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Zach Klaassen: Hi, my name is Dr. Zach Klaassen. I'm a urologic oncologist at the Georgia Cancer Center in Augusta, Georgia. I'm joined today for a UroToday discussion with Dr. Gautam Jayram, who is the director of the Advanced Therapeutics Center and an Oncology Urologist at Associates in Nashville. We're delighted for you to join us, Tom. Thanks for joining us today.

Gautam (Tom) Jayram: Great. Thanks for having me.

Zach Klaassen: We're going to talk today about the operationalization of blue light cystoscopy. I know you've got a lot of experience with this. Just to start out for our listeners, what's the mechanism of how blue light cystoscopy works and the general indications for these patients?

Gautam (Tom) Jayram: Blue light is an optical agent that is FDA approved for enhanced imaging of bladder cancer. It's an interesting molecule that gets put into the bladder and basically interacts with the heme biosynthetic pathway of cells, where it has photo porphyrins that incorporate into the cells. Those porphyrins actually light up under different optical wavelengths and they accumulate in rapidly-dividing neoplastic cells. So if you expose it for enough time, the thought is the cancer cells are going to accumulate these porphyrins and then the porphyrins will light up when you expose them to a certain wavelength of light.

And so the indications really are for patients who are suspected of having bladder cancer or have a history of bladder cancer. This can be used to better visualize their bladder and better identify concerning lesions.


Zach Klaassen: And so from a high-level view, just looking at the general conglomeration of clinical data, what data do you look at when you're talking to patients, whether it be from a rigid or a flexible standpoint when you're presenting this option to your patients?

Gautam (Tom) Jayram:  A lot of the data initially was centered around rigid, where patients who were going to the operating room would have this placed in their bladder and then they would have a resection of a visible tumor. So a tumor that was already known to be there. The data suggested that you were having better resections and you were able to see your margins a little bit better. That was kind of the subjective feel from a lot of the investigators on that trial. You were doing a more complete resection. And then the interesting thing is they found during that study that you were picking up 20%, roughly, more disease that maybe wasn't seen initially, and these were sometimes satellite lesions, these were lesions that were unrelated to the primary lesion.


And so, that really set the tone, I think, for the follow-up flex study. Honestly, I'm a big fan of using it in the flex setting. Just my personal opinion is that it's probably more valuable in the flex setting because you're talking about detection, which is critically important. The flex study, which was done in 2018, multicenter study that was in the Journal of Urology, had a lot of prominent institutions and a lot of really well-known bladder cancer experts on that trial, randomized patients to get white light and then to get blue light, and then to basically go down the pathway at that point. What they found is about 30-35% of patients who were on the blue light pathway were found to have more cancer detected or cancer detected that was not found on white light.


That's a significant number and that's what I tell patients, is about 30-35% increased detection compared to white light. And as you can imagine, most of the lesions that you're detecting, and that's what was shown in the study, are going to be carcinoma in situ, which is a difficult lesion to see. It's a flat lesion. Especially in an office, busy office setting where you're doing quicker flex cystos on your high-risk hematuria or bladder cancer patients, it's nice to know that you have something like this that can really give you the best imaging possible.


Zach Klaassen: That's great. From a manufacturing standpoint, there's been an FDA reclassification from class III to class II. In your opinion, how does that sort of set up the production and maybe the market over the next year or two for blue light cystoscopy?

Gautam (Tom) Jayram: One thing that has happened, one thing that is unique to blue light, when they were approved, they were approved with the KARL STORZ platform, which is the scope and the tower that you need to do the blue light cystoscopy. So what's happened is, over time, KARL STORZ is a huge company, they have a lot of applications within surgery, and there hasn't been that much new innovation and technology that has really been incentivized or been required in this space and blue light. And so what we've seen, especially in flex, because flex is still somewhat newer, there's not as many users, is that we don't have the availability of the scopes, the scopes getting repaired, some of the parts, all of those things are actually very challenging because there's no real other competitors in the market and there's no other companies that do this.


So we're hopeful that the FDA reclassification is going to allow other companies to enter this market to provide an imaging partner with blue light. And if that happens, I think we're going to be in better shape to provide our doctors and our peers more resources, because what we're seeing right now is that there's not a whole lot of options if the blue light scope breaks, goes down, if a new doctor wants to utilize it. Where is it being manufactured? How many new scopes are available? Those things are all limited right now, and we're hoping this reclassification will help that.


Zach Klaassen: That's great. I appreciate that response. Maybe a bit of a two-part question. How have you sort of operationalized logistics, including blue light, in your practice and with the CMS changes in reimbursement we saw in January of 2023? Has that changed either utilization in the ASC from a logistical standpoint? How do you do this on a day-to-day basis?


Gautam (Tom) Jayram: Everyone's a little bit different. As you know with bladder cancer and how they survey, it still is interesting to me when I go to meetings and talk to people, do things differently in terms of office biopsies, office cystos, anesthesia. My approach is, I like to do as much as I can in the office. I think that's good for patients. I try to avoid anesthesia. As you know, this population is elderly, they're sick, they're vasculopaths, a lot of them are coming from a long ways away, so I try to do as much as I can in the office, and this helps me do I think as quality of examination as I can. My high-risk hematuria patients and my positive cytology patients and my NMIBC patients who are being followed on surveillance, those are kind of the groups of patients that I use this on.

Certainly if someone has a big bladder mass on a scan, we're going to go to the operating room and do a TURBT. But it's that group of patients who you're thinking about, "Okay, well can I avoid a general anesthetic by doing blue light in the office? Can I gain more information?" Even if you see a tumor, a small tumor, sometimes you can plan your operation in the OR a little bit better. "Do you need paralysis? What kind of anesthesia do you need? For us, do I need to take it to the hospital? Can I do it in my surgery center?" These are things that I think really help our patients in terms of figuring this out, and I think blue light helps that.

In terms of the reimbursement, I think we're making progress, where we have more than we did. The ASC reimbursement was recently updated and it is significantly better, but I can tell you, for an independent surgery center like ours, it's still not enough to really drive a lot of this volume to the ASC if you have a self-owned ASC. So that's another reason to do it in the office. The office, the cost is a little bit better, you do get a buy-and-bill Medicare rate on the agent, and then there are several ways that we have found to make this more financially palatable. There are rebate structures through GPOs. The STORZ rental equipment has some perks to it that we can use. It's really nice equipment.

So I would say this about the financial piece, and I get asked this all the time. A lot of times in community urology we look at things on a line item basis, "Okay, well how much does this get us for spending this?" And I would say, we probably are not doing ourselves justice or our patients justice by doing that. We've got to look at the whole program. Honestly, for us, we have one of the busiest clinical trials programs in the country, we have a huge tertiary referral center from a lot of different areas, patients coming from a ways away, and so if we can do anything to keep patients in our building, to get patients access to advanced therapies, to get patients on a clinical trial, that all kind of pays off, literally and figuratively, at the end. And so I would argue that there's secondary revenue and a lot of other things involved in building a bladder cancer program that are benefited by having something like this.

Zach Klaassen: No, that's great. I think you kind of touched on a little bit in terms of which patients you're really going to consider for. If you can just highlight for listeners what the top two or three groups of patients are where this is really vital. I think in my practice, the patients with CIS or the cytology you can't quite find where it's coming from. Maybe just sort of highlight what those patients are that you really think this is a critical technology to use on.

Gautam (Tom) Jayram: Yeah. Certainly my NMIBC patients that have had a lot of CIS in the past, those are patients that really benefit from this. Patients that have a positive cytology, you can't really see it, and you can do it both in the office OR. I usually do it in the office. The high-risk hematuria group is, I think, still a good group also, because again, even though they're high risk, there's still 60-70% of those patients that won't have tumors. And so, if you schedule them all for a TURBT or a cysto in the OR, you're probably exposing an unnecessary number of patients to anesthesia. And then elderly patients on anticoagulation, those are patients that, again, really, I think as urologists or as cancer surgeons, sometimes we don't realize all fully competing risks in these elderly patients. I mean, just getting out of bed for them sometimes has risk, stopping their blood thinner definitely has risk. And so, for the elderly patients on anti-coag, I almost always start with the blue light to really, really make sure that we need to do something else.

Then the other kind of emerging group that I like to do this in is my low-grade patients, my intermediate-risk bladder cancer patients. These are patients that have, as you know, frequently recurring lesions. They rarely need anything crazy. They rarely need some big wack TURBT. So I like to do this in the office with a little bit of nitrous we use and I just kind of spot fulgurate early lesions and we can avoid doing anything big in the OR. Those are the groups I like to use it in.

Zach Klaassen: I think that's great. I think the one thing you hit on twice already, and I think it's an important point, is this is a morbid population and we know that the 2-4% morbidity, even mortality, after TURBT, those patients are out there and we see them. I've worked with residents in saying, "This is the guy we've got to be careful of. This is the lady we've got to be careful of," because that repeated TURBT two to three times a year is not benign for those patients specifically. So I think it's a great analogy for the utilization of blue light.

Just to sort of wrap things up, I mean, I know over the last 18 months or 2 years there's been a lot of discussion about blue light utilization. There are some barriers. The company and us as physicians are working through those. We talked about the FDA reclassification, we talked about utilization in CMS reimbursement, so blue light's not dead. What sort of take-home messages can you give for our providers and listeners with regards to your experience with blue light cystoscopy?

Gautam (Tom) Jayram: I joke around with people, once you use it and once you become really integrated with it, you can't go without it, honestly. It's like the rearview camera on your car when you're backing out in your parking spot. You don't absolutely need it, but when you have it and then it goes away, you're kind of scratching your head.

I think that, number one, we're moving into an era where non-invasive testing and non-invasive treatments, really, but non-invasive testing and evaluation is really important. That's what we're seeing with biomarkers and really trying to figure out how to risk stratify patients without having to put them through a lot. And so, I think that blue light is a great tool if you're a bladder cancer person and you have a complex bladder cancer practice where you see a lot of pretreated patients and patients who have had a couple of rounds of this, a couple of rounds of that and went away for a while. I think it is really a really vital part of being, I think, on the cutting edge of treatment and evaluation for these patients.

I think, like you mentioned, some of the logistical concerns are there, but hopefully we'll get over it. It's in the NCCN guidelines and it really is the best thing you can do in terms of, I have patients come to me and they say, "Well, they weren't offering this across the street or whatnot." I think patients are looking for this. I think patients are getting savvier and they really want to go places where they can potentially avoid a general anesthetic or something really invasive if they don't need to.

Then lastly, I think there's a lot of future spinoffs with blue light that are really, really fascinating. I think image-guided therapy, things like Pluvicto kind of on a smaller level, where if you have a lesion in a bladder that's tagged to Cysview, you can really open up a lot of possibilities with targeted treatments and some potentially cool things down the road. So I think the technology is really interesting. It definitely works. If you've seen a bladder, almost all of us have had that case, those of us that use it, where you look at it and you switch between white light and blue light and then you're like, "I definitely would not have seen this if it was just white light." We've all had that case. For me, it's several. And so I think that makes you appreciate that there is real value to it.

Zach Klaassen: No, fantastic. Thanks so much for your time, Tom. Great expertise and discussion. Really appreciate your time.

Gautam (Tom) Jayram: Thanks.