Garcia pod

00:00:05 Speaker: welcome to the Targeted Oncology Treating Together podcast. I'm Doctor Pallav Mehta. I am a medical oncologist specializing in breast cancer for about twenty years. I'm also the medical director of Reimagined Care. I will let Jorge introduce himself. Well, thank you, Doctor Mehta. Really appreciate the opportunity for today. I am Jorge Garcia. I'm a pharmacist by training. I have spent most of my career in oncology and in the health system setting. In my last role, I was the assistant vice president of Baptist Health South Florida. About twelve hospital organization in the four southernmost counties of the state of Florida. And there it was a kind of a new oncology program. So we had the opportunity to launch new car services. Also establish new gene therapies. Get through the process of getting national accreditation. And now we have extensive experience with bispecific products as well. a few months ago I launched Patagonia Healthcare. I'm the founder and the principal of that organization. And Patagonia really aims to work with provider organizations to establish better sustainable access to Pharmacotherapeutics. So I'm really looking forward to the discussion today. I did read about Patagonia. Congratulations on that. That's no easy feat. just looking at your background, I mean, you've really you've done so much in the last, I think it's probably fifteen years since you finished your training, but really involved in a lot. So this will be great conversation. And, specifically the topic of this conversation, as you said, is complex therapies, advanced therapy. the terminology is kind of still being figured out as to what we're going to call them. but we know that treatments have really changed. I remember when I came out, into practice almost twenty years ago, there was a couple of oral drugs and, you know, we had our standard IV chemotherapies. Immunotherapy was still a few years away. And then the rest of it was just a kind of a fantasy dream. And here we are today with these really complicated, bispecifics and, and re-engineered cellular therapies. and the space is daunting, I think for, for us as clinicians, certainly for patients to think about all the, the issues. So, maybe let's set the stage on what are these therapies? why are they different? what makes them so different from prior sort of chemotherapy that we were, you know, most of us are used to. Well, thank you, doctor. And I think I think you're right when I think about the evolution of therapeutics in oncology, the main way to care for these patients have really been through the delivery of these immunotherapies, chemotherapies, and then advances in diagnostics and medical science in general. In the last few years, we've almost doubled the amount of rare diseases that we even know of. And so that is stimulating a lot of innovation in that space for new therapies for these diseases. Right? so it's great that we continue to have better treatment options with a lot of science fueling that. But on the provider end, we need to figure out how they fit into patient care and what sort of treatment modalities are most appropriate for these therapies. I think chemotherapy, understanding that their toxic regimens really get stablished in these, infusion center sort of environment with highly specialized teams monitoring and helping patients tolerate as best as possible. when we began to use, immunotherapy, the safety profile of these products completely different. And, the monitoring really needs to go well beyond the one hour that that patient may be on the infusion suite, because they may be more sustained toxicities that patients may experience at home and throughout their lives, right? As many patients may be working professionals and things of that sort. Now, when we get to Car-T bispecifics, now we're seeing, a lot of activity in the pipeline for gene therapy and some therapies that are already out commercially. We begin to think of these as completely different modalities, right? bispecifics as an example, allow us to have multiple targets for one disease, which is really great, but may bring about, CRS, cytokine release syndrome, icans and other safety concerns that are serious and could be acute. And so it really calls upon us to have systems in place that allows us to identify and respond when actionable to be able to keep patients, safe. And so I think the easy response to that was, okay, these patients need to be in the hospital because that's where we can monitor them more appropriately, like happen when we identify neutropenia as a side effect of chemo. It's also life threatening, but we don't do that stuff. Impatient. Today we figure out a way to manage these patients in the ambulatory setting. So I think, again, the bispecifics are just lending us now an opportunity that we have some experience. Clinical trial experience and some real world experience to really think about what is the most optimal site of care delivery for these patients. That gives us the best quality of life for these patients, while providing us the level of monitoring that we truly need. it's interesting because we're right now. When you think about bispecifics and then, you know, maybe separately, even, with the car-ts as a breast oncologist, I certainly haven't used one of these, but in my reimagined care role, we're thinking about these a lot because there's real need to, not have patients get admitted to the hospital. And maybe you could just briefly talk about what is happening today. let's say there's a car t patient the conversation happens with the oncologist. They're about to deliver it. What happens with that patient? are they getting admitted to the hospital? what does that entail for them? How many days, what's the average that you're seeing right now? something like a car T treatment that is arranged to be provided in the inpatient setting really is month into the planning of the process before that patient actually comes in. There is such a heavy lift that needs to happen with obviously the collection and the processing of the cells and working with the innovative company on that end, but also with the health plan, Making sure that there is an authorization, that they have the clinical justification to support the procedure. A lot of internal care coordination, transitions of care, things that we need to have in place leading up to the transplant. but also, after the patient gets discharged, there have to be a number of things in sequence from a transitions of care standpoint for us to position that patient from success. So different teams are involved in coordinating that. inpatient services, this may sound simple, but just being guaranteed a hospital bed for a procedure like this is very complex because most inpatient areas that I know they are at capacity. And so for example, I'm used to a process where capacity is code black. And I remember walking into this hospital every single day. It's a code black, meaning there are more patients in the E.R. and sometimes hallways waiting to be admitted than there are beds available. there may be already patients standing by on sister hospitals that perhaps don't have the service that the patient needs waiting for a transfer. And so bed capacity, it's truly takes science and art. again, allocating a bed for this procedure could be really, really challenging. I think for, for this reason, also with our years of experience and added confidence, we have been very interested in understanding how it could be done on the outpatient setting. I think nationally we continue to make better progress to that end, but there's still a lot of work that needs to be done to be able to open better access to Car-T on the outpatient setting. That means that we would not have to lean on these, highly utilized inpatient areas. Obviously, we know that a hospital setting is a high resource setting where the cost of care. It's a lot costlier than a similar setting on the outpatient end that may have less labor cost associated with it and other sort of efficiencies. And so from a quality of care, from a patient satisfaction standpoint and from a hospital, economic efficiency, moving this treatment to an outpatient setting would be a win win for all the stakeholders involved, if that makes sense. it definitely does. And I think you mentioned something that's really kind of vital in this in this conversation. The the cost of these drugs can be, astronomical and potentially depending on the health system or the oncologist's practice that we're talking about can scare them away from doing these things. I'm interested to hear how you sort of think about the different types of scenarios where patients are treated. So, I always sort of try to break it up into there's independent practices, just solo, you know, five physician practices, there's the integrated practice networks like US oncology or Texas oncology, Aon, you know, these places, there's health systems like community health systems. And then there's academic or, NCI, comprehensive type centers. how do you approach those, both in your company, in your experience, how have you kind of thought about these therapies for the different, stakeholders there? Well, look, I think of this, we know that the largest disparities in cancer care that we have here in our country are due to how readily available that cancer service is. And so there are different NIH studies that have looked at patients within one same state, but they live close to a metropolitan area versus patients that live in more rural areas. the cancer disparity significantly increase in terms of how early these patients are diagnosed and the overall outcomes of their treatment being significantly worse if they are in rural areas. So in my head, I'm always thinking we need all of Health-system oncology and all of community oncology to get to more cancer patients and to get to them sooner in their disease journey. to be able to eliminate cancer care disparities. I always through professional organizations and others have worked very closely with the entire, cancer community to try to open access on both ends. I think the specifics, it's very unique and key because due to the label requirement of some products to have some hospitalization associated with the treatment, and that has put, community oncology at a disadvantage because they don't necessarily have these inpatient settings. now over time, we have been trying to identify ways to expand access. And one of those ways have been to get those community practices to collaborate with the hospital, to be able to perhaps help with a step up dosing or that phase where the patients are most likely to have a reaction. And if tolerating well, then that patient can come in for continuation in the community oncology setting. And, you know, that model has worked in some markets. But the overall value proposition to a hospital is still very poor. It's this concept of, oh, take my patient when my patients most likely to need hospitalization, or you may need to give them tocilizumab or there may be complications. And oh, by the way, only give me this patient back if they're tolerating well. so I think that, by the nature of that, we're really not setting ourselves up for success. My true long term belief here is that community oncology, it needs to be fully capable to completely independently be able to provide bispecific services, because we know that far beyond malignant hematology, this technology is going to touch every patient type. And we already see indications out there well beyond that malignant hematology. And so I'm very proud of of colleagues in the community setting that are leaning on technology and other tools to be able to become fully independent at providing these services to patients. And I guess to, to loop this back to where I started with this community oncology, that's a much better job getting to those rural communities than hospitals many times are able to. So again, making sure that they have bispecifics as a treatment modality and that they can own it from beginning to end, I think should be a priority for all of cancer care. Well said. And I think we're on the same page about that. I spent the first eight, nine years in a community practice. And just the especially if you're in a rural area, the level of trust I think patients have with that community, setting and the, the physicians and the nurses is very different than maybe some two hour drive away at the ivory tower potentially that they, you know, they're just kind of nervous about going to for their care. in terms of maybe some, practical improvements or adjustments that say a community health system, for example, could make because personally, we've had conversations with health systems that are interested in, in doing this. but they're nervous. They're nervous because they are physicians maybe aren't so comfortable. Maybe they're not as experienced in the malignant heme space. Their nursing team's not so comfortable. Their administrators are really nervous because the bottom line, there's a lot of zeros on those drugs. And so having something go wrong and not being able to give something they've purchased. So there's a lot of these different risks. And what would you say from the perspective of capabilities, what sort of capabilities do you think community health system would want to put in place? And how much of it is, you know, buy, build partner? So I see two main areas that we need to build confidence around. First, I think you mentioned that the cost of these products could be significant. Frankly, that's what we see across cancer care. That's what we continue to see across therapeutics for rare diseases. These are therapies that are impacting a smaller number of patients. And so it's. It's reasonable that the cost is going to be higher. We are also seeing significantly higher costs associated with gene therapies. I put that in a completely different bucket. because they're just very distinct. But I think trying to instill confidence in community health system. You mentioned understanding that these bispecifics are still like those specialty therapeutics, like immunotherapy in terms of our ability to buy and bill like we have immunotherapies. that's a little bit different from Car-T. And it's definitely different from gene therapy, where in my experience, we are never going to be able to, have the same reimbursement level than we see with specialty products. The specialty products are providing that more lucrative fee for service, more predictable, that is the public CMS payment schedule of ASP plus six or four percent if you want to take into account sequestration, and then any commercial plans that may be a percent of charges. To me, that is the best type of healthcare reimbursement that I know they're for, for drugs and outside of drugs, perhaps outpatient surgeries. So the reimbursement component, I think is solid, whether we're thinking about Medicare reimbursement or commercial And sometimes for administrators, being able to retrospectively dissect real life claims of patients that have previously treated has been a very good way to relate the success that there could be as it relates to the reimbursement that is in place for this bispecific. For this bispecifics specifically, the other thing that I think is very important for us is that we gain clinical confidence in form by the growing amount of real world evidence as to how we can appropriately manage these patients. I think at first, reasonably only leaning on the small subset of clinical trial patients, we had a lot of questions about CRS and predictability and response to treatment and the role of prophylaxis therapy, thinking about tocilizumab as an example. Now today we know that we know more. We know that CRS is not like Covid related CRS. We know it's more responsive to treatment. We know that there is to a high degree of predictability on those CRS and Icon schedules. We are learning more about the role of tocilizumab. What patient population can benefit, or perhaps which ones do not? We're also learning about dexamethasone which is a very easy low cost intervention that can help. Again, have a huge impact on how we manage the patients. So I think better reassurance on the economics and the cost structure. Yes. This this is high cost treatment. The alternative of the treatment are also high cost. and by the way, these bispecifics are moving to earlier and earlier lines of therapies. And that's usually done due to cost effectiveness of the therapies compared to the alternatives. So that should help instill confidence in that group as well. So it's a combination of that and bringing to the forefront with real world evidence how we truly are making progress, getting better handle. Now what remains constant is that we need to have a good process to monitor these patients so that we know when an intervention is actionable. That's key. And even with the different confidence and the different tools that I'm describing to you, everything still centers around the fact that patients will have toxicities. It's not a matter of, if it's more a matter of when. And we need to have good processes in place to respond to patients when they do experience these toxicities. what I've learned about these, these drugs, you know, from bispecifics and some of the cellular therapies is that it's it's like you said, it's most will have some degree of toxicity. It's the rapidity with which you identify it. And then quickly identifying the severity of that toxicity to then intervene accordingly, which is, it's an interesting challenge in the virtual space. it's something we at reimagine care, one of our core products is around kind of symptom management and virtual assistant and, using wearables and, and all of that. how do you think a virtual solution could be? I know Patagonia, has availability of twenty four, seven clinicians. And how do you think that plays into it? Is it better for our health system to partner with an outside entity? Or is it just better to build their own infrastructure. To do these things. And obviously every system is different. But I'm curious what your thoughts are on that. A couple of things. Although I look at health systems perhaps a little bit more advanced and a little more capable, I realized that when I come to that conclusion, I am thinking of the hub, that flagship hospital that has the capabilities, the large majority of the times, those systems still do not have the means to have the capability in their satellite locations. and so that is an opportunity. Oftentimes the main barrier when you look at expanding the bispecifics within the large health system setting does come down to personnel. It comes down to competency development. the ability to have some level of logistics and infrastructure as to what to do if the patient is to show up in the emergency department, for example, in the middle of the night. And the ability to cross train all the individuals that may potentially come in touch with the patient, that makes it really challenging even for the most capable of the systems. So I do believe that technology can play a monumental role there. Definitely. a very important role in community oncology where the practices are smaller, the resources may be different. They may not have someone up overnight. Providing monitoring the technology truly can be a game changer in that setting. But also in the hospital setting. I think having a system that filters and can help discern between what is an expected symptom versus something that is really actionable and something that needs to eventually get to the hand of an individual that is going to interpret what what's going on is going to determine if an action is needed. That is going to be helpful and useful for any type of setting, providing these specifics. And so I do think that leaning on technology solutions here, we know that technology, AI and other modalities are helping healthcare in very meaningful ways in rare disease finding patients years earlier and things like that. Definitely here in specifics, I think the technology will play a major, major role. And as our task is to open access, I think bringing technology to the center of that is what pays dividends down the line. I like what you said about the teaching everyone in the chain, how to manage it. I think that's an important, aspect of this that sometimes is forgotten in this inpatient to outpatient, like we know for Car-T therapy, the reimbursement, the margin differentials when a patient is admitted and then hospital is paid under a DRG for Medicare patient, a DRG based reimbursement, they lose. I mean, it's a six figure loss or somewhere in that, versus if they do it in the outpatient setting, it's a six figure gain. And so there's a huge, margin swing for them. But I think what gets lost is what you said, which is if that patient has an issue and they're not coming to the cancer center, who are the other people in their orbit that need to know, how to manage it. we know, the er, for example, clearly that's somebody that could be in touch with that patient. what educational things would we give them? But what about the caregiver and the role of the family anything that you think we could provide them that that would help them manage and potentially identify, issues with their loved one? one of the main challenges with competency development is maintaining them. We know that there is a turnover in healthcare. And so this is not a one time and done thing. This is an ongoing effort to ensure that the staff, including new staff, is going to be comfortable, competent. so it is a big lift, that is done on an ongoing basis. you mentioned the care givers. the types of things that we lean on them to identify at home, the things that they need to be reporting. What I've run to a few times is that at the beginning of the treatments, patients have a caregiver because a sibling maybe flew from Pittsburgh down to South Florida in this example. But then a couple of weeks into it, that caregiver was gone. And so patient logistics, it's not to be underestimated here. It's really, really key. and important that caregiver may mean that you may need to, be detailing or educating a sibling on one week and a neighbor on the other week. logistics of being able to get to their appointments with transportation vulnerability and the real world, getting it on the way. it's the real stuff. That's why I'm glad that we have. Clinical trial data, but then also our patients living in the real world with all of these other challenges that present that are helping us understand how to best provide these treatments. I wanted to circle back on something that you mentioned at the beginning of the question, and that is the very different reimbursement structure that we see when we deliver some of these services on the inpatient side versus the outpatient side. And this is really key for us to understand and wired into our process to ensure that we can have sustainability of the service going forward. I think when Cathi programs came to be a while ago as a community, we struggled understanding the true costs associated with the service. It's not just about the drug, it is about everything else that happens around it. That is a cost ultimately leading up to the treatment of the patient. And so we lean on cost accounting and other methodologies that, in my experience, are far from perfect everywhere I have been. because the whole idea is that you cost the service well, so that then you can price it and hopefully negotiate a contract that covers the full cost of your service. The drug, all the resources that you deploy to provide the service, and ideally something that gives you a little bit of a margin for you to be able to sustain the service. So quality programs struggled. And I think that over the years, we have acknowledged that as a community and the payment rates have improved, we see that Medicare has increased their payment rate over the years. But we do need to learn from that experience to understand that going forward, especially anything where we require a single case agreement with the payer, which would happen with Car-T, it definitely happens with gene therapy as we get into the one million plus cost of treatment that we need to do a good job showcasing to that health plan all the true costs, well beyond the cost of the drug. So that is sustainable in the long term. I think that's key to all the things are for some facilities that may be three forty be eligible. If they do provide the treatment on the outpatient setting, they may qualify for this lower cost. Three forty be in that same entity, that same drug. If they provided an inpatient setting, they're not getting that three forty B benefit. That could be a huge differentiator. And then as you mentioned earlier, inpatient services can be subjected to the payment. I think a lot of the high cost of ends up being about an outlier criteria or stop loss. but still could be subjected to DRG payment. Whereas same drug on the outpatient setting. We're looking more at a fee for service that again, it's a good reimbursement model to ensure that we recover the cost of the drug and even the cost of everything else that is being provided to the patient that is not billable. And so I'll close with this. I'm a pharmacist by training. And so in my programs I have had twenty plus pharmacists providing direct patient care services. None of which have been billable. And so something else that I think we need to keep in mind, and when we help health plans understand the service that we are providing, yes, it is the drug, what is available. But there are a lot of other complementary services that are being provided that are essential for the patient to tolerate the regimen, to have a good outcome from the regimen and so on. So lots of considerations here. It is. it's so complicated. I didn't realize the single case rate and I guess it's continuing to evolve, you know, these conversations you're having with each treatment, essentially saying this particular cellular therapy, this is what you're going to pay us and it'll be a complete total cost, that you have to present to them. finding these hidden sort of work that's being done behind the scenes is really important. you mentioned this ops, you know, oncology pharmacy, you know, I have this amazing OPI that sits with me in my breast clinic. I'm at the MD Anderson site in new Jersey and, I couldn't function without her there. Neither could the other oncologists there. Where do you see the role of the OP? I know it's expanding and I'm thankful that it is. And where do you see the role of the OP both in the the outpatient setting? for this clinic and then maybe even as we've thought about it, even in the virtual setting, to utilize ops to really kind of improve that point of contact, care for the patient. I have to tell you, in my decade and a half career, I have seen this transition of that outpatient pharmacies where it was really more of a push. At the beginning, I was at the University of Pittsburgh Medical Center, and we've gotten approved to send a pharmacist to help the infectious disease team, because we were beginning to learn about antibiotic stewardship and things like that. And the team did not want it. The team is like, no, we know what we're doing with antibiotics. We're good. so we pushed and pushed and sent the pharmacist in, did phenomenal things. And the other infectious disease team found out that the other team had a pharmacist and they didn't. And so then they are like, that's not fair. You need to give me a pharmacist too. And so I have seen that evolution to where pharmacists now add so much value. And I tell teams, you put a pharm.d and an MD together, magic happens. I'm very, very optimistic about added value of pharmacists as we look into the future. We know that today they do a great job managing toxicities, hopefully anticipating those reducing, trying to prevent toxicities to begin with. But they're a great source of drug information too. And as our treatment options continue to evolve and our sequencing continues to evolve, pharmacies are just really great resources that have somewhat protected time to go out there and understand truly what is a unique, individualized treatment option for a patient. Add to that precision medicine where now we have that to fall back on to identify on a on a individualized manner what may be a good treatment choice for patients. I have some colleagues that are in this space. when those results come back from really the tumor, the gene composition of the tumor, they are really able to look at what drug is going to have activity, which may not be the first line recommendation. And what other treatments can they use down the line to potentially not prevent patients from participating in a clinical trial that they may qualify? And it's really impressive what they do. Last thing I'll do here is I do think that AI will augment the outreach of pharmacists. And we like even as a student, I was using tools like, you know, vigilance and thorough doc to try to identify patients that, you know, it's rules based. So who has an INR of three and is on warfarin, you know, it's just a few years ago. And so it triggers and it gives you that. I think that with better tools, we're going to be able to find rare diseases that we may not always be thinking about a little bit earlier in the journey. By building this suspect list criteria that can give us high quality patients to review. We're already doing things in that space with rare diseases, and the pharmacists are at the forefront of those initiatives. So I'm very hopeful that we can continue to play a role there as well. Yeah, especially in cancer, where, you know, I was saying earlier to somebody that when I finished fellowship, I think there were about ten oral oncolytics and now there's, one hundred and seventy and counting. to have a pharmacist there who understands the specific, pharmacokinetics, pharmacogenomics drug drug interactions. My pharmacist has a clinic. once a week, it's a virtual clinic where I can put my patients in particularly, you know, even these complex therapies where you could imagine a scenario where it's the physician sees them, the APN sees them and the pharmacist sees. So there's this sort of, you know, cocoon of care that, really will Benefit the patients. just in the last few minutes, we have, I want to talk about something that I think near and dear to my heart. One of the reasons I made a career shift a few years ago, I was a clinical administrative and research medical oncologist for about seventeen, sixteen, seventeen years and then decided to go part time and go into the startup space and particularly what Reimagine Care was doing. Originally, we were trying to figure out how to give certain treatments in the home, and I still feel that it's going to it's already starting to happen. I think we were a little maybe a little ahead of the game in the market. Wasn't quite ready at the time four years ago, but I'm curious what your thoughts are there's the inpatient, then there's the outpatient and then there's the home. Where do you think home based therapies. What's the potential for that? Is there a way to figure this out? Well, here's what we know. When you survey patients, about where they want their, therapy, there is overwhelming support for delivering that in the home setting. and we see that we also have, University of Pennsylvania and a couple of other models that are very well documented. They're sort of validated that there are oncology treatments that can successfully be provided at home. And so I think leaning on that, we see potential. I do think that the payer landscape has to evolve more to support providers who want to bring care to the home. And so home, infusion as an example, not supported by Medicare. the cost of care delivery at home could be highly cost effective to a payer. I personally would have anticipated that payers would have been more aggressive towards the opportunity of providers wanting to bring some more of the services home, but what I have experienced is that the payers have lagged on their ability to provide the contracts on those settings. So I think we have some work to do, but I think patients ultimately do want the care there. I think that as healthcare entities, if we don't figure it out, other disruptors could be Amazon, could be other disruptors. We'll figure it out. And so I think it's in our best interest to continue to develop the muscle on how to deliver services that are appropriate for the home setting in the home setting. taking the help that we can from technology and all the tools that would allow us to do that. but I think we still need to do a little bit more of, of work to get there. Yeah, I can imagine. You know, bispecifics where the first seven to fourteen days, there's all these risks with CRS and Icans. But after, you know, two or three months, I mean, it's just another dose, but the patient still has to come in, drive, take off work, park, go in for a sub-q injection, that for which the toxicities are going to be minimal, where you could imagine a scenario where they go into the home. And if we can figure we will together figure that out. patients moving from the inpatient, Into this outpatient. Are they concerned about safety and comfort? Are they really pushing for this? And then how do we get them to maybe be part of our voice to systems like payers and and, the government. I think it's important to point out that as we transition from having not just car t's available to now also having these bispecifics available. This is that off the shelf treatment that really has significantly allowed better outreach for patients to come closer to their communities. The whole concept is not having to displace that patient from the supporting structure of their home, their families. And so these bispecifics have, by and large, helped us to that end a lot. But even as in the patient community. We now don't remove them from their home setting, right? And to have to be hospitalized and they're able to ambulate to an outpatient setting to get the treatment. I strongly believe that that plays from a the psychology of it is therapeutic. patients feel better supported. They may not feel as sick as if they are staying overnight in a hospital setting. but it helps with their energy level. Maybe the prospect of what they may think is going to be the outcomes of the disease. So from a quality of, of life and a patient satisfaction standpoint, it's really huge. I'm hoping that all the entities that will pay for this are listening to us here because, ultimately There's a clear need on multiple fronts. And and we'll have to figure this out.

00:40:59 Speaker 2: Jorge, thank you again. I'm sure we'll be chatting.

00:41:02 Speaker 1: love to. It's finally great to meet you, doctor Marta.