Ashish Kamat: Hello, and welcome to UroToday's Bladder Cancer Center of Excellence. I'm Ashish Kamat, Professor of Urologic Oncology and Cancer Research at MD Anderson Cancer Center, and it's a pleasure to welcome, once again, Professor Stephen Williams, who is no stranger to this platform.

Dr. Williams has done a lot of work when it comes to high value care. He leads the UTMB health system's high value care center. He's Chief of the Division of Urology, and he's not a stranger to publishing high impact, but controversial, subject matter. And one that has recently been the subject of a lot of discussion, and all good, bringing to attention the fact that surveillance guidelines for low-grade Ta bladder cancer are often not followed, and this was published in the JAMA study is the topic of today's discussion.

So Stephen, without further ado, let me hand the stage to you.

Stephen Williams: Thank you very much, Dr. Kamat, and thank you, UroToday, for this opportunity to discuss our recent publication, and the title for today's presentation is Surveillance Guidelines for Low-Grade Ta Non-Muscle Invasive Bladder Cancer Often Not Followed: Results from Our Recent JAMA Study.

So the costs of bladder cancer care is quite substantial and approaches almost $174 billion, and this is driven by the increased use as well as treatments and then the survival outcomes as well as also too, even more recent years is up to $6 billion in 2020. And we know bladder cancers often could be a lethal disease and substantial costs that we've described in various disease states, particularly in muscle invasive bladder cancer [inaudible 00:01:49] is a void a non-muscle invasive bladder cancer, in particular, Ta low-grade.

So this gives an opportunity to understand the value in healthcare and the primus for assessing treatments, as well as also to building off our prior background in describing value care in the setting of low-risk, non-muscle invasive bladder cancer.

So what we ended up doing was describing surveillance, treatment, outcomes, costs, and predictors of increased costs or, potential thereof, using large population-based data. And the database that we used was our SEER Medicare database and a little over 13,000 patients, age 66 to 90 years old with Ta low-grade non-muscle invasive bladder cancer and really, the lack of granularity in using these large population-based data really limit us to who designate low-risk, non-muscle invasive bladder cancer. However, we are able to identify Ta low-grade disease.

We assessed from 2004 to 2013, as well as we also required patients to have a 12-month pre- and post-diagnosis of continuous care through Medicare to ensure adequate reporting. And then in addition, our primary endpoint, once again, is focusing on surveillance, as well as treatment practice patterns with secondary endpoints being on oncologic outcomes, recurrence, progression, and then also, costs.

So the results of our study, I'll dive in quickly here, is over time, we noted cystoscopy to significantly increase over the study period, as well as imaging, and imaging itself, markedly, concluded CT scan MRIs from 30 to 47% with urine psychology and other bladder cancer markers also increasing during the study period.

And over time as well, we also looked at treatment patterns, which 17.2% of patients received BCG, 6% receive intravesical chemotherapy, mainly mitomycin C. And what's also important here, and we'll discuss further, the recurrence rate, we were quite surprised, but we used a proxy for this, which was any transurethral section of a bladder tumor greater than three months from index was 1.7%, but was also important is progression, which we used a surrogate of any definitive therapy, including radical cystectomy, systemic chemotherapy, and/or radiotherapy was 0.4%.

And over the period of time, we also looked at a cost that are associated with treatment for this disease, which actually increased 1.6 fold or 60% over the study period, which increased also was associated with recurrence and then with further sensitivity analysis, one would suspect, and we found as well, with progression.

The limitations of this study include SEER has, although staging great information, really lacks the granularity and particularly, when we're assessing recurrence and progression disease, which are proxy that we used, and I also explained earlier, perhaps led to a marked underestimate of recurrent disease, but also introduces unreliability that is sometimes quite often found with large piece population-based data, and Medicare costs cannot... we cannot comment on any third party payers and may underestimate the true cost burden of this disease. In addition, this also points... this is not a cost effectiveness study, and costs are actually only up to one year from diagnosis date, so we really don't know, necessarily, the long-term costs that remain to be determined, but this does provide an excellent benchmark.

So in conclusion, despite the low rates of recurrence progression, once again, using our surrogate rates, rates of surveillance testing increased during the study period and in addition, their non-negligible use of treatments for this disease. Our annual cost of care increased over time, particularly among patients that had increased progression and/or recurrence. However, we need efforts to improve adherence to current practice guidelines with a focus on limiting the overutilization of surveillance testing and overtreatment, which I must say, and I applaud the EAU and AUA for now recognizing this and deescalating, ultimately, how we are diagnosing, as well as treating, this disease, as we described here, also, to the rising costs that are associated with bladder cancer.

These findings were published in JAMA Open, and this is a nice kind of slide that points today that Tomorrowland No More and Oncologic outcomes, costs and really, value-based care is going to be our increased focus when we're looking at all types of diseases.

Thank you.

Ashish Kamat: Thank you so much, Stephen, for taking the time to explain and go through the results of your findings and your publication.

I think the point that you made is spot on. We are doing a lot more in the patient population where less might actually be better, if not more beneficial, to the patient. And the rising costs are clearly something that we need to curtail because otherwise, it'll just be unaffordable for the system to focus on the more advanced disease states where patients clearly lose their lives if we can't have appropriate funds to direct our resources there. So I applaud you for leading the study and, of course, full disclosure, I was part of the study, and it was a pleasure to be part of it.

Let me ask you a couple questions. Number one, with all the work that you've done and are constantly doing, any thought to exploring more current data sets and seeing if this trend of increased expenditure holds true?

Stephen Williams: Absolutely and thank you for bringing that to the attention because yes, these data are almost 10 years old, so there is a new data set that we are going to investigate and really, hopefully, provide also too, in turn, up to 20 years of data or patients that we could follow and understand not only more recent data, but over the long-term cost of care.

Ashish Kamat: Now, the increase in cost that you saw with the increase of imaging and markers, clearly, I mean, that is occurring, and it's independent of the other facts that emanated from this dataset, which is the recurrence rate, which really, as you pointed out, 1.7% is really much lower than we see in the real world, and you had to make some assumptions and sort of you're at the mercy of the data set.

But the rising cost factor is independent of that recurrence rate, right, so what do you think is driving that increase in utilization? Do you think it's lack of appropriate education? Do you think we, as bladder cancer experts, are not doing our part, or do you think it's a more litiginous society where people feel that they have to get all these markers and imaging just in case?

Stephen Williams: Yeah, that brings an excellent point, and it also brings me into my experience in my healthcare system and understanding or trying to optimize and provide high value care. I must say that I have yet to come into circumstances where a provider or even patients want to get additional testing for no reason, but also too, it's understanding the downstream costs and then ultimately, come to be honest. If you focus on the patient and the patient-centered care, really trying to adhere to guidelines, but also too, importantly, really getting the information to the providers and patients because more often, as you and I both know or any provider, right, the C-word and cancer word is a very scary word and really, providing the adequate information reassurance will also help mitigate any litiginous concerns.

Being in Texas, we have a different type of healthcare legal environment with tort reform, but I think if we focus, most importantly, on the patient optimizing the appropriate care, and as we've seen here and you know, with the increased diagnostics, imaging, post-diagnostic office visits, and/or even inpatient admissions for complications resulting from these treatments, I think it is going to be a combination effort, and in 2030, CMS is moving towards value care-based models that are currently being critically evaluated. I think once we decrease a fee-for-service-type healthcare system models, this will lend even more premise to really trying to adhere to metrics that will improve the quality of care that we're able to provide for these patients.

Ashish Kamat: Yeah. You hit on all the key points that I was going to, in some ways, ask you to bring up, so I'm glad you did, which leaves me time for a couple more questions. One of it is you mentioned this earlier and, of course, you and I have talked about how the different guidelines help us to identify patients who get off this rollercoaster of frequent cystoscopies and imaging and, of course, the UK guidelines go to one extreme where they literally discharge the patient back to the primary care physician are international bladder cancer guidelines, which, of course, you lead the HSR group of, suggest that you could maybe do this after five years, which is in alignment with what the EAU says and sort of in alignment with what the AUA says. But clearly, there has to be a discussion with the patient and the physician.

What's your sense as to whether data such as what you presented in this paper will... how that will help us convince patients and providers to actually adhere to those guidelines?

Stephen Williams: Well, and once again, I think it comes to providing from a large population-based data, take into account, obviously, the inherent limitations that we've provided or described, but we really need to mitigate the rising costs in our spiraling healthcare system, improve value to the patients, and our data, at least, adjust even albeit, it's almost 10 years old, provides a moment of pause on what we have been doing and what measures could be perhaps, as you just mentioned, from the EAU standpoint is discharging the patient to really limit the overdiagnosis and really, the increased surveillance costs that are associated with disease.

As we have shown, and others have shown, this is not with bladder cancer. Low risk or TA low-grade, in our case, that we've studied, carries significant... or there's absolutely no risk of a death from bladder cancer itself, but competing causes are obviously attributing to the overall survival, which in this population, the mean age of bladder cancer being 73, we really need to address, and that perhaps, is what we've seen already with the guidelines and what will be probably more enforced, I imagine, in the future as you obviously sit on a number of those guideline panels.

Ashish Kamat: Right. Once again, Dr. Williams, thank you for taking the time and spending it with me and our audience truly appreciate it. Hopefully, we'll see each other very soon in person.

Stephen Williams: Absolutely. No, I look forward to it and thank you and UroToday for this opportunity.