The Ideal Patients for TAR-200 and Barriers to Treatment Access

In the final section of this roundtable series, Gordon Brown, DO, and a panel of urology specialists—Tim Richardson, MD, Bryan Mehlhaff, MD, Chris Pieczonka, MD, and Eugene Cone, MD—dive into the practical considerations and challenges surrounding the use of TAR-200 in the treatment of high-risk bladder cancer. The panel discusses patient selection criteria, including potential limitations for patients with anatomical challenges or compliance issues, and emphasizes the importance of managing toxicity profiles and tracking device usage. They also explore operationalizing TAR-200 in clinical practice, touching on its ease of use, logistical benefits, and strategies for navigating access and payer considerations. The conversation highlights the compelling data from the SunRISe-1 trial, emphasizing the therapy’s durability and its potential to transform bladder cancer treatment, while addressing the real-world challenges of integrating such therapies into everyday practice.

Watch this series from the beginning: Novel Therapeutics and Personalized Therapies in NMIBC

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Dr. Brown:
So is there a patient that you wouldn’t put a TAR in the appropriate clinical scenario? 

Dr. Pieczonka:
I think I’d be leery about a post-prostatectomy patient. So I think somebody with a wide open bladder neck or somebody who’s had a big TURP, whether or not they would seat the right way, and/or a woman who has, and I think that this is borne out in some of the anecdotes on studies, somebody that has a very large descendant cystocele or something like that. So I think there are some people that may not be ideal candidates for the device. 

Dr. Brown:
Some patients are just bladder cripples too, right,- 

Dr. Pieczonka:
Yeah. Yeah. 

Dr. Cone:
And there are some of the intravascular therapies that seem preliminarily they have an even lower side effect profile. So if a patient is coming in and already has pretty significant irritation, that might draw me towards being more likely to prescribe one of the ones that has an even lower adverse gastro profile. 

Dr. Pieczonka: 
That’s true. 

Dr. Mehlhaff: 
And you’re on a schedule, so some of that will dictate therapies that you offer. 

Dr. Cone: 
And I guess the loss to follow up concern too. I don’t think that it’s going to be a huge problem, but if a patient has already shown that they are unreliable, flight risk, they’ve no-showed surgery,- 

Dr. Mehlhaff: 
There will be some big bladder stones out there. 

Dr. Cone: 
…I don’t think that I’m going to be putting a TAR into that patient. 

Dr. Pieczonka: 
But now that you bring that up, it makes me think about it. We’re going to need to do pretzel tracking, right? 

Dr. Cone: 
Yep. 

Dr. Brown: 
Just like the stent cards, stent cards back in the day. And that’s something that can be done even electronically, time of replacement potentially within the practice itself. So let’s kind of finish things up here. I think we’ve talked pretty efficiently about what our clinics need to expect, how we’re going to operationalize this from the practice. Really some compelling trial results we’ve seen from SunRISe-1 here and in paradigm changing this patient population, and if it continues to track this way, really superior to what’s currently in the marketplace. We’ve talked about patient selection, toxicity profiles and management of same, and trying to really formalize these bladder clinics with anointing a stiffer bladder champion potentially from our prostate champions. But let’s talk about accessing these therapies, right? All that’s great. The data’s compelling. Not only our CRs are high, but it’s durable. And that’s really what we’re talking about here. Durability seems to be the inflection point here that differentiates this therapy from other therapies in the marketplace. Everybody’s alluded to that here on the panel, but we got to get access to it, right? 

And that’s a real world practical solution, or problem, I should say, that we’re going to have to overcome. So I want to hear some of the thoughts about, how do we manage that? What does that look like? Are payers going to be on board with this? And how do we get our patients in need on drug? 

Dr. Mehlhaff: 
I think my office historically has done really well of making sure the key points are in a note, the data is there for a patient. So now the prior authorization people can do their job and submit that, find out if prior authorization is needed. If it is needed, get that prior authorization. And then ultimately, I don’t know, the cherry on top is if I can carve it out in private contracts where we have a dictated rate of reimbursement that we’ve agreed on so that there’s no haggling over it after the fact. 

Dr. Brown: 
Tim, Chris, any thoughts? 

Dr. Richardson: 
I think it helps that it’s an in-office product, if you will. Anytime you’re dealing with the patient’s prescription plan, that always creates just infinitely more headaches. So I think that the buy and bill model definitely, definitely eases a lot of that. Yes, we’re going to have to do appropriate documentation. Yes, there’s going to be a risk to our business model when purchasing high dollar supplies. You want to make sure that you’re actually going to get that back and not be upside down. Those are all easily overcome. 

Dr. Mehlhaff: 
Which we’ve all dealt with with everything we’ve gone through. 

Dr. Richardson: 
Yeah, we’ve done that over and over. So I don’t see a big worry in access, to be quite honest. I think just the geographic is probably the biggest hindrance to access for some patients. But everything else, we’re used to dealing with, and I think we’ll deal with it this time around too. 

Dr. Pieczonka: 
I think that we’ve had some very significant challenges with immunotherapy, intravascular availability vis-à-vis access for cost, but I’m hopeful that because this is a device that elutes medicine, it’ll be similar to the spacing products for prostate cancer, and there was not an issue with those. So those are something that kind of like a similar type of thing, that there’s medicine in the device, and that didn’t seem to be an issue. And the immunotherapy things just have been an issue, just to be fully transparent. We’ve had difficulty with patient access with those out of the gate with the medicines that are FDA-approved. 

Dr. Cone: 
I think some of this is going to develop as the market itself develops. Right now, we are really in the first real year-long period of having these much higher dollar products beyond the market standard of care. And three to five years from now, I anticipate that there’ll be a whole lot less pushback. We saw it with… We’ve seen it with many drugs, many imaging things over the years, prostate MRI. All of a sudden, we went from a lot of pushback to, “Yeah, sure, go for it.” 

Dr. Cone: 
And so five years from now, I anticipate that we’re not going to really be dealing with much pushback at all. But some of it, I think, is going to have to do with where products are comparatively priced as to whether insurers are happy to cover them.