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Thanks for joining us in this episode of Pharmacy Hot Topics, where we sit down with our experts and discuss what is currently top-of-mind in the world of pharmacy. My name is Chavon De Urioste, and joining me for today's episode is Patricia. She goes by Patties, Roberts, Director of Pharmacy, overseeing oncology services at University Hospital Sidemen Cancer Center in Northeast Ohio. We also have Indrani Carr, Manager of Bournullary and Drug Policy at University Hospital's Health System, and Jason Bergspagan, Inter Manager of Oncology Pharmacy and Laboratory Operations at UW Health in Wisconsin. This group plans to talk about the management of high-cost medications in the oncologic setting. Welcome, and thanks for joining us today. Thanks for having us, Chavon. Thanks for having me. Happy to be here. Thank you. Well, we have a lot to cover, so I'm going to get us started with our first topic, which is defining what it means to be a high cost on pelagic drug. Is it based on cost per dose, annual spend, or other factors? I know you all handle inpatient and outpatient settings, so feel free to clarify if the definition differs between practice settings. Let's start with Pattie. So at University Hospitals, we don't have a specific definition for a high-cost oncologic agent. We don't have a threshold, so to speak. Most are very expensive, and that would be the same for inpatient and outpatient. However, I'll let Indrani talk a little bit about our high-cost strengths on formulary that are reviewed by a separate formulary subcommittee, as she's the content expert here, and that would be whether they're oncologic or non-oncologic. Thanks, Pattie. We recently created a high-cost drug therapy subcommittee that works in tandem with our normal formulary process, so right in conjunction with the review that we normally would do for our formulary process, but we now have engaged all of our different stakeholders, like revenue cycle and finance, and our pre-certification department, etc., etc., to be involved with specific high-cost drugs that are over $150,000 per therapy. So a great example is something like elevities that is quite expensive. We're talking multi-million-dollar drugs that are usually given once for curative therapy. So that's our break point in terms of high-cost drugs, and I'll turn it over to Jason to talk about UWU's process. Yeah, thank you. So we've had some similar approaches at University of Wisconsin. Similarly, we have not, I would say, purposely set a objective threshold just because we want some kind of latitude to send products through our committee and our structure without being overly prescriptive. I would say generally, cost per dose is kind of what would push something into being considered, though if we do have a product that's going to have a significant annual spend kind of based on utilization and number of patients that could qualify it as well. And then both sites of care and patient outpatient would be considered. I think as we get into a rev cycle, like Adriani mentioned, certainly if whether it's going to be administered on the inpatient setting, outpatient, kind of what we expect in terms of margin, cost, revenue, those types of things would kind of go into our discussion. Great. Thank you all so much for your input. So moving on, there's there's been a significant increase in the number of oncology therapies receiving FDA approval in the past few years. Our requests for formulary inclusion of high-cost handles, like a sera, formal high-cost committee. So at University of Wisconsin, we have one as well, kind of similarly structured. I think, you know, overall, we wanted to just be more proactive with how we approach these agents versus kind of, you know, one-off or non-formulary types requests. So our committee similarly includes, you know, really just a larger group of stakeholders. I think at minimum, you know, increased transparency across the organization within pharmacy as well as outside of pharmacy to understand how these higher-cost agents are going to be, be impacting us. You know, I do think overall, we have a responsibility, you know, to be good stewards. And I think having that structure in place, you know, helps us do that with a lot, you know, allowing all these kind of various stakeholders to provide their expertise. Thank you, Jason. And how about you and Dronie? Thanks, Sean. I'll add in addition to something very similar that Jason described. We also have used our new subcommittee to really help us with the implementation. So start to finish from that initial request all the way through our first patient and monitoring how that first patient's care went, what are the rev cycle implications, et cetera, is really what we're focusing on right now. We're in a very infant stage of working through our first couple of drugs and our initial pre-cert process for those. But the key point I think that Jason pointed out, which is really good, is transparency for these groups and ensuring that everyone that is a part of this committee understands their responsibility to these high-cost drugs. It's the first time we really had all of these groups in a room together talking about something as high-cost as these types of medications. So it's been really good for us to connect those dots and really try to help folks understand and figuring out the best way to communicate that is the current strategy and hurdle we're working through right now. Do we prefer every month meetings? Do we prefer every week email updates? Those are the types of things we are pro-conning at the moment with our first couple of drugs. Yeah, well I appreciate you both, you know, providing some kind of structure to a very complex process. Jason, in your experience, what factors might help determine formulary approval versus a denial? Well, I think certainly we, you know, rely on some of our old standards, you know, safety, of course, and efficacy, you know, trying to understand what specific, you know, patient populations and many of these products are, you know, very niche populations, patients see benefit. You know, I think given the cost, you know, some of the common questions are, you know, from a formulary perspective, if we do want to include, you know, certain, you know, restrictions or more specificity, just to ensure that, again, given the cost that we're really seeing use and utilization only in those specific populations that, you know, we know based on clinical evaluation, should derive that benefit. Thank you. And Jeremy, do you have anything to add as far as your experience with what helps with approval? Great question. So our formulary process really hasn't changed in terms of looking at of CNC, just like Jason's process is. I think one of the pieces that has been added is ensuring that we're taking a look at not only our local payer coverage, but also what our estimated reimbursement might be. That has really helped us understand a broader scope as we're evaluating a drug. And we also added specifically oncology value analysis for our medications that are in the oncology space to understand the value of adding a medication based on the types of evidence that was used for approval and safety in the different trials. So that has also helped us be more efficient in our evaluation. That's wonderful. That's interesting. So let's say the oncologist is working with the near electronic health record and is entering an order for a formulary medication, which is considered high cost by our institution. Are there any strategies that you employ to increase awareness of costs, such as media, a soft stop or a hard stop or additional review and approval process? And Johnny, if you don't mind, I'll start with you. Sure. We have a couple of categories related to, I would call them soft and hard stops. We use a lot of restrictions from a formulary standpoint. In that category, it might be something that is on formulary, and we have restricted, but maybe we don't use very often. So we'll have to make sure we're monitoring on a patient by patient basis if we need to bring that product in versus if something is restricted, but outpatient only, that may be another indicator for our providers that we need a prior often file to be able to provide that product. Or if they want to use that product inpatient, we do have an official process to request an inpatient use of an outpatient oncology specific drug. Those requests are vetted by our clinical pharmacy specialist pairing for that patient and our chief medical officer and oncology oversight for the health system, one of our providers. So that's another category that we work with, and we also may have restrictions even specific in our inpatient setting where that may require specific utilization criteria. We also do have a process where if we have something restricted, we know that our normal utilization where we expect to see patients, we may have one-off cases, especially at our academic medical center, because we're seeing the sickest of our sick patients. So we do have a process to vet an out of restriction request, which is handled by a specialist and a pharmacy leader at that location. And then if they need backup from the flomillary team, we are a part of that. And then, of course, we have our normal, emergent, non-formulary case evaluation happens all the time in oncology where there's a new chemotherapy approved by the FDA. And we now have a patient in front of us who we need to take care of. So we have a case-by-case basis evaluation for those types of patients as well. That's great. And Johnny, I appreciate that you incorporated how you handle those non-formulary requests that may pop in. Jason, how about UW health? Have you handled increased awareness, or do you utilize like any kind of hard stops or soft stops? Yeah, I mean, we employ a lot of those similar strategies. So it's kind of reassuring to hear that there is a similar approach across our systems. I think, overall, whether it's high costs or not, we've definitely tried to increase our proactivity again. So trying to limit these one-offs, non-formulary cases where we don't have that infrastructure, whether it be in the EMR and the formulary system in place to help with some of that decision support. So I think just from our vision perspective, that's improved. Similar to in Johnny, we recognize as an academic center, there are going to be times where we have products new to market or patients in front of us that are going to need either quicker access to a product that had yet to go through a formulary or maybe a more non-standard approach. So for that, we do leverage our oncology P&T committee, kind of in a peer review format, to do kind of the clinical vetting of those types of requests. And then we would, after that type of approval, would then move forward some of the more operational pieces. Thank you so much for sharing. It sounds like it's similar, but slightly different process you have. So even with built-in mechanisms to rein in inappropriate uses of high cost therapy, it can still get out of control very quickly. Can you tell me what your process is for monitoring the use of these high costs on philagic drugs at your practice sites, and we'll start with you, Patti. Thanks, Sean. So since I've been working in the organization at University Hospitals, it's about two and a half years ago, we are annually at minimum reviewing outpatient restricted medication use that has been used in the inpatient setting. And I target that because you've learned all about Indrawny's processes to manage our formulary, that I say Indrawny's processes because she's fostered the establishment of all of them, but University Hospitals processes to manage our formulary. And when we assess drugs, we assess whether they need to be on the inpatient formulary or they should be used outpatient only with special exceptions because we do have patient care cases at our academic medical center that might require their use. So I annually review all of our currently restricted outpatient medications that are used on the inpatient setting. And since that has started, I've gotten by in from our physician leadership to create a request, a formal request process to use outpatient restricted drugs on inpatients. That allows a our CMO and myself and Indrawny to see the case and then consult with the team or with the pharmacy specialists involved to make a decision for that specific case of patient care that we might need to use an outpatient, usually more expensive medication on the inpatient setting. And since this process is new in 2024, the data from the form request process will be used to compare to my normal annual review of the outpatient restricted meds used inpatient to see how we're doing and our adherence to the form process, which I'm pretty confident in, but we'll be double checking ourselves. Additionally, unfortunately, there's an occasional problem where inpatient charges for some of these medications get caught up for days and weeks due to all of the pieces required to document administration because we are charged on administration in our health system, as well as all the epic financial cues necessary for charge QA. So we really keep close tabs on some of the high-cost medications, like CAR-T's, in partnership with finance. At this time, it's very manual work, but we're less than a year into epic and we have a goal to be doing this more automated in the coming months. Thank you, Patty. It'll be interesting to see how the data presents itself with your new system in 2024. Jason, how about you? Do you have any kind of process for monitoring the use of these high-cost drugs? Yeah, I'll maybe take a little different spin on this one. I grew Patty, I think, from like RevCycle perspective, it's really important that our systems have that type of infrastructure in place as she described around these products. I'll maybe talk a little bit on the clinical side and use CAR-T as an example. So I think many of these high-cost therapies, someone has a rule of thumb, are becoming increasingly complex. So certainly on the health system side, we're devoting more resources programmatically to help manage them, to ensure that our patients are getting the best possible outcome. So I think from a clinical side, as well, in terms of monitoring, certainly we want to ensure that from an outcome perspective, our patients, again, are maximizing how they're doing with these therapies. So within our various programs, in CAR-T, for example, that's something that we're tracking a lot more closely, just because of the larger investment that, as an organization, we're making into delivering these higher costs and often highly complex therapies. And lastly, sometimes incorporating a visual presentation of drug spend is helpful. Have you created a dashboard or a report specifically for high-cost on prologic medications? So what information does it provide and who monitors it? Jason, I'll start again with you. Yeah, I think this is a really important question. I think certainly an area that we'd all like to continue to improve and provide the most updated and best type of information transparently across the organization. I can, I guess, speak kind of CAR-T, I think, is a good example, again, in our institution in terms of a program where we do have high investment in terms of the therapeutic, as well as the program itself in managing those patients. So we do have kind of an ongoing, I think, dashboard would be probably the right term that is managed and monitored mainly by the pharmacy team. I think certainly from a cost perspective or tracking administrations, cost, margin, revenue, those types of things, perpetually, again, having kind of more eyes on that regularly, just because of the larger investment in that program. I think, again, conversely, on the other side of the clinical side, we want to understand how our patients are doing on these therapies. So things like our, kind of some of our core, like patient outcome, types of standards, just something that we include in review on that as well, just to ensure that kind of the resources we're putting in from a clinical perspective are, you know, being focused on kind of the best areas. Now, that makes sense in assessing the prescribing topics and the revenue where it's going as well as the patient outcomes. Patty, how about you at your institution? I really appreciate that Jason shared some of the clinical monitoring space as well at his institution. I think that's a really good way to think about the full medication use process, how our teams are integrated in both the inpatient clinical care, as well as the business of pharmacy. At university hospitals, we do not have a current dashboarding system at this time for monitoring these medication administrations. Right now, I would say in terms of referring to the clinical world again, our clinical pharmacy specialists are extremely educated and diligent making sure that, you know, at minimum, well, their clinical care for these patients is complete. And then they are watching, especially our high cost medications like CAR-T that the nurse documents all of their administrations accurately and following up if they're not forgetting to document all of the pieces that they need to trigger the administration completion and then the charge. Very, very manual process, but they're keeping diligence to it. I would like to see in a future more use of some analytic tools in our department to see more of the use of these medications in real time. And that's a goal for 2024 for myself and my team. And I definitely think, as I've talked to you guys about the outpatient restricted medication request process, that there's going to be opportunity to optimize that process and what medications. I have a feeling there are certain medications people are not requesting routinely, because just a cute patient need and frequency, for example, udenica, which is our formulary medication for pagphograstum. A lot of times we'll use that inpatient due to care coordination and transitions of care. And they don't want the tediousness of submitting each time a form to ask for using that. So I'm a feeling that is. And it's still something that we need to tackle in a separate project for appropriateness. Thank you, Patty. I appreciate you sharing your goals for the future as well. To wrap up, when you share any factors, you feel are key to providing support in managing high cost oncology therapy in the inpatient setting. And Jason, I'll start with you. Yeah, good question. I mean, I think number one, you know, kind of setting expectations. We've talked about some of this. So I think having a formulary process where site of care is considered. So when you're considering new therapies to market, what are therapies that are going to standardly be administered in that patient setting or what therapies you would allow in the inpatient setting due to their potential complexity? I think with kind of setting expectations, we've already kind of highlighted our committee structures at both our organizations in terms of how we increase transparency and let the large group of stakeholders understand the impact of these high cost therapies, particularly when administered inpatient. I think, you know, having a process for deviation, we've kind of touched on so, particularly in our academic centers, you know, we know that we're going to have, you know, patients that, you know, may come up where there may be a request that's maybe a little bit off script. And that might, that's okay about having the right group of stakeholders that review that for appropriateness, kind of to that theme of setting expectations and having transparency across the organization is really important. So I'm trying to do anything to ask. I second everything that Jason said. I think that in terms of stakeholders, definitely having your embedded clinical pharmacy specialists who are aware of the formulary who can who are on rounds having the conversations with the doctors about using different medications, knowing when they're appropriate to use, knowing when they may not be that appropriate to use, as well as the relationships with the medical staff and those who are holding the medical staff accountable to adhering to the formulary, having conversations about patient care and just making decisions on using some of those restricted drugs. And I think Jason's first point was about the formulary process, definitely think infrastructure and systems being built are definitely needed. So emphasizing his points exactly. Thanks, Jason. Well, thank you all for sharing your expertise. That's all the time we have today. I want to thank Hattie and Dronnie and Jason for joining us to discuss high cost medication stewardship of oncologic medications. If you haven't before, I encourage you all to check out the ESHP's online resources. You can find member exclusive offerings such as the preceptor toolkit, the research resource center and more. Thanks again for joining us for this episode of Hot Topics in Pharmacy. And if you enjoyed today's conversation, be sure to subscribe to the ASHP official podcast for more great content. Thank you for listening to ASHP official, the voice of pharmacists advancing healthcare. Be sure to visit ashp.org/podcast to discover more great episodes, access show notes and download the episode transcript. If you loved the episode and want to hear more, be sure to subscribe, rate or leave a review. Join us next time on ASHP official.
