(upbeat music) - Welcome to the ASHP official podcast. Your guide to issues related to medication use, public health, and the profession of pharmacy. - Thanks for joining us in this episode of Pharmacy Hot Topics, where we set down with our experts and discuss what is currently top of mind in the world of pharmacy. My name is Hannah Tricket, and joining me for today's episode is my co-host, Cassandra Simkins, and our guest, Derek Graham, Director of Medication Management at WVU Medicine, and Brian Sayer, Chief Pharmacy Officer at Charleston Area Medical Center in West Virginia, about high-cost medication stewardship. Welcome, and thanks for joining us today. - Thank you for the opportunity. - Yes, thanks, Hannah, happy to join today. - So my first question for the two of you is this. How do you define a high-cost drug? So is it cost per dose or do you look more at total annual spend? And I'd also love to hear if the definition of a high-cost drug is the same for inpatient versus outpatient settings. And also if it's the same for an academic medical center compared to a smaller or more rural hospital. So I'll start with you first, Derek. - Yep, thanks for asking the question. I really do think that this is an area of focus for all health systems across the country and was highlighted in a recent webinar that ASHP put together to get some thought leaders to talk through these considerations of how to handle these high-cost medications. Within WVU Medicine, while we do not have a standard definition for a high-cost drug, we evaluate the fiscal impact of adding a medication of formulary when that's requested. And we present that impact at our pharmacy and therapeutics committee that has representation of all of our sites across the health system ranging from small critical access hospitals up to our academic site. The impact is evaluated both globally at the health system level and also at each of the facilities in contact stuff that's expected use and total drug budget. Within WVU Medicine, we developed internal fiscal impact scoring tools that take into account whether medications predominantly used in the inpatient or outpatient site of care as the reimbursement of those medications is much different. And it's also worth noting that the acquisition cost of a medication can vary by hospital type, whether or not that hospital is a dish hospital, critical access hospital, rural referral center, et cetera, and whether or not the medication has orphan drug designation status. Likewise, the pair mix can vary wildly depending on the disease state. And so within each of the monographs for evaluation, for the inclusion of a medication on our formulary, we create a pay or cross-tap report for each of these agents to identify any risk for underpayment or insurance denial. And because WVU Medicine's mission really centers around trying to treat patients within their own communities, we work hard to make the revenue cycle piece work so that we can provide this care at the local smaller sites whenever possible. Obviously, there's operational concerns with some of these more complex medications and the pair of landscapes constantly shifting. But whenever possible, we really do try to treat patients within their communities across the state and surrounding states. - Thanks, Derek. And now Brian. - You know, I have to agree with Derek. We have very similar processes. When you look at these, defining a high-cost drug, I have sort of a running joke with folks here in the organization, the administration as well, that if it ends in MAB, it means a lot of money. And when you really think about it with all the monoclonals that are coming out, that's where we're seeing a lot of our impact with our drug spend. So as we evaluate each of these products, both on the acute care side of the house and the outpatient as well, inevitably you're going to spend a considerable amount of money on particular drugs. But I think the key is that financial impact. What is the benefit to the patient? And is our insurances and other payers covering these medications? What's that financial impact to the organization? Again, one of my mentors over the years always made a statement, do the right things right for the patient and the dollars will follow. That absolutely holds true when you look at utilizing high-cost drugs. You know, in our outpatient space, it's just like Derek mentioned, site of care. Are these even in our ambulatory and in our retail pharmacies? What's being covered? Are we getting the reimbursement that we need to at least at a minimum break even? I think the other piece that really comes into play and it's a big help for us as an institution is the 340B status. If these drugs are utilized in our infusion centers, in our cancer centers, in our clinics, and rightfully so, the 340B program has been instrumental in helping us to overcome some of these obstacles and barriers to treatments. - Yeah, definitely. Thank you both for those considerations that you take into account when defining your high-cost medications. My next question is related to whether or not you have a high-cost drug committee that handles the review of these medications. If so, what is the membership and reporting structure like? And if you don't have a formal committee, how are these requests for a formulary edition handle? So this time we'll start with you, Brian. - Thank you. We do not have a here at Trustee Medical Center. We do not have a formalized high-cost drug committee. And I think part of that reason, as we've looked over time, is the fact that so many of these medications that are coming out now are thousands and thousands and thousands of dollars. So we incorporate that straight into our processes with our P&T committee. Like I mentioned earlier, if you do the right things, right, the dollars will follow. So we do our clinical reviews, just like any other medication, making sure that, yes, the outcomes justify the costs. The safety profile is there. And then ultimately the financial piece. We run through all the possible scenarios of payers. What's the prior authorizations? What's the, and again, if it's a, we'll just say some like oral medications. Yeah, we can add some high-dollar drugs to our acute care side of the house, but can they get that drug now when they leave the organization? What's that process? Making sure that the patient can continue that treatment. So we always do, like when our financial piece, is there any end-tap payments that are available? Making sure that we have things built. We've added some drugs to formulary that it's taken quite a while to make sure that we have it built in our computer systems and on the finance side so that we aren't going to be able to get paid for those drugs. And our physicians are great and they understand it. They've been very fiscally responsible in making sure that we use medications appropriately when it's needed. Yeah, thank you for that. And Derek? Yeah, I want to echo a lot of what Brian said in that we often incorporate all the fiscal elements of evaluating a medication into our clinical subcommittees of our enterprise therapeutics committee, 'cause we want to make sure that we have the expertise of the physicians that take care of patients in each of these therapeutic areas when we're discussing each of these medications. As we know that the value of a medication is really the clinical outcomes associated with that medication divided by its cost. There is one area that we added a little bit more structure to and that is an area of genetic and cellular therapy. Back in 2021, we developed a task force specifically to address those therapies as they were oftentimes, you know, in the north of $400,000 a million, really high cost and presented a lot of logistical challenges with regard to procurement, administration, and billing of those medications. And this task force developed standardized workflows that we incorporated the process throughout from the ordering procurement administration and billing of those medications to make sure that we got each of those steps right along the way. And really that task force stood up standard workflow documents that could guide all the users just in time, because oftentimes they were infrequently ordered as to what those procedures and processes were that we needed to ensure payment on the backhand of those medications. And still today, the members of that task force are brought in in real time to create a redundancy to assure that steps necessary for payment are followed and crossed off. And oftentimes we're engaging in single case agreements with payers upfront to ensure that the cost of the expensive medications will be covered once we've already administered the medication to the patient. And now we're in turn billing for their services. - Really great insight into the workflows and the committee structure you both have in place, especially the additional group, their footage and genetic and cellular therapies as we know that those are often very high cost medications. My next question is for Derek. Hannah, I'm curious as to what factors help determine formulary approval or denial for these high cost meds. And do these factors differ significantly between your large academic medical center sites and your smaller, more rural hospitals? - Yeah, it's a really great question, Hannah. And oftentimes high cost medications meet a previously unmet therapeutic need. So these were disease states that really didn't have a robust therapy previously. That presents a bit of a challenge for the organization in order to ensure that our patients that need these therapies, receive these therapies, particularly in the case of rare diseases. I will highlight with our governance process with pharmacy and therapeutic committee, we do have an enterprise PNT that reviews these medications and adds medications or chooses not to add medications to our enterprise formulary. But each hospital does have the autonomy to not add a medication to local formulary if they feel that they don't have a strong need for the medication or they would not be made financially whole if they added the medication to the formulary. So there is a piece that each of the local sites do play in this process. When we're evaluating the medication at the enterprise level, our internal clinical impact scoring tool takes the fact that whether or not there's other therapies that are available to treat the patients or if this is indeed a truly a previously unmet therapeutic need, and we take that into consideration as well as the level of evidence from pivotal clinical trials and any endorsement by medical societal guidelines to help govern the decision about addition of a medication to the formulary. The pair landscape and revenue cycle evaluations that I previously talked about are layered into the formulary evaluation monograph as well and represent part of the value discussion that we have at the P&T committee meeting. And then site of care, hospital type and pair mix, all play a role in the decision making process, both the global level, but we're also able to highlight any considerations for operationalization so that if a medication, for instance, is an orphan drug and are critical access and rural referral centers do not have access to 340B drug discounting of that medication, that may not be the site of care that wants to incorporate this medication on their own local formulary as the net margin of that medication may be different. So while we're evaluating the medication through the enterprise process, we work to highlight some considerations for local implementation that sites can utilize to make the decision for their local formulary evaluation for themselves. - Thank you for sharing some insight into these processes. The next question I have is for Brian, for non-formulary high-cost drugs, who can place requests and how are they received? When you're ready, we'd love to hear from you, Brian. - Thank you, Cassie. Within our institutions, basically any provider is eligible and able to order non-formulary medications. In certain situations, we will restrict drugs to certain disciplines or service lines, but in most general terms, providers can order what's within their scope of practice. So when we get to these high-cost drugs, we don't have, at this point in time, any type of extra restrictions when it comes to ordering from a non-formulary process. Our non-formulary process is the same for any medication, the way it works, and just to be blunt, we use a paper process, which tends to work very well. Typically, we'll get an order or phone call and pharmacy of the provider wanting to use drug X, and it's not a one-formulary, so we work with that provider to come up with what are alternatives. Are there other things that are on-formulary that make clinical sense? And if not, we'll go down the path to using our non-formulary process, which again, it's paper, some documentation that we keep in file, and even at that point, if we still don't within pharmacy agree that this is something that could be users, other alternatives, you know, we'll engage others with the medical staff. There's processes that we have built in place in our policies. So we just take the stance that if a patient needs a drug, we're gonna do what we can to help take care of that individual. Now we still do our same processes as part of this evaluation for utilization is again, what's the cost? Can we do a quick search to see are we gonna be able to get compensated for that? And again, like I mentioned earlier, it's the fact if we start a patient on a particular drug in the institution and they need it once they leave, can they get it? So we'll engage social services and others at that point to try out either of the prior authorization processes, 'cause at the end of the day, if they can't get it when they leave, that's just, we're really building that patient into service. - That's a very, very good point. Thank you, Brian, for providing us that information. The next question I have is for you both, what is the estimated FTE requirement to adequately manage high-cost drugs at your institution? Additionally, we'd appreciate if you could touch on how many non-formulary high-cost drug requests you receive on average every month or even every year. For this question, we would like to start with Brian. Here at CAMC, we don't have really a dedicated, it's called a high-cost drug individual, but it's more of a shared responsibility across our buyers and our clinical team. I would estimate that it takes approximately, if you really kind of average that on a monthly basis and dealing with all of the other purchasing requirements, probably one FTE to spend the time to do these right processing information, it works through it on the back end as well. 'Cause again, it's not just one person, it's a lot of people working on it at one time, so to add the total number of labor hours adds up fairly quickly. I don't wanna say that we receive it varies, but probably in the neighborhood of two, maybe three non-formulary requests a month, and some of these are duplications. So it may be a particular drug that we will get, say the first of the month, who might have a patient later on in the month, that needs the same medication. So then we even take the process from that point, all right, we're getting multiple non-formulary requests. Is this now something that needs to be considered for addition to our open formulary? - Thank you for that. Now let's hear from Derek. - Yeah, really great question. In reality, managing high-cost drugs requires collaboration of many individuals across several pharmacy and non-pharmacy teams. And I think the concept of the number of non-formulary requests really kind of depends on site of care, if that's an infusion center, clinic-administered meds, or if it's in the inpatient space. So to really put a number to it, the number of non-formulary medication requests, and even the subset of those that are high-cost, is a really, really small number. We really work hard to proactively monitor pipeline medications and use population health data to estimate how many patients may receive any of the newer pipeline medications, even before medication becomes readily available to order. And so we're trying to be as proactive as possible on the newer innovative therapy so that we're not presented with a situation at bedside or at chair side, and we're not caught a bit flat-footed, and we don't have our thoughts gathered around the use of that medication. I will say that we do have one pharmacist FTE dedicated to facilitating the formula review of oncology and ambulatory clinic-administered medications and infusions. And that individual coordinates a couple of our key subcommittees of our enterprise P&T, being the Hematology Oncology Subcommittee and the ambulatory subcommittee. We also review costly inpatient medications every day through a report that's generated, and the individual that participates in those activities is one of our part-time employees. Really just takes her probably less than 30 minutes a day to lay an eyeball on each of those medications in a retrospective manner. But she helps identify any prescribing trends and whether or not we need to consider any medications for formulary inclusion moving forward, are there alternatives that we can build out into our therapeutic interchange to help facilitate decision-making upon point of care and to help with any additional planning or communication of any budgeting needs to our pharmacy leaders across the health system. - That's really great insight into how your institutions handle high-cost, non-formulary drug requests and the FTE requirements. It's interesting to hear the similarities and differences between institutions. The next question I have is for Brian. Do you deploy any soft or hard stops for ordering high-cost medications? Additionally, do these processes vary with medications based on if they're a formulary versus non-formulary, or do they require a specialist to proceed? When you're ready, Brian would love to hear from you. - Thank you. So we've tried to keep things as consistent as possible. You know, I think consistency in your procedures and how you do things leads to better and more repeatable outcomes. So in our whole process around the formulary and even non-formulary medications, we'll start with the non-formulary side. Again, we mentioned earlier about our, call it our paper process. Immediately, if you get a non-formulary medication, it goes through a couple of checks and balances, communication and collaboration with that provider to determine what goes on. So at that point, let's call it, it's a somewhat of a hard stop. You know, we don't just automatically process those orders and let's call our wholesaler and see if we can get the drug in or call around other facilities within the state to see if they can't transfer some drug does for the, to take care of this one individual. So we work through those processes to come up with what's the best avenue moving forward. And within our processes, we have opportunities to engage associate chief medical officers to have some conversations around the clinical benefits and even some of the financial pieces. We have folks at our ready call to help us with some of the financial analysis that goes on. But as far as anything special that we do around the high-cost drugs, I think it gives us pause when you see this, whoa, that drug is gonna cost $50,000. This one's gonna be $100,000. It's like, okay, it's expensive. But should our processes necessarily change whether it's a $25 drug or a $100,000 drug? If it's the right thing for the patient, we need to follow a similar process. And from that, we don't have specialist pharmacists that intervene unless, again, we just had a situation here recently where it's like, okay, let's call it one of our pharmacists who take a look at the patient, help us with the bedside decision-making. And sometimes with the collaboration with the provider just right at the front end, we're able to make those decisions. Yes, this is the right thing for that patient. Or no, you know what, here's a better option. And let's move forward with that. - Thanks, Brian. I really love the emphasis on keeping the patient front and center in all of these decisions. So thank you for that. My last question is for Derek. And you touched on this a little when discussing FTEs required for managing high-cost drugs. But it's related to data analytics. So do you have a dashboard or report for monitoring your high-cost medications? And if so, what information does it provide? And can you speak to who monitors it or intervenes and situations when there's opportunity to improve our prescribing habits? - Yeah, it's a really good question. And I think it highlights a couple strategies that we've put into place with WVU Medicine. We've developed work queues and email alerts for medications used in the inpatient space that exceed $1,000 or more a day. And then also reports and work queues that identify underpayment or did not payment in the ambulatory space. And these work queues are monitored both by pharmacist, president, the local site, and also at the enterprise level to quickly identify any concerns or trends. And so at the local site, that's really important given the proximity of that pharmacy team with the providers and clinical staff. But at the enterprise site, that oversight allows us to evaluate trends that maybe we only see one instance of something at one critical access hospital, maybe one at another community hospital in the system, but we're able to put it together a little bit more quickly when we evaluate in the context of the 25 hospitals that we have within the health system. So that's a bit of the strategy that we've put around the monitoring piece. I will note that we have a pharmacy business operations team at WVU Medicine that evaluates the impact of adding a medication after we've added to formulary for approximately six to 12 months post implementation. And that helps us monitor any coverage gaps or sure up any of our upfront assumptions that we used in our scoring tools to make sure that we got those estimates exactly right. Anytime that we identify any discrepancies in that, we bring the folks that were present for the formulary decision making together to assess what the impact of that situation is and to help us decide if we need to take that medication back for any further review or for any further refinement of our clinical criteria for use or perhaps implement an operational pause, perhaps if we need to add some coding or some additional evaluation before the bill goes out and such. - Well, Derek, thank you highlighted some really great ideas for others to potentially incorporate into their workflows if they currently don't have a process for ongoing monitoring of these high-cost medications. Well, that's all the time that we have today. I wanna thank Cassandra for hosting with me as well as Derek and Brian for joining us to discuss high-cost medication stewardship. If you haven't before, I encourage you to check out ASHP's online resources. You can find exclusive member offerings such as the Formulary Management Resource Center, the Compounding Resource Center, an updated medication safety resource center. You can also participate in ASHP's Connect Communities where you can post questions and exchange ideas with peers. Thanks again for joining us for this episode of Pharmacy Hot Topics. 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 wanna hear more, be sure to subscribe, rate or leave a review. Join us next time on ASHP official. (upbeat music) (upbeat music) (upbeat music) (gentle music)
