Unscripted - The AMCP Podcast: Transforming Chronic Idiopathic Constipation with a Drug-Free Treatment Solution (Part 2)

Fred Goldstein 0:01 

Welcome to Unscripted, the AMCP podcast, a look inside managed care pharmacy. Listen in as experts explore the challenges, innovations and opportunities shaping healthcare for millions of patients. This episode of Unscripted, the AMCP podcast is sponsored by Vibrant Gastro Inc, delivering predictable relief from chronic idiopathic constipation, CIC without the side effects and higher costs of prescription medications. This is the second of three episodes. Welcome our guests, Dr Christine Frissora, gastroenterologist and Associate Professor of Clinical Medicine at the New York Presbyterian Cornell University Medical Center and Dr Ken Schaecher, Chief Medical Officer Emeritus University of Utah health plans, and he currently serves as an Associate Medical Director at a regional health plan, as well as practicing as a general internal medicine specialist. We'll be discussing a cost effective breakthrough transforming chronic idiopathic constipation CIC with a drug free treatment solution. Welcome back, doctors. Thank you. Thanks. So let's begin with you, Dr Schaecher, in the previous episode, we touched briefly on some of the utilization issues that impact costs. So what are the economics, and in particular, the costs to payers? 

Ken Schaecher 1:16 

As we recap a little bit over the previous discussion, we talked about how chronic idiopathic constipation, not just the disease itself, but its treatments, can have significant economic burden for both the patients and healthcare systems and payers. There are direct and indirect costs that are seen by health plans as it relates to not only the drugs or therapies that are used to treat idiopathic constipation, but also the management of the side effects. In addition, due to some of the issues around chronic idiopathic constipation, we see increased utilization on ER on occasion, hospitalization for patients who require dis impaction or are having severe abdominal pain simply because they're so badly constipated. And these can be significant. As a matter of fact, recent studies have shown that these costs could range as high as $33,000 a year for patients, which sounds like a lot for something that people don't really talk about or think about a lot, but it's real, and these patients do incur costs that for a disease that health plans don't really think about can add significantly to their bottom line. 

Fred Goldstein 2:39

So given, you know, some of the costs you talked about, and it's obviously pretty high, what are some of the other areas that these costs are attributed to? 

Ken Schaecher 2:47 

They’re, they're, you know, obviously, one of the places is the drugs themselves. The prescription drugs that are used to treat these drugs are fairly expensive. In a five, $600 or more range a month, you've got the numerous over the counter therapies. And we have to keep in mind that for Medicaid, particularly over the counter therapies are covered, and so this can be a significant cost to a Medicaid plan, as well as to the individual costs. And even Medicare plans are now providing these over the counter benefits, um as part of their Medicare Advantage plans. So these can be a significant cost center. But then there's the the unplanned or urgent office visit set apart. There's the cost related to going to the emergency room because you're severely constipated, and you may not know it, and you're experiencing abdominal pain, or because you're severely constipated and you want them to treat you because you have been unsuccessful yourself. We also have the number of imaging and diagnostic tests that patients take on trying to find an answer, because it's hard for many patients to accept the fact that there we don't know what's causing it. There's the indirect costs that you might see that are related to not only the patient missing work or missing school and those sort of costs, which, frankly, are pretty soft for health plans. But there's also the indirect costs that occur because that are not recognized, related to patients who decide my drugs for hypertension, my drugs for my cholesterol, my drugs for my diabetes, may be causing this problem and may stop them. Also. If you've ever had belly bait, and most of us have, when you're not feeling good, you don't tend to take your medications. You. If you're not taking your medications, your health problems aren't getting resolved, and you're going to have more downstream costs are related to those conditions, and those are some of the indirect costs we're talking about. 

Fred Goldstein 5:10 

I think it's fascinating, because the indirect costs are really an issue that employers think a lot about today. And so when they're when they have an employee who is less productive at work or not able to show up at work because of issues like this, that's become a big deal to them, and so they really do look at those costs very much more than obviously a payer would. So let's talk now about all of these results that we have, the issues that patients and physicians face with the current treatments, and given that and the other issues that we talked about, such as the patients and physician satisfaction or dissatisfaction with current treatments. Has there been any innovation? You touched on it briefly, but let's talk a little bit about that and the how that innovation impacts costs. 

Ken Schaecher 5:49 

Thanks, Fred. There has been some innovation in this space, and I think it's exciting. So here we have what's called the vibrant system, and I'm going to let Dr. Frissora tell you a little bit more about it. 

Christine Frissora 6:02 

The vibrant system is a new treatment for treating chronic idiopathic constipation in men and in women. How it works is, this is a pod activator. You take the capsule, place it into the pod. This light will turn green. When it turns green, the patient can swallow it, and when they swallow it starts jiggling intermittently down to the large intestine, and that results in the bowel movement. In clinical trials, the outcome is called a complete spontaneous bowel movement, meaning that the patient goes to the bathroom and empties, empties completely, and then they can get back onto their life. This is an exciting advance for us, because a lot of patients who are on medications, either prescription or over the counter for constipation, suffer from side effects. They can have abdominal pain, bloating, diarrhea, fecal incontinence, dehydration and some of those symptoms are demoralizing. Some of those symptoms lead to emergency room visits, and some of those symptoms are dangerous if they get dehydrated. So there are many patients, as Ken said, they're already taking medicines for diabetes, hypertension, other co morbid illnesses, they don't want to take any more medications. So this capsule, the vibrant capsule, is a non pharmacologic treatment for constipation. It's not a medicine. It's a vibrating capsule, the vibrant system. So patients like it because it's a natural approach. They activate it, they swallow it. And by the way, this is taken in the evening, and it's interesting, because circadian rhythm does play a role in defecation. Waking up is a trigger to defecate. So you take this at night, you wake up, you go to the bathroom, and that's it. It is very simple. So the vibrant system does represent an advance in our field. It does fill an unmet clinical need. And when I'm in the office, it's gastroenterologist patients are coming in. They don't want to hear about fiber and that sort of thing. They're suffering. They don't feel well. They want an effective, safe treatment. So if I show them this, they're very interested, and it really is gratifying, because they have hope and they're interested. So this has been an exciting improvement in treating our patients, and that's why we are here today to discuss this great advance. 

Ken Schaecher 8:42 

I would also add something that's important to note too. This is, as Dr Frissora pointed out, this is a non pharmacologic solution, and it also, because it's non pharmacologic, it doesn't have any drug drug interactions. You do not have to worry about interacting it interacting with the other medications, because, as Dr Frissora pointed out in our previous podcast, these patients can have a multiple other co morbidities that are contributing to their constipation, like diabetes or obesity or other conditions, and they're on medications for those conditions, interacting, not interacting, with those drugs reduces the side effects of the other drugs too. So again, another unique way that this offers on improved health solutions, and Dr. Frissora is going to talk a little bit more about some of the advantages of the vibrant system in just a moment. 

Fred Goldstein 9:45 

This episode of Unscripted the AMCP podcast is sponsored by Vibrant Gastro, the vibrating capsule for CIC. So let's get back to you. Dr. Frissora, you talked about some of the advantage of the system, but can you talk about some of the data and some. Of the specifics. 

Christine Frissora 10:01 

When we compare the vibrant system to pharmacologic treatments, we do see some advantages. When we compare the vibrant system to Lenape, we see less diarrhea. In fact, there was a much lower incidence of adverse events. When we look at patients taking the therapy, the patient's persistence in taking the therapy was 50% better compared to Lenape, which is one of the standard therapies for chronic idiopathic constipation. The vibrant system is only taken five out of seven days. One capsule is taken every evening, five days a week. It's not an everyday treatment, and we see a high response rate with the vibrant system 40% compared to other therapies, which are lower. Last, there is a common application to use with the vibrant system. This is an app that patients can download from the App Store, and they screen in the QR code, and then their device is linked to their app, and so their app will give them feedback on their treatment and how their treatment is working. And many patients get a lot of relief using the app with the treatment that gives them a lot of mental relief. 

Fred Goldstein 11:13 

Fantastic. Thanks for that information. Dr Schaecher, what are the advantages of the vibrant system over pharmacological interventions to the payers? 

Ken Schaecher 11:20 

Well, I think there are several. One it's actually compared to the brand pharmaceuticals such as Linzess and some of the other agents used to treat chronic idiopathic constipation, it's less expensive just for the acquisition addition, as Dr. Frissora noted, the persistence and compliance is better, upwards of 50% better than Linzess in one year. It has been shown in the studies direct costs and indirect costs are obviously less, given that the studies have shown no more than a 1.2% incidence of diarrhea with this device where drugs like Linzess and the others the secret dogs can have over 20% incidence of diarrhea. You can imagine that the indirect costs are significantly less for patients having to then manage that aspect of their condition, also because it is more effective. You're seeing less ER visits. You're seeing less hospitalizations, less time off, which is an indirect cost, but nonetheless important to both the patient and the employers. Lastly, the recent study that was done that Dr Frissora was part of showed that compared to Len aquatide, there can be several $100 to several $1,000 less expensive over one to three years by use of this therapy, you know. And again, if members are more satisfied, they use less health care.  

Fred Goldstein 13:07 

Excellent. Thanks for that. And thanks Dr. Frissora and Schaecher for joining us on Unscripted the AMCP podcast. This episode was sponsored by Vibrant Gastro. Learn more about the drug free solution at Vibrant Gastro.com