Jason Hafron: Thanks so much, Ashish, for having me. I really appreciate it.
Ashish Kamat: So Jason, you and I have talked about different things in person and online, and of course, at different venues, and we're normally focused on the data, the percentages, the response rates, the AEs in this ever-changing field of bladder cancer, with a special focus on non-muscle-invasive bladder cancer. But today really, I'm almost looking to you to educate me, in addition to our audience that's listening. Because sometimes sitting in the academic world, especially where I am at MD Anderson, I become relatively ignorant to what the actual challenges our community colleagues are facing. And you, on the other hand, have been very instrumental, amongst the leaders in the group, in actually making access to drugs for patients through the community oncology milieu more accessible.
And this happened, for example, when BCG, we couldn't split the vial. And of course, the LUGPA groups championed this at the AUA, got the split dose billing sorted out with the newer therapies, gene therapy, and now of course, we have TAR-200, or INLEXZO™, which is a procedure code, it's a J-code. So maybe in general, if you could chat about how this evolution has occurred across the different therapies, and then with the new J-code for the TAR-200 device, let's just stick to non-trade names, how would you reveal that to people that are listening and curious about how that happened?
Jason Hafron: Yeah, no, thanks, Ashish. Great comments and great intro. I think a lot of where the independent urology groups learned this, and the importance of drug delivery is with advanced prostate cancer. We've been having advanced prostate cancer centers for almost 15 years, and a lot of the challenges that we face, and initially when we set up these programs, we're seeing it again with bladder cancer, and it's exciting, there's so many great therapies. TAR-200, gemcitabine intravesical system is a great option. But really, the reality is, and you kind of touched on it, a therapy is not truly available in independent or private practice until the practice is essentially a reliable pathway to deliver it.
So I'm not at the ivory tower of MD Anderson, where you probably can just check a box and it shows up. A lot of what we have to do is develop these pathways so that when we order these therapies, or the TAR-200, we have processes in place. And I think that's the key, or that's the difference, is that we work on these processes so that when we find a patient who qualifies, who's truly BCG-refractory, CIS, or even papillary now, that we are... It's not a fire drill, it's an established protocol that we follow, and I think that's where we succeed. And the difference between my area, or my institution and your institution is we have the ability to be very nimble. I mean, you have multiple layers of bureaucracy, but it's upon us to develop these systems.
Ashish Kamat: Yeah, no, I think that's a great point that you made, because, just again, full disclosure, even at a place like MD Anderson, we still develop our own internal protocols and internal pathways, and when something is approved, we go through the EVAC committee. I mean, we have to show value. It's easier for our folks to get access to the drug, but just being good stewards of healthcare dollars, we too have an internal, sort of a triage system in the sense that, "Hey, try this. It's not that you have to try this, but try this. Maybe it's cheaper, then go to something more expensive. Consider this just to make it easier." But like you said, we have a lot of bureaucracy. Whereas you don't, but at the same time, it is a little bit of an onus on the practice, because ultimately, the practice will suffer if you're not a good steward of healthcare dollars. So if someone is listening, coming from a smaller practice that doesn't have access to all your resources, what are some of the steps that you would recommend they adopt or follow to get this in their practice?
Jason Hafron: Yeah, so FDA approval is just the beginning of access, it's not the completion of access. And I kind of divide it up, or we think about it in four stages, essentially. One is clinical eligibility. Does the patient clinically qualify per NCCN, or per guidelines? Does this patient really... Going to benefit from this therapy based on the published literature or the published guidelines? That's step one. Step two is the financial clearance. Will the payer cover it? And under what requirements? And I think that's where we spend a lot of time too, is making sure that, what are the financial clearance, or the hurdle, or the pathway to get the drug approved? Because TAR-200 has a J-code, that's a huge advantage. And then we essentially decide if it's going to be a Part B drug, or we're going to send it out through a specialty pharmacy.
It's hard to get into the weeds of that, and that just has to do with your payer coverage, what's your risk tolerability, financial risk tolerabilities, or your practice. But once you establish with financial clearance, then it's operational readiness. And we know this very well, can your team, or our team acquire the drug? Appropriately store the drug? Do they know how to administer the drug? And can they document it appropriately? So a lot of that's kind of the third stage. And then finally, a lot of where we spend a lot of time too is this kind of concept of longitudinal execution. Are we doing what we're supposed to be doing? Are we able to complete the therapies? If you look at TAR-200, it has a very well-defined treatment schedule. Are we able to maintain that treatment schedule? What percentage of our patients are getting through complete therapy? What percentage of our patients are having AEs? And try to keep this ongoing internal quality metrics to see if we're doing a good or bad job, or if we have to pivot or make improvements along the way.
Ashish Kamat: Yeah, I like that you mentioned that as part of the financial responsibility, because I think that's also, in general, just good practice for each practice, each individual physician to know what the AE in their patient population is. So separate from the financial aspect, I think it's very important. And it's similar to the Re-TUR for, say, TA disease. I always tell people, "Hey, you need to know your residual tumor rates. If you go back and you have a 0% Re-TUR positivity, you don't have to recommend it. That means you're doing a good resection the first time." Same thing with anything that's intravesical that has AEs. The one thing that you touched upon, I want to ask you a little bit, how does the fact that it's a procedure that's done either by a physician, or a mid-level, how does that factor into how you think about it from a cost perspective? Or does that factor in? That versus a drug that's administered by a nurse?
Jason Hafron: Not really. I mean, I don't know if we're at that stage yet. I think we're still at that infancy, and I think we're not... I know this can be done by a mid-level, we've seen it. We can do this in our sleep as urologists, but I think where we are today is, we want our urologists to be comfortable with the procedure. And once we get that comfort level, then I think it'll be feasible to transfer to the APPs. So we're not there yet, but I think that is a goal of ours as we iron out all the kinks and get everything straightened out. But right now, it's not a huge, really... We don't really critically look at physician time versus APP time at this point. But I think as we get scale and more sophisticated, more comfortable, I think that will come into play. But right now, new therapy with awesome market-leading CR rates, we want to just focus on getting the process right, and I think we're not ready to shift to the APP, but in time, we will once we're comfortable.
Ashish Kamat: Yeah. I mean, clearly if you look at the actual numbers and the durability, I mean, clearly it's a new bar that people have to aspire to, not beat because that's not the reason a drug gets approved, but at least aspire to be compared to. So I think that's clearly important. Jason, I'm going to ask you one question, and it might be a little uncomfortable, but I've heard this thrown about in national meetings, and even behind closed doors, and I always stand up for my colleagues in the community. I've trained people to go in the community, because I think we don't want patients coming to academic centers if they don't have to. We want them to be able to get care wherever they are. But then I hear this comment thrown about, saying, "Oh, in the community, the doc's going to go for the most expensive drug, because they can pocket that 4.65%." I'm not going to ask you whether that's true or not, but I want your response to that comment when you hear it.
Jason Hafron: Yeah, I don't agree with that. I think there's clearly options, and we never choose therapies based on profit margins. We always say, "Pick the best therapy, have that good discussion with the patient, go through the risk benefit with the patient, and really have that shared decision-making conversation." If you're picking therapies based on profit margin, you will lose, the practice will lose. You want to practice the highest level of urology, and it shouldn't be dictated by profit margins. That's just the wrong way to look at it. What you want to do is give the best outcome to the patient. Yeah, there's options, and there's different reimbursement margins, but the reality is, you've got to pick the right treatment for the right patient, and depending on logistics, or financial issues. There's so many factors that you got to consider.
And if you think about it, good bladder cancer care is that durability, keeping the patients on therapy, keeping them on this is the most successful. So if you don't pick a therapy that aligns with their goals, or their comorbidities, or their social situation, transportation issues, you're not going to be successful. And the most successful patients we know are the ones that you can make basically follow the trial protocols. And if you're not able to achieve it, you pick the wrong treatment, you're really not going to get the results that you expect. So I don't think that's inappropriate, and I think, Ashish, you've always been a great partner to the community, you've spoken to our LUGPA, and I think it's, we have to work together as urologists to develop new therapies, and work together to improve quality of care. So I think that we want to be as aligned as possible, and offer the same level of care that an academic, or an MD Anderson offers.
Ashish Kamat: Yeah, no, and I absolutely have always believed that from the get-go, because it's not us versus you. That's not how it is. It's all of us doing it for the patient. And even when I have trainees that come here, and I tell them, "Hey, if you want to do fellowship and then go into private practice, more power to you, because we need good people in the community." I mean, that's great, the smallest center. So anyway, but that's a little bit off the topic, but-
Jason Hafron: No, it's a good question, but we've got to talk about this stuff, because if there's thoughts of that, that's not what community urology is about. It's access to care, delivering the highest quality of care to patients in the community, and then always having these great partnerships with our academic partners within the metropolitan areas we serve.
Ashish Kamat: So Jason, you and I have chatted, and we could lose track of time and talk for 30 minutes, but I'm looking at the clock, and in closing, to someone that's listening, saying, "Oh, there's all these new therapies. I want to get them in my practice." Some closing key highlights or information from you?
Jason Hafron: Yeah, I think just to be global and high level, I think documentation is really important. I think you need to document that the patient is the appropriate risk, using the AUA risk stratification, have appropriate op note, have appropriate pathology report. And all of that is really critical to using these drugs, because these drugs are expensive, they have great numbers and great outcomes, but you really... To make a program successful, you have to use these drugs as indicated. And the only way you can do these drugs as indicated and use them appropriately is you have to document it. And if it's not documented appropriately, one, you're not going to find these patients, but two, you're not going to get reimbursed appropriately.
Ashish Kamat: Great. Great points. Thank you so much, Jason.
Jason Hafron: Thank you, Ashish.