Stephen Williams: Hello. My name is Dr. Stephen Williams, and I've been invited here today by UroToday to speak specifically in regards to the macro and microeconomics of blue light cystoscopy with Cysview® in nonmuscle-invasive bladder cancer. I'm the Medical Director for High-Value Care at the University of Texas medical branch in Galveston and the Chief of Urology. Here are my conflicts of interest.

So, the costs of bladder cancer care are substantial. And one of the key facts is that cancer care is expected to increase from 158 to $174 billion from 2010 to 2020. And this was largely driven by increasing cancer incidents, improved survival outcomes, and costlier treatments, and an ever-expanding healthcare market. An estimated cost of care for bladder cancer particularly will increase from four billion to six billion in 2020. And it should be known that the survival difference over the last three decades in bladder cancer has remained largely unchanged. However, bladder cancer is one of the most costly cancers. And the increased costs are associated with more advanced disease. However, there are limited studies that have addressed the economic considerations in bladder cancer, despite the large financial impact of managing this disease.

This is a graph illustrating the estimated U.S. national expenditures for cancer care in billions of dollars. And, as you can see, bladder cancer, although it has a decreased incidence relative to the other cancers, is quite a costly disease. And this also expands into our European colleagues. Where here in this particular graph, we're looking at the bladder cancer healthcare costs in the population, which are largely driven by, here you could see the pharmaceutical costs, as well as the hospital care costs, are largely driving these costs in the market. In addition, we see an uneven resource allocation, particularly of funding, for studies in bladder cancer. Where you can see on the right side of the graph, both in the U.S.A., as well as also in the U.K., is ill compared to other cancer types.

We recently published an editorial describing transurethral resection of bladder tumors, and more importantly, to highlight that it's the mainstay of surgical treatment, diagnosis, of course, but also treatment. However, this technique has remained unchanged since it was first described over 60 years ago. However, there have been few advances, but some of the most notable advances include photodynamic diagnosis, high definition imaging, bipolar energy, and then, which has gained an increase in popularity is en-bloc resection. These advances are pale in comparison to the frequency in which they're actually used.

So, what I did, and collaboratively with Photocure, is looking specifically at a budget impact model objective to quantify the impact of using Cysview® in the flexible and/or rigid setting compared to a white light alone. And this will give a highlight of the costs that are associated with using Cysview® or blue light technology versus white light cystoscopy alone. As we are entering a healthcare climate, particularly that was trained prior to a pandemic, however, it's going to be increasingly pressing, we need to stay acutely aware of expensive technology uses, but also understanding the overall impact in regards to caring for patients, and particularly in this population. We looked at nonmuscle-invasive bladder cancer, including CIS, as well as among patients with suspected or known to have lesions. And the model of intervention performed was comparing blue light cystoscopy in the flexible and/or rigid settings with white light alone.

What we wanted to do, as this is a cost-effectiveness analysis, is to use prior data from epidemiological clinical data and, in addition, reimbursement data, which we use national average Medicare reimbursements. And then, we adjusted this to my own institution where it was applicable. In addition, we used the geometric mean costs for APC for the assumed percent of reimbursement for office, as well as the ambulatory surgical center.

Here are the assumptions that we used to compare white light versus white light, blue light cystoscopy. And we use these two studies, particularly Stenzl and Burger, to understand the use of blue light in regards to reducing cancer recurrence in nonmuscle-invasive bladder cancer, as well as the photodynamic diagnosis of nonmuscle-invasive bladder cancer with blue light, which was a meta-analysis recurrence.

And this is a model patient flow chart based on the AUA and NCCN bladder cancer guidelines, which were used in our assumptions. And, as we all know here, this model we wanted to consider two patient populations particularly. One would be the new assessment for the first occurrence of bladder cancer. And two would be the surveillance for recurrence. As we know, these are the significant costs that are associated with nonmuscle-invasive bladder cancer that we wanted to pay meticulous attention to. And we assumed, based on the assumptions, that this was in accordance with the guidelines recommended. And here the treatment of the disease followed AUA guidance, which of course now varies from low, intermediate, and high-risk disease.

And this is an example treatment and surveillance flow for a low risk of recurrence, where you have a diagnosis of low risk of recurrence, there's no treatment and surveillance at three months, versus a single instillation of chemotherapy with the surveillance and, in addition, understanding that those that may recur as well as those that are no recurrence with the corresponding surveillance afterward.

The clinical inputs included 50 patients. In addition, as I mentioned before, the facility inputs were performed as an outpatient. And the cost considerations were included annual investment for the technology. But also too, all other inputs used base-case assumptions.

And here's a base case scenario of the inputs for reimbursement for both the blue light and white light. And, as one could see here, it's quite comparable for both. And this is a case-based input of the actual costs, which is very important when you're discussing cost-effectiveness type research. And charges are one thing, but we wanted to look at costs. And I think that's very important when you're determining what are the direct costs associated with either technology.

And then, that difference in reimbursement for the cost was one dollar per cystoscopy. And the practice can anticipate being reimbursed more than the costs by one dollar a cystoscopy. So, how do we explain this? The base case scenario outlines the comparison between current utilization of only white light cystoscopy versus future utilization of white light and blue light and two practice settings and expresses a net difference of reimbursement and costs. To drum this down, institutions that adopt white light plus the blue light, will see a roughly $70 loss in the cost per cystoscopy, but gain about $24 in the office per cystoscopy, leading to a loss of $46 per cystoscopy across the board, which is quite comparable and actually ends up being, we'll see a one-dollar increase in reimbursement for the blue light versus the white light when you use our model.

So, hopefully, this gives a brief illustration looking at the macroeconomics, but then also too, using an example with a model that has been developed and demonstrating the cost-effectiveness and the appropriate utilization of our technologies that we have at hand. Thank you very much.