Alicia Morgans: Hi, I am so delighted to have here with me today a friend and colleague Dr. David Penson, who is a Professor of Urology and the Chair of the Department of Urology at Vanderbilt University. Thank you so much for being here with me today.

David Penson: You for having me. I appreciate it.

Alicia Morgans: Of course. So I wanted to talk with you today about some really important concepts that we've actually discussed a lot of over the years, quality of life and financial toxicity. And I'd really like to start with quality of life and how you think of this sometimes difficult to define the concept.

David Penson: Yeah. So, we all know what quality of life is for ourselves, but it's very hard to define. I almost want to take that line from a Potter Stewart from the Supreme Court when he's talking about obscenity, "I can't define it, but I know what it is when I see it". I think we all know what quality of life is when we see it, but when we try to study it because part of our job as doctors is to improve both quantity and quality of life, we really run into trouble measuring it.

So there are a lot of different ways to think about it. There are a lot of different definitions. For, at this point, the model that I liked the most actually goes into three areas, and you look at physical experience, psychological experience, and then social life and social experience, and they all feed into someone's quality of life. And when you start to parse it down that way, you're able to measure those pieces using questionnaires.

Now, the fourth piece, which we should talk about, is financial toxicity, which we don't normally think about when we're thing about the quality of life, but let's face it, it's a big part of our day-to-day existence. And with the cost of healthcare going up, up, up and finding different ways to pay for it, that financial burden, that financial toxicity is having as big an influence on our patients' quality of life as the other three things maybe combined because it affects the other three things as well.

So, that's how I look at quality of life. It's not worth going into these long definitions, it's basically, we want to look at the patient's physical experience, his or her social experience, and his or her psychological experience and the financial toxicity of the disease and its treatment.

Alicia Morgans: I completely agree. And I think it's a little bit of a different model or an algorithm that I think about where I've thought about quality of life as being certainly the patient report of their physical, emotional and social domains, but also the adverse events sometimes that they experience directly related to treatment, and all of that can be affected by an X factor, which includes things like financial toxicity. And I think that it's important for us as clinicians to not solely focus on efficacy or toxicity of treatment, but really to include the other pieces of that model, which is exactly what you're saying.

David Penson: Well, and I would actually say, and I completely agree with you, I think financial toxicity is going to be a modulator for all of the other domains, but it's actually a toxicity and adverse event in and of itself. And I think that's the new leap we're now starting to make, which we'd never done before. And I think it's an important leap.

Alicia Morgans: Absolutely. So let's think about financial toxicity, specifically as it relates to GU oncology, because we are GU oncologists after all, and you actually outlined so beautifully some examples of financial toxicity in inpatients with cancer at a recent keynote address that you gave for GU ASCO 2020, which was just lovely. I'd love to hear you give some of those examples, just to put financial toxicity into context for those of us who aren't necessarily the patient in most cases.

David Penson: Sure. And thank you. Thank you for your kind words. It was fun giving the talk, I'll say that.

When you start to think about financial toxicity, and this is not my idea, these other people have laid this out, you're looking at different domains. There's a psychological domain to it, there's a material domain to it and there is a behavioral domain to it. So the material domain is actually the actual layout of dollars. The psychological domain is the worry associated with it. And the behavioral domain is how people cope with it. Financial toxicity has an effect on all three of those areas. So let's talk about each one in turn, right?

What happens with patients? How much do they lay out for their care? And the numbers are staggering. And it's not just pharmaceuticals, although that's a big contributor, it's lab tests, it's doctor visits, it's imaging, it's travel to and from the doctor. There are indirect costs like time off of work. If we just look at direct costs alone and we look across all of cancer, the median burden, and people say the annual burden is about 11%. Now, what does that mean? The out-of-pocket costs as a function of annual household income. So imagine that you're spending 11 out of every $100 just on your cancer care before you pay your rent, before you pay for your food. And of course, these are all after-tax dollars. So, that's the material effect, it's significant.

Next is a psychological effect. We see the patients worry about this anywhere from 25 to 50% of patients are experiencing real worry and bother about financial toxicity. And then there are the coping mechanisms that they take. So in other words, they're going to look and say, "Okay, fine, what am I going to do?" Well, they have two ways they can go, they can either affect their clinical care, which they do. Sometimes they put off seeing the doctor, sometimes they put off getting that lab test, sometimes they don't take their prescriptions, they cut it back. And then there's this other concept, which is, "Okay, fine, I'm going to sacrifice in other parts of my life. I'm not going to be able to take that vacation. I'm going to work more. I'm going to spend less time with the family."

So it's very pervasive throughout every element of their life. And we see that not just in GU malignancies, but across the board. Docs don't think about that. It's not our jobs. We're thinking as clinicians, "How do we keep this person alive?" But we need to start because a lot of what we're doing is actually adding to that. And the first step is admitting that there's a problem. You got to be aware of it. I think a lot of docs aren't even aware of what it's costing their patients.

Alicia Morgans: I think that's absolutely true. One of the examples you actually gave was really putting into context an oral agent that many of us prescribe on a regular basis and laying out what that drug would actually be in terms of out-of-pocket costs for patients who have coverage, who have Medicare D, just thinking about not only the initial out-of-pocket costs, then the donut hole, which hopefully we're going to close, but even if we do, does not fix this, and then the longer term costs. Can you just quickly try to give an example?

David Penson: Sure.

Alicia Morgans: Because that I thought was very eye-opening.

David Penson: Sure. So the example I used was sunitinib, and I don't want to pick on a particular drug, the reason I chose sunitinib was because the median duration of use according to studies is one year. And Medicare resets once a year, so it is a nice round example. But when you look at it and you say, "Even in 2020 where we've closed the donut hole, patients in the very first month are going to go right through the donut hole." So, they're laying out 300 bucks upfront, then they're paying 25% copay up to about $2,700, now they're in the "donut hole," which was reduced from 100% to 25%, and that stays until $4,700. They're still not out of January when they're on these expensive agents. Now they got the rest of the year, only 5%. Well, it sounds great on the surface, right? I only have to pay 5% of the drug. But when the drug is $13,000 a month, it adds up.

So even with good Part D coverage, these patients are having to front $9,000 a year roughly to pay for that drug. So you say, "Well, okay, it' a great drug," and it certainly is. But $9,000 on the median annual household income in the United States pre-tax is $63,000 is a big chunk of change, it's 15% of the income. And that's for one drug. It doesn't include the doctor visits, the lab visits, other drugs, et cetera.

So I mean, it's really shocking when you look into it and most doctors don't think about it. I mean, honestly, I've only started thinking about this in the last six months to a year. As you know, I see a lot of prostate cancer patients. When I'm writing enzalutamide, abiraterone, apalutamide, whichever drug it is, I'm not thinking, "All right, well they have insurance so it's going to be covered." Even with the copay, it's still going to be a lot of money for these patients.

Alicia Morgans: So thank goodness in GU and urologic oncology, we often have access to patient copay assistance programs because for these medications, which are life-saving for these patients or life-prolonging at least, without them I don't know that they would be possible. So, that is something at least.

David Penson: That is absolutely something and I think it's great that the pharmaceutical companies do it and other foundations do it and it's absolutely critical. One of the things that we need to do as providers is that we need to be aware of it, so that way we can tell patients this is available to you. And I think a lot of urologists, but I think docs in general, just don't know it's out there and it's critical that we're aware of it so we can tell a patient, "Make this call, I'll fill out this form for you," and we can help them out.

Alicia Morgans: Absolutely. And in opportunities where we have a choice, there are some drugs that cost more than others, and that may actually be important to our patients, and so it's important for us to engage around those issues.

David Penson: Yes, absolutely. I think that one of the things that we don't take into account when we're choosing therapies is cost. And I mean, let's use the STAMPEDE data. When you're looking at months and months of abiraterone versus a relatively short cost of docetaxel, yes, it costs the system less for the chemotherapy, but it probably costs the patient less, too. And for some patients, they may prefer the cytotoxic agent and the reduction of financial toxicity as opposed to the avoidance of the cytotoxic agent, which a lot of patients, as you know, want to avoid with having this large copay that they have to cover for a number of months to years.

Alicia Morgans: Absolutely. I think it's important for us to think about, as physicians, that all of these issues, all of the stress, actually does cause biologic effects. Cortisol goes up, cancer control could be impaired, other things could be impaired. Co-morbidities could be worsened because of the stress that we cause our patients.

David Penson: Oh, I think you're absolutely spot on. There is data out there that backs you up on that. We know that there's data tying financial toxicity to other elements of quality of life and there are physical elements of quality of life. In prostate cancer, for example, it's been shown to have financial toxicity associated with worse outcomes in urinary balance, sexual function, which is surprising to me. But when you really think about it, actually it's not that surprising at all. And Scott Ramsey a bunch of years ago looked across all cancers and basically showed that if a patient declared bankruptcy, a cancer patient declared bankruptcy, they were significantly more likely to experience mortality in that same five-year period. It is something biological, it's environmental as well for sure, but I think you're right, there's a biological component because patients are worrying and that affects hormone levels in their body.

Alicia Morgans: Absolutely. So as you think about this topic, and I sincerely appreciate your knowledge and your passion around this in educating us, how do you think we can take steps forward and try to do something about it?

David Penson: Well, let me start by saying the definitive solutions are probably political. Healthcare costs money and there needs to be a change in the way we look at things in state government and federal government. But to say we can't do anything until that occurs as a cop out in my opinion. There are a lot of things that clinicians can do and there are resources that we don't leverage. The first step, to steal a line from Alcoholics Anonymous, is admitting that there's a problem. And I think a lot of doctors, they don't want to talk about cost, but we have to. And then what can we do after that? Well, the first thing is talking to the patient and letting them know there are resources available. Ballparking costs is immensely helpful to patients and showing them where resources are. If you're practicing in a large institution, you probably have real resources available to you. If you're in a smaller practice, you can always, as we talked about before, talk to companies, talk about assistance, get an idea of what it's going to cost.

The other thing I think docs need to do is we need to think long and hard about the tests we're ordering and the drugs were ordering. As you alluded to before, sometimes there are multiple choices and we have to consider cost, but sometimes we order things that are, as I would call it, discretionary, or that are off-label that have been shown to have a small benefit in terms of some proxy outcome around survival. Do we really want to do that if it's going to cost the patient five figures over a year or two? Is it really worth it to the patient? And so I think we have to start thinking about that. I'm not saying we shouldn't do it, I'm saying we need to lay it out to the patient and let him or her decide if that's the direction they want to go into. It's really an extension of shared decision making, which we're all about right now. This is just another domain that we have to consider.

Alicia Morgans: Absolutely. Well, I sincerely appreciate your expertise and I appreciate your vision for a path forward. And I hope that next time that we talk we can talk about the progress that has been made in this arena. So thank you so much for your time.

David Penson: Thank you for having me.