Unscripted - New ACG Guidelines for Crohn’s Disease and Ulcerative Colitis: What Clinicians and Payers Need to Know

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Welcome to Unscripted, The AMCP Podcast, a look inside managed care pharmacy. Listen in as experts explore the challenges, innovations, and opportunities shaping health care for millions of patients. This episode of Unscripted, The AMCP Podcast, is sponsored by AbbVie Inc. At AbbVie, we find answers that make life better for patients and our world. This year, the American College of Gastroenterology released two important and long overdue guideline updates: one for ulcerative colitis in adults and the other for the management of Crohn's disease.

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Also in adults. In this episode, we'll discuss the impact of these changes with Sheena Crosby, PharmD. Sheena serves as the inflammatory bowel disease clinical pharmacist at the Mayo Clinic in Florida. She provides patient education, assists with insurance navigation, and monitors medications for the management and treatment of Crohn's disease and ulcerative colitis. Welcome, Sheena. Thank you, Fred. I'm excited to be here.

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It's really a pleasure to get you on, Sheena. So it's been quite a while since the ACG clinical guidelines were updated. Can you tell us a little bit about that and sort of where we are with them now? Absolutely. So it's been about six years since the last guideline update, and we've had a great number of advances. That's why we're so excited to be able to share this information with everyone, to show how much has changed and how many more options we have for the treatment of Crohn's disease and ulcerative colitis.

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The wonderful thing about these guidelines is that they make a great impact in ensuring that our patients get optimal care, and we now have a lot of different options for advanced therapies, especially to help treat moderate to severe Crohn's disease and ulcerative colitis. So from a shared decision-making standpoint with our patients, it really gives them more options to ensure that they are also involved in what medications they want to try.

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And also to get them the best benefits—to get into healing, to get into remission. So what are we seeing now, let's say, in terms of the goals of therapy? How has that changed? Absolutely. So when we're thinking of goals of therapy, our goal is to get to symptomatic remission as part of our treat-to-target strategy, our STRIDE guidelines.

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So, in regard to their symptoms, are their bowel movements improving? Are they no longer seeing rectal bleeding? Are they no longer having abdominal cramping, no longer having urgency—or at least less urgency and fewer bowel movements? Those are all really important to make sure that we listen to our patients and ensure that we help improve their quality of life.

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That's super important. Second, we also want to make sure that we aim for remission. So that would be not only clinical remission with symptom improvement, but also endoscopic remission and making sure that patients are improving on their imaging and scopes, and even by noninvasive biomarkers of improvement such as fecal calprotectin. Those are all really important things for us to monitor while patients are starting therapy and as they're maintaining on therapy.

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So it's really different now, I guess, because we are really talking about remission in this case. Yes, exactly. That's so true when it comes to things like, you know, our past experiences with the previous guidelines. It really was a step-up approach, you know, using our older medications like mesalamine to help patients with their symptoms.

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But now we're using more of a top-down approach, especially if a patient has more moderate to severe disease and is symptomatic and we're seeing disease progression from scope to scope. It's very important for us to start that advanced therapy early to help prevent complications from their disease. Serious complications of Crohn's disease or even ulcerative colitis can include hospitalizations, surgeries, nutrient deficiencies, even anemia due to blood loss, as well as colon cancer.

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And so that's why we find that starting early with these advanced therapies is very important, where the benefits outweigh the risks—the small risks, really—compared to those serious complications of progressing disease. Yeah, we've really seen this in a number of areas now with these new advances in medications, etc., that you sort of flip the whole protocol upside down, in a sense, and go earlier with these more advanced therapies that used to be a step up to them. And obviously then we're beginning to see these sorts of remissions or longer periods of time before development of issues. So it's really a fantastic change. How do you look at that when you're talking with patients?

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Yes, absolutely. You know, I think when it comes, you know, when it comes to the patients that I see, oftentimes I do see a lot of new starts.

I see a lot of patients who are new starts to medications. So they're considered what we call biologic-naive. And I see a good variety of patients who may have had inflammatory bowel disease for years and have tried multiple different options, and now we need to go to the next step. So it's very important for us to look at it together with regard to what our goals are.

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So our goals, too, oftentimes for patients involve their quality of life, right? How can I help them get back to their work, get back to school, get back to being with friends and family—you know, their normal day-to-day. Even their energy level is super, super important, making sure that, you know, those improve. And so I like to set those goals individually with each patient because I feel like that gets their buy-in through shared decision-making too.

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And then when we think about it, it's also very important to think about what they've tried before. You know, if they're biologic-naive, we may have more options with regard to our newer therapies to start off with, versus just going with perhaps the older medications. Don't get me wrong, they're very good—something like infliximab or, you know, the anti-TNF agents—they're considered the gold standard.

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But when we're thinking about patients' concerns for levels of immunosuppression and a decreased level of immunosuppression, oftentimes I can get them to consider starting therapy if we maybe choose something that is less immunosuppressive. And so that's why it's really helpful that I work collaboratively with my inflammatory bowel disease providers. They give me options in terms of what they think would be great medications for them.

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And in terms of, you know, they may give me a preference here or there out of those different options. But when it comes to talking with the patient, I can at least present that to them, tell them how each one works—mode of administration, onset of action, side effect profile—comparing all the different side effect profiles and where these classes stand.

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And that typically can help us get an idea of where we want to start with therapy, or where we want to transition to from one therapy to the next. One of the things you're responsible for, Sheena, is insurance navigation. How should payers be looking at this? One very important, critical, strategic point in the guidelines that were made is that they suggest against requiring the failure of conventional therapies before initiation of our advanced therapies.

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That's really important, especially when our goal is to get patients to healing quickly. You know, if we work from a step-up approach, when you prolong that—especially in a patient who may already have moderate to severe disease—that can increase their risk of severe complications. So it's very important to get ahead of the game and to get our patients started on an advanced therapy.

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Fantastic. So are there any other changes that should be considered by the physicians or patients as they look at this area when it comes to you? You know, it's very awesome to know that we've got a lot of great different therapies now other than our 5-ASAs and anti-TNF agents, just to review the different medication classes that we do have and the new medications that we have.

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I wanted to review those briefly as well. You know, in addition to our anti-TNF agents and our 5-ASAs, we also have other advanced therapies that we can use for moderate to severe Crohn's disease and ulcerative colitis. Specifically for Crohn's disease, we've got our anti-interleukin class. There's the anti–interleukin-12/23 blocker, which is ustekinumab. There's our anti–interleukin-23 blocker class, which includes risankizumab, mirikizumab, and guselkumab.

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And there's also upadacitinib, which is considered a JAK1 inhibitor. And that is, particularly in the U.S., FDA approved for those patients who have failed anti-TNF agents or who were intolerant to anti-TNF agents before—they must have gone through those first—for ulcerative colitis.

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We also even have S1P modulators. Examples of those would be something like etrasimod or ozanimod. These are oral medications. And so when I talk with my patients, it's very important to get an idea of what they imagine they would be most adherent to with their lifestyle with regard to these medications—are they okay with infusions?

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Are they okay with injections, self-injections? Are they needle averse? You know, are they scared to use these injections from that standpoint? Or do they prefer oral therapies? And that can oftentimes help shape how we want to transition to or start a new advanced therapy. So I do take that into account as well.

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In addition to the newer drugs that we have, we also have newer dosage forms. So having the ability to have a subcutaneous injection for maintenance is really important—can be really important—for many of our patients, with regard to, you know, they may not have the time, whether it be work or school, to go to an infusion center, or they may not want to have home infusions; they may travel a lot.

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You know, those are all things that we like to consider. So now we also have new dosage forms for some of our older medications. For instance, vedolizumab is one for which we have a subcutaneous maintenance injection, and for infliximab we also have a subcutaneous maintenance injection as well, depending on, you know, disease severity and how these patients are doing.

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And that can also help determine how fast our providers may want to transition our patients from the infusions to the maintenance injections, but that will definitely be patient-specific. And when I meet with our patients, I also like to go through and help them see where different medications lie in relation to each other, like side effect profiles.

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And that can really be helpful as well. When we're thinking about induction and maintenance, that's something that I really wanted to highlight too with our patients—and with our payers even—is that it's very important to make sure that we have successful induction. So there are phases of our various medications that we can use. For instance, we may have an induction infusion, like with risankizumab; they do need three infusions—one at week zero, one at week four, and one at week eight.

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And then starting at week 12, they can start the maintenance injections every eight weeks. That's just an example. But that's why it's very important that I ensure that our patients do finish out those whole three infusions for the loading doses, or that induction phase, to make sure that we get patients into remission and then—or ideally—get them towards that goal and then have proper maintenance thereafter.

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So those are all things that I look at, especially with our patients, and it's very important to tell them that they're not in it alone, that they are being monitored. So proper monitoring is also important, with adequate blood work as well as, you know, disease-state monitoring too. So fecal calprotectin is something that can be utilized with our patients and ordered for them through a stool study test to see how those levels are, and that can be used as a baseline test.

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And then to compare how those levels of inflammation in the gut are doing. And that also can be a sign of how patients are responding to these various medications. So I think it's very important to understand that even these noninvasive biomarkers of inflammation, like fecal calprotectin and CRP, are also considered covered by our payers, because we can use them over time in addition to scopes and imaging.

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I think it's really fantastic how much you've gotten into the shared decision-making. I know it's a critical issue for Mayo and certainly as you work with your patients. I know a lot of other facilities out there, and providers and practitioners are working on that shared decision-making process. And it's great to hear how in-depth you take that with your patients.

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Yes, it's an exciting time. I love having all the options to go with them, and they feel like they really can take the lead on their health care. You know, they really are engaged in their health and they don't feel like they're being, you know, necessarily always told what to do with their health. They're also kept in mind to make sure that we reach our goals both clinically and personally, which is just fantastic.

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Well, I'd like to thank you, Sheena, for joining us today. Thank you so much for having me. I greatly appreciate it. And thank you for listening to this episode of Unscripted, The AMCP Podcast. This episode was sponsored by AbbVie Inc. For more information about AbbVie, go to AbbVie.com.