studied. Technically that data coming out soon— I think the PIONEER TEENS trial is [where] it will be studied— and if it's being used for diabetes, it's [indicated for children aged] 10 and up, and if it's being [used] for weight, it's age 12 and older.
[Studies] have shown it's beneficial, but [these] other studies aren't as long-term to necessarily say that [these medications are] going to prevent complications like they do in adults; that data must be extrapolated, essentially, because our trials aren't as long and they're not going to be as robust in the pediatric population.
We can assume it's likely going to cause that, especially from the TODAY2 trial that came out a couple of years ago, [which] shows that [the condition is tied to] worsening metabolic syndrome in pediatric patients. So there is a huge need for these medications at that age, but this also makes it hard because they can't get the medications either.
So I feel like people need them both for obesity and type 2 diabetes. And the American Diabetes Association (ADA) guidelines and other guidelines have been pushing more towards looking at obesity like a chronic disease state; if you're obese, and the longer you stay obese, the more likely it is that you're going to start getting other complications with it. It is very important, and I think we're seeing too that, in society, some piece of obesity must be, I feel, genetic. There are people who just cannot gain or cannot lose weight [and] we don't really understand why. So, these patients are at risk, I feel like it's good that they're being used in pediatrics to help. But since we can't get them stably, it makes things hard to adjust their therapy.