The Benefits and Challenges (Present and Future) for the Urologist Treating mCRPC

I’m going to talk the benefits and challenges for the urologist treating CRPC. These are my disclosures.

So I’m going to try to convince you why you should be treating patients with all these advanced therapies. So this is a snapshot of our practice. We have 16 urologists, a radiation oncologist. We incorporated a medical oncologist. We built our center ten years ago. We’ve just gone on our tenth year anniversary, and we provide all outpatient urology services under one roof. And the only thing that we don’t do is some of the surgery that requires outpatient surgery. We have a surgery center, radiation oncology, pathology, and we have a very robust imaging. We have a very robust research department, which I head. And I’ve now gone on my 20^th years of doing clinical trials and have, as of my last count, 214 trials under my belt. And I’m also the chairman of the Advanced Prostate Cancer Committee.

And this is our pathway for treating prostate cancer, whether it’s castration sensitive or resistant, we really believe that it’s a multidisciplinary approach that’s required. We have the urology, oncology, radiation oncologist, pathology, pathologist. And we also incorporate palliative care. We even have one managed primary care group that will not allow their patients to get any of these advanced therapies until they talk with a palliative nurse. And they have the nurse that talks with them, and then they’ll okay, they’re approve the therapies. We also have a nurse navigator that navigates these patients through. We even have our advanced prostate cancer tumor board monthly. All of these people show up. We even have our billing people so that when we try to sit down and make recommendations together that we’ll know whether or not these patients are going to qualify for the therapies. We have an advanced prostate cancer clinic that meets weekly. I’m one of the docs. We have another one of our physician campaigns that does it, and also our medical oncologist is involved in our clinics. Our medical oncologist really when it comes down to it administers the chemotherapy, and he does that at his office. Otherwise, everything is administered in our office. We also have a bone health management. That’s really what got us started years ago. It’s run by our physician extenders. They get the patients started, and then eventually the urologists are managing these patients. And in addition to this, we have a GU tumor board that meets monthly for all the GU cancers.

So this is the treatment landscape since 2017. I think that Mike Cookson, and Dan Petrylak, and Lenny have shown you all of these drugs, but basically these are the therapies since 2010: sipuleucel-T, radium-223, enzalutamide, abiraterone and cabazitaxel. We start our—the minute patients start on ADT we put them in our bone health clinic. They get a DEXA scan and they get started on vitamin D and calcium, and as time goes on if they need antiresorptives they’ll get denosumab or bisphosphonates.

So we have the five new therapies that have been available, each with a unique mode of action. And it’s imperative for the urologist to know how to treat these patients when it comes to the administration, dosing, and adverse events. And I got this quote from Chuck Ryan, the right, so that we can administer and determine the right therapy for the right patient at the right time. And all these therapeutic options now allow us to sit down with the patient and have our patient physician shared decision making on their therapies.

So this is classically the way that the protocol went before 2010. This is the pathways. Urologists usually would have the patient, start the patient on ADT and maybe some of the first generation anti-androgens. Once they progressed, got pain, became symptomatic we sent them to the oncologist where they’d get docetaxel, or they might have been started on some of these secondary hormone therapies, like ketoconazole and DES. And what I found was, you know, docetaxel was approved back in 2004, first one, therapy approved on overall survival. We would get the patients, they would be somewhat symptomatic, they would progress. We’d send them to the oncologist, the oncologist says well, the patient is not ready for chemo yet, send them back. Then the patient would come back and then he would get worse, and we would send him to the oncologist, and the oncologist would say, ah, the patient is too advanced, we really can’t, we’re not going to help. So that’s the kind of frustration that we had initially.

And then as far as the radiation oncologist, we would send them patients that needed spot welding, severe pain from a bone met, or if they had impending spinal cord compression they would take care of that. And then they were using the radiopharmaceuticals, like beta emitters that were around, samarium and strontium, they had a lot of side effects. There were no overall survival advantage. So, and they weren’t using it that much. But that was the pathway before.

So now why should urologists treat mCRPC patients, I’ll try to tell you. We have the patients. They’ve been with us since diagnosis, we know them, they trust us. I believe we can provide better continuity and patient care, and if done right I think we can facilitate it better. So why stop at ADT and then hand off to the oncologist when we have all these new therapies available to us? So, if we don’t figure out how to treat these patients someone else will, and of course, it would be the medical oncologist. And I think that Dave was mentioning that most medical oncologists are busy treating other cancer types. So to get a specialized GU oncologist you’re either going to have to go to the university or do what we did and we got our medical oncologist to really be tuned up on all GU therapies. And radiation oncologists, how are they getting into the mix here?

I can just give you an example, in our neighborhood there was a radiation oncologist who hired another radiation oncologist, and he administers a lot of therapy for prostate cancer. But he just recently hired a medical oncologist who had a pretty big practice in the city, and so now they—and they advertise. And so I think they’re trying to get in the mix of capturing these patients and treating them. So here’s our other competitors on the playing field. And it’s interesting, because the university just acquired that practice. And then there are hospital systems that will do it, whether they’re academic or non-academic. They all want to compete for that prostate cancer business. And then, of course, there are cancer centers and Centers of America. So if we don’t do it these patients are going to get treated, but they’re going to get treated by someone else. And I’ll show you why we need to be doing that.

What should treatment for mCRPC be multidisciplinary, yes, of course, absolutely, but the urologist should be the quarterback of the team. And if we don’t learn how to be the quarterbacks then I think that we’re going to be relegated to being the water boys. And I think that now that we’re seeing all these payment models, and bundled care that’s coming down the pike, we’re going to have models where I think eventually they’re going to—the payers and especially Medicare are going to come out and they’re going to say we’re going to give one group all the money to treat, to take care of prostate cancer. And so we don’t want to be in position where we’re the subcontractors. We want to be the contractors in this business. So I think it’s imperative for the future, if you’re going to want to continue to treat these patients that you’re going to have to move into that kind of position.

Now, this is just an aside. I know that Dave, he’s married to a beautiful wife, Jody, and he’s very athletic, he’s very virile, and that’s why I’m worried that he loves football and he loves our two quarterbacks who are Super Bowl quarterbacks, Peyton Manning and John Elway. And I’m afraid that if he keeps looking at these pictures for too long he’s going to develop priapism, and one of these talented urologists are going to have to treat him.

These are some of the caveats. If you’re going to be in this you don’t want to be a dabbler. You don’t want to just be able to use one of these therapies and then just hand-off. You need to be as knowledgeable or more knowledgeable than the players on the field. And I think Dan made a good point, this really should go to the people that do it best. And I think that we need to make an effort to learn how to do that best. And we have an opportunity to do that. And that’s with these advanced prostate cancer clinics. And I give credit to the AUA, LUGPA, guys like Neal Shore, Mike Cookson, who have put on these programs to teach us how to develop an advanced prostate cancer clinic. The material is out there, we just have to learn how to utilize it and implement it.

This is a newer model for urologist to take charge. And it provides the ability to expand your practice and sustain a higher quality of care and improved patient outcomes. And I agree, I agree with Dave, and these patients—and Lenny, that these patients actually, I’m seeing better outcomes in our managed program. These patients would live for a year or two. I’m seeing that it’s not uncommon to see these patients going on for four years. So I think we get better outcomes. We can retain our patients, we’ll grow our revenue and promote a center of excellence.

And so this is what’s involved in creating a successful advanced prostate cancer clinic. You have to identify a physician champion, a nursing champion, administrative champion. You’ve go to integrate that into your business, and you want to collaborate with multi-disciplines so that you can have a multidisciplinary approach, but we’re going to subspecialize in prostate cancer, and eventually GU cancer.

So if can improve the patient care. We can actually be proactive in their management so that we can start treating them earlier and they can get the advantage of these therapies that we offer. We have protocols, we can integrate this and give comprehensive treatment, it’s coordinated, and it’s convenient for the patient so that the patient doesn’t have to be going all over town. And we try to integrate this so that we can make it really patient friendly. And I’ll show you what else we do.

Patient satisfaction is a win-win for you and your practice. And if they’re dissatisfied it’s also a lose-lose situation for you. And I’ll tell you why, because patient satisfaction is one of the metrics that being used in the value-modifier methodology, and I’m going to talk about this in a later slide.

When we treat patients we can have them remain in our care longer. And these patients don’t want to be transferred or shipped off to other specialties. They’ve been with us for so long that they get to know our staff, they’re comfortable in our offices, so they don’t to have to go off and see other people that they consider strangers.

And so prostate cancer treatment can offer revenue opportunities also. So in addition to our ancillaries, like our radiation oncology, imaging, pathology, we now can do in-office dispensing and set up our pharmacies. And it’s not that difficult to do. And we’ve been able to do through UROGPO, which is a group purchasing organization that’s actually going out throughout the country and trying to help your practices set up an advanced prostate cancer clinic. But as far as in-office dispensing, it’s not that terrible to do. All you have to do is apply for a National Pharmacy Number, it takes about a month. And then there is the QS-1, which is a national plan benefit processor. You get their software. What they can do is they’ll figure out the eligibility of the patient, and they go through the payers. They’ll figure out how much the patient has to pay. And they have a program that we can just print off the prescriptions. And so I think that it’s something you need to look at.

Now classically, and I’m going to look a commercial model, but as far as pharmacy dispensing, classically we’ve had the suppliers like, and these are just examples, I just throw these names up here, but McKesson, Cardinal, Besse, they supply—so if you write a script for abiraterone or enzalutamide for your patient, they’re going to take it to a specialty pharmacy. Now CVS, Walgreens, Rite Aid, they actually have specialty pharmacy subdivisions. So these patients can’t just go into a Walgreens or a Rite Aid, but these are the ones, and also Diplomat and some others, that are the specialty pharmacies and they will get the prescription for the patient. They go through the suppliers. And through this existing model we also go through the suppliers and get things like GnRH, radium-223, denosumab, and sipuleucel-T.

That’s the existing model. The new model now is where we have a purchasing organization that can buy at discounts from the suppliers and we can order, if we order abiraterone or enzalutamide we can do this in-office dispensing, and it will go through the UROGPO, and also for your in-office things like radium-223, sipuleucel-T, denosumab, we can get that through this new model.

And Medicare is a similar kind of model, except that we’ve got Part D, which are prescription part. And Part B is the office dispensing, where we do the infusions and things like GnRH. And so the new model also kind of mimics this. We go through UROGPO. Again, the oncologists, US Oncology which has oncology practices across the country, they act as a group purchasing organization. So this something to think about.

And so what are challenges? Well, the biggest thing is you get your practice to commit to this. So you need to get these champions, the physician, nursing, the administer, and that’s what I outlined before. But the biggest thing that I see is convincing partners to refer patients to the physician champion. So I’ve gone out and helped groups try to setup an advanced prostate cancer clinic, and I think this is the biggest stumbling block for a lot of them. It depends on your economic system, now the economic system we have at TUCC is we’re communists for capitalism. And so we share in everything. If you are in a traditional kind of a group where you bill, you get compensated for all your patients then it’s difficult to do, but you’ve got be thinking along a different model as we move forward, and that’s the only way that you’re going to be able to integrate all this into your system. So you have to allocate staff, and in some cases hire additional staff, or use your existing staff. We hired a nurse navigator this last year that’s really been just a tremendous boost for our clinic. You’ve got to integrate the EMR so that you identify pathways and patients. From the financial end you’ve got to be able to do the billing, approve the costly therapies, make sure that you’re getting the pre-authorizations so that you don’t lose any money. If you have one sipuleucel-T patient that doesn’t get paid you’re going to lose a lot of money. But it’s pretty well worked out and we haven’t really lost any in doing that.

And then you have to have space. Usually you can maximize your existing space, and if not, sometimes you have to get new space for infusions, injections, and patient visits. And then the big thing is to operationalize this whole thing, so that you can balance the clinical excellence with your protocol development, identifying patients and balance that with your business.

So these are some of the challenges for the physician champion. You really need to know this. You need to know this landscape, you need to know how to manage these patients, know how to manage their adverse events, and stay on top of the latest innovations and options. And we treat patients according to the FDA indications. I think the urologists are pretty strict about this, because if you treat a patient that let’s say the M0 space where the FDA hasn’t approved that drug you may not get paid, or the payers may not even allow you to use those drugs. And then we use the accepted guidelines, like the AUA and the NCCN. And even at our advanced prostate cancer tumor board every month we sit down, we have all the input from the docs. We have a copy of the AUA guidelines and the NCCCN. And at the end of that visit for when we talked about the patient, we actually generate a letter, we put down that we followed the guidelines and they qualify for this reason, or they’re a level one. And we send this letter back to the primary care physicians. And the primary care physicians understand what we’re doing. And I use them pretty liberally. If I have a patient that develops problems with hypertension or diabetes, they’re happy to help out. So we do integrate primary care to that extent. And then you also have to—need to, the champion has to develop these treatment pathways.

So, experience with this disease can expand our horizons. Neal Shore just talked about this yesterday, where we now have therapies for metastatic bladder and renal cell that I think we can learn to administer. And they’re in the pipeline. Lots of immunotherapy. I think this made me go back to TKI inhibitors for renal cell. But I think we can become more involved in other cancers. And then it may even spark some interest in clinical research trials.

Again, I think with the all—the NCCN on the first page it says all patients with cancer should be offered a clinical trial. And it’s nice to have that in your practice, because that’s another thing that we do. We offer patients a clinical trial if it’s available. So we can offer, through research, tomorrow’s therapies today. This will either be no cost in most cases, or a very low cost to the patient. It gives prestige to your practice, and again, we get into that patient satisfaction metric. They’re very happy in these clinical trials. It generates income if you can do it right. It’s kind of tricky and you just have to make sure that know what you’re doing and taking on the right studies. But I think this is something that you should really think about, if you’re not doing clinical research, especially younger guys, to develop this kind of a program in your practice. And then the physician, referring physicians want their patients to get the best. And they can get that, they can get these cutting edge therapies in research. In fact, again, we have this managed care group of physicians who they love it when we put patients on trials, because they’re not having to pay for the abiraterone or the enzalutamide, or any of these, or sipuleucel-T or whatever therapies we’re giving.

So, I just want to spend a minute talking about the shifting paradigm in medicine for our reimbursement. We’re going from a volume-based system to a value-based. And this is changing rapidly. It’s here today, The Medicare Access and CHIP Reauthorization Act (MACRA) is here today. And this can open opportunities for forward thinkers to enhance their urology practice. So this kind of emphasizes the need to develop a specialty clinic where you can be efficient, you can offer higher quality of care, and hopefully at a lower cost.

So this is what’s happened, this is MACRA. This has replaced the Sustainable Growth Rate (SGR), remember the SGR? Every year we kept getting threatened that we’re going to have to pay back 2%, 5%. It got to the point where I think we were up to 20% or 25% that we were going to have to pay back to Medicare. So MACRA replaces that system. And now Medicare is tying fee for service to performance. And this incentivizes us to do these advanced or alternate payment models.

Now, I know that probably none of us are involved in alternate payment model (APM) unless you’re like in a pioneer accountable care organization (ACO) at this point. But if you are in an approved APM then you will get 5% increase in your annual reimbursement. If you’re not, which that’s where we all fall into right now, we go into this maximum-intensity projection (MIPs), which is an incentive program that’s based on this whole program here, which is the value modifier. Now, how do they calculate this value-modifier? And you’ve probably already heard this year already where you are with respect to this. But it is a composite of quality over cost. And how do they measure all this? Well, you’ve got your clinical care, patient experience, patient satisfaction, care coordination, efficiency. I don’t understand how they’re coming up with this final number at this point, but that’s going to go into the composite score for quality. And then we have our cost. So in order for you to either increase, you can be positive, neutral or negative. And so if you’re positive you’re going to get a few percentage points above Medicare, neutral, you’re going to stay the same, and negative, you can lose. And I don’t know, Neal, is it up 5%? So you can either gain up to 5% or lose up to 5%. And so that’s here right now. And so I think it is incumbent upon us to try to develop these alternate payment models.

And I have to credit LUGPA, Neal Shore is the president at this point, Gary Kirsh, who is the past president, is now the chairman of the task committee to develop some of these pathways. And this is going to take a lot of work. We also have Raoul Concepcion, who was one of the past presidents who was on the – – connect side of things. And so what the initiative is that they’re going to look at two diagnoses, and I think it’s infection after prostate biopsy and localized prostate cancer, so that we can get into this bundled program. And this is where the Medicare wants to look at things where we have a diagnosis code across the country, and there’s a whole variation on how people treat. So we want to have all the urologist swimmers swimming in one lane so that we can improve the quality and decrease the cost. That’s the only way you’re going to get to an increase in your Medicare. And so, but if you’re in an APM, if you’re an approved APM then this goes out the window and you don’t have to worry about this. So it’s going to be incumbent upon us to try to get these implemented. LUGPA has really taken the initiative and we really have to give them a lot of credit, but it’s going to take a lot of work. And they’re going try to develop these programs, and it may or may not work. But this is really the only way that we can try to be innovative. And there’s no question, reimbursement is going down. We can’t expect to be making a lot more money over the years, we just don’t want to lose a lot. And so it’s incumbent upon us. And also we’re hoping that patients are going to get better care.

So, with all of that, I want to conclude by saying seize the day, carpe diem. There are new therapies, new challenges, and there are new opportunities. I’ve been practicing for 30 years. I’ve always felt that the glass is either half empty or half full. I’ve always looked at it as being half full. We’ve always been told the sky is falling, we’ve still managed to make it, and I think we have some new opportunities to try to excel in the future. So I think that urologists can and are playing a greater role in the care of patients with metastatic castration-resistant prostate cancer. So thank you, and I hope you enjoy the rest of your stay.