Hello, everyone, and welcome to Prescribing Terzapatide for OSA, the Practical Implementation and Challenges, sponsored by the American Academy of Sleep Medicine. My name is Giuseppe Guillamello, and I'm a pulmonologist and sleep physician working at St. Luke's University Health Network in Bethlehem, Pennsylvania. I will be serving as the moderator and host in discussing terzapatide with our experts, Dr. Diana Plata from Rush University Medical Center and Carly Burdich from Midwestern University. They are joining us to help dissect what a clinical appointment should look like and to offer tips and discuss management challenges while prescribing this medication. Before I introduce our speakers, I'd like to remind you that our audio is muted and your video is off. We encourage you to include any questions on the topic for either the speaker in the Q&A section of the Zoom platform. The webinar is being recorded and will be shared with everyone that registered for the webinar. In accordance with the updated Accreditation Council for Continued Medical Education Standards for Commercial Support. All right, well, thank you. And thank you, everybody, for joining us. I just wanted to start briefly by having you all have the opportunity to just look over our learning objectives, which, again, today we'll be talking about the clinical indications and contraindications of terzapatide, the discussion of possible combination therapy, the discussion of framework for integrating obesity management for both short-term and long-term management, administrative challenges, and the risks and liabilities associated with compound medications and pharmacies as well. So first, I'd like to try and introduce our two speakers. This first is Dr. Diana Plata. Dr. Diana Plata is a graduate of Rush University Sleep Medicine Fellowship and is a board certified physician in internal medicine, sleep medicine, and obesity medicine. Dr. Plata leads a hybrid practice integrating comprehensive care for the patients with sleep disorders and obesity-related conditions at Northwest Community Healthcare in Arlington Heights, Illinois. Thank you, Dr. Diana Plata, for joining us. Thank you. Thank you. All right. And I'd like to introduce Carly Burge as well. Carly is a board certified obesity medicine specialist and an obesity medicine association fellow. She serves on the board of trustees for the Obesity Medicine Association and the Illinois Obesity Society and is the co-founder and immediate past president of PAs in obesity medicine. She practices obesity medicine at Healthy for Life in Naperville, Illinois, where she is also the director of clinical education. Carly, thank you so much for joining us as well. Thanks for the invitation. Thank you. So I'm very, very excited to host you both. I'm very excited for what you have to offer for us upon these discussions. So let's get started without further ado. Oops. Okay. So I just kind of wanted to start with the fact that there's been a lot of angst, I would say, and a lot of consternation for multiple sleep physicians that I've talked to about the prospect of implementing this into their practice, right? And I think that part of that is there's a lack of complete understanding. So I think that the easiest way to tackle this problem is to kind of take it through something that we do every single day, which is a patient encounter, right? So we'll divide it into sections as if we're walking through an encounter with our patients, talk about the pre-charting to kind of get an idea of what the patient is who's walking in the door, then talk a little bit about the encounters, both in the discussions with the patients, the implementation and planning for the patient, talk a little bit about the collaboration that's necessary, and then obviously the post-encounter management immediately as well as long-term. So I think there's a lot that you guys will be able to offer, and I think by talking through each one of these things, we'll be able to quell some of that anxiety, all right? So let's move forward. All right. So Deanna, I'd like to start with you, if that's okay. And what we're going to talk about here is in our pre-charting. So the patient that's hitting the door, okay? So I wanted to kind of get a sense because, you know, you've had this hybrid practice going for a bit. So you kind of have an understanding, too, of the type of patient that may be hitting the door in a sleep medicine office, which may be a little different than what would be presenting in somebody who has obesity medicine alone, just kind of trying to implement different GLP-1s or different medications. So I was wondering if we could talk a little bit about the differences in expectations sometimes these patients have, as well as also kind of talk a little bit about how the trial patient may be a little different than somebody who you're meeting that may still qualify for some of these medications. So if you could. Yeah. So thank you, Giuseppe, for the question. And so in the sleep clinic, what you will be looking for trying to identify is a patient with moderate or severe obstructive sleep apnea that has obesity consistent with a BMI greater than 30. Now that is important for both practical reasons from an insurance coverage standpoint, that's what they'll be looking for, but also it's what's in line with the Surmount OSA trial. So that's the person you're trying to identify in sleep clinic. And that could be from patients who are already existing in, you know, already in your practice that are on pap therapy, you try to identify them. This could be new patients that come that have never heard of this type of medication before. And now it will be patients that are coming to the sleep clinic to want to be tested because they want to be on this medication because they know this might be a way to get coverage for medication. So it can come in all these varieties. And this is a little bit different from the patient that we're looking at in the obesity clinic because there we are looking at sometimes even patients who have BMI in the overweight sort of category who have medical comorbidities that could include sleep apnea. But it doesn't have to be severe. It could just be mild as one of their comorbidities or such. So that is the, it's a little broader in the obesity clinic and it's a little more narrow when you're treating it from the sleep medicine standpoint. Yeah, it makes perfect sense. And I think that, I guess my question too kind of lies on the fact that again, in the sleep medicine clinic, we tailor to some degree to the obstructive sleep apnea and the understanding sometimes of the patient related to, you know, not just the obstructive sleep apnea, not just managing that stuff and integrating that this is going to be a lifestyle change altogether, not just, you know, a resolution to their obstructive sleep apnea. And I think that sometimes the patient that hits the door from sleep medicine may have different expectations on that end of things sometimes, but, you know, it's definitely something that I think is very important for them to understand. Now another thing I kind of wanted to touch base on, because it's something that you mentioned too, is that sometimes, you know, while we have the trial data that showed moderate to obstructive, moderate to severe obstructive sleep apnea, you mentioned in some previous discussions that sometimes we'll have somebody who still serves as a good candidate, even though they say have mild obstructive sleep apnea as well. So are you sometimes finding that those patients are also asking you and how do you counsel them if you can find different avenues to treat? Yes. So I do have patients with mild obstructive sleep apnea that I treat. In that regard, I think of it more, at least for myself, especially because I have a hybrid practice that I am then treating obesity more so than I am treating the mild sleep apnea. And if that improves, that is obviously great. But you know, I see it almost akin to a metaphor that Dr. Atul Malhotra made in a recent podcast where he talked about lung cancer and smoking. You know, it's like, how can you address lung cancer without addressing smoking? And I think, you know, that goes in all various sort of realms from severe to like mild. And so it's the same thing, you know, you're treating obesity, which would be the same as like addressing the smoking. And you can benefit anything from mild sleep apnea to severe sleep apnea. But the challenges for the sleep doctor is still going to be that, at least right now, the insurance companies are not likely to cover this for mild. If you're targeting the obstructive sleep apnea diagnosis, it's not likely to be covered for those with mild sleep apnea alone. Yeah, no, it makes perfect sense. So I think that it's good to think of it in a couple of different ways, understanding where the insurances are going to be looking at it as well. So yeah, but if we could also, Deanna, if you don't mind talking a little bit, because there's been a lot of concerns specifically related to the contraindications, what you think is truly absolute versus more relative contraindications, or something that will give you pause when you're trying to discuss this medication with a patient? Yes. So there's absolute contraindications to the use of terzepatide are going to be a personal or family history of medullary thyroid cancer, which is very rare already in itself, then a personal or family history of multiple endocrine neoplasia type 2, and then obviously, like an allergy to a type of medication like this otherwise. Then there are a few things that, as you said, give me pause, and I tread with a lot of caution. So amongst those things are going to be a patient with previous history of gastrointestinal disease, and that could be anything from cyclic vomiting to gastroparesis. The reason why that gives me pause is because it might mean that this is going to be a very difficult medication to tolerate for these patients. Also a history of pancreatitis, that is going to give me a significant amount of pause and I may not even proceed in patients with previous history of pancreatitis. I wrote in here, eating disorders, unfortunately, you know, weight management delves into issues also with body dysmorphia and such things. So you want to make sure that the medications are being used for health promotion and not, you know, for other purposes. Patients with renal failure also, you got to monitor carefully because the medication can also cause a decrease in fluid intake and water intake, and so that can lead to volume depletion and an AKI. So that's also something that we're cautious with. This point here of uncontrolled diabetes, so this has been reported for semaglutide, which is a similar medication, of course, to this one, not exactly the same. But rapid correction, glycemic correction can be an issue with a type of optic neuropathy. So also patients that need to be monitored very closely. When it comes to pregnancy, I always advise that this needs to be stopped two months at least prior to attempting conception, to trying to conceive. There's just simply not any good data in pregnancy yet for me to feel comfortable trying this in pregnancy. And then depression, suicidal ideation, also a concern for, I'm not clear what the reason is, but it's not like I won't stop using it, but I will be monitoring for recurrence of mood symptoms while patients are on it. Yeah. And I can speak to that a little bit if you want. Depression and suicidal ideation, that has been seen with other weight management products, not specifically GLP-1. So because it's been seen with other weight management products, there's still that kind of warning about it. So again, it's not a contraindication necessarily or anything like that, but just something that we want to monitor. And I think we want to take a holistic approach to our patients anyway. So we want to kind of be checking on their mood before they start treatment and just monitoring it throughout. And certainly if a patient does develop suicidal ideations or anything like that, we would want to obviously take care of that first and stop that medication at that time. But it's really less to do with this medication and more to do with indications with other weight management products. Yeah. And I think that it gets to a point we'll probably discuss in a little bit as well, is again, the compendium of illness, not just the fact that this is something to help with weight loss, but understanding exercise, understanding behavioral issues are very imperative in the management of this medication too, right? And I think that when Deanna brought up the eating disorders thing, it kind of struck me pretty significantly because it wasn't something I immediately thought of, right? But it is something that I think is a very impactful thing. And if you don't have the understanding of what may be happening underneath behaviorally, right, that's another thing to be aware of as well. So very fascinating stuff. So do we want to talk about the eating disorders a little bit more? Because I have some thoughts about that too. Sure. Take it, please. Yeah. So when it comes to eating disorders, a lot of studies show actually that self-directed dieting is more likely to lead to eating disorders than if a patient is in a comprehensive obesity treatment program. So I think, you know, people are concerned about eating disorders as we should be. Eating disorders are very serious, so we should be monitoring all of our patients and especially with these medications that can really significantly suppress appetite. We want to make sure that our patients are eating because sometimes patients are like they don't have much appetite and they're like, this is great. I just won't eat all day. And that's not good. That's where we're getting into disordered eating. So that's why it's just really important. And again, it doesn't have to be a super in-depth conversation, but we want to have that conversation about what are we eating on a daily basis? What's your breakfast, lunch, dinner, snacks? So we have some idea of what our patients are eating. And certainly if we feel like they're getting into, you know, an unhealthy relationship either with body image or with food, then that is something that definitely needs to be addressed. But I do want to make people aware that self-directed dieting. So there's a lot of atypical anorexia out there where people may have obesity and they don't look like they have an eating disorder, but they may have atypical anorexia where they're not eating much at all. And so again, this is something we have to just monitor for all of our patients. But studies do show that patients in a obesity treatment center are less likely to develop eating disorders than self-directed dieting. Fascinating. That's good. That's good to know. Okay. So let's move forward for the interest of time. One second. Okay. Great. So next, I kind of wanted to shift to Carly a little bit and kind of ask you a couple of questions. So we've had a couple of webinars we've had so far, and we've had the discussion obviously about the follow-up, which seems to be in the beginning to some degree at approximately one month interval. And obviously, as you might imagine, as I'm sure you're very busy as well, that the interval follow-up for a sleep physician when they're also trying to manage sleep disorders can be a little bit challenging. So if you could talk a little bit about your structure and how you do it, and then maybe some suggestions on how we might be able to bridge that gap of frequency, that would be incredibly helpful. Sure. Yeah. As you mentioned, the recommendation is typically when people get started on those medications because there is a gradual escalation dose, right? So especially when we're getting patients started, when we're still figuring out what that right dose is and whether the patient's ready to escalate the dose or not, and that depends a lot on both their response to the medication as well as side effects. So if the patient's still having side effects, most of them are those GI side effects, nausea, vomiting, diarrhea, constipation, and those are usually transient. So they usually are more pronounced when the patient first gets started on the medication or when escalating the dose. So when I'm following up, if we're starting a patient on a medication and we're following up in a month, I want to make sure that those side effects have gone away before I escalate the dose. For people who are a little bit more sensitive and are still having a little bit of nausea at that time, I usually hold off on escalating the dose until all of those symptoms have gone away. So that's why initially that monthly follow-up can be very important until they reach a good maintenance dose, and then maybe you can space it out every two or every three months. So I do realize that that's challenging for some practices. So a couple of thoughts there. One is you could train a staff member to check in on patients in between visits just to ask them how they're doing, if they're having any side effects. Maybe take a brief dietary history, what do you eat in a 24-hour day, just to check in with patients and then have certain things, if there are certain concerns, they discuss it with the provider to see if that patient does actually need to come in sooner rather than later to see the provider. So you can use your staff, you can use telehealth check-ins, a brief check-in, or even if you have messaging, ways to message patients just to kind of check in with them in between. You can also look to your community and see who else is in your community. Perhaps there's a dietician or a health coach or somebody else in your community who you can incorporate into your program who can check in on the patients from time to time and kind of create a protocol around that. And then lastly, I would also say, you know, this is for a lot of sleep specialists who are considering adding this. This might be something that they want to consider is do they want to add some additional staff? And here's where I'll do a shout out for PAs and NPs as well. You know, perhaps if you add some more staff, people that can see patients maybe on a little bit more regular basis, maybe somebody that actually has an interest in the obesity treatment side as well and can help bridge, you know, the sleep medicine and the obesity medicine. So those are all some, you know, practical ideas on how people can make sure that they're having those frequent touch points because they are very important when they maybe have some time limitations themselves. And Deanna, I don't know how you do it in your practice or you have other suggestions. Yeah, no, I mean, it's very similar. Again, I'm in a special position because I have this dual clinic, right? So we do see at the beginning patients every once a month and that, or every four weeks, and that is important. Once they're at maintenance, we space it out a little bit, but not, you know, at the beginning, it's still like every eight weeks, six to eight weeks. And so, and I do think those check-ins are, even they're not on that titration schedule on the medication anymore, I do think those check-ins are still really important because of what you brought up earlier, Carly, about not, sometimes they say, I'm just not eating, you know, or they're not eating enough protein. And that obviously can lead to unintended consequences. So I think this is still becomes important. And I do have, I think adding staff that can do that is a great, great idea. Agreed, yeah. No, I think having, Carly, if you could just make 500 of you, that would be great so that we could just disperse the wealth. But also any, you know, training additional faculty would be great. But other things I kind of want to, for interest of time, continue to move on with, you know, so the concerns that a lot of patients have is even in the dialogue with patients, right? And they're not really sure exactly how to counsel them. So some of the common questions I put up here, but probably the one that I hear the most by far is, is this going to be a lifelong therapy, right? So Carly, if you could chat on some of these questions and how you counsel patients for those kinds of things. Yeah, that is definitely a very common question that we have. And I usually will start off with the example of another chronic disease, say hypertension, right? So when we start somebody on a medication for hypertension, how long do they need to be on it? Well, forever, for however long they need to stay on it, to keep their blood pressure controlled. So we put somebody on a blood pressure medication, it lowers their blood pressure into a healthier range. We don't then take them off of that medication once their blood pressure is well controlled, right? We keep them on it because that means that the medication is doing its job. And so that's how I kind of explain this to patients. A lot of people still, they don't see obesity as a chronic disease the way that they would view hypertension, dyslipidemia, diabetes, right? These are all chronic diseases. And we know when people start medications, they usually have to stay on them long-term. And so obesity is no different, right? So the body fights that weight loss. There can be dysregulation in that energy regulatory system that's causing that obesity. So the medication makes it so that patients can have better control of their appetite and are able to stick to their nutrition plan and lose weight and keep it off long-term as long as they stay on the medication. But we know that there have been studies like the SIRMOUT4 trial, the STEP4 trial, lots of studies that look at what happens when people discontinue the medication. So they put everybody in the trial on the medication. And then after 36 weeks in the SIRMOUT4 trial, half of the participants received placebo and the other half stay on the medication. Those who stayed on the medication actually continue to lose another 5% of their body weight. And those who went on placebo regained on average about three quarters of the weight that they had lost. And so this is what we see in every study over and over again, is when you take away the medication, the vast majority of people regain weight. Now, if a patient says, okay, well, what if I lose weight and I stay on the medication for a year and I'm in maintenance for six months and I really wanna try to get off of it? Of course, I will work with every patient and take it on an individual basis. And especially if that person has made a lot of lifestyle changes, we try lowering the dose first and see how they do. And then we can try getting off of the medication. And then again, we follow up monthly, right? We follow up a little bit more closely again at that point. If they're able to keep the weight off and their appetite is controlled, then fantastic. We do that as long as we can. But if we start to see that the weight starts to go back up or the appetite is out of control, then that's an indication that this person will likely need to stay on therapy long-term. So that's kind of how I handle it with patients. And I think if we explain it or explain obesity as a chronic disease, just like so many other chronic diseases, then that makes a little bit more sense to patients. So that's kind of how I approach it. Makes perfect sense. Okay, and moving forward for interest of time, as far as the other thing, I was gonna direct a question here to Deanna as far as the patients here are looking at this medication as the panacea. The whole point is that I can get rid of this stupid CPAP machine. It's going to completely eliminate it as ever being used again, and maybe inappropriately think that, right? Or maybe they're also considering, maybe I can use this medication to bridge to some kind of other therapy, maybe an oral appliance as an example, or Inspire as an alternative. So how do you counsel these patients? Yeah, so I think what it's important to do is to set realistic expectations for a patient, right? And so, and I see that too, because I think people get a lot of information from media that can be misleading. So as we may or may not know, in the Surmount OSA trial, the patient saw a reduction in HI by about 50% for many patients with severe OSA that is gonna lower the severity of symptoms, but it's not going to put them into remission. And so those patients will continue to need treatment. And I think it's important for patients to understand that. And this is actually also very similar to the data following other weight loss interventions like bariatric surgery. So that's one important thing to make sure patients understand. The other thing to understand is that weight loss is a process that can take months, years sometimes. And to me, I emphasize how important it is to treat obstructive sleep apnea during this process because treated OSA can facilitate weight loss. The last thing you need is a patient trying to lose weight. You're encouraging physical activity, but they're so sleepy, so tired all day long that they can't engage in that kind of activity. So those are the points that I try to stress to the patient. And so really it's more of an adjunct therapy than just a solo thing. No, it makes sense, absolutely. Okay, no, those are very, very helpful points. So, and I agree that people have to take into consideration that it is a process, right? And sometimes having the combined therapy works better than one or the other alone. So yeah, absolutely, I agree. So just to move on, Carly, I wanted to direct these questions more towards you in part, because I think that one of the biggest concerns that sleep medicine physicians have embarking in this specifically is that they don't feel that they have the appropriate training necessarily from an obesity standpoint, such that they don't know exactly what their targets are. They don't know exactly what labs to check, what vital signs to keep an assigned on, what kind of weight loss goals and how much weight is appropriate while on this medication and also how to counsel the patients about side effects or how to use the injection even if they're not comfortable with discussing that. So if you could just touch base on some of these things and let us know how you typically go about it in an encounter and give us an idea of how we might be able to implement. Sure, so I mean, I think for one thing, there's lots of great places to get some training in obesity medicine. We don't all have to become obesity medicine specialists or become board certified, but there's really great education through organizations like the Obesity Medicine Association. They have a fundamentals course that's kind of like a weekend course that gives you a lot of the basics. Then there's organizations like the Obesity Society. So there are many places where people can get some basic obesity management training. There's also even a certificate for people in primary care, which could also, you know, would be appropriate for somebody doing sleep medicine through the Obesity Society and AAPA. And this is for physicians, PAs and MPs. So there's lots of opportunities to get some basic training, which I do think is a good idea if we want to start. Obviously, we wanna make sure we're educated if we're using, you know, some of these tools. Another great place to get some tools on training, especially regarding trizepatide, is your reps, your pharmaceutical reps. They can provide you with these demo pens so that you can show patients in the office how you do the injection. It's very simple and there's good instructions that come with the pen, but having that demo pen and showing patients in the office can be very helpful too. And they can be a great resource for additional education as well. So just a few ideas there for a little bit of training. And then as far as baseline labs or testing, so there's not any specific requirements for labs that you have to do before you start this medication or labs that you have to follow, you know, with starting this medication. But that said, anytime I see a new patient, I'm always going to make sure I get some standard baseline labs. So I do still think, you know, if the patients haven't had those done in the last six months, it's a good idea to just get some basic labs, a CBC, a CMP. I like to do a TSH, a thyroid with reflex, a lipid panel, hemoglobin A1C. I like to get a fasting insulin if the A1C, even if the A1C is normal, to get an idea of insulin resistance. And I use that with the glucose and I calculate a HOMA insulin resistance score. You don't necessarily have to do that, but some of those basic labs that I just mentioned are great labs to get started just to have those. And then, you know, maybe you check them every six months or a year, depending on, you know, if there were any abnormalities. Or oftentimes, you know, if they're getting those labs done with their primary care provider already, just having a copy of those labs so that you can kind of just see what's going on with the patient. So that's what I would say as far as labs. Did you have another question? Oh yeah, no, I was just going to ask about more for the weight loss anticipation. What you think as far as the amount that you think is appropriate and in timeframe-wise and how maybe you'll talk a little bit about protein or fluid intakes, those kinds of things. Absolutely. So one other thing I wanted to mention, because we talked about vitals as well. So maybe if you're not used to getting a height and a weight at every visit, make sure you're getting that. So you're getting a BMI. And then I would also recommend doing a waist circumference and you can also calculate a waist to height ratio. I've always used body composition analysis, but I realized that's more specific to obesity medicine. Not everyone's going to have access to that, but it's important to kind of monitor what kind of weight patients are losing. We want them to lose primarily fat mass and we want to preserve muscle mass as much as possible. And so that's where the dietary counseling and the exercise counseling comes in because those are two crucial and important factors to help minimize muscle mass loss and to maximize fat mass loss. So from a nutrition standpoint, protein is super important. Dan already mentioned it, making sure they're getting sufficient protein. So during weight loss, while people are losing weight, the recommended amount is about 1.2 to 1.5 grams of protein per kilogram of ideal body weight. Now that's a lot to calculate. You're probably not going to calculate that for every person. So a good rough estimate is usually about, you know, 75 to 100 grams of protein for women, maybe 100 to 130 for men, somewhere in that ballpark. So protein is super important, making sure that they're getting sufficient fluids because as their appetite is suppressed, it may also suppress their thirst signals. And not only that, but we get a lot of our fluids from the food that we eat. So if they're eating less food, they may be getting less fluids that way as well. So making sure patients are staying well hydrated. And then for physical activity, it's just basically following those physical activity guidelines of about 30 minutes a day or 150 minutes a week. And then also adding at least two days of some strength training or resistance training. Now, if a patient is starting out and they're not doing any exercise, we don't start there, right? We just have that conversation around, what are you doing right now? And, you know, what are some ways that we can increase your activity gradually? So that's- Yeah, and I think that leads to the next conversation, next slide very quickly, which is, again, we obviously want to be able to, as physicians, be able to help our colleagues as well. And obviously, you know, resources are scarce for everyone. So we can't really be sending every single patient that we're putting on terzepatide to a dietician or exercise physiologist or a psychologist or behavioral health. So I guess the question I have for you here is what kind of other resources and tricks do you have that somebody may be able to direct a patient to or locations that a patient may be directed to? And then just a little bit briefly on, like, which patient you do feel might be really good to get to a nutrition and dietitianist specifically. Yeah, I think sometimes it even starts with kind of figuring out what the patient's baseline diet is and kind of their education level around nutrition. Like, do they know what a protein is? Do they know where good sources of protein are, good sources of fiber, vitamins, and minerals? And just kind of, if you go through like a 24-hour dietary history, you just say, let's just go over, what did you eat yesterday? Starting with when you woke up, what was the first thing you ate or drank? And kind of go through their day. It kind of gives you an idea of their dietary pattern, what they're typically eating like. Now, some patients, they might have a fairly healthy diet already and they're getting sufficient protein. And so those patients may not necessarily need to go to a dietitian. But if you have a patient who maybe has very low skills in cooking, eats a lot of fast food or processed food, and then when you kind of talk to them about protein in their diet, they're not really sure what that even really means or what that looks like, that's a patient that might benefit from having more education around it and more support and going to see a dietitian. For the physical activity piece, I love using our physical therapy colleagues. So if you have a patient, especially if they have some limitations with joint pain, arthritis, back pain, that can be a great place for patients to get started. So, you know, maybe you can work with a primary care provider or orthopedic specialist or have the patient talk to them to see if they can get started with physical therapy, if they're a little hesitant or if they have a lot of barriers to physical activity. That's wonderful. Yeah, no, I think that those things are very important. And then obviously some online resources, I'm sure would be of excellent benefit for patients so that they can engage in different ways if they cannot get to some of these specialists, right? Yeah, and there might be community things or there might be, you know, a local Weight Watchers or some other, you know, commercial program that they could enroll in or something at the YMCA or just kind of look around in your community and see what other community support systems are out there. And that can be a great adjunct, you know, to your program or obesity specialists, of course. Yes. So moving on with Diana, I have a quick question for you. Obviously, when you last spoke to Dr. Lastra at the U of Chicago, you guys spoke a little bit about some of the challenges that occur immediately after the encounter where you're first managing the medication and probably one of the biggest hurdles you thought was associated with the prior authorizations and where there's a barrier, unfortunately, for a lot of these patients to get these medications. So how do you confront this problem and what do you think is the best way to approach it? So, yes, I said it before and I'll say it again. This is a huge source of administrative burden when it comes to these medications and also a source of both provider, physician, APP and patient frustration. These are barriers to care, is what prior authorizations are. That all being said, I think from a practical standpoint, what helps us, so in some health systems, you might already have prior authorization teams like large academic medical centers, large health systems, because these are not the only drugs that need prior authorization. So there's a lot of expensive drugs out there. So you might be able to tap into a resource like that, that you maybe didn't even know existed because we weren't dealing with these types of expensive medications. So that's the first place to look. But if that's not available, one very important thing is a very well-trained medical assistant. You know, after a while, these prior authorizations start all looking alike. They start asking the same questions, requiring the same type of documentation. So if you can find a staff member that can be trained, that is, and then you can keep them happy in your practice, that's a really important resource right there. And then the other part is the notes. The notes should be very organized, like good templates, so that the medical assistant can easily find the information that is required for these types of prior authorizations, like comorbid diseases, like the BMI, like the drugs that have already been tried. So that is the types of things that should be very easily accessible in the note, combined with a well-trained staff, I think that can make the process easier. It's still a source of frustration, but I think that will help. Absolutely, I agree. So yes, hopefully this will get better as time goes on, and more of these insurances will be more sympathetic, I hope, but we'll see how it goes. Hopefully less so a problem in the future. All right, another interesting thing for you, Diana, too, is the interest of compounding pharmacies. So, you know, you prescribe the medication, it goes out, the patient gets this frustration, maybe with the prior authorization. They look around and search because they don't have a lot financially. So they're trying to find a different way, and these compound pharmacies are able to provide them the product at usually a cheaper rate. So how do you talk to patients about compound pharmacies and the concerns associated? Yeah, good question. So this actually does come up fairly frequently. And I think the important first step is to acknowledge how frustrating the system is. So first go at it with understanding and empathy because most people are just trying to do what they can to improve their health in a way that is accessible to them. And the drugs are very expensive and the coverage is not equitable, right? So first understand where the patients are coming from. But bottom line for me comes down to safety. So these compounded medications are modified formulations of the drugs, right? And these modified formulations have not undergone the rigors of clinical trials that require FDA approval. That is true, even if they are compounded at these FDA approved pharmacies, the drugs, the compounds themselves have not gone through the clinical trial. So I do not feel confident of their safety profile. And therefore, I do not use them and I always tell patients, I would not do it to my family, I would not do it to myself, so I would not give it to my patients because first is do no harm, right? So that's sort of like where I go and then I obviously try to work with them on trying to find alternatives, maybe in the form of savings cards or direct to patient discount type of situations or other medications, but that's how I approach it. Yeah, and I think that obviously this is an evolving process as well, because obviously terzapatite it sounds like is no longer going to be on the shortage list as well. It's not anymore. Neither is semaglutide. And so that's, thank you for bringing that point up. The only reason this was even legal is because of this loophole where if a drug is in shortage, it's okay to compound. Well, these drugs are not in the FDA shortage list anymore, so it's not okay to compound them anymore, even from a legal standpoint. I was actually looking this up yesterday in anticipation and I believe terzapatite, that deadline to stop compounding was in March. And for semaglutide, there's two different types of pharmacies that can, one of those deadlines is in April, the other one is in May. After those deadlines, this medication is not in shortage, it's technically illegal to do this. And so also a very good reason why it's not something that I would encourage anybody to do. Makes perfect sense. All right. And over to one of the last portions of this is more on the long-term management. And this is something that I probably reached to both of you. Maybe you guys can both take a turn on discussing this. Because again, as has been mentioned many times, let's say we finally get the patient a target weight, right? And now we're thinking that the apnea may or may not be gone, right? So the question is, you know, how do we go about managing this? Because the other big concern is now we've met a target. And even though clearly, as Carly mentioned earlier, this is something of a chronic disease and should be continued to chronically manage, we may encounter some insurances that may state maybe, you know, they don't have apnea anymore, they're not obese anymore. So maybe they won't approve of the medication. And then also just a little bit on the comorbid management of other medications and how much you feel like dipping into that versus reaching to our primary docs for help to make sure that you have a good relationship there as well for helping them long-term with their other comorbid meds. So I don't know if Diana, you want to start first on your point? Yeah, so you bring up the concern about once either the OSA has been put into remission or the BMI is under a normal range now. So what's going to happen to their coverage, for example? I, and most people who do this for a living, I think will go to the insurance company under the claim that even though it's in remission, the disease, whether it's obesity or sleep apnea, it's still present because as soon as we discontinue therapy of any kind, that's true for the CPAP, it's true for the medications, the disease will recur, right? And so I don't say, oh, this is a person like who has no obesity anymore, or I'll say it's not sleep apnea, it's still sleep apnea, it's just well-controlled. So that's what I will do. And I will say that a lot of the times that works, but then you might have issues where there might be insurance companies out there that do not allow that and that creates an unfortunate situation. So you start having to try to find alternatives to continue treating that patient, right? Fortunately, for both of these diseases, we have some other treatment options, but that could present. So that's like from the more practical standpoint. From a medical standpoint, I will continue therapy as long as the patient requires it. And as Carly mentioned before, if patients are adamant about discontinuing therapy, we can give it a trial, closely monitored, and then see where we go with the understanding that it's very possible and sometimes likely that we will need to resume treatment as we previously had. Does that answer your question? It does. And I guess the other hesitation or concern that was brought up in the previous webinar and podcast was sleep testing, right? Do you retest or what do you do on that end of things? I mean, I would, yes. And so the weight loss data in general, whether it's, you know, the medications are fairly new, but even after bariatric surgeries, supports testing after about 10 to 20% of body weight loss. And I would still do even if it's a risk that you have some insurance company out there that will say, Oh, I don't have it anymore. I mean, I think still it's important to know where your patient is in regards to their disease. So that's how I go about it. What do you think, Carly? What's your approach? Yeah, I agree. And even before we had this medication, you know, sleep apnea was always something that I would want my patients, you know, that I screened for and that I had my patients tested for. And then if they were on treatment, you know, after, like you said, about, you know, 10-15% body weight loss, send them back to their sleep specialist to get retested, because you want to make sure and especially that, you know, the right settings that they still need it and all of those things. So I do recommend the retesting as well. And as far as you know, the documentation, I do always put the initial BMI as well. And so you know, this even if the patient's BMI is normalized, this was their start BMI. Therefore, in my mind, they still have obesity, right? We're just controlling it better. So that's also what I do from a documentation standpoint. Yeah, that's I mean, I think that it is important to kind of, as you mentioned, focus on it being a chronic illness, and then in managing everything around it, right. So as well, around the medications to that they take for hypertension and diabetes, and all these other things, too. You have to kind of also state that, yes, you know, maybe this is helping, but you have to be conscious and adjust while understanding all of these things are chronic conditions, and trying to manage all of them. So I do want to kind of pause here, because I do want to kind of get to questions, because there's quite a few interesting ones as well. So I kind of want to bring them up. These are the take home points for which everyone can read afterwards, which kind of also speaks to the discussion that we had today. But I do want to give time to the questions. So the first one I'll bring up is from Tara Cavell, who basically stated, how would you approach prescribing in a patient with alcohol use disorder? So I don't know if one of you want to take that one. Yeah. No, no, please. You know, that's definitely something that needs to be addressed. But one interesting thing that we're seeing with these medications is that they seem to also help people not want to drink as much, and other kind of addictive behaviors, they seem to affect that. So I wouldn't be surprised if this patient did get started on this medication under close supervision, of course, and making sure that their liver functions and everything's okay. And of course, getting them treatment for their substance abuse. But I wouldn't be surprised if you actually saw a decrease in their alcohol consumption with these medications, because that's what we're seeing in the clinic. And I don't know if you see that as well, Diana, that, you know, some addictive behaviors are reducing and the desire for alcohol is reducing in these patients. That is exactly what I was going to say. I actually feel good about this patient population, about using it, because I have seen a significant reduction in alcohol intake after the initiation of these medications. So I think it's helpful on both sides, on both ends. So I agreed. And I think that there's a couple of questions that I kind of want to reach to, one of which is, any pause in patients with ophthalmologic issues that you've noted in this specifically, that you're aware of? Not outside that I've seen, not this drug. We got other weight loss drugs that we got to be careful with things like glaucoma. But not this one outside of this point I brought up earlier related to rapid control of glucose in an uncontrolled person with diabetes. Yeah. Another question was from an anonymous attendee that basically stated, wasn't diabetes mellitus included in the exclusion criteria in the Surmount trial? So my understanding was they were excluded, correct? So in the different trials, so the Surmount 1 trial was the initial trial for terzapatide, the weight loss trial. And in that trial, they excluded patients with type 1 and type 2 diabetes. Then the Surmount 2 trial was specifically in patients with overweight and obesity and type 2 diabetes. And so they kind of separate out patients with type 2 diabetes oftentimes in these trials because the outcomes tend to be different. They tend to have less weight reduction than people without type 2 diabetes. And that is most likely just an effect of they just have more progressed metabolic disease, right? Somebody with type 2 diabetes versus somebody who doesn't. And so that's why they exclude patients with type 2 diabetes in some of these trials. It's not because you can't take these medications for type 2 diabetes. Obviously, they're also approved for type 2 diabetes under a different name, right? Under the name of JARO. But that's why they separate them out in the trials. And I do believe perhaps in the OSA trials, they did exclude patients with type 2 diabetes as well. But it's for that reason. Yeah. Yeah. Also, I wonder if the same attendee, but basically asked, is there an upper limit for BMI to qualify? What about patients with severe OSA and coexisting OHS? Maybe Diana, you could take that one. An upper limit, like beyond a certain BMI that we couldn't use it? I think that's what they're implying. No, I have not. No, I have used them on patients with any BMI greater than 30 would be okay. I must admit that I have not yet looked at how it has affected yet obstructive, or sorry, obesity, hypoventilation syndrome. So I can't comment too much of that because I don't have the data. But there is no upper limit to the BMI use. Yeah, I can imagine from a respiratory perspective, that the weight loss that is contributing to the obesity, hypoventilation would contribute to you not prescribing this medication, right? If anything, I think even more a reason, because you're taking away potentially the respiratory pathology along with the obstructive sleep. But, you know, it's certainly something to take into consideration. Another question that, and this is something I have had some questions about myself, is any luck switching from other meds, like say semiglutide, to ZepBound? And when you kind of pull the trigger for that, and have you had difficulty doing that? I... I'm sorry, go ahead. No, no, please. I mean, I have before, you know, sometimes if a patient was on semiglutide before, and, you know, maybe they kind of plateaued, and they're not quite, we still feel like that they would benefit from further weight reduction, we can certainly try switching to terzepatide. And we know, I mean, now there's even a head to head trial between semiglutide or between Wigovi and ZepBound. And where we saw, you know, I think in the trial, it was about 20% or 21% weight reduction with the terzepatide compared to about 13% with Wigovi or with the semiglutide. So we do see in the trials superior, even in a head to head trial, superior weight reduction with terzepatide. So, you know, certainly that could be a reason. And especially if a patient, like I said, has plateaued and still has additional need for weight reduction, you can certainly try that and see if you can get additional weight reduction with terzepatide. And again, now that we have this new indication of OSA, that would be, you know, a good reason also to try that terzepatide because semiglutide is not approved for OSA. So, you know, and in some patients you may not see further weight reduction, but I think, you know, in the right patient, it could be worth a try. Yeah. And I would add to that, that other than hitting the weight loss plateau and switching to terzepatide, the other reason that I've done that is for tolerance. So even though these two drugs have very similar side effect profiles, patients perceive side effects a little bit differently from semiglutide to terzepatide and back and forth. So somebody who was not tolerating, we'll just say Wigovi, might do very well with terzepatide. That's been my experience. And that's another reason, other than a weight loss plateau, why I might switch them. Yeah, that makes perfect sense. And I think that, I mean, if anything, the obstructive sleep apnea diagnosis now adds another tool for us, right? On the obesity end or, again, the other argument, terzepatide adds another tool for the obstructive sleep apnea treatment. So I think that, yeah, whatever way we can get these patients on it, if that's what's best for them, is the best way to go. So there are a couple other questions, quite a few, actually. I hope we can get to them. So any thoughts about utilizing terzepatide in older adolescents with severe obstructive sleep apnea and obesity? Well, I mean, it probably would be, my guess is it would be the effective therapy, but I want to say this is not yet FDA approved for the pediatric population. That's correct, yeah. So it would not be covered. But there are other weight management products. So if you can, you know, again, if you're going to an obesity specialist, there are other products that are approved for adolescents. So, you know, there are options. So another scenario here by Christopher Hope, insurance requires an HST and is found to have mild obstructive sleep apnea and doing well on AutoPAP. How do you go about getting a PSG to see if they might be a candidate for terzepatide? I'm a little, I'm wondering if they mean that they still have obesity and you want to kind of co-manage? I'm not sure if that's what they're looking for. But again, indication, moderate to severe obstructive sleep apnea, right? Correct, yeah. I personally have not had any luck yet getting just the mild sleep apnea approved. And maybe you can go about it just based on the basis of obesity, but mild will not get approved. And then to repeat a sleep study, maybe to a PSG, if the patient has had a significant weight change while they've been on their AutoPAP, since they had that HST might be a good justification to do a repeat sleep study. Because then they might have, if they've gained weight, their severity may have increased and they might not be a candidate. I hope that answered that question. It did. So I think we're running up against the time. Just one more question. And then I just wanted to, again, put our thanks out to everybody. Wanted to put out on this slide, obviously, thanks to all the committee members who contributed, as well as the ASM staff who helped facilitate this. If you have any questions, we will continue to address them after the webinar as well with the experts so that continue to submit them if there's other concerns that you have. So there's just one other one I'm going to throw out there just because it's staring in front of me and I'm curious. What changes in diet do you recommend initially to minimize nausea and GI problems and what drugs work best to treat the nausea? I can start this one off. I mean, one thing is, you know, having patients really be aware of that satiety signal and to stop eating when they're starting to get full. So they're not eating too large of volumes because this medication slows down gastric emptying, so the rate at which the stomach empties. So if people are eating too much too fast, that's going to cause a lot of issues. So eating smaller meals, also making sure to avoid fatty foods. Fatty, greasy foods will really cause the GI side effects to be worse. And then I always just talk about, you know, healthy eating overall. So either protein first, especially with these patients, protein first, make sure you get your fluids, get your fiber from your non-starchy vegetables, you know, some berries, nuts, healthy fats as well. But again, not overdoing it on the fats. And I have very few patients who actually need a medication to help with side effects. Usually just the counseling around the smaller meals, avoiding fatty foods, and just letting them know that, you know, you may have this transient GI side effects. And usually it goes away with time. Most of my patients do pretty well. Diana, what about you? Yeah, I agree. One thing I would add is, at least anecdotally, it seems like going long periods of time without eating anything will trigger that nausea a little bit more so as well. And you're right. I mean, I try not to use a medication to like treat another medication side effect in a very rare occasion. I may use a Zofran for like vomiting, but then that comes with like a concern for constipation, right? So it's, we always, always want to make sure that we are, first of all, educating them so they know what to expect. And then with these dietary modifications, most people are going to do well. Wonderful. Well, thank you, Diana. Thank you, Carly. We love having your expertise in these situations. It's been a fascinating conversation. I think we could talk for probably another two hours, honestly. But I do appreciate everything you guys have brought to this. I appreciate everybody who joined in the webinar. I think there's still so much to learn, and we have so much opportunity. And I'm very encouraged, right? I want to kind of also put out there myself that I think that we should, you know, take this opportunity, learn as much as we can, and put this medication forward for the patients that we need it because we can make a tremendous impact with this and maybe have less concerns about some of the things that maybe we could still manage if issues arise. So plus leaning on experts like you guys, you know, you guys are wonderful. And it'll be an incredible asset to have to help these patients with this treatment. So thank you again, everybody. And I hope you enjoyed the webinar. Please let me know if you have any questions. And I also encourage you to attend any previous or upcoming ASM webinars or the ASM Foundation webinars or podcasts to learn more about this and other topics. Thank you, everyone. Thank you.

Terzapatide

Obstructive Sleep Apnea

American Academy of Sleep Medicine

Clinical Practice

Patient Engagement

Weight Loss

Continuous Positive Airway Pressure

Prior Authorizations

Chronic Condition

Dietary Guidance