Patient ID, Protocol and Procedure in NMIBC

In part five of this NMIBC roundtable, the panelists discuss key aspects of integrating new therapies, such as TAR-200, for NMIBC into clinical practice. The panel examines the advantages of TAR-200, including its ease of use, shelf stability, and minimal infrastructure requirements, as well as its potential to reduce systemic toxicities compared to immune-based therapies. The conversation addresses logistical and operational challenges, such as managing staff comfort with novel treatments, identifying appropriate patients, and implementing pathways for therapy deployment. The role of advanced practice providers (APPs) in managing procedures and patient follow-up is highlighted, alongside the need for dedicated bladder cancer navigators to streamline patient identification and treatment authorization. The discussion also considers risk stratification education, balancing procedural demands within practices, and ensuring consistent access to therapies across multiple clinical sites.

Watch the final segment of this roundtable series: The Ideal Patients for TAR-200 and Barriers to Treatment Access

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Dr. Brown:
So I guess I want mention one thing, and I think we had gone to infrastructure and have a conversation around that, but I do think we should make a comment that the combination or commentary strategy here of an IO and intravesical are kind of impulse in a lot of oncology is that more is better, right? And in this case, actually less is probably more, at least based on the data we have thus far. 

And I think that’s going to be good both for a patient access perspective as well as a toxicity perspective ultimately in this patient population. So you guys started the conversation around infrastructure. Right? So there’s dramatic differences in some of these products coming market that in terms of infrastructure need, what it looks like, how we operationalize this. And I think we should distinguish amongst some of the infrastructure requirements to actually get these up and running within the practice itself. So the TAR we’ve kind of described as something you can have on the shelf, it’s easy to deploy, you can store it at room temperature. And the experience thus far by the panel has been pretty user-friendly, from a delivery as well as retrieval of the device itself. Do you notice they have any kind of typical stent-related side effects that you see with a foreign body that makes it maybe a little bit more pronounced? Or is that something that hasn’t been observed?

Dr. Richardson:
No renal side effects. I mean with stents you oftentimes get renal colic and reflux. I have not experienced that, but it’s just the typical bladder stuff. It’s bladder spasms, urgency, frequency, dysuria. It seems to be worse at first, and then either they get used to it or it kind of subsides a little bit. 

Dr. Brown:
So for some of the other therapeutics, the real distinguishing factor is the ease of use. And you can have almost a buy-and-build capacity where you can have these readily available for the appropriate patient. Is that a factor that you’re going to consider in operationalizing these new treatments within your practice? The infrastructure requirement? 

Dr. Pieczonka:
I think ease of use, but also ease of staff anxiety. So I have some concern about some of these immune-based therapies that we had some pushback with our staff just about mixing BCG, which has been around for 50 years. At one point… Oh boy, I’m embarrassed to admit this, but I will. So we actually put a hood in because our staff said, “Put a hood in. And we put a chemical hood in and the staff felt better sitting in front of a chemical hood when you needed a biological hood. 

And the reason I bring that up is that there’s something to be said about that. That we have to be sensitive about our staff members, particularly as we have gotten out of the business of being able to afford registered nurses. And we have a lot of medical assistants doing these things that the use of this particular product is not going to put any stress on them, and mixing things that are immune-based where there may be some biosafety, real concerns may be harder for our staff to get in front of or feel comfortable with. So that’s not quite what you asked, but I think that’s an important component to kind of think about. 

Dr. Brown:
I do too. And I think that making them… Because they may be the ones mixing or delivering a lot of a variety of these therapies over time. And I do think that infrastructure plays in potentially. And where you have a therapeutically equivalent choice if it’s easier to deliver and access is comparable, I think that that becomes an inflection point for some practices, especially practices which may be not have the same kind of finances or resources or maybe in a more rural area, even with under a bigger umbrella of a larger practice consortium. 

So let’s talk a little bit about patient ID. We mentioned a little bit earlier, we’re looking at protocols and procedure development. Does that champion driven based on our APC models? Is there another way to go about that? Do our prostate cancer champions become our bladder champions or do we need a separate person within our practice? 

Dr. Mehlhaff:
I like the idea of initially a navigator. I mean, pathology report comes in. I mean, that’s a clerical duty to categorize and, I don’t know, put it in your EMR and an observation field so it’s searchable. All of that stuff I think is very analogous to what we do already, tracking biopsies, but we just need to formalize that risk categorization, which we currently don’t do. 

Dr. Cone:
And I think that’s a position that you can justify from a P&L standpoint pretty easily, just in terms of these newer therapeutics are significantly more expensive. So making sure that they’re delivered to the appropriate patients and that the appropriate patients are identified. And then especially if you have a clinical trial program, that person’s invaluable for identifying patients to go onto trial. So I think it’s easier to operationalize them on that. 

Dr. Mehlhaff:
And getting your documentation right, so then your prior authorization staff has what they need so they can get things approved. I mean, it’s all that at the same time. 

Dr. Richardson: 
I think it’s very similar to the orals for prostate cancer. Even the small, maybe less organized urology groups when they start dispensing or just prescribing those medications they typically had one person that would oversee. If there’s a prescription written, they would look at it, do a chart review, make sure that it’s appropriate. The same thing can happen for BCG, so to speak. So we don’t have a navigator yet for bladder cancer, but I think we obviously will need one relatively soon.

But to me that seems like the easiest line in the sand to draw, is any patient that has BCG ordered… Because every urologist is used to ordering BCG. I mean, that’s just ingrained in our head. But any patient that has BCG ordered, I think that’s a perfect point for a navigator or someone who’s designated in your office to review the chart and make sure that they’re on the right path. 

Dr. Brown:
So in theory, we probably need bladder champions too. People who that may or may not be the cystectomist in your office. It might be. I mean, honestly, the cystectomist might be in the OR all the time. So they might not be able to do some of this patient ID and care that’s required. These patients may end up with them ultimately, but it may or may not be the same person. But I do think kind of anointing or identifying a separate person. Because as this patient population ages, meaning the baby boomers continues to age, the numbers are just going to increase. And so I think the end that we’re going to be treating in our clinic is really going to explode ultimately over time. 

So as we kind of walk through what it looks like, are we thinking about a scenario where the mid-levels would follow up in these patients and we would see them at some kind of well-defined interval. We’re also talking about maybe taking two R’s away from the partners. So what does that look like? How do we have that conversation? Because these patients are going to require procedures which our patients in theory have been doing for their entire practice. Is that similar to the prostate cancer conversation or is it a different conversation? 

Dr. Pieczonka:
I think that’s going to be a tough conversation to start with, because I think that right now we’re talking about BCG refractory carcinoma in situ, and that’s generally speaking, a fairly smaller group of patients. This becomes a different animal if the data reads out and it’s moved earlier. Because at the core of this is I think risk stratification and lack thereof by the physician colleagues. I am not entirely sure that when we do risk stratification that all my colleagues know what that is. And so I think we’re going to have to take some steps collectively about educating them. Because that’s where it’s really going to make a difference. Particularly those intermediate risk bladder cancer patients where you may have precision guided therapy options and you don’t want to miss that. And so that’s a big lift for us in our practice. 

I think the other thing is we haven’t quite solved for what you kind of alluded to, which is there is a potential productivity component on this. So going to a bladder… No one cares about prostate cancer patients because they’re time intense. 

Dr. Richardson:
They’re non-surgical. 

Dr. Pieczonka:
And for those of us that do that, they’re non-surgical. There’s not a lot of individual reimbursement for that. This is literally the exact opposite. And how we sort of move in that direction is something we have to work through as a practice. I’m not sure. 

Dr. Mehlhaff:
I disagree a little bit with what you said. Because even running an advanced prostate cancer clinic, it’s like, well, this is my patient. I took his prostate out eight years ago. Why should I send him to you? And it got nothing to do with economics or procedures or anything. It’s just, well, I like this guy. And I’m like, well, maybe he’d like to have better therapy. How do you say that? So I already have that problem with prostate cancer. So when you start now I’m taking your cystos away from you, then that just takes it to another level and another facet. 

Dr. Cone:
Also, I think that I’m sort of envisioning a system in which it doesn’t have to be an all or nothing. I mean, I do think that the post-TUR cysto, before initiating one of the novel therapeutics, is probably going to be important. But then it would not be hard to teach anyone in your practice how to put a TAR device in and how to exchange it. And everyone in your practice is very, very capable of doing a surveillance cystoscopy and picking up a recurrence. And if you have a partner that every single time you’re doing the post-TUR cysto before you’re initiating therapy, there’s recurrent disease, you’re having to take the patient back for a re-TUR. That’s maybe an opportunity for some quality improvement on that standpoint. But that’ll declare itself over time. And I don’t necessarily think that we need to be taking the TUR as taking the cystos. It’s really more about just controlling the access to these therapies and making sure that they’re deployed appropriately. 

Dr. Pieczonka:
I think one thing that’s going to be interesting in this is that the site of service for where these procedures are going to be done, particularly with TAR 200, is going to matter. And I envision that that can be done in each one of our offices. We all have multiple offices. I can tell you that I think you could probably administer some of the immunotherapies in each one of our offices, but I can’t take that risk of having a very, very expensive product with somebody who may only handle it once or twice and, oops, it gets dropped on the floor or something. And then it’s like, then what? 

So I think the nature of that is going to make this easier for us to embrace as a practice, because I think that I would envision that we can have this be in all of our… I think we have multiple offices in our catchment area.