Ruchika Talwar: Hi, everyone. Welcome to UroToday's Health Policy Center of Excellence. Today, I'm excited to be joined by Dr. Dan Joyce, who's a urologic oncologist at Vanderbilt University Medical Center in Nashville, Tennessee.

This video is going to be the first of a few that we'll be launching to explore the effects of advanced prostate cancer medication costs on everyone who sees advanced prostate cancer patients—providers, patients, caregivers. Our hope is that this resource can help alleviate some of the concerns that come with these often very expensive medications. Dr. Joyce is going to do a deep dive into some of his work. He's really an expert on this topic. And again, we're just thrilled to have him. Thanks for being here with us.

Daniel Joyce: Thanks so much for having me. It's a real honor to be here and talk about something that I care passionately about. So, I appreciate it.

All right. So, Dr. Talwar asked me to talk about out-of-pocket costs for these oral cancer therapies that we use for prostate cancer. And prostate cancer, especially in the metastatic disease space, really is an interesting place to look at this because we have a lot of different treatments—over a dozen different treatments, some oral, some not—lack of comparative effectiveness research, really head-to-head evaluating them as far as cancer outcomes go. And these treatments are widely different in the amount of costs they have.

So, I have no financial disclosures.

When I started looking at the cost of advanced prostate cancer care, this was really the one publication that existed out there. There wasn't much being done in looking at these oral treatments. And this is a really nice study that came out of Michigan where they used SEER-Medicare to look at those patients who had Medicare Part D, so the oral drug component of Medicare. And they looked at those patients filling abiraterone or enzalutamide—what were their out-of-pocket costs?

And what you find is really interesting, and maybe not all that surprising, but that little figure on the right is each health referral region and their out-of-pocket costs. So, you see there's a wide variation in what a patient may experience for their out-of-pocket costs depending on where they're receiving care. What does that look like in monetary terms? Well, for those without the low-income subsidy ... So, Medicare has this built-in low-income subsidy for people with low incomes. It helps offset their out-of-pocket costs. But for those patients without that subsidy, the monthly average cost of these drugs was about 700 bucks, but that could range up to $3,500. The first six months of treatment, it can be as high as $4,500 on average, but that can range up to almost 10 grand.

So, these are widely varied costs even in the Medicare population. And so, the question we wanted to ask was, "Well, what about commercially insured patients? What are these treatments like for them? And how do they compare to some of the other treatments that are available in this space, like chemotherapies or just ADT monotherapy?" So, we used the OptumLabs Data Warehouse and looked at a 12-year period of all these patients who are commercially insured, and we lumped their treatments into one of three groups: androgen deprivation monotherapy—just standard ADT—novel hormonal therapy, which are these oral cancer drugs, and then non-androgen systemic therapy. These are your chemotherapies and bone-directed therapies.

What did we find? Well, not surprisingly, these oral treatments are expensive. And this is adjusting for any potential confounders. And what we found is that those oral therapies were 18 times higher for out-of-pocket costs than just ADT monotherapy. And if you look at the patient characteristics that are associated with higher out-of-pocket costs, they're not overly surprising. There are older patients, Black race, higher comorbidities, and lower income—all experience higher out-of-pocket costs.

Now, the figure there in the bottom right shows another kind of interesting aspect of this, and that's that these out-of-pocket costs are really a small proportion of patients that are making up for the large amount of costs. So, it's not an even distribution. Most of the patients get them at very low cost, but there's a small percentage of patients that are carrying the load for the higher out-of-pocket costs associated with these treatments. And at the end of the day, what it looks like is oral therapies on average for a year of treatment is about four grand compared to just $165 for the ADT monotherapy.

Now, usually at this point, when I'm talking to people, they say, "Well, that's because they're not generic. Wait until they get generic; all of this is going to go away, everything's going to be good." And that's sort of true, but not really. And this is another really interesting study done by Stacie Dusetzina that was published in JAMA Network Open, and it looks at abiraterone and tracks the out-of-pocket costs as these generic versions of abiraterone become available. And what you see is that sometimes that generic brand is cheaper than the brand-name drug. However, depending on what dosage of that generic drug you take, it can actually be the most expensive option on the market. So, clearly, just turning a drug generic doesn't answer all of our problems.

Now, the Inflation Reduction Act, I think, goes a long way in helping these patients. It does a lot of things, but perhaps the most important in this setting is capping that out-of-pocket cost for Part D enrollees to $2,000, and that takes effect in 2025. It also allowed Medicare to negotiate prices for certain drugs. And actually, there was just an article in the New York Times discussing what those first drugs are going to be. Unfortunately, none of them are prostate cancer drugs, but maybe we'll get there someday.

I can't not talk about this stuff without talking about your work, Dr. Talwar, in looking at, well, how is that Inflation Reduction Act going to affect our patients with advanced prostate cancer? And that you can see here, I mean, it's obvious, the $2,000 cap makes a difference. So, if you're looking at all these different treatments—apalutamide and enzalutamide—the blue is prior to the Inflation Reduction Act, the orange is post, and there's obviously huge savings here.

The other piece of this is what are some other ways that we can reduce costs for these patients? And again, your work, largely cited by Mark Cuban, really highlights the impact that circumventing our current way of getting drugs might help patients. So, the Cost Plus Drugs basically cuts out the middleman and allows patients to get their drugs—generic drugs—at a much lower cost than what they might get through insurance. And you can see abiraterone is on the right. And I agree with Mark Cuban that this is amazing. I mean, the blue is what it costs Medicare, the green is what you can get it through Cost Plus Drugs.

Now, the downside to this is that you're cutting out the insurance company. So, you're now kind of pushing patients to basically say, "Your insurance stinks, just get it through somebody else and pay for it." And that has obvious problems because you're not factoring in all the things that come with an insurance plan, like your out-of-pocket max and deductibles and things like that.

So, at the end of the day, my question as a clinician, politics overwhelms me and makes me depressed. So, as a clinician, I just ask myself, "What can I do? How do I face these out-of-pocket costs? How can I make this better for my patients?" And I think the answer of what not to do is just to pretend it doesn't exist. I think that's what a lot of us want to do because we make up excuses like, "We're not trained in this. We don't have the data available to deal with this." But when we do that, I think we do our patients a disservice.

So, this is a study that was published in JCO that looked at conversations surrounding financial issues in routine oncologic practices. And what they found was that costs were raised by patients a third of the time—28% of the time—but they were only acknowledged when that happened by the physicians 40% of the time. So, we need to do better. When our patients are expressing concerns, we need to acknowledge their concerns and talk about it.

This is another study that is of a similar vein, but it looked at physician communications about out-of-pocket costs. And what they found is that 63% of patients want to talk about these costs with their physicians, but in reality, it only happens about 15% of the time. So, there's a huge gap here that we need to do better with.

And we wanted to seek a little bit more about learning how these patients experience specifically in prostate cancer with these out-of-pocket costs. One was affecting them differently than, say, other cancer spaces, but also kind of identifying ways in which we could make it better for them. And so, we did a mixed methods approach. We evaluated patients using an instrument that was validated in solid malignancy, assessing financial toxicity—so the harm that comes to these patients from these out-of-pocket costs.

And then we lumped them into focus groups based on whether they were experiencing high or low financial toxicity. And we wanted to dig in, in those focus groups, to get the nitty-gritty of how maybe we could help, and what are some themes that arise when they're dealing with getting their care for advanced prostate cancer? And what we found was summarized in this figure, and it's a little complex, but the message is simple. Basically, patients, when they get an advanced prostate cancer medication, there's a workload that comes with that, and that workload involves direct costs—these are the out-of-pocket costs—but also indirect costs like traveling to treatment, paying for parking, all the ancillary stuff that goes with receiving care.

And patients deal with that workload in various different ways, and their ability to deal with that workload really depends on the resources that they have available. Now, obviously, some of those are financial resources—just your income, what you have in savings—but there are also psychosocial resources, and this has a lot to do with their ability to deal with uncertainty, what their quality of life is from side effects of treatment. And interestingly, what we found was that the way we communicate with our patients can impact both of those things—so they can facilitate and support the resources that patients use to cope, and they can also decrease the workload that the patients are experiencing.

Furthermore, if you involve informal caregivers—so these are the patients' family members, loved ones who are charged with taking care of them while they're undergoing treatment for their disease—that actually heightens this experience even more. So, it's not just the patient that is being affected by these out-of-pocket costs, it's their families, it's the people taking care of them, the people that have to take off work to be there for them. And so, really, I think we don't involve them enough, and there's an opportunity there to have more of a cohesive, comprehensive approach to dealing with both out-of-pocket costs for these treatments and also the financial toxicity that comes from them.

The final thing I'll say is that there was a really strong theme throughout all this analysis, and that's the idea that patients just want to know. They want to be able to expect what they're going to have to pay and for that to be accurate. So, cost transparency is a huge deal for these patients, and that's not surprising either because anybody who buys anything wants to be aware of what it's going to cost before they buy it. And right now, in healthcare in general, but especially in this space, I think we just do a really poor job of doing that, mainly because it's complex. But I think there are ways in which we can tackle this better, especially as clinicians, we exist in this intermediary to our patients, and they're relying on us for, one, our recommendation of what treatment they should have, but also our recommendation of what the highest value option is for them. And in order to get that value assessment, you've got to know out-of-pocket costs. You've got to know the indirect costs and other toxicities that come from these treatments.

So, that's all I have. Again, I really appreciate getting to talk about this. This is a huge topic, as you can imagine, that really has a lot of different facets to it. But I hope this has been at least a helpful overview.

Ruchika Talwar: Great. Dr. Joyce, I mean, what a phenomenal presentation. Not only did you go over some of the issues that drive those increased out-of-pocket costs, but I love how you ended with a framework that clinicians can use to try to address some of these difficult issues in the clinic.

Let's pivot back to one of the studies that you alluded to early on. You demonstrated in your work that patients potentially are underinsured—patients who have characteristics that we would potentially suspect—older age, minority patients, lower income—in the commercial space, who may be underinsured have a lot higher out-of-pocket costs. Now, from the perspective of clinicians who see these patients, what can we do to help? Are there resources out there? Are there programs that they could turn to? Understanding that a lot of this may be regionally specific, institution specific, but talk a little bit about what strategies we have here.

Daniel Joyce: Yeah. It definitely is region specific because every different health institution is figuring out how to deal with this a little bit differently. Some institutions are implementing financial toxicity tumor boards. So, a board of people that come together that are both financial people, financial assistance people, but also doctors. And they get together and they say, "Okay, what's the best treatment for this patient? And then, how can we get them the best cost?" And a lot of that involves understanding their insurance.

Now, I think that that's not the norm. I would say the norm is, for me, I see a patient in clinic, I say, "This is what you need. You need abiraterone and ADT." And then, they get shuffled off to somewhere else, usually a financial advisor that goes through a specialty pharmacy, and then they figure out the nitty-gritty of that. The problem with that, in my opinion, is that the decision has already been made on the treatment, and it's really cumbersome and often impossible to then backtrack and come back if that's too expensive and say, "Oh, actually, shoot, we could have done apalutamide, and that would've been cheaper for you, but we've already set this wheel in motion, and we can't fix it anymore."

So, I think it's going to take a different system, truthfully, and I don't think we have that yet, but it's going to require that clinicians, one, know their patients' financial status coming in. And there are some basic things you can do to get an assessment of what their financial toxicity or financial background may be coming into your clinic. One is just to look at their insurance before they see you. But two, if a patient starts talking to you about costs and other financial struggles that they're having, don't just brush by that. Dig in, figure out what's going on. They may tell you, "I have really awful insurance, and I'm being told this is out of network, and what am I going to do about that?" And that can start a conversation to at least get a better understanding to get them plugged into the resources at your institution that can help them.

Ruchika Talwar: Totally agree. Totally agree. I think it's very easy to withdraw when the conversations get difficult or perhaps we may not have as much familiarity with how to help in the situation, but I think you're right, we should do exactly the opposite. Lean in, talk to them about their concerns.

The other thing I'll mention. Now, there are a lot of opinions out there on how physicians interact with our industry counterparts. And I think this space is one in which we can actually partner as clinicians with our industry counterparts because oftentimes these companies have patient assistance programs or other resources or mechanisms by which they can get certain aspects of the drug costs reduced or certain copays waived. Now, we won't get into the discussion about how that can affect their insurance potentially, because that's a hot topic right now, but it's a space that I think is evolving, and it's important for us to at least be aware of it because it still may work out in the patient's interest there. So, that's one other aspect of this.

Now, as we wrap up here, I'll ask you, what is your general advice for urologists who see these patients in clinic? How do they even get the conversation started about what this may cost the patient?

Daniel Joyce: I think step one is, before your patient gets into your clinic office, understand what your financial resources are for these patients, and that requires a conversation with your specialty pharmacist. It requires you to understand what number they call to talk to those people or how they get transitioned over to them. Because having that information, in addition to knowing some of the basic resources that can exist outside of the insurance realm, like Cost Plus Drugs, GoodRx—these are resources that every clinician should know and make their patients aware of, I think. But I think having good knowledge of those resources before your patient gets in front of you is going to help the most.

And then, just taking the time to listen to them when they do discuss costs, and then make sure you know how to deal with that. Whatever it is in your area that can help you deal with that. Know the person that you can give a call, or know the nurse that knows how to get them into the resource they need to help cut their costs down. But yeah, it's not easy by any means. And a big portion of my future work is trying to figure out how to make it easy because I think it's possible. I think we can make this a lot easier than what it is. It doesn't have to be as complex as it is. And I think we have technology now available that does allow us to streamline this a little bit better and empower both clinicians and patients with more information.

Ruchika Talwar: Absolutely. And we're really looking forward to seeing that future work come to fruition because there's a big need here. Thanks so much for spending a few moments with us and sharing your important work with the UroToday community. We really appreciate it.

Daniel Joyce: Thank you. It's a pleasure to be here.

Ruchika Talwar: And to our audience, thanks for joining. We'll see you next time.