Read the Full Video Transcript

Alicia Morgans: Hi, I'm so excited to be here with Dr. Neal Shore where we're talking about Photocure and some of the implications in clinical practice.

Neal Shore: Yeah. The classic device technology that Photocure pioneered more than a decade ago now is what a lot of people referred to as blue light cystoscopy. And in the U.S. we call it Cysview, other parts of the world, it's called Hexfix, but essentially it's placing in a chemical just about 30 to 45 minutes before a cystoscopy. And what it does is it's a photo porphyrin derivative that basically goes to transitional cell cancers and they become under a blue optic lens. Or when you go convert from white light to blue light, you see these pinkish reddish findings that oftentimes you would never see with white light. And so it's in the guidelines. There's level one evidence that this is a really enhanced way to be a better diagnostician and also even a better resectionist.

So you see all the tumor that's there, particularly small papillary lesions and carcinoma in situ, and you resect them better. So better diagnostician, better resectionist. There's a very good reimbursement all throughout Europe and most of Asia, and it's been reimbursed in the U.S. for the longest time. But unfortunately, through some of the vagaries of our CMS system, there's a site of service differentials such that hospital based systems get reimbursed very well, both on a diagnostic and a resection side, even when they're doing it in an outpatient way. But because it's hospital based, the reimbursement for it is very positive.

And that has not always been the case in the outpatient ambulatory surgery centers or even in the clinic. Now, that changed about a year or so ago for diagnostic purposes using flexible cystoscopy in the clinic if you were going to do the blue light application for Cysview technology. And then most recently it changed again for an enhancement of reimbursement in the ambulatory surgery centers. It's not really optimal, but it's much better than it was. So this is an issue regarding site of service differential. No one argues the clinical benefit. It clearly has benefit. It's in the guidelines across the board in bladder cancer internationally is making you a better diagnostician, endoscopically, making you a better resectionist. So we're making some slow progress, but at least we're making progress.

And so a lot of our colleagues really want to use the technology. I know the folks at Photocure have partnered with Beacon as well and are doing ongoing trials to try to get more and more accessibility for our patients. And at the end of the day, patients want to be diagnosed as efficiently as possible, and they want their TURBT, their resections to be as efficiently performed as possible. So then you get less recurrences as really the concept goes.

We have developed more and more therapies specific for carcinoma in situ, BCG unresponsive, more may be coming out that in the BCG and IE population. So again, that's a different stage of the disease from low-grade papillary. If we can find more carcinoma in situ early and in BCG unresponsive disease, we can treat patients with intravesical therapies now with nadofaragene firadenovec which just got an FDA approval. And then of course pembrolizumab based on KEYNOTE-57. So being a better diagnostician when you do your cystoscopy with blue light, the Cysview technology as well as a resection, but we have to make sure that the reimbursement does not continue to disfavor outpatient ASCs where 85% of this type of care occurs.

Alicia Morgans: Well, and just to follow up, does it really affect the rate of use of this particular approach in these centers? I would assume so, because not being reimbursed, it's going to be really challenging to get the work done.

Neal Shore: Yes. Spot on question. Perfect, and you're absolutely right. When you do surveys, 90% of tertiary academic centers, hospital based urologists have blue light technology accessibility. And it's fairly ubiquitous throughout most of Europe, but in the community, the numbers are still very, very low. There's some initial cost investment and there's the tech to learn, it's very basic. It's not particularly complicated. There's a little bit of a throughput and flow in terms of your nurses to get the patients in a little bit earlier, put the catheter in, put in the medication, take the catheter out, and then do your normal cystoscopy, your normal TURBT. But there is some upfront investment, there's the cost of using the infusion of the chemical, the photo porphyrin derivative essentially. It's extremely safe, extremely well tolerated, there's no pre-medication.

Healthcare is an economic model, and so we continue to hope that we get ... and we've made some incremental improvements. I think we can still do better. We have a paper that I recently published in Urologic Oncology, which we speak to the modeling that if you were to have this available, you'd pick up more carcinoma in situ, you'd pick up more smaller cancers and you'd be a better resectionist. And we did some economic modeling showing the health economic outcome reporting benefit to that. And that paper was published almost exactly at the same time that CMS made some improvements. But I'm still hoping that we can get some better changes in 2024, in 2025, the next time, or maybe at the end of 2023 when they're revising CMS reimbursement policy.

Alicia Morgans: Well, I think you're not alone. I'm sure patients are hoping for the same, especially since it is, to your point, so much more common for them to get care like this in their communities where they are, rather than traveling to the large centers where it can be very difficult for multiple reasons to get into those centers of care. So thank you so much for taking the time, certainly to do this work, but also to talk through these challenges. I sincerely appreciate your expertise.

Neal Shore: Yeah, no, thank you very much.