Retiring ASCO Chief Medical Officer Dr. Richard L Schilsky gives a far-reaching interview with ASCO in Action podcast host ASCO CEO Dr. Clifford A. Hudis, who examines Dr. Schilsky’s trailblazing medical career, his leadership in ASCO and indelible mark on its research enterprise, and what he sees for the future of oncology. ASCO’s first-ever Chief Medical Officer even offers some friendly advice for Dr Julie Gralow, who starts as ASCO’s next CMO on February 15, 2021. In a touching tribute, Dr. Hudis also shares what Dr. Schilsky’s friendship and mentorship has meant to him personally, and suggests that Rich will still be supporting ASCO on critical priorities moving forward. Don’t miss this exchange with one of oncology’s greats!

Transcript

DISCLAIMER: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

CLIFFORD HUDIS: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org.

The ASCO in Action podcast is a series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer. My name is Dr. Clifford Hudis. And I'm the CEO of ASCO and the host of the ASCO in Action podcast series.

For today's podcast, I am especially pleased to have as my guest my friend, colleague, and mentor Dr. Richard Schilsky, ASCO's chief medical officer. Now, I am sure that many of our listeners have already heard that Dr. Schilsky will be leaving ASCO in February of 2021, retiring.

However, I want to reassure everybody that even in retirement, he will continue to make contributions and provide leadership to all of us. And his illustrious and path-blazing career in oncology spanning more than four decades is not quite over thankfully.

Rich is ASCO's first chief medical officer. And as such, he has made a truly indelible mark on all of us. He started with a proverbial blank piece of paper. The position had no precedent. It had no budget. It had no staff.

But now after just eight years in the role, he has helped make the CMO a critically important position at the society. And I have to say that success is more than anything due to Rich's vision and his leadership. And that's some of what we'll be talking about today.

So Rich, thank you very much for joining me today for what I hope is going to be a great casual but informative conversation about your amazing career, your unique role at ASCO, and maybe most importantly in the end what you see for the future of oncology not just in the United States, but around the world. Thanks for coming on, Rich.

RICHARD SCHILSKY: Thanks, Cliff. It's great to be here today.

CLIFFORD HUDIS: So with that, let's just dive right in and start at the very beginning. Rich, tell everybody why you decided to become an oncologist and maybe share a little bit about what those early days looked like for you and, in that context, what it was like to have cancer at the beginning of your career.

RICHARD SCHILSKY: Well, I knew from an early age that I wanted to be a doctor. And in fact, I had written a little essay when I was in sixth grade as a homework assignment called My Ambition. And my mother had tucked that away in a scrapbook. And I found it a number of years ago. And on rereading it, it was quite amazing to me to see what I was thinking about even then.

Because I said not only did I want to be a doctor, but I didn't think that was enough, that I wanted to be a medical researcher because I wanted to discover new information that would help people heal from whatever their diseases might be.

And so it was never really any doubt in my mind that I would be a physician. I went to medical school at the University of Chicago. But I was living in New York City at the time having grown up in Manhattan. And the only year we had off in medical school, the only time we had off in medical school, was the summer between the end of the first year and the beginning of the second year.

So during that time, I went back to Manhattan. And I was able to get a fellowship from the American College of Radiology that allowed me to essentially hang out in the radiation therapy department at New York University Medical Center, which was within walking distance of where I grew up. And so I would go over there every day. And I was taken under the wing of a young radiation oncologist.

And of course, I wasn't really qualified to do anything at that point except to follow him around, talk and listen to the patients. But that turned out to be a really formative experience for me because we saw the whole gamut of cancer. We saw head and neck cancers. We saw lung cancer. We saw patients with breast cancer and prostate cancer.

And in those years-- this is the early 1970s-- many of these patients have fairly locally far advanced disease and were quite debilitated by it. But listening to their stories, hearing about their hopes and their struggles, really demonstrated to me the human side of cancer.

So I went back to school and thought about this in the context of my own personal experience, which dated back to when I was in college when my mother's mother, my maternal grandmother, was diagnosed with breast cancer. This was 1968. And as you well know, there were very few therapies available for breast cancer in the late 1960s, mostly hormone therapies.

And my grandmother had the treatment that was considered standard of care at that time, which was extended radical mastectomy followed by chest wall radiation. And some years after that first mastectomy, she had a breast cancer that developed in the opposite breast and had a second extended radical mastectomy and chest wall radiation. And these were very traumatic and disfiguring procedures for her to go through.

Anyway, long story short is after another few years, she developed bone metastases and then brain metastases. And there was really very little that could be done for her other than hormone therapies. And having observed her go through that illness and realizing how limited our treatment options were and then having the experience after my first year in medical school pretty well cemented for me that I wanted to be an oncologist.

I thought actually about being a radiation oncologist. But then I did my internal medicine rotation in medical school, fell in love with internal medicine. And that sort of put me on the path to be a medical oncologist.

The clinical challenge of caring for cancer patients, the emotional attachment to those patients, and, of course, even then, the unfolding biology of cancer was so intellectually captivating that I actually applied for oncology fellowship when I was a senior medical student. So even before going off to do my medical residency, I had already been accepted as a clinical associate at the National Cancer Institute to start two years hence. And that's how I became an oncologist.

CLIFFORD HUDIS: So it's so interesting. Because, of course, the story I'm sure for many people interested not just in oncology, but even medical education, there are little things that don't happen nowadays that happened with you like that last little vignette about the early acceptance into an advanced training program before your fellowship among other things.

Can you remind us about the timeline? Because I think one of the things that many of our listeners often can lose sight of is just how new oncology really is as a specialty. ASCO itself founded in 1964. And the first medical oncology boards were mid-'70s, right? So you were in med school just before that second landmark, right?

RICHARD SCHILSKY: That's right. I graduated from medical school in 1975. I started my oncology fellowship in 1977. And I got board-certified in medical oncology and joined ASCO in 1980. And so that was the time frame at that point.

CLIFFORD HUDIS: So the internal medicine was actually, if I heard you right, just two years, not the now traditional four.

RICHARD SCHILSKY: Yeah. I was a short tracker. I did only two years of internal medicine training rather than three. I did my training at Parkland Hospital and University of Texas Southwestern in Dallas with at that time a legendary chair of medicine, Don Seldin, who I had to get permission from him to leave the program prior to completing the third year of residency because I had already been accepted into fellowship at NCI.

And he, Seldin, who was a brilliant chairman and a brilliant nephrologist, was not at all interested in cancer. And it took a bit of-- I was going to say arm twisting, but it really took bleeding on my part to get him to agree to allow me to leave the residency program to go to the NCI. But he eventually agreed.

And in those years, the first-year clinical fellowship at the NCI was like being an intern all over again. There were about 15 of us. We were on call overnight in the clinical center once every two weeks. We cared for all of our inpatients as well as had a cadre of outpatients.

We did all of our own procedures. We had no intensive care unit. So patients who were sick enough to require ventilator support, we cared on the floor in the inpatient service on our own with guidance from senior oncologists. It was a bit different from the way it is now. But, of course, it was fantastic on-the-job training because we just learned a ton and had to learn it very quickly.

CLIFFORD HUDIS: So that's actually a great segue to the advances because there was a lot to learn then. But, wow, there's a lot more to learn, I think, now. And I have real sympathy for trainees and younger oncologists for the breadth of what they need to learn. Again, just testing your memory, but platinum came along pretty much in the mid-'70s as well, right? That was a pivotal expansion of the armamentarium for us.

So what do you see-- when you summarize progress in cancer research and care over these decades, what do you think are the most pivotal or revolutionary milestones that you identify over the span of your career?

RICHARD SCHILSKY: Yeah. It's really interesting to think about it historically. There were the early years of discovery in oncology from the 1950s to the 1970s when we really had the introduction of the first chemotherapy drugs and the miraculous observation that people with advanced cancer could actually obtain a remission and, in some cases, a complete remission with chemotherapy and combination chemotherapy in particular.

And so that was the formative years of oncology as a medical specialty and really proof of concept that cancer could be controlled with drugs. When we got into the 1980s, the 1980s in many respects were the doldrums of progress in clinical oncology. There really was not a lot of innovation in the clinic.

But what was happening and what was invisible to many of us, of course, was that was the decade of discovery of the fundamental biology of cancer. That's when oncogenes were discovered, when tumor suppressor genes were discovered, when it became clear that cancer was really a genetic disease. And that is what transformed the field and put us on the path to targeted therapy and precision medicine as we think of it today.

So I think that clearly understanding the biology of cancer as we do now and all that it took to lead us to that point, which was a combination of understanding biology, developing appropriate technology that would, for example, enable the sequencing of the human genome and then the cancer genome.

And the other formative technology in my opinion that really changed the way we care for cancer patients was the introduction of CT scanning. When I was still a fellow at the NCI, we did not have a CT scanner. If we needed to get detailed imaging of a patient, we did tomography. And if you remember what tomograms looked like, they were really blurry images that you could get some depth perception about what was going on in the patient's chest or abdomen. But they really weren't very precise.

When CT scanning came along, it really revolutionized our ability to evaluate patients, assess the extent of disease, stage them in a much more precise way, which then allowed for better patient selection for curative surgery, better radiation therapy planning. So we don't often point to imaging advances as some of the transformative things that paved the way in oncology, but I think imaging is really overlooked to some extent.

So I think the technology advances, the biological advances, are the things that really allowed the field to move forward very quickly. And by the time we got into the mid-1990s, we were beginning to see the introduction of the targeted therapies that have now become commonplace today.

And then it was around 2000, I think, that we saw the introduction of Gleevec. And I'm reminded always about an editorial written by Dan Longo in The New England Journal a few years ago. And Dan and I were fellows together. We worked side by side on the wards at the clinical center and became very good friends.

And Dan in his role as a deputy editor of The New England Journal wrote an editorial a few years ago that was titled "Gleevec Changed Everything." And Gleevec did change everything. It changed our entire perception of what were the drivers of cancer and how we might be able to control cancer very effectively and potentially put it into long-term remission.

Now, of course, we know now that the whole Gleevec story is more of an exception than a rule in targeted therapy. And, of course, we know that tumors become resistant to targeted therapies. But we couldn't have known any of this back in the early years of oncology because we had no real insight into what caused cancer to grow or progress. And the notion of drug resistance, while we realized that it occurred, we had no idea what the mechanisms were. So it's such a different landscape now than what it used to be. It's quite remarkable.

CLIFFORD HUDIS: So as you tell the story, there's, of course, a lot of focus on technology, whether it's biology and understanding the key features of malignancy or imaging or more. But what I also note in your story and I want to come back to is the people. And I can't help but reflect on where we are in this moment of the COVID-19 pandemic. Yes, we've moved to telemedicine. Everything can be accomplished via technology. And, yet, the human touch is so important.

When we think about being in the room with people, when we think about face to face from the context of career development and your own career, you touched on Dr. Seldin, I think, already from the perspective of internal medicine training. But are there are other mentors or important shapers of your career that you think we should know about?

RICHARD SCHILSKY: Well, probably, the most influential person early in my career in medical school was John Altman. John, you may know, was the inaugural director of the University of Chicago's NCI-designated Cancer Center, which was one of the very first NCI-designated cancer centers in 1973 after the National Cancer Act of 1971 created the cancer centers program.

And John, who was a leading oncologist studying Hodgkin and non-Hodgkin's lymphoma, was a faculty member there. He was the director of our cancer center as I said. He took me under his wing even when I was in medical school and served as a real role model and mentor to me.

When I was in my internal medicine training as I mentioned earlier, Don Seldin, the chair of medicine, was never particularly interested in oncology. So, to some extent, I didn't have-- I had great internal medicine training. But I did not have good mentorship in oncology. When I got to the NCI, then my whole world really opened up.

And the two pivotal people there in my career were Bob Young, who was chief of the medicine branch and was my clinical mentor and remains a mentor and friend to this day, and then, of course, Bruce Chabner, who was the chief of the clinical pharmacology branch.

And in my second year of fellowship when we all went into the laboratory, I went into Bruce's lab. And that's where I really got interested in the mechanism of action of anti-cancer drugs and ultimately in drug development and early phase clinical trials. And both Bob and Bruce remain very close to me even today.

CLIFFORD HUDIS: So I'm concerned about time on our call today on our discussion. Because we could obviously fill lots of hours on all of these remarkable experiences and amazing people you worked with. But I'm going to ask that we fast forward a little bit.

You and I share, I think, passion and love for ASCO. So I think that it's reasonable for us to focus a little bit on that for the time we have left here. You didn't start out obviously as chief medical officer at ASCO. But you were a really active ASCO volunteer and leader. Maybe tell us a little bit about some of the ASCO volunteer roles that you engaged in and what that meant to you at the time and how that led to this role.

RICHARD SCHILSKY: Well, I'll be brief. I joined ASCO in 1980 at the first moment that I was eligible to join ASCO. I had attended my first ASCO meeting the year before, 1979, when I was still in my fellowship training. And it was clear to me even then when the whole annual meeting was about 2,500 people in two ballrooms in a hotel in New Orleans that that was a community of scholars and physicians that I wanted to be a part of.

And so, over the years, I did what people do even today. I volunteered to participate in whatever ASCO activity I could get involved with. Over the years-- I think I counted it up not too long ago-- I think I served or chaired 10 different ASCO committees, more often serving as a member, but in a number of those committees also serving as the chair over many years.

And as I became more deeply involved in ASCO and saw other opportunities to engage, I had the opportunity to run for election to the board and was-- after a couple of tries was elected to serve on the board and then eventually elected to serve as ASCO president in 2008-2009.

But the attraction of ASCO in many ways was a community of diverse but, in many ways, like-minded people, people who had similar passion and drive and focus. But I think what you get at ASCO in many ways is the wonderful diversity of our field. If you work in a single institution for much of your career as I did and as you did, you get to know that institution pretty well. You get to know its perspectives and its biases and its strengths and its weaknesses.

But there's a whole world of oncology out there. And you can get exposed to that at ASCO because you meet and work with colleagues from every clinical setting, every research setting, people who have remarkable skills and interests and passions. And it's just a wonderful environment to help develop your career. So I consider myself to be extremely fortunate to have had the journey in ASCO that I've had culminating, of course, with ultimately my coming on the staff as ASCO's first chief medical officer.

CLIFFORD HUDIS: We often joke about that blank sheet of paper. But in retrospect, it's very obvious that you had built up that collection of LEGO blocks, and then you assembled them all into the ASCO Research Enterprise, a name you gave it.

And it really, in retrospect, builds, I think, very cleanly upon all of your prior experience, but also the vision that you developed based on that experience for how research should be conducted. Can you maybe share with everybody the scope and vision for the ASCO Research Enterprise, what the intent was, and where you see it going, and what it includes today?

RICHARD SCHILSKY: Sure. I won't claim that I came to ASCO with the whole thing fully developed in my mind. As you said, when I came, I literally did have a blank slate. Allen Lichter, who hired me, said, come on board and help me make ASCO better. And so I, in a sense, reverted to what I knew best how to do, which was clinical research.

And having in my career been a cancer center director, a hem-onc division chief, a cooperative group chair, I had a lot of experience to draw on. And it was obvious to me that ASCO was fundamentally an organization that took in information from various sources, evaluated it, vetted it, collated it, and then disseminated it through our various channels, most notably our meetings and our journals.

But ASCO itself did not contribute to the research enterprise. And that seemed to me to be a lost opportunity. We knew that ASCO had lots of data assets that could be of interest to our members and to the broader cancer community. But they were scattered all around the organization and not particularly well annotated or organized. So we began to collate those. And they are now available to ASCO members on the ASCO data library.

I recognized that we did not have an organized unit in ASCO to support or facilitate or conduct research. So, in 2017, we formed the Center for Research and Analytics and brought together staff who were already working at ASCO but scattered in different departments but all people who had an interest in clinical research or research policy and brought them into this new unit, which has really become the focal point for research work at ASCO.

We recognized that ASCO members for many years were interested in surveying their colleagues, surveying other ASCO members, to help advance research questions. But ASCO actually had a policy that prohibited that.

So that never really made good sense to me. It seemed like a lost opportunity. And we were able to create a program and have the ASCO board approve it whereby any ASCO member could opt in to participate in what we now call the Research Survey Pool.

And in doing so, they are essentially agreeing to participate in research surveys conducted by their colleagues. So that program is now up and running. There are, I think, eight surveys that have been completed or are currently in the field. And this is now a service that ASCO provides through CENTRA to its members to enable them to survey their colleagues for research purposes.

Most importantly, I think we saw an opportunity back in 2014 or 2015 to begin to learn from what our colleagues were doing in clinical practice as they began to deploy precision medicine. And there was a lot of genomic profiling that was going on at that time. It was revealing actionable alterations in roughly 30% or so of the tumors that were profiled.

But there was a lot of difficulty in doctors and patients obtaining the drugs that were thought to be appropriate to treat the cancer at that particular time because most of those drugs would have to be prescribed off label. And there was not a sufficient evidence base to get them reimbursed. And, moreover, even if they could be reimbursed, there was no organized way to collect the patient outcomes and learn from their experiences.

So that led to us developing ASCO's first prospective clinical trial, TAPUR, which really solves both of those problems. Through the participation of the eight pharmaceutical companies that are engaged with us in the study, we are providing-- at one point, it was up to 19 different treatments free of charge to patients.

These are all marketed drugs but used outside of their FDA-approved indications. And we were collecting data on the patients, the genomic profile of cancer, the treatment they received, and their outcomes in a highly organized way.

And so now this is a study that we launched in 2016. We're now almost to 2021. We have more than 3,000 patients who have been registered on the study, meaning consented to participate, more than 2,000 who have been treated on the study. And we are churning out results as quickly as we can about which drugs are used or not useful in the off-label setting for patients whose tumors have a specific genomic profile.

So we built all this infrastructure. And having this in place has also then allowed us to respond rapidly to unmet needs. So when the COVID-19 pandemic overwhelmed all of us, and when our members were looking for information about what was the impact of COVID-19 on their patients, one of the things we were able to do because we had CENTRA, because we had a skilled staff and an infrastructure, was to very quickly stand up the ASCO COVID-19 registry, which we launched in April of this year.

And there are now about 1,000 patients who've enrolled in the registry from around 60 practices that are participating. And we will follow these patients now longitudinally and learn from their experiences what has been the impact of the COVID-19 illness on them and their outcomes, how has it disrupted their cancer care, and ultimately how that impacts their overall cancer treatment outcomes.

So as I now contemplate leaving ASCO after eight years having started with a blank slate, I'm very proud of the fact that I think I'm leaving us with a remarkable infrastructure. We now have a clinical trials network of 124 sites around the country participating in TAPUR that we never had before. We have through the work of CancerLinQ a real-world evidence data generator that is beginning to churn out valuable insights.

We have a capacity to survey ASCO members for research purposes. We have an ability to stand up prospective observational registries to gather information longitudinally about patients and their outcomes. We have a core facility in CENTRA with highly skilled data analysts and statisticians that can support these various research activities.

So ASCO is now primed, I think, to really contribute in a very meaningful way to the gaps in knowledge that will forever exist in oncology just because of the complexity of all the diseases we call cancer. And that's what I mean by the ASCO Research Enterprise. It is in fact remarkable and, I think, powerful enterprise if we continue to use it effectively.

CLIFFORD HUDIS: Well, that's an interesting segue to my next thought, which is really about what comes next. I'll talk about you. But let's start with ASCO first. Your successor, Dr. Julie Gralow, obviously has been announced publicly. She's an accomplished clinician and researcher. She has a known recognized passion for patients, patient advocacy, clinical research through her leadership at SWOG but also health care equity and global oncology.

So from your perspective, having created all of these assets and resources, what advice would you give Dr. Gralow publicly on how to make the position hers, what to take us to next? And I do want to acknowledge for everybody listening that the hints I've been making up until now are that Rich has agreed that he will continue to contribute as a leader to TAPUR for the short term, at least, at least the next year helping Julie get fully oriented to this program and others. So what will your advice be to Julie?

RICHARD SCHILSKY: That's a great question. She's a great selection. And congratulations on hiring her. I think there are two key issues, I think, maybe three. One is to have a broad scope and cast a wide net. Oncology care and cancer research and cancer biology are incredibly complicated and nuanced and broad in scope.

And although Julie is an accomplished breast cancer clinician and researcher, in this role at ASCO, you have to be very broad. You have to understand all of cancer care, all of cancer research, all of policy and advocacy not as an expert in necessarily in any one aspect of ASCO's work, but you have to understand the impact of all of those things on cancer care providers and on cancer patients.

And it's important to always be looking to the future. The future is going to be here before you know it. And we as a professional society have to prepare our members for that future. So that leads me to the second point, which is listen to the members.

The members are the people on the front lines who are delivering care to patients every day. And, fundamentally, ASCO's job is to be sure that our members have all the tools and knowledge and resources that they need to deliver the highest quality care to patients every day. So listening to what they need, what their struggles are, what their burdens are, is extremely important.

And then the third thing I would recommend to her is that she get to know the staff and colleagues that she'll be working with. ASCO has a remarkably accomplished, skilled, motivated, passionate staff, many of whom have been with the organization for years, if not decades, who understand what ASCO can and cannot do and who understand what our members need. And she will be well advised to spend a good portion of her first few months on the job just listening and learning from her colleagues.

CLIFFORD HUDIS: That's always good advice for anybody making a big career move. But, of course, the wisdom you bring to it is palpable and much appreciated. And I'm sure Julie will be taking your advice. And, by the way, so will I continue to do that even after you make your move. So speaking of your retirement, can you share with us a little bit about what it's actually going to look like for you? Is it about family? Or are you still going to have some professional engagement? Again, I suggest that there might be some already, but maybe you could expand on it.

RICHARD SCHILSKY: Yeah. I'm still fully focused on my work at ASCO. And, of course, as you know, when I wake up on February 15, I will no longer be ASCO's chief medical officer. And it's going to be a bit of a rude awakening. Fortunately, I will be able to continue my engagement with ASCO through the TAPUR study as you mentioned. I will, of course, forever be at ASCO member and a donor to Conquer Cancer and be willing to serve the society in any way.

I have a number of activities that I've been involved with even throughout my time at ASCO. Not-for-profit boards, for example-- I'm on the board of directors of Friends of Cancer Research. I'm on the board of directors for the Reagan-Udall Foundation for FDA.

I plan to continue with those activities as long as they'll have me. I've been serving the last few years on the board also of the EORTC, the large European cooperative clinical research group. And I expect to continue in that role.

Beyond that, I will see what opportunities come my way. I think one of the things about retirement if you will that I'm looking forward to is the opportunity to pick and choose what to work on based on what interests me without having the burdens of having a full-time job.

On the personal front, of course, we're all looking forward to crawling out from the pandemic. I've basically been locked in my home outside Chicago since March. And I'm looking forward to getting back out to a little bit of a social life. As you know, I have two grown daughters and now three grandchildren, two of whom are in Atlanta, one of whom is near by us in the Chicago area. So looking forward to spending time with them as well.

So it will be a change for me to be sure after working as hard as-- I feel like I've worked for really now 45 years since I graduated from medical school. But I also feel like I'm not quite done yet and that I still have ways in which I can contribute. I just feel like at this point, maybe it's time for me to choose how I want to make those contributions and spend a little bit more time doing some other things.

CLIFFORD HUDIS: Well, both you and my predecessor, Allen Lichter, are modeling something, have modeled something, that I think is not often discussed but can be very important. For people and for institutions, change is not a bad thing. And setting the expectation that you will pour your heart and soul into something but not necessarily do it alone or forever and not prevent others from taking that role at some point, that's a really-- I think it's a selfless kind of sacrifice in a way.

Because, of course, you could stay and do what you're doing for longer. But as you and I have discussed, there is a value for all of us collectively in having fresh eyes and new people take organizations in a new direction. That's how I ended up here frankly. And I think that's the kind of opportunity you're creating right now, something that should be celebrated in my opinion.

RICHARD SCHILSKY: Well, thanks. And I couldn't agree more. When I look back at the arc of my career and having all the different kinds of leadership roles that I've had, I basically have made a job change every 8 to 10 years. I was the director of our cancer center for nearly 10 years. I was associate dean for clinical research at the University of Chicago for eight years, another position that I created from a blank slate at that institution.

The exception was serving 15 years as a CALGB group chair. But that was a position I really loved and enjoyed and felt like at the end of the first 10 I hadn't quite accomplished everything I wanted to accomplish.

But the point is that I think it is both necessary for organizations to have regular leadership change. And it's also refreshing for us as individuals. There gets to a point where you feel like you can do your job in your sleep. And I actually think that's a good time to make a change.

Because if that's the way you feel, you're not being sufficiently challenged. And you're probably not being sufficiently creative. And so it's a good time to move on and refresh your own activities and give your organization a chance to bring in someone to hopefully build on whatever you've created and bring it to the next level.

CLIFFORD HUDIS: Well, I agree with all that, although I think your comment there about doing the job in your sleep would not apply because I'm pretty confident that the environment and opportunities have continued to evolve in a way that has made it interesting from beginning to end. But you don't have to rebut me on that. I just want to thank you very, very much, Rich.

As we set up this podcast, I expected that we would have a really fun and enlightening conversation. And, of course, you did not disappoint. We could talk for much, much longer if we only had the time.

On a personal note to you and for the benefit of our listeners, I want to share that Rich has been for me a remarkable friend and mentor and colleague. I first met Rich at the very beginning of my career when my mentor, Larry Norton, pushed me out from Memorial into the larger world. And he did that first and primarily through ASCO and the Cancer and Leukemia Group. Those are really the two places where I was exposed to the world.

And through the CALGB, Rich really began to offer me and others, many others, opportunities that shaped careers plural, mine and others. So when I got to ASCO as CEO, Rich was there. And I knew I could always depend on you to be clearheaded, intellectually precise, constructive, visionary. And the thing about you, Rich, is that you never would say yes to anything unless you knew for sure you could do it and indeed, I think, how you could do it.

I always share this story which your staff at CENTRA pointed out to me. And I have to admit that I hadn't picked it up myself. But in all the years of now working down the hall from Rich, probably hundreds and hundreds of hours of meetings, he never has taken a note in front of me. And, yet, everything we talk about, every action item we conclude to pursue, they all get done.

So I don't know, Rich. You have a remarkable way of organizing your thoughts and your plans, keeping it together, and getting things done. And I'm going to miss that tremendously in the years ahead.

So, Rich, I want to say congratulations. Congratulations on reaching this really important milestone in your life. Thank you on behalf of ASCO and the broader oncology community and the patients we care for and their families for making the world a better place. And just as a small thing, thank you for joining me today for this ASCO in Action podcast.

RICHARD SCHILSKY: Thank you, Cliff. It's been great.

CLIFFORD HUDIS: And, for all of you, if you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. And, while you're there, be sure to subscribe so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org. Until next time, thank you for listening to this ASCO in Action podcast.

In the latest ASCO in Action podcast, ASCO CEO Dr. Clifford A. Hudis shares a quick preview of what's to come for the 2020 ASCO Advocacy Summit and Week of Action, which will take place September 14-18.

Typically, ASCO volunteers from across the country gather in Washington, D.C. to advocate for policies that will improve access to high-quality, equitable care for people with cancer and ensure robust funding for cancer research through in-person meetings with their Members of Congress. Due to the COVID-19 pandemic, the 2020 ASCO Advocacy Summit will be a virtual event, but participants can expect the same important advocacy and education opportunities that the event provides every year. All ASCO members are encouraged to participate in the Congressional Week of Action by signing up with the ACT Network (through the Advocacy Center on ASCO.org).

Subscribe to the ASCO in Action podcast through iTunes and Google Play.

Transcript

Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Dr. Clifford Hudis: Welcome to the ASCO in Action Podcast, brought to you by the ASCO Podcast Network, a collection of 9 programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all of the shows, including this one, at “Podcast dot ASCO dot org” (podcast.asco.org)

The ASCO in Action Podcast is ASCO’s podcast series that explores the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for—people with cancer.

I’m Dr. Clifford Hudis, CEO of ASCO and the host of the ASCO in Action podcast series. For this podcast, I wanted to share with listeners a preview of the 2020 ASCO Advocacy Summit and Week of Action taking place September 14-18.

Typically, ASCO gathers volunteer advocates in Washington, D.C., in September for education sessions and in-person meetings with their Members of Congress.

Due to the COVID-19 pandemic—like so many events scheduled to take place this year—the 2020 ASCO Advocacy Summit will be a virtual event, but that said, participants can expect the same advocacy and education opportunities that the event provides every year.

ASCO volunteers will meet with Members of Congress and their staff by phone or video to advocate for policies that will improve access to high-quality, equitable care for people with cancer and ensure robust funding for cancer research.

Advocacy Summit attendees will also attend webinars to receive education and training on lobbying Congress and the current political landscape.

What is different this year is our online Week of Action, which will give all ASCO members an opportunity to advocate on critical issues of great importance to the cancer care delivery system in the United States.

Participants in the Week of Action will amplify the Advocacy Summit’s messages through email and social media messages to Members of Congress using ASCO’s ACT Network. And, it’s easy to get involved and make your voice heard. You just need to click on the link to the ACT Network in the Advocacy Center on ASCO.org and sign up to receive ASCO ACT Network emails. Then, you’ll get all the information on the fastest and easiest ways to contact lawmakers delivered directly to your inbox. We hope you will participate as much as you can—the effort will take just minutes. Even one message a day by every ASCO member to your representatives in Congress will have a tremendous impact.

During the virtual Advocacy Summit, which will be held in the middle of the Week of Action on September 16, ASCO volunteer advocates will have their virtual meetings with Members of Congress and their staff. The three issues or “legislative asks” that they will be discussing will be the same asks that ASCO members will contact their Members of Congress about during the Week of Action.

One, we will ask Congress to support legislation—The CLINICAL TREATMENT Act, which will give all Medicaid beneficiaries coverage of routine costs when enrolled in clinical trials—coverage Medicare and private insurance plans already provide. The importance of improving health equity has become even more apparent during the COVID-19 pandemic, and this legislation takes us one step closer to that goal.

Two, ASCO volunteer advocates will request lawmakers to co-sponsor the Safe Step Act, which will help protect patients from harmful step therapy protocols, which ASCO believes is never appropriate in the treatment of cancer.

And three, we’ll address the impact COVID-19 has had on cancer practices and research. Specifically, advocates will ask Congress to endorse maintaining reimbursement flexibilities for telehealth, as many oncology practices have rapidly transitioned to telehealth to ensure patients continued receiving treatment during the pandemic.  We’ll also be asking Congress to provide emergency funding to the National Institutes of Health to mitigate disruptions caused to labs and clinical trials by COVID-19, and to restart research across the county.

These are the same issues that participants in the Week of Action will be advocating for all week long in their outreach to Congress.

The goals of the Advocacy Summit and Week of Action are to advance priority legislation, amplify the collective voice of the cancer care community on Capitol Hill, and to get ASCO members involved in advocacy initiatives.

Members of Congress and their staff have grown accustomed to virtual constituent meetings, and personal stories continue to be the most effective form of advocacy, so the Advocacy Summit and Week of Action—even virtually—remain critical to ASCO’s larger advocacy efforts.

In addition to the meetings and messages between advocates and lawmakers, the ASCO Advocate of the Year and the Congressional Champion for Cancer Care will be named during the Advocacy Summit.

In closing today, I encourage everyone listening today to follow the Advocacy Summit through social media by way of the hashtag ASCO Advocacy Summit (#ASCOAdvocacySummit) on Twitter AND to participate in the Week of Action through the ACT Network.

A link to the ACT Network and all the information you’ll need to participate in the Week of Action is available at ASCO dot org slash ASCO Action (www.asco.org/ascoaction).

Until next time, thank you for listening to this ASCO in Action podcast and if you enjoyed what you heard today, don’t forget to give us a rating or review on Apple Podcasts or wherever you listen and while you are there, be sure to subscribe so you never miss an episode.

The ASCO in Action Podcast is just one of ASCO’s many podcasts; you can find all of the shows at “Podcast dot ASCO dot org” (podcast.asco.org).

ASCO President Lori J. Pierce, MD, FASTRO, FASCO, joins ASCO CEO Dr. Clifford A. Hudis in the latest ASCO in Action podcast to discuss how her childhood inspired her to become an oncologist and how the theme of her presidential year, “Equity: Every Patient. Every Day. Everywhere.” is more important than ever as the country responds to a healthcare pandemic that is disproportionately impacting people of color.

“Every patient, no matter who they are, deserves high-quality care and every patient has the right to equitable care,” says Dr. Pierce. “We have to get to the root causes to understand the barriers that patients face if we’re going to really make a difference, so it’s important to me that equity be front and center of everything that we do."

Subscribe to the ASCO in Action podcast through iTunes and Google Play.

Transcript 

Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. 

Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network. This is a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. 

The ASCO in Action Podcast is ASCO's series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for--people with cancer. My name is Dr. Clifford Hudis. And I'm the CEO of ASCO, as well as the host of the ASCO in Action Podcast series. 

Today I'm really pleased to be joined by Dr. Lori J. Pierce, ASCO's president for the 2020-2021 academic year. Dr. Pierce is a practicing radiation oncologist. She is a professor and vice provost for academic and faculty affairs at the University of Michigan. And she is the director of the Michigan Radiation Oncology Quality Consortium. 

Dr. Pierce, thank you so much for joining me for this podcast. My hope today is that our conversation will give our listeners a better idea of who you are, what and who has had important impact and influence over your life, and what your professional career and path as a radiation oncologist has looked like. I also hope to highlight what you hope to accomplish during your presidential year. 

Dr. Lori Pierce: Thank you, Dr. Hudis. I'm glad to join you today. Before we get started, I just want to note that I have no relevant financial relationships to disclose. 

Dr. Clifford Hudis: Now before we start to discuss the details of your presidential theme and your current role at ASCO, I think our listeners will be really interested to learn how your childhood inspired you to become a radiation oncologist. And I hasten to add ASCO staff were really excited by the stories that you shared when you gave an all staff presentation a few weeks back. So, can you talk a little bit about your childhood summers in North Carolina, how they were informative for you, and how they inspired your career? 

Dr. Lori Pierce: Sure. I'm happy to. So first of all, I'm originally from Washington D.C. But my father's family, which is quite large, is from a small town in North Carolina called Ahoskie. And that's in the north eastern part of the state, maybe about 30 minutes just beyond Virginia. And I have tons of relatives. I used to love to go visit them every summer because I would get spoiled. 

But that was in the south in the '60s. And in retrospect there was significant segregation there. And I again would have a great time going to visit my family. But I noticed--and it was something you noticed and you put in the back of your head--that when there were health care issues, there was one doc that my family could use. And he was great. Doc Weaver, he did it all. 

He was the one who would come to the homes, deliver babies, take care of all the medical issues--he did at all. And so, people just revered him because he always seemed to help people. And that stuck in my mind. That was actually when the first times that I thought about possibly becoming a physician because he always seemed to make people better. 

But then also the experience as I got older made me acutely aware that there was indeed segregation in Ahoskie and that there was inequity in care. Even Doc Weaver seemed to be a great doctor for someone--I was 5 or 6 at the time. And to my eyes, he was great. Clearly there weren't choices in terms of care. And that was my first exposure to inequity in terms of health care. 

Dr. Clifford Hudis: Well that's interesting, of course. And obviously we're going to circle back to this. But before we get to that, one of the things that I always point out to Nancy Daly--who's the CEO of Conquer Cancer--is that all roads lead through Philadelphia in medicine. You proved that true, right? 

Dr. Lori Pierce: Yes. So, I went to the University of Pennsylvania. I got my degree in engineering. I should say at that time I clearly was planning to go into medicine. But I was going to go into radiology. And so biomedical engineering was a great area to pursue. I majored in biomedical engineering and minored in chemical engineering from the University of Pennsylvania. 

And so, then I applied to Duke for medical school. I was accepted. But I decided to defer my admission. And so, I worked for a while before going into medicine. 

Dr. Clifford Hudis: Well that's interesting. And when you deferred your admission, was this because you had something you wanted to do, or you needed to essentially to save money in order to go to medical school? What did you do in that break? 

Dr. Lori Pierce: Yeah. So, it was very much the latter. My parents were absolutely wonderful people. And they focused very much on education from my sister and me--for us to go to the best possible colleges. My parents never had an opportunity to go to college. And so, they very much wanted the best colleges for my sister, Karen, and I. 

But we had a ground rule in our family. And that was that if my sister or I decided to go and pursue education beyond undergraduate degree that we would need to pay for that. And so, I knew that. And even though I was very fortunate to get quite a bit of scholarship from Duke, there was still going to be a lot that I was going to have to pay. 

And so, I made a decision, instead of taking out a lot of loans, that I was actually going to work. At that time--probably now as well--being an engineer brought a very good salary. And so, I elected to defer my admission for medical school and take the offer that gave me the most money. 

And that ended up being a job in Round Rock, Texas, which is just outside of Austin. And I have to tell you this was back in 1980. And it's not at all what Round Rock is like now. I hear Round Rock--since industry is there now--is really just a suburb of Austin. But at that time, Round Rock was a sleepy town I-35 from Austin. So, I can live in Austin and work in Round Rock. 

And it was a very interesting experience. I worked for McNeil Consumer Products. I was the second shift supervisor. And it was an interesting time because here I was fresh out of undergrad, green behind the ears, and an African-American woman, as a supervisor to people who were generally in their 40s through 60s, most of whom had never been out of the state of Texas, and you look at that and you say, oh my gosh. How did I get here? Why am I here? Why did I decide to do this? 

And you think about how different people are. But when you start to work with people, you realize that there are common threads. And you find those common denominators. And you learn that even though we may look different on the outside, there are a lot of things that are similar in the inside. 

And I think the lessons that I learned as that second shift supervisor have served me well in medicine because you can always find a common denominator with patients, even when apparently at first look, it looks like you're very, very different. So, they were very good lessons I think that I learned that I wouldn't have done had I not chosen that path. 

Dr. Clifford Hudis: So, I think that some of what you learned will no doubt pop up as we talk in greater detail now about your presidential theme. Let me just start by saying for me personally, this is one of the highlights of the year for me each year, when our president comes on board in a sense and begins to present their vision for their theme and what they hope to see us achieve over the year they serve as president. 

And it's amazing because of course the wide range of background experiences as well as aspirations that different people bring. And you certainly I think came into this with a very clear vision of equity for every patient every day everywhere. Can you expand I think--I wouldn't say speak on this because you've already begun to touch on it--but can you expand on what you were hoping to see accomplished through this theme and what motivated you to focus on it specifically in your role as ASCO president? 

Dr. Lori Pierce: A multitude of things. It's hard to really pick out one. But certainly, I think we all are acutely aware of the different outcomes for people of color. In terms of almost any industry you look at, the outcomes are less favorable, significantly so for people of color. And you look at those numbers and you know that there are reasons to explain this. 

And it's not just biology, which is what a lot of people propose. And quite often it's not biology at all, that clearly these patients are lower socioeconomic status. The majority of these patients are poor. Late diagnoses, inability to receive treatment, transportation issues--there's a whole myriad of reasons why the outcomes are different. And you look at that, and you say, every patient no matter who they are, deserves high quality care. And every patient has the right to equitable care. 

And we have to get to the root causes to understand the barriers that patients face if we're going to really make a difference. And so, it's important to me that equity be front and center in everything we do. And ASCO again has done so much. That's at the heart of ASCO, of making sure the message is there that every patient deserves high quality care. 

But I wanted to actually make equity our theme. Equity has actually never been the theme at ASCO. So, I want to actually call it out and make it our theme for the year. 

Dr. Clifford Hudis: Well the timing of course in many ways is really quite remarkable. I know a lot of people would use the word fortuitous. And the truth is that just means in a sense coincidental. But that's what it was. 

In early 2020 certainly nobody could have anticipated that we would be facing, nationally and globally, a pandemic that would so disproportionately impact people of color or that there would be a tipping point through yet another brutal crime against a black American and that this would so completely capture the nation's attention. And I have to say broad support. Can you speak a little bit more therefore about the timing of these events and your theme and why this is so important for us to act at this point? 

Dr. Lori Pierce: I think you summed it up actually very nicely. Again, the theme was chosen before the pandemic. It was just the theme that I felt was the appropriate theme at this point in ASCO. And then the pandemic happened. And we saw how it disproportionately affected those who had comorbidities, those who were the essential workers, so those people who didn't have the luxury to work from home. Often the people who had a lot of comorbidities and the ones who were most at risk for contracting the virus and subsequently dying from the virus. 

And I actually take a little bit of pride in that I'm from the state of Michigan. And Michigan was actually one of the first states that started reporting the COVID data by race and ethnicity. So, it was actually one of the first states that made the observation that there were cohorts of patients that had a significantly worse outcome. And so, the country--the world learned that people of color did more poorly with COVID. 

It's not enough to say, OK, these people do poorly with this. We then have to dissect the reasons why and provide explanations, so we get to the root of the problem. So that's COVID. And then we saw that more of the senseless deaths that we've seen in the past, but we've seen even more of as of late. 

And maybe that's because we now have cell phones. And we see things a lot more--things that have probably been going on for quite a while. We know that these have been going on, but maybe not to the degree that we know now. And we have to acknowledge there's structural racism. And so, once we acknowledge that, then the next thing is we have to initiate steps that eradicate it. And we have to initiate mandatory steps to eradicate it. 

So, then you come back to the theme--equity, every patient, every day, everywhere. And I should have said in everything that we do. We see these horrors playing out. And we can look at that and say--maybe not the pandemic, but the senseless murders--we've been here before. We've been here with the protests. We've seen all that before. And nothing has changed. 

I am cautiously optimistic that this time is different, that the world is in a different place. And this is no longer acceptable. And people are not going to look away, that they are going to stare this down. And they are going to create change. 

And so, I am I'm optimistic that this will not just be another set of deaths of poor people at the hands of police, that the world is awake now, and change will come. And so, the theme of equity is perhaps more impactful now than it ever would have been in the past. 

Dr. Clifford Hudis: I'm going to just switch gears here a little bit, and speaking from personal experience, both warn you and challenge you that the year as ASCO president goes really quickly. And given that and given the lofty ambition, is there any way that you would be able to commit to what you actually want to see get done? What box can we actually check off during this term? 

Dr. Lori Pierce: I like the way you phrased that. I think back--there was an interview that I did when I was President-elect--and someone said what do I want my legacy to be? And I pushed back on that because you can't create a legacy in a year. It goes by very, very quickly. And so, I think the question is, what do you think you can realistically accomplish in a year? 

And the answer that I gave to them is going to be similar to the answer that I give to you. And that is you want to use your time and take a great organization like ASCO and perhaps make it even greater. And I think that is a very real goal here because again, I am building on a strong foundation of a lot of what ASCO already has in place. 

Equity is at the heart of everything ASCO does. You know this. You're the CEO. You know this. And so ASCO has stood up so many programs in their various divisions that relate and are based on equity of care. But ASCO by being large and being complicated can have some of these programs in silos. And if I can help to connect the dots, if you will, and make it almost a seamless presentation of equity, that will be a major strength. 

For example, one of the things that I want to do--and people have told me I will not be successful--others have tried and were not successful--and that was to embed equity in our annual meeting. As you know what we've typically done is have sessions that are dedicated for equity, which is great. And they've been fabulous sessions and wonderful speakers. 

The problem is a lot of our members have not taken advantage of those opportunities. And it's not because people don't want to know about equity. I'm sure it's just they're trying to fit so much in a short amount of time because there's so much going on at the same time at ASCO, trying to learn all the latest therapies. And they just don't have time for the equity sessions. 

So, I get that. So, a strategy would be to embed equity in the sessions. And again, I've been told that this has been tried before and has failed. That doesn't deter me. That doesn't dissuade me from moving forward with this and being optimistic that it will succeed this time, again, because we're in a different time now. I think the world has awakened. And equity is very important. So, it is very high up on people's checklist when they go to ASCO. 

And then second, I'm the president of ASCO. So, I hope to use both of those to gently push this idea so that we really can capture more of equity in all of the sessions, or the appropriate sessions at the annual meeting. 

Dr. Clifford Hudis: Well I've got to say--speaking of connecting the dots, which was the image you used--there is one I think area of progress that's already taking shape. And that's this exciting new collaboration between ASCO and the Association of Community Cancer Centers, or ACCC. This is focusing on increasing participation of both racial and ethnic minority populations in cancer research, which to your point, is something that we have been focusing on for years. But we really need somebody to move the needle. Can you talk a little bit about this initiative and what you hope to see formed and accomplished through this? 

Dr. Lori Pierce: Sure. So, I am very happy--actually, largely thanks to you for putting Randy Oyer, who is the president of ACCC, and I in contact with one another--to set up this collaboration. So, we all know that if you look at people of color--let's say African Americans and Hispanics--and look at their participation in clinical trials, it is much lower than their representation as cancer patients. If you look at most the numbers, maybe it's around 3% to 5% of patients in the clinical trials are Hispanic or African American, whereas those two groups make up about roughly 15% of patients with cancer. So, there's clearly a disconnect in the representation of those ethnicities and races in our clinical trials. 

And so many have tried to come up with strategies to improve the enrollment. And we are working together--ACCC and ASCO--we're putting together a very robust steering committee of individuals who have thought long and hard about accrual of minorities under clinical trials. And we are sending out an RFI to request ideas from people in ASCO and ACCC who also have been thinking long and hard about this issue for their strategies--their suggestions for strategies for how we can improve accrual. 

And then the steering committee will review what we take in as well as our own thoughts and then try one or two of these strategies within TAPUR. As you know TAPUR is the trial with an ASCO. TAPUR is completely run by ASCO. So, we have the flexibility to be able to try out new things. It's almost like a laboratory, if you will, for new ideas. 

And if we see that there are one or two strategies that do seem to be successful in terms of increasing the uptake of minorities, these will be strategies that we can suggest to some of the cooperative groups to employ in their trial. So, it's an exciting time to use TAPUR as a laboratory to try out new strategies. And I am very grateful for the opportunity to be able to work with Randy and all of the infrastructure that ASCO has to make this a reality. So, we're working on that. 

Dr. Clifford Hudis: Well that's great. This is not to put you on the spot. And there may not be any more. But is there anything else that you want to make sure ASCO members hear or take away from this conversation? What's the one message that you think that they should receive from our conversation? 

Dr. Lori Pierce: I guess we're all in this together. The beauty of ASCO is from member engagement. We just have fabulous members in terms of their motivation to make lives better for our patients. And so, I guess I would ask if there are any additional ideas that our members have that will help us move the needle even more and even more quickly, please reach out to me. 

I would love to hear people's thoughts. We're always open for new concepts. And it takes a village. And I just would hope people would feel comfortable providing ideas for us to go forward. 

Dr. Clifford Hudis: Well that's great. Thank you, Dr. Pierce, for taking the time to speak with me today. I'm really grateful to you for this. And I'm excited as well for the year ahead, both for you and for all of us at ASCO. 

Dr. Lori Pierce: Thank you so much. 

Dr. Clifford Hudis: I want to remind listeners that you can visit asco.org to learn more about the ASCO ACCC initiative. And even better that's where you can submit ideas that will help address the issues related to longstanding barriers to diversity in cancer clinical trials. We want to hear from you. 

Until next time, thank you for listening to this ASCO in Action podcast. And if you enjoyed what you heard today, please don't forget to give us a rating or review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode. 

The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org. 

American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Piyush Srivastava, the past chair of ASCO’s Clinical Practice Committee, in the newest ASCO in Action Podcast to discuss the recently released ASCO Special Report: A Guide to Cancer Care Delivery During the COVID-19 Pandemic. Dr. Srivastava was instrumental in developing the report, which provides detailed guidance to oncology practices on the immediate and short-term steps that should be taken to protect the safety of patients and healthcare staff before resuming more routine care operations during the COVID-19 public health crisis.

Subscribe to the ASCO in Action podcast through iTunes and Google Play.

Transcript 

Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  

Dr. Clifford Hudis: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. 

This ASCO in Action podcast is ASCO's series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer. 

I'm Dr. Clifford Hudis, CEO of ASCO. And I'm the host of the ASCO in Action podcast series. I'm really pleased to be joined today by Dr. Piyush Srivastava, the past chair of ASCO's Clinical Practice Committee. Dr. Srivastava is also a practicing gastrointestinal oncologist, the regional medical director of the End of Life Options program, and the director of Outpatient Palliative Care at Kaiser Permanente Walnut Creek Medical Center in California. 

Today, we're going to talk about the recently released ASCO Special Report: A Guide to Cancer Care Delivery During The COVID-19 Pandemic. 

Dr. Srivastava was instrumental in developing the report. And we'll speak today about the guidance that the report provides for oncology practices as they return to more routine care delivery. Piyush, thank you so much for joining me today. 

Dr. Piyush Srivastava: Thank you, Dr. Hudis for taking the time to speak with me. Just before we start, I just want to say that I do not have any relationships to disclose. So, thank you. 

Dr. Clifford Hudis: Thank you very much for joining us today. Now, just to provide some context, today as we speak, we're approaching month five of the COVID-19 public health crisis in the United States. We've had more than 2.15 million confirmed cases of the virus and well over 100,000 deaths. 

In fact, as we record this today, several of the largest population states in the United States-- California, Texas, and Florida-- are just reporting their largest single-day increases in cases and the health care systems in some of their big cities are approaching the kind of near breaking point that we saw earlier in New York. So, the problem is still very much with us. 

When the outbreak began, oncology practices nationwide immediately began making operational changes designed to protect the safety of patients and the safety of staff. This meant adjusting to resource shortages that were unfolding and complying with national and state restrictions on elective procedures, among many other things. 

Today, communities across the country are in varying states of recovery. And as I just described, some of them actually are probably pausing their recovery right now. Either way, they are facing a real transition in terms of oncology practice. And some are returning to something more like routine care while continuing to be acutely attuned to protecting the health and safety of both patients and staff. 

So, Dr. Srivastava, could you start us off and tell our listeners just a little bit about what's happening in your own practice and how you have been adapting to the changing circumstances? 

Dr. Piyush Srivastava: Of course. I would be very honored to share my experiences at Kaiser Permanente in Northern California. So, at the start of the pandemic, we were very fortunate to be nicely set up to provide care remotely. We've had a very strong existing telehealth structure. So, we were quickly able to adapt to the pandemic situation. 

Initially, we nearly went 100% remote, with doing all of our new consults and chemo checks via video visits and telephone visits. If a patient needed some more attention, to be seen by a care practitioner, many times that we would coordinate with the on-call physician on site, who would see the patient on the chemotherapy infusion chair. 

We also looked as an institution which services we could provide remotely and take off site and so that we didn't need to bring the patients into the cancer center. For example, we activated our home health nursing team to be able to provide port flushes in the home setting. 

We also made a very conscientious effort to see what treatments and what procedures that we could postpone or actually decrease the frequency or increase the timing in between events. For example, bisphosphonate administration and port flushes, which we increased to do every three months. 

What was extremely eye opening and inspiring to me is a large organization such as Kaiser Permanente was extremely nimble and flexible and was able to respond to the outside pressures. I believe, when I speak to my colleagues across the country, that many people experienced the same things with their institutions. And their institutions responded very flexibly to the ongoing pandemic. 

Dr. Clifford Hudis: Thanks very much. It's really interesting, I think for me, and I'm sure for many of our listeners, to hear how you adapted but also to compare that with their own experiences. It sounds to me like some of the key features were clear eye on the safety of patients and staff but also having a structure that respected the needs of the clinicians from the beginning. And then, of course, understood that the flexibility overall was a key attribute. And I just think that's something that many people will be reflecting on. 

As we hit it from that one in a sense, forgive me, but anecdote, which is how one center, one operation adapted, I wonder if you could talk a little bit about ASCO's role in providing the more general guidance that you helped to develop. Why did this society feel it was necessary to provide guidance at that level? 

Dr. Piyush Srivastava: Yes. So, as we are all extremely aware, many individual health care professionals, institutions, and health systems look to ASCO for mentorship when it comes to oncology care. So, this current pandemic was no different. I believe ASCO felt a strong duty and a responsibility to partner with the oncology world to ensure the highest quality and efficiency of cancer care and delivery through this pandemic. 

Also, the beginning of the pandemic, there was a lack of really clear guidance from federal and state agencies. So, cancer care providers and administrators looked to ASCO to help develop their plans of providing care during the pandemic. Now, also opening and ramping up as well, they're looking to us. 

Dr. Clifford Hudis: I see. So, as we think about staff at ASCO headquarters, it's really pretty straightforward on a daily basis. Our decisions to open headquarters, for example, or not are predicated, number one, on the safety of our staff. So, when you look at the Special Report, what would you say was the one or the several overarching goals that drove the development of the Special Report? 

Dr. Piyush Srivastava: So, when constructing the report, we did very much realize that there are so many varied practices across the country, really around the world, right? For example, we have small rural practices. We have medium-sized private practices. We have academic centers, and we have hospital systems. And all these organizations look to ASCO for cancer guidance and guidance to cancer care delivery. 

By no way were we going to be able to solve individual operational care delivery issues for each practice. So, the Special Report is made to serve, if you will, as a starting point or a launching pad for individual institutions to develop their own policies and operational adjustments. 

So, what I would like to do now is maybe just dive a little bit deeper into some of the specific policies and practices that were outlined in the report. And as I look at it, it was really broken down into stages of patient care. 

So, for example, before a patient even arrives on site, many practices are in a sense pre-screening them or triaging them. What are some of the methods that you have seen put into place and that have been effective that we should recommend to practices just getting open? 

So, the Special Report lists out very clearly sequential steps to consider in safely bringing patients into cancer centers. And I'll highlight a few of them, which I feel is extremely important. The first step is to actually reach out to the patient well before their scheduled visit to the cancer center. So, if we can call these patients and family members well before their visit, we can educate them as to the process that they'll experience when they come into the cancer center. 

Allow them to ask questions and to give the reasoning behind or the why to we are doing this. I think that will go a long way. So transparent communication, I think, will reduce anxiety and fear. 

I also believe an effective second step was to do a quick check in, anywhere from 12 to 48, 72 hours prior to the actual visit, depending on what your operations would allow, just to check in to make sure that you're screening for the COVID symptoms and the patient doesn't test positive to any of those symptoms. 

I may just add also in the first step, when you reach out to the patient well before their appointment, that's also a good time to screen for COVID questions. And then a third implementation can be as a single point of entry. 

So, when a patient comes into the cancer center, there's one point of entry so that way a temperature could be checked, a patient could be screened again for those COVID symptom questions. And so that when that patient arrives inside the cancer center, there's been essentially three checks and balances of checking for COVID-19 symptoms. 

So, this provides obviously the safety to minimize the risk of bringing COVID into the cancer center. But I also think an extremely important added benefit is that the staff and providers will feel confident and safe that the institution has done these many different steps to ensure their safety as well and to minimize their risk of exposure to COVID. 

Dr. Clifford Hudis: I see. So that's one part of this. Now, the implication in all of this is the volume coming through the clinics is likely to be lower. And one of the ways in which it is controlled, of course, is through the reduction of less critical face-to-face encounters and arguably an increase in telemedicine. What are some of the considerations that you think oncology practices should factor into their use of telemedicine in care delivery? 

Dr. Piyush Srivastava: Yeah. That's actually a fantastic question, because telemedicine has really-- well, telemedicine was forced upon most institutions. And the institutions had to really find an effective way to provide care remotely. So, it's a very interesting and important topic. For example, I think one thing that I personally struggled with, and I think my institution struggled with is, who is the right patient for telemedicine? 

So, the report talks about specific patient categories that you can think of that would be easier to provide patient care remotely. So, for example, those that are not requiring in-person physical exam, those who may not actually actively be getting chemo treatment, those that don't need any in-office diagnostics. So, don't necessarily need lab work tied to that appointment or you don't necessarily need imaging exams at that moment. 

Other visits that the report recommends to think about is follow up. So, follow up could be done through telemedicine. Or those that are on oral oncolytic treatments. And so, it's a quick check in just to make sure that they're taking the medication and the adherence is high could be done by video or by phone. 

A couple of things to consider with telemedicine, obviously, is the audio and visual capabilities. And so even in the Bay Area in California, we do have spots that don't have the best reception. And so that can become problematic. So that's something to also think about. 

The other sort of counterbalance or countermeasure to this is just to make sure that patients feel that they're being taken care of and they feel satisfied. So in my own practice, I've now adopted that when we finish a video visit or we finish a telephone visit, I let the patient know that I have felt comfortable with the interaction and that I felt that I was able to accomplish the care plan and execute the care plan as needed by the video and phone. But then I ask them, do they feel comfortable and are they OK proceeding this way or do they prefer face-to-face visit. 

Dr. Clifford Hudis: Yeah. I think that's an interesting observation about telemedicine. I think everybody is feeling their way right now and learning. And we want to be careful not to go too far away from the direct physical encounter since so much can be lost without those subtle cues from body language and classic physical findings as well. Now, coming back once more to the workforce, the report addresses how we maintain a healthy workforce. 

And it specifically, I think, gets into questions of testing and scheduling and even dealing with stress. Can you walk through that a little more about antibody testing or saliva or nasal swabs and the frequency and exactly what facilities and practices should be thinking about for their staff? 

Dr. Piyush Srivastava: Sure. And this is an extremely hot topic, and the interesting thing about this topic is it can vary widely just depending on what's available at that moment in your location, what the county is ordaining and what the state is ordaining as well. So, there's a bit of variability. 

But what the Special Report does very nicely, it lays out considerations for institutions to think about when they are caring for the workforce, both physically and emotionally. So, this Special Report lays out some PPE guidelines, and really, it's based on what the CDC is recommending. 

And as we know, as one of the largest sort of scientific research-based organizations, it's important that we bring the CDC's sentiment forward when we talk about PPE, especially with PPE stewardship as this goes on for some time, we may have some issues with the supply chain. 

The other thing the Special Report calls out is to really have institutions make sure that they are putting their health care practitioners in the forefront. So, checking in with health care practitioners to make sure that they are not ill, that they're feeling OK, that they haven't been exposed to anybody outside of the medical system. And I think what's really, really special about this report is that it really talks to the practitioner's well-being. I think this is scary for any provider in the front line. 

We are also worried about our own health and what we can bring back to our loved ones outside of the medical center. But also, I think all of us as oncology providers are feeling a little disillusioned and a little saddened, because we are not able to provide oncology care like we normally have been. 

And so that's a huge adjustment for the oncology provider. And of course, that comes with some moral distress. So, the report also calls out for institutions to check in with their health care providers to make sure that their emotional well-being is good and to also make sure that they feel that their family and loved ones are safe at home. So, I think that was a really added benefit. 

Dr. Clifford Hudis: Yes. Really important to acknowledge the importance of all of that to the individuals. And it is not just about narrowly the safety of the surfaces and workspaces they're in, but really in a sense their holistic experience in life. I want to turn to the broad public approach to cancer care and focus on the corners that we cut, if you will, in going into this crisis, the compromises with old ways of doing things that we very quickly adopted. 

The report focuses on some of those immediate short-term steps that we took. And I think looking at the effectiveness of that, I can tell you that I asked the ASCO leadership on the staff side and on the volunteer side why those adaptations couldn't just be our new permanent normal. 

That is to say, if it was safe enough to do telehealth in April of 2020, why isn't it safe enough to do it forever? So that was the nidus of our Road to Recovery Task Force. And I know you sit on the group focused on care delivery. What do you think we can expect from that effort? 

Dr. Piyush Srivastava: Yeah. And this is fantastic. I am honored to be sitting on the Road to Recovery Task Force, because I think this is an issue that's facing every oncology care provider in the country and, frankly, around the globe. And the task force is composed of a group of really active and very intelligent oncology providers who are putting their minds together collaboratively to see how we can continue to provide cancer care in an efficient and in a high-quality manner moving forward beyond the pandemic. 

And as you said very nicely, Dr. Hudis, we have gained several insights through our care over the last few months, and can we harness those insights and continue to practice oncology in a very efficient and high-quality manner? 

So, the task force is extremely comprehensive. The group is addressing several buckets, if you will, that are very pertinent to oncology care and delivery. So, they're looking at health equity. They're looking at resetting clinic and patient appointments. 

They're looking at practice operations, telemedicine, home infusion. I know that's something that we've all been grappling with. Financial assistance to practices, which is extremely important when we look at the economy around us. 

Quality reporting and measurements. So, we want to make sure-- we want to challenge ourselves to make sure that we are practicing the highest-quality cancer care that we can. Utilization management. So that's also extremely important as we are looking at the economy around us. 

Psychosocial impact on patients. So, this has been obviously extremely traumatic for patients in their very vulnerable state. The task force also is looking at provider well-being, which once again, I can't reinforce how important that is as we go back into somewhat normal operations, whatever that normal may be, but looking at the sort of stress that the providers are feeling in that. 

And then ongoing preparedness I think, which is extremely essential, because we just don't know what the virus will do over the next year and what might also come in the future. So, the task force is extremely collaborative, extremely thorough. And it is a group of very active individuals on oncology care that are bringing their brilliant minds together to come up with some guidance. 

Dr. Clifford Hudis: Well, I think that's really great. As we wrap up now, I wonder if at the highest level if there's a single or several major takeaways that you want listeners and our entire community to take away from these recommendations? 

Dr. Piyush Srivastava: Yeah. You know, I've actually had some time to reflect. It's been a very privileged experience for me to be a part of this and to be a listener and to be a learner from all these brilliant minds around me who are putting their heads together to accomplish this. I find that recommendations in the Special Report to be very thoughtful and very comprehensive. 

I do hope practices remember that these are actually guidelines to help them develop and change policies at individual institutions. I also hope that oncology practitioners and administrators remember that we're all in this together. And so, there is going to be an ever-changing environment. 

So, I hope that this report is just a start of a collaboration that can be ongoing with ASCO and with oncology providers around the world. I am fully confident that ASCO is a tremendous and a large resource for us in the oncology world to be able to accomplish collaboration and to actually uplift and maintain cancer care during and after the pandemic. 

Dr. Clifford Hudis: Well, that's really, I think, is nice and as great and complete a summary as one could hope to hear. So I want to thank you, Dr. Srivastava, for speaking with me today. I'm really grateful to you for your time on this whole initiative and the effort that you've put to it as well as, of course, for the time today. 

Dr. Piyush Srivastava: I appreciate it. It has been a great honor. And so, thank you very much to you, Dr. Hudis, and thank you very much to the ASCO staff, who do a tremendous job on a daily basis to make sure that we are doing the best we can. 

Dr. Clifford Hudis: So, the Special Report, and later, ASCO's Road to Recovery, are all part of ASCO's larger commitment to providing information, guidance, and resources that will support clinicians, the cancer care delivery team, and patients with cancer, both during the COVID-19 pandemic and then well beyond it. 

We invite listeners to participate in the ASCO survey on COVID-19 in Oncology Registry or ASCO registry. This is a project where we are collecting and then sharing insights on how the virus impacts cancer care and cancer-patient outcomes during the COVID-19 pandemic.  

We encourage all oncology practices to participate so that we will have the largest possible data set and represent the full diversity of patients and practices across the United States. 

I'll remind you that you can find all of our COVID-19 resources and much more at asco.org. And until next time, I want to thank everyone for listening to this ASCO in Action podcast. 

If you enjoyed what you heard today, please don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. And you can find all of the shows at podcast.asco.org. 

In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Jonathan Marron, incoming Chair of ASCO’s Ethics Committee and a lead author of the new Ethics and Resource Scarcity: ASCO Recommendations for the Oncology Community During the COVID-19 Pandemic. 

In this episode they discuss ASCO’s recommendations, why ASCO developed this guidance, and what patients, families, and the entire medical community need to know about allocating limited resources during the COVID-19 Pandemic.  

Subscribe to the ASCO in Action podcast through iTunes and Google Play. 

Transcript

Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content that offers enriching insights into the world of cancer care. You can find all of our shows, including this one, at podcast.asco.org. The ASCO in Action podcast is ASCO's podcast series, where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer.

My name is Dr. Clifford Hudis, and I'm the CEO of ASCO. And I'm proud to serve as the host of the ASCO in Action podcast series. Today, I'm very pleased to be joined by Dr. Jonathan Marron, incoming chair of ASCO's Ethics Committee and a lead author of ASCO's recent recommendations for the oncology community on ethically managing scarce resources during the COVID-19 pandemic.

Dr. Marron is also a bioethicist at Boston Children's Hospital, a pediatric oncologist at Dana Farber Cancer Institute, and he is on the Center for Bioethics teaching faculty at Harvard Medical School. Today, we're going to talk about those recommendations. And I'll note that they were published just recently as a special article just in early April in the Journal of Clinical Oncology. We'll focus specifically on the reasons that ASCO took this step and what it is that oncologists, patients, families, and the entire cancer care community need to know about this issue. Dr. Marron, thank you so much for joining me today.

Dr. Jonathan Marron: Thank you so much, Dr. Hudis. It's really a pleasure to be speaking with you, and an honor as well. Before we get started, I do want to just point out that I have no conflicts of interest to disclose.

Dr. Clifford Hudis: Well, that's great. Now, just to provide some context as we start this discussion, it's the middle of May as we're recording this. In the United States, the COVID-19 public health crisis bubbled up to awareness a little bit in January, became seemingly near threat in February, and seemed in the public's eye, I think, to breach our shores at the beginning to middle of March. So, we're about four months, more or less, into this public health crisis.

The US has had now about a million and a half-confirmed cases of the virus. And I think this week, we crossed the 90,000 number in terms of deaths from the virus. From the very early days, there was-- and we all remember this-- an extraordinarily emotional and widespread concern that medical resources, and especially ventilators, but also medications, as well as space, critical and intensive care beds-- those three things, that they would be stretched, that some communities would be especially hard hit, and that, as a consequence, access to those resources might be limited.

And when that arose as a concern, what followed, especially for people who work in this field, and bioethicists in general, as well as everyday clinicians, was the very real possibility that they would be forced to make some painful and difficult choices. And I'll say some of our members wrote about these experiences as well in ASCO Connection and elsewhere. So, can you now maybe help our listeners understand why ASCO in particular thought that this situation needed to be addressed and why we decided to provide the very specific guidance that you took part in creating in the form of these recommendations?

Dr. Jonathan Marron: Absolutely. So you really highlighted a couple of the main questions and concerns that we had that we wanted to do our best to address, in the sense that at the outset of the pandemic, it was really difficult to tell what direction things were going to go and just how bad everything was going to get. Seeing the experience in China and seeing the experience in Italy, there was significant concern that, as you mentioned, our health care system would not be able to support the critical care needs that we would have. There is a long history of people thinking about how to utilize and best utilize resources like this in the setting of scarcity.

One of the concerns that comes up whenever you have to make these difficult or realistically impossible choices is how you're going to do so. And so really, that's where we came, as oncologists and as the ASCO community, to try to figure out how we could best represent the oncology community and to ensure that cancer unto itself was not going to keep a given patient from having a fair chance to access these potentially lifesaving resources, even in the setting of a public health crisis like this, even in the setting of scarce resources.

Dr. Clifford Hudis: So, I remember as this was being developed having conversations with, I think, you and other members of the panel. I'm going to push a little bit on at least one of the areas that I think is really a concern but can be misunderstood. And that is this high-level statement you just made that people with-- if I understood correctly-- that people with cancer might find themselves discriminated against in these moments of triage, fundamentally. There's one ventilator. There are three patients at need. And God forbid we're ever in this situation-- how do you decide who gets it.

On the one hand, of course, there's a fairness doctrine. But on the other, there is a medical reality. And cancer is not one thing. So, could you just talk a little bit about what we mean when we say protecting the cancer patients? And let me be clear. We're not saying that cancer as a diagnosis, stage, prognosis should be ignored exactly, right?

Dr. Jonathan Marron: Absolutely. And I think what you said there really is one of the most, if not the most, important aspects here, that there are a couple of different ways that you can go about trying to take, as the example that you had of the three patients, and decide which of those three will get the ventilator. If not the perhaps fairest way would be simply to make a choice at random and say each of those three individuals has an equal chance at it, and we'll flip a coin or do some other random way of deciding who will get it. That's certainly fair.

But some people would say, you know what? They may not be equal in all ways. And if we're trying to maximize our resources and maximize the potential outcome benefits of these scarce resources, we want to do something more than just do something-- choose randomly. And we've actually learned in the past from work with community groups that people don't love the idea of randomly choosing things like this, in a public health emergency or otherwise.

And so then-- the question, then, is OK, so how are you going to make that choice. If we're trying to maximize health care outcomes, and which you usually think about that being survival, we want to use medical information. But then the question is, what is the information that should be used.

So, one of the concerns is that there could be certain disease processes, cancer or otherwise, that would be seen as exclusion criteria. That's to say, OK, we have these three patients. We have one ventilator. Patient one has cancer, so therefore we're going to not even give them a chance at that ventilator. And that's really where this comes in. That's not the way to do this. Cancer absolutely should come into the consideration. But that patient's specific cancer-- their diagnosis, their prognosis, the medical information-- the best medical information that we have, the best evidence-based medical information that we have about their specific disease so that we can make an informed decision, or at least a maximally informed decision about who is the most likely to survive if they are given access to the ventilator or ICU bed or whatever it might be.

Dr. Clifford Hudis: Yeah, I think this was one of the areas that you had to read somewhat carefully and be patient to understand the context, because if I understand correctly-- and with no disrespect to our colleagues outside of oncology-- one concern is that in the ER, a patient who once had cancer might just be, in a blanket way, discriminated against. But look, I was a breast cancer doc for 30 years. Most of my patients were, frankly, cured. And the fact that they had breast cancer in 1996 is of essentially no meaningful relevance to any medical decision, almost. I'm oversimplifying it here, rather.

But our concern, I think, was that in the front lines, under duress and pressure, that mistaken judgments might be made, and we wanted to advocate for that. Is that-- I may not have said that so elegantly. But is that-- that was one of the concerns in the other direction, right?

Dr. Jonathan Marron: Absolutely, yeah. And it's certainly conceivable that somebody, in a very well-intentioned way, would think that OK, this patient currently has cancer or at some point in the past had cancer. And as wonderful as the electronic record is, sometimes it can be difficult to tell if something is a current medical problem or a past one. But either way, simply the diagnosis of cancer is not the be-all, end-all. And there needs to be a thoughtful and ethically rigorous process by which these decisions are made. And that's what we hoped to inform with the paper and with the recommendations.

You know, it's interesting. And if I may just think of the sweep of time, I always put things in the ASCO context. So, the society was founded in '64. The medical oncology boards were in the mid-70s for the first time. The curative systemic therapies for testes cancer, for the lymphomas were a little before that, obviously, and in that general era. It is quite a testimony, when you think about it, to the advances in oncology that we're now worried that people will, in a sense, make too much in the negative direction about prognosis of a cancer diagnosis.

Dr. Clifford Hudis: And I'm thinking of the last few years, where suddenly there are tranches of survivors of melanoma and non-small-cell lung cancer and other diseases that historically had a very poor prognosis, and now they may still have, on average, a bad prognosis. But there are survivors and long-term survivors with formerly incurable diseases. They need to be protected, in a sense, from this one-size-fits-all judgment, right?

Dr. Jonathan Marron: Absolutely, yeah. And as a pediatric oncologist, I run into that every day that people assume that, oh, my gosh, children who are diagnosed with cancer, that they're dying left and right. And people are generally quite surprised to hear that we have an 85% survival rate in children with cancer. So that certainly would be a concern in that population as well, that if there were the setting of resource scarcity that a child could come in and say, OK, well, they have cancer, even if it's active cancer, but they, in many cases, would be expected to have a very good chance of survival.

Dr. Clifford Hudis: It's interesting you bring that up, because I will say in a distantly related aside, certainly one of the more interesting and repetitively surprising conversations many of us have is the one that involves pediatric oncology with friends and neighbors or whatever who aren't that familiar. They're always surprised at the high success rate in that field. And it just makes the point that we can't let a diagnosis stand as the only interpretable fact. So, look, these recommendations establish an important principle. A cancer diagnosis alone should not keep a patient from a fair chance to access potentially life-threatening-- or rather lifesaving, sorry, resources, even during a public health crisis.

But let's go a step further. One of the other recommendations in there were that decisions regarding allocation of scarce resources should be separated from bedside decision-making. This one, I struggled with as a reader as well. And I wonder if you could explain to our listeners what the intent or thinking behind this recommendation would be. As I ask that question, in my mind's eye, I picture I'm called to the ER. The ER doc is looking at my patient's dropping O2 sat and is turning to me for advice and guidance and understanding of the disease specificity or the specific disease circumstances in this patient so they can make the triage decision. And I'm struggling to understand what we actually mean by decisions regarding allocation of scarce resources should be separated from the bedside.

Dr. Jonathan Marron: So ultimately, that piece comes down to the fact that we as humans and decision-makers are imperfect. And it would be unreasonable and probably impossible to expect that any one of us, as a clinician or just as a person, could reasonably weigh all of these different things simultaneously, because there is ultimately a huge conflict of interest in saying that I am the clinician taking care of this patient in front of me, but simultaneously, my job is to steward the resources for my institution or, even more broadly, the resources for the entirety of the country or whatever I might consider to be my patient population. And so what we are trying to-- the message we were trying to send with that piece is not only that it shouldn't be the oncologist who's making that resource allocation decision, but it's actually not the emergency room clinician who should be either, because it's just completely unreasonable to expect someone at the bedside to be weighing those two things at the same time and to be making an unbiased decision.

Dr. Clifford Hudis: Well, apart from the pandemic and the specific kinds of acute resource shortages that the paper addresses, the truth of the matter is, we've been talking about finite healthcare resources and hard choices for years. And these questions often are raised in the context of oncology. So I want in that way to just ask you about something that you mentioned at the very beginning, but I'm going to push you to a more precise answer, the recommendation that says allocation of scarce resources in a pandemic should be based on maximizing health benefits. And you alluded to that a little bit.

So, can you just expand a little bit on what it is you mean? You've said overall survival is often taken as one. But of course, there are trade-offs. There's quality-of-life issues. There are a number of people who might benefit modestly, more people, fewer people, benefiting more deeply, whatever it is. So, I won't hold you to this exactly, although it's being recorded. But what do you think should be the goal when we talk about maximizing health benefits? What exactly does that mean?

Dr. Jonathan Marron: So, this is really where we get into the weeds with this, as you were sort of alluding to. So certainly, we want to save the most lives. I think there is general agreement from most people out there that that's a reasonable and a fair way to look at this. One of the questions that's been debated most over these past couple of months as we've been thinking about these things, perhaps more than we ever have before, is whether we want to somehow integrate the idea of saving the most life years.

So, what do I mean there? So, the idea that a person who is expected to live five years, do we think about that life differently than a person who's expected to live another 45 years? Intuitively, I think many people would say, oh, well, if we have to make that choice, that awful, impossible, choice, we should save the person who is going to live 45 years over the one who's going to live five years.

That's getting at this question of saving the most life years, number of total years of life. And so with that, I'll ask you, is there anything else you think ASCO members or the cancer care community or health care institutions should understand about this work in this moment? Is there anything their families and patients you would want to-- is there anything else you'd want them to know about this that we haven't touched on?

I mean, I think one really important but really challenging piece about all this is the role of communication, in every sense of the word, that these are absolutely unprecedented times. And these types of decisions, if and when they have to be made, are luckily things that-- the kind of decisions that we don't typically ever have to make. And so if they have to be made, ensuring that oncologists who have the long-standing relationship with patients and families take on a role of communicating with patients and with their families as much as they can to explain why these decisions are being made, and why they have to be made, to ensure that everybody is on the same page I think is really important.

What makes this even more difficult is the fact that most hospitals now have visitor policies such that families and caregivers often, if not most times, are not able to be at the bedside of patients, which makes this only that much harder, but makes communication that much more important.

I would want to highlight something you just said, because it resonates, at least for me, and I think for many in our in our community. And that is communication. At root, of all of this is dependent and made easier and smoother by high-quality communications.

Dr. Clifford Hudis: And I would actually extend what you said by pointing out that it also includes discussions about intentions and desires on the part of patients. And this is something we who take care of cancer patients, I think, do try to spend a lot of time on. This discussion is much easier if a patient who does know about a life-limiting prognosis is clear about what they want. Certainly, for the whole team, some of the ethical dilemmas might be minimized that way, right?

Dr. Jonathan Marron: Yeah, I couldn't say that better. That's one thing we try to highlight in the guidelines as well, that we consider advance-care planning and having goals-of-care discussions to be really at the core of clinical oncology practice. And that continues in the setting of this pandemic. And if anything, it's only more important.

Dr. Clifford Hudis: Well, I think this is really great. I hope that listeners find this discussion intriguing and go and take a more in-depth look at the actual publication. I want to point out that the recommendations that we've been discussing are just one part of ASCO's longstanding commitment to provide information, guidance, and resources that will support clinicians, the cancer care delivery team, and patients with cancer throughout their journeys, and also during this COVID-19 pandemic. That is, what we're doing here is not unique to this pandemic moment, even if the acuity of the need is heightened.

There are some other resources that you should be aware of, including patient care guidance for oncologists who treat patients with cancer during the COVID-19 pandemic. There are guidances available for practices on how to adjust our policies in response to the virus and, just recently, on how to begin to return to more normal styles of work. There are also updates on federal activities that have been aimed at responding to this crisis. And everybody knows that this has been a very fast-paced time of change.

We recently launched the ASCO survey on COVID-19 in Oncology Registry or ASCO Registry. And our goal is to collect data and share insights on how the virus has impacted cancer care, but also cancer patient outcomes throughout the COVID-19 pandemic. And we encourage all oncology practices to participate so that we can gain the largest data set possible, and therefore represent the diverse population of patients and practices around the United States.

I want to remind listeners you can find all of these resources and a whole lot more at ASCO.org. There is also patient-focused information available at Cancer.net. And with that, until next time, I want to thank everyone for listening to this ASCO in Action podcast. I want to remind you that if you enjoyed what you heard today, you should take the time to give us a rating or review on Apple Podcasts or wherever you might listen. And while you're there, be sure to subscribe so that you never, ever miss an episode. I want to thank Dr. Marron for joining us today.

Dr. Jonathan Marron: Thank you, Dr. Hudis. It was an absolute pleasure to join you.

Dr. Clifford Hudis: And lastly, I want to remind you that the ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at Podcast.ASCO.org.

In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Ray Page, Past Chair of ASCO’s Clinical Practice Committee and President of the Center for Cancer and Blood Disorders, to discuss the benefit of drug repository programs solely for oral medications that are maintained within a closed system.

These programs can play an important role in helping patients afford their treatment and can reduce the financial toll on the cancer care delivery system, provided that important guardrails are implemented to keep these programs safe.

Subscribe to the ASCO in Action podcast through iTunes and Google Play.

Transcript 

Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. 

Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. The ASCO in Action podcast is an ASCO series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer. 

My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series. For today's podcast, I am really pleased to join once again Dr. Ray Page. Dr. Page is a past chair of the American Society of Clinical Oncology's Clinical Practice Committee, he is the President of the Center for Cancer and Blood Disorders where he also serves as a medical oncologist and hematologist, and he's a great and good friend of ASCO's. 

Earlier this year, ASCO released a position statement on state drug repository programs outlining the society's support for such programs solely for oral medications and provided that they are maintained within a closed system. ASCO's statement also makes recommendations to help ensure that these programs are implemented appropriately with sufficient patient protections in place. 

Today, Dr. Page and I will discuss the important role that these programs can play in helping our patients afford their treatment while reducing the financial toll on the cancer care delivery system as a whole. We will discuss the important guardrails that are needed to keep these programs safe. And with that, I want to welcome you, Dr. Page, and thank you for joining me today. 

Dr. Ray Page: Thank you very much, Cliff, for having me for this conversation today. And I just want to let you know that I have no disclosures for this conversation. 

Dr. Clifford Hudis: Thanks again for joining us today, it's a real pleasure to talk with you once more. And I want to get to today's subject. First and foremost, what are state drug repository programs? How do they work and what's the purpose? 

Dr. Ray Page: In its simplest definition, a drug repository program is basically a legal process that allows unused drugs that have been prescribed to patients to be able to be donated and reused rather than thrown away or set aside if it's no longer needed. Its purpose is to offer a practical way to increase access of prescription drugs for patients. And often, this process can offer more timely access to drugs with a negligible financial impact for the patients. And this was a program that has managed at the state level, and it's subject to individual state laws and State Department of Pharmacy rules and procedures. 

And these kind of programs are of exceptional importance to cancer patients who are constantly challenged today with getting affordable access to vital drug treatments for their disease, and these issues are described very well in ASCO's 2017 position statement on the affordability of cancer drugs. And this has all been on the radar of ASCO's State Affiliates Council in recent years where our state society presidents and their executive directors have shared model state legislation to advance these kinds of drug donation programs in their individual states. 

Dr. Clifford Hudis: So, Ray, before we go any further, can you tell me, what does this actually mechanically in practical terms look like at the level of a practice or from the perspective of a patient or a pharmacy? What actually happens physically with product in the context of a repository? 

Dr. Ray Page: It really varies from practice to practice and state to state, but Cliff, I can tell you that I see this in my own practice absolutely every day in my doctor-patient interaction. And this is really what's gotten me personally intensely interested in pursuing and establishing laws in Texas to allow for pill donation. Because ideally, we would like to have that transaction between the doctor and the patient of being able to get unused drug for those patients where the drug's not used anymore 

And so there's many reasons why in the office, these people don't need the drug anymore. They could have progression of disease that requires new drug, or alternatively, they could have completed their treatment regimens that may have resulted in a cure. But oftentimes there can be interval dosage adjustments due to side effects and toxicities where they just need a new prescription. 

And lastly, I just have to mention a little bit about the negative impacts of the pharmacy benefit managers in this world, and I'll refer our listeners to our previous podcast that we did together a few months ago just understanding the global concerns of the PBMs, but however, I'll just say that their drug distribution process oftentimes contributes to the tremendous cancer drug wastage that we have in the United States. 

Dr. Clifford Hudis: Well, I mean, picking up on that, if readers take a look at ASCO's position statement, they'll see that we identify there the fact that appropriately-implemented drug repository programs can help address some of the cancer drug waste, And if I remember correctly, this was quantified by researchers in New York at Memorial Sloan Kettering Cancer Center. I think they found an estimate of about $3 billion annually. 

The question is, exactly what causes this waste? And you alluded to the fact that you see this in your practice as well, but I just want to be really clear and in a practical sense, this waste is that a patient is dispensed-- I'll say, for argument's sake, 60 pills, and has progression of disease or a toxicity-based dosage adjustment and comes back for a routine office visit and still has, for argument's sake, 20 of the pills leftover. And the goal here is to essentially recycle those pills back into the supply, is that right? 

Dr. Ray Page: That is correct. And so that's the basic mechanism. And as practicing physicians we see this issue all the time, where for the reasons that I explained, there's always unused pills that we don't need anymore. And if there is a mechanism by which we can safely transfer that drug to somebody that can actually use it and need it, there can be substantial positive impact with that for our patients. 

Dr. Clifford Hudis: And is it only a financial benefit, Ray? Or are there non-financial benefits as well that this repository programs can somewhat mitigate? 

Dr. Ray Page: Yeah. Well the financial impact of this is huge. The Americans are paying over $61 billion a year in out-of-pocket expenditures for drugs, and drug abandonment can have serious effects on a patient's health leading to hospitalizations, extensive health care cost, and even death. And the British Medical Journal reported an estimated $3 billion in leftover cancer drugs are discarded in the United States every year, and that's truly a tragic impact on our society. 

But also, outside of financial, in 2015 the Environmental Protection Agency estimated that about 740 tons of drugs are wasted just by nursing homes every year, and obviously this can't be good for our environment, and we've all heard reports about many of these discarded drugs ending up in our water systems. So redistribution and enabling access to these unused drugs can help alleviate some of these problems that go outside the finances. 

Dr. Clifford Hudis: Well thank you for that. I mean, high out-of-pocket expenses have been for a long time a serious concern for us at ASCO, and you've I think touched on how this can help reduce them. My question is, are there any pushbacks from patients or providers with regard to these programs? I mean, I can imagine that there might be some bureaucratic overhead that might represent a challenge for small practices or maybe there's some risk associated with it, but I'm just guessing. Is there any clear objection to these that we should be thinking about and possibly working to mitigate? 

Dr. Ray Page: In general, in my interactions with my patients, most everyone has negligible concern about getting a donated drug for immediate use. There should be informed consent and disclosure, obviously, but the patients generally trust their physicians recommendations and are truly interested in just getting the opportunity to get access to the drugs. From a patient's perspective, I generally think that their greatest concern are just getting quick access to the oral drugs so they can get started on their cancer therapy as soon as possible, often to alleviate active symptoms that they're having, and to alleviate some of the fear of just not getting access to beneficial drugs. 

And the physicians I think share that same sentiment of the patients, but in addition, physicians have concern and desires and assurances that these donated drugs are indeed safe for re-distribution. 

Dr. Clifford Hudis: And Ray, is that what the informed consent would allude to? I was sort of wondering when you said informed consent. In a sense, is there anything different in the informed consent versus what would but with any other cytotoxic prescription, for example? I mean, is there really a way to describe the potential risk or the changes in the risk that there might be some loss of purity in a substance or substitutes? Or-- I'm just trying to figure out what the consent really ultimately conveys. 

Dr. Ray Page: At least through some of the mechanisms that I'm familiar with that we've developed in Texas is basically there's just a disclosure form that the drug that was in possession of the patient, that they just sign a disclosure that they haven't tampered with it, messed with it, they're stored properly, those kind of things to create those assurances. And then the patient's just given a basically informed consent that they're aware that this transaction has been through a patient and outside the pharmacy. 

Dr. Clifford Hudis: I see. OK. I mean-- so it sounds to me like we're just, in a sense at a societal level, trying to basically make it clear that there's a theoretical risk of some loss of control, but it's, from a practical point of view, not particularly high, right? 

Dr. Ray Page: Yes. And I think many oncologists across the United States have just had those experiences with patients in the office that maybe don't have the financial resources, they're looking just for access to drugs. And if there's drug that's available that's been donated, a lot of patients seem to have no problem accepting the drug. And again, I mentioned that a lot of the patients generally trust their physicians' recommendations in that transaction. 

Dr. Clifford Hudis: Well, I just have to say, I'm as you're talking, I'm reflecting on my own practice experience over the decades. And even for old and inexpensive drugs, it always bothered a lot of my patients that they couldn't simply give their inexpensive tamoxifen, for example, or aromatase inhibitors-- generic drugs, for that matter-- to somebody else in need when they no longer could use it. I think they just were offended by the waste. And even apart from the financial aspects that you've so clearly described, there is, I think, a real altruistic desire to use these drugs and not discard them wastefully, and it's nice to see that there may be the opportunity for patients to satisfy that need. 

Dr. Ray Page: I agree with you, Cliff. I think there is a strong sense of altruism with our patients. Without a doubt, I think patients have extreme difficulty taking a drug that they know that they-- that the cost of that-- monthly cost of that drug was, say, $12,000 or $16,000, and that they're forced to discard it or flush it in the toilet or turn it in without it being potentially used by somebody else that may be in need, because they've certainly been in those shoes and experienced that themselves. 

Dr. Clifford Hudis: As you know, ASCO strongly supports repository programs, but we're very focused on oral medications, and we make the assumption that they will be maintained within a closed system. For our listeners, can you describe the difference between a closed system and open system and why we would be favoring a closed system? What makes it safer? 

Dr. Ray Page: So, Cliff, to define a closed system versus an open system, a closed system is a way to have the spirit of having an overabundance of precaution to assure patient safety. And basically, that allows for drugs that are prescribed to a patient and they bring back in that they have appropriate disclosure and supervision, and those drugs are reviewed by a pharmacist and assured that they're safe and able to be recycled according to state laws and pharmacy board rules. 

And that's as opposed to an open system where, say, you have a patient that comes into the office and they got a bottle of pills that are unused and they give them to the physician, and then the physician turns around and redistributes those drugs to the next patient who's in need. 

Dr. Clifford Hudis: I think for many listeners, and probably for even more of our patients nowadays, when they think of cancer treatment, many people are used to thinking about perennial therapies, infusions and the like. But this is really focused obviously on oral medications. What are some of the oral treatments that have been made available? You indirectly alluded to some in terms of price, but what are some of the specific ones that have been successfully made available to patients through drug repository programs so far? 

Dr. Ray Page: Great question, Cliff. I'll just emphasize it today. Over 40% of cancer therapies that oncologists prescribed are oral drugs, and we have several hundred experimental oral cancer drug that are in clinical trials. So it's anticipated that as time goes on in the future, we're going to be prescribing more and more oral cancer therapies rather than patients spending all day in a chemo chair getting IV infusions. And that's a great thing for our patients. 

But currently, I estimate that there's probably over 100 oral anti-cancer drugs and supportive care drugs that are being prescribed to our patients, and these encompass a wide range of treatments, including your classic cytotoxic chemotherapy pills, hormonal agents, molecularly-targeted drugs, and symptom management drugs. And so each state has a drug repository program, has its own pharmacy rules for that redistribution. And in general, most of these drugs, in order to be available, must be in untampered and in secure packaging such as blister packs. 

And so most states require inspection by a pharmacist, and therefore, there's a number of great drugs that may not be readily available for redistribution based on state laws and pharmacy rules that are designed to protect patient safety. 

Dr. Clifford Hudis: Are there other safeguards or any other provisions you think that state drug repository programs could take advantage of to improve their ability to serve patients? Is there anything else we should be doing, you think, as we gain experience with these programs? 

Dr. Ray Page: You know, Cliff, I'm very pleased that ASCO came out with this position statement in support of the drug depository program that are being developed by each state. And ASCO has provided a few guiding principles for states to consider in their programs, and I think the ASCO recommendations for redistribution in a closed system is in the spirit of an abundance of precaution to assure patient safety. 

However, like I said, this can potentially reduce the availability, but ASCO has made some recommendations to the states to where they want to assure that if they're not in a closed system, that the state and federal legislative address the concerns of drug related redistribution that are not in a closed system, that the surplus medications are administered in a safe, effective, and private manner in accordance with the prescribing clinician's guidance. 

And the state should have a liability protection in accordance with their state health regulatory authority, and that includes such things as the informed consent and disclosures that we talked about. And then ASCO and other professional medical organizations should continue to make efforts to educate physicians about the existence and the value of these programs, and then ASCO also suggests that this drug repository program should be implemented and no additional cost, or at least as a negligible cost to the patient. 

Dr. Clifford Hudis: Ray, I think that's great, and I actually, personally and on behalf of the membership and our whole community, applaud you for your activism in this area. Is there anything else that you haven't said that you would want our listeners to know about or have we pretty much covered it all? 

Dr. Ray Page: Yeah, Cliff, I think there is just a couple of closing thoughts that I want to convey to you. So first, most states allow the redistribution of pills and blister packs, but not pills that are partially used in bottles as we've discussed. But during the last couple of years and again today, I want to implore to the pharmaceutical manufacturers to package their new, often very expensive anticancer drugs in blister packs. 

So studies have shown that packaging in this way usually results in improved patient safety and compliance with taking their pills, but most importantly, if for whatever reason those pills are not needed anymore by the patient, the patient or the prescribing institution can donate those pills for redistribution to a fellow patient with a similar cancer. So it's the right thing to do. 

And lastly, most states have some form of drug repository program already in their laws; however, unfortunately, most states do not have the program properly turned on. A few states, such as Iowa and Wyoming and Oklahoma, have successful programs working for the patients, but some states have rudimentary programs that need expansion. And then many states need to update their laws and get their programs working again, and this is not an easy process by any means. 

I've been working for many years to get a meaningful Texas law passed, which although not perfect, we got a law passed in 2017. And in Texas in the last couple of years, we have been working on the rules and the forms and the processes, and I'm proud to say that my cancer center in Fort Worth is the first registered provider in the state of Texas, and we are currently working with the University of North Texas Health Science Center School of Pharmacy on this, and we've been collecting donated drugs, and we hope that very soon we'll be the first provider in Texas to re-distribute cancer drugs in the state of Texas. 

So again, this is not an easy process, but I encourage all states to dust off and modernize their laws to allow cancer patients the ability to get affordable access to drugs through such opportunities as the drug repository program. 

Dr. Clifford Hudis: Ray, again, I just have to emphasize how deeply grateful I am and I'm so happy to see that you've taken this on and with so much passion. It is hard to understand an argument against this, and that doesn't make it easy, but it's good to be right and it's good to see the effort that you've put into this and to start to see this success. It really does matter to patients as we have been discussing. 

So for those of you who want to read more about this, I encourage you to open up ASCO's position statement on drug repository programs. Also there you can find breaking cancer policy news and more, all of that at ASCO in Action. That's on the website at asco.org/ascoaction, remembering that ascoaction is written here as one word. 

And until next time, I want to thank everyone for listening to this ASCO in Action podcast. I want to remind you that if you enjoyed what you heard today, we'd love it if you'd give us a rating or a review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss another episode. The ASCO in Action podcast is just one of ASCO's as many podcasts. You can find all of the programs at podcast.asco.org. 

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis provides an update on a new initiative, the ASCO Survey on COVID-19 in Oncology Registry (ASCO Registry), which aims to help the cancer community learn more about the pattern of symptoms and severity of COVID-19 among patients with cancer, as well as how the virus is impacting the delivery of cancer care and patient outcomes.

“We have an urgent need to learn more about how COVID-19 is directly and indirectly affecting the people with cancer who we serve. In times of crisis, it’s especially important that we learn from every patient so that we can refine our approaches and continue to provide the highest quality care,” said Dr. Hudis.

Subscribe to the ASCO in Action podcast through iTunes and Google Play.

Transcript

Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy, should not be construed as an ASCO endorsement.

Dr. Clifford Hudis: Welcome to the ASCO in Action Podcast, brought to you by the ASCO Podcast Network, a collection of 9 programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org (“Podcast dot ASCO dot org”)

The ASCO in Action Podcast is ASCO’s podcast series that explores the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for—people with cancer.

I’m Dr. Clifford Hudis, CEO of ASCO and the host of the ASCO in Action podcast series. For this podcast, I wanted to provide a quick update about one of ASCO’s newest initiatives, the ASCO Survey on COVID-19 in Oncology Registry, which we’ve launched in response to the COVID-19 pandemic.

It’s clear that the COVID-19 pandemic poses a threat to people all across the globe.

Since the worldwide outbreak of the coronavirus, we’ve learned that certain populations – including individuals with cancer – are more likely to be vulnerable to the worst outcomes from COVID-19.

However, there’s still so much that we do not understand. We have an urgent need to learn more about how COVID-19 is directly and indirectly affecting the people with cancer who we serve.

In response, ASCO recently announced the new ASCO Survey on COVID-19 in Oncology Registry or ASCO Registry for short. This exciting new initiative was developed under the leadership and vision of ASCO’s Chief Medical Office Dr. Richard Schilsky, with support from a dedicated team of professional staff who work for our Center for Research & Analytics (CENTRA).

The ASCO Registry was established so that we can learn more about the pattern of symptoms and severity of COVID-19 among patients with cancer, as well as how the virus is impacting the delivery of cancer care and patient outcomes.

We’re not just looking at point-in-time data on patients with cancer. The ASCO Registry will capture longitudinal data on how the virus impacts patient care and outcomes throughout the COVID-19 pandemic and into 2021. We hope that longer-term look will tell us if the virus resulted in specific complications for patients, delayed patients’ ability to get a specific type of treatment, or if certain approaches resulted in better outcomes for patients.

Once we have sufficient data in the Registry, we plan to release periodic reports to the cancer community and the broader public on key learnings. These reports might include details like the characteristics of patients with cancer most impacted by COVID-19, estimates of the severity of disease among patients with cancer, changes or delays to treatments, and the implementation of telehealth in a cancer care setting.

We also hope to be able to report on the clinical outcomes among patients with cancer during the pandemic. And, we might even learn that certain unconventional approaches might allow us to deliver care more efficiently or safely without jeopardizing patient outcomes.

The ASCO Registry is open to all U.S. oncology practices. That includes physician-owned, academic, hospital or health system-owned practices, and hospitals themselves.

Participating practices will be asked to complete a baseline data capture form on each patient with cancer who has a confirmed diagnosis of COVID-19.

Later, practices will be asked to provide follow-up information on each patient’s status, treatment, and outcomes.

Data will also be collected on practice-level changes, such as new screening procedures, implementation of telehealth in the practice, and changes to clinical trial enrollment procedures.

The ASCO Registry will securely collect limited patient identifying data – such as zip code, date of birth, gender, race, ethnicity, type of cancer, and comorbidities. By collecting this type of data, it will be possible for us to conduct longitudinal analysis.

Data from practices participating in the registry will be collected and securely stored on the CancerLinQ® platform.

We’re not alone in our work to better understand the impact of COVID-19 on the cancer care system and the patients we serve. Other registries, including the COVID-19 and Cancer Consortium (CCC19) and the American Society of Hematology (ASH) Research Collaborative COVID-19 Registry for Hematologic Malignancy have already been launched, and other multi-site registries are in development.

We are encouraging all oncology practices to participate in one or more registries based on their specific needs and to reflect the patients they serve. Each of these registries has a different focus and timeline, so participating in multiple registries will not compromise our efforts or prevent all organizations from working together. We are actively looking for opportunities to collaborate with our colleagues on these initiatives.

The ASCO Registry is part of our ongoing efforts to provide the most current information and resources the virus to our members and the larger oncology community.

We’ve developed a wide variety of COVID-19 resources to support clinicians, the cancer care delivery team, and patients with cancer.

Some of those resources include patient care guidance for oncologists treating patients with cancer during the COVID-19 pandemic; guidance for practices on how to adjust their policies in response to the virus; and updates on federal activities to respond to this crisis.

We’re also co-hosting a weekly webinar series with the Oncology Nursing Society on COVID-19. Each webinar examines a range of issues to help clinicians care for people with cancer during the COVID-19 pandemic.

You can find all of these resources and more at asco.org. Patient-focused information is also available at cancer.net.

We invite all of our listeners to learn more about the ASCO Registry on asco.org.

In times of crisis, it’s especially important that we learn from every patient so that we can refine our approaches and continue to provide the highest quality care.

Until next time, thank you for listening to this ASCO in Action podcast and if you enjoyed what you heard today, don’t forget to give us a rating or review on Apple Podcasts or wherever you listen and while you are there, be sure to subscribe so you never miss an episode.

The ASCO in Action Podcast is just one of ASCO’s many podcasts; you can find all of the shows at podcast.asco.org.

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis is joined by Dr. Jason Westin, member of the Government Relations Committee of the Association of Clinical Oncology, to discuss CAR T-cell therapy, a groundbreaking and lifesaving cancer treatment that comes with significant side effects, a jaw-dropping price tag, and limited locations where treatment is currently available.

“This is potentially home run therapy for patients who have decades of life left to go,” says Dr. Westin.  While he stresses that CAR T is a major step forward in ridding the world of cancer, Dr. Westin worries about the high cost of the treatment, which “is an incredible amount put upon the system.”  

Subscribe to the ASCO in Action podcast through iTunes and Google Play.

Transcript 

Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement. 

Dr. Clifford Hudis: Welcome to the ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. 

The ASCO in Action podcast is ASCO's podcast series where we explore the policy and practice issues that impact oncologists, the entire cancer-care deliver team and the individuals we care for--people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO as well as the host of the ASCO in Action podcast series. 

For this podcast I am really pleased to have Dr. Jason Westin as my guest. Dr. Westin is a member of the Association for Clinical Oncology's Government Relations Committee. And he is the director of lymphoma clinical research in the Department of Lymphoma Melanoma within the Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center. 

Today Dr. Westin and I will discuss chimeric antigen receptor, or CAR T-cell therapy. Two years ago, ASCO named CAR T-cell therapy as our advance of the year in our annual Clinical Cancer Advances Report. CAR T is a groundbreaking and life-saving treatment for children and young adults with acute lymphoblastic leukemia, and also for adults with diffuse large B cell lymphoma. 

But it comes with serious side effects, an extraordinary price tag and a limited number of places--at least in the United States--where the treatment is currently available. Today Dr. Westin and I will discuss the current state of the science on CAR T-cell therapy, as well as access issues that are facing those patients who are seeking treatment with this new modality. Welcome, Dr. Westin, and thank you for joining me today.  

Dr. Jason Westin: Thank you for having me. Before we begin, I'd like to disclose that I have clinical trial funding disclosures that are listed on the ASCO conflict of interest website. Those that I view to be specifically relevant for today's discussion include advisory work as well as clinical trial research funding for CAR T-cell companies including Kite/Gilead, Novartis and Juno. I also do clinical trial work with Celgene, Genentech, AB V, Amgen, MorphoSys, Curis, and 47 Inc.  

Dr. Clifford Hudis: Thank you very much for that. We appreciate that. Let's get into the real focus of our conversation today. And let's start, of course, with CAR T-cell therapy. What is it, for those who might not be familiar? How would you describe it? And further, what makes it so potentially transformative in oncology?  

Dr. Jason Westin: CAR T-cell therapy is an incredible breakthrough for our patients fighting cancer. The word car--c a r--stands for chimeric antigen receptor. What a CAR T-cell is taking a T-cell that's functional and in the body to fight infections, infusing a new receptor on the outside, often a receptor that has an antibody fragment fused to parts of a T-cell receptor that now allow this car T-cell to recognize the wolf in sheep's clothing that's the cancer. 

CAR T-cells are usually modified genetically using a virus to introduce new DNA into the patient's T-cell. And these are prepared in the lab, modified in a way that these can now recognize a surface marker, and then these cells are re-infused into the patient, where they can now grow. They can now find the cancer, and they can destroy it 

This has been potentially transformative because it is something that has completely different resistance mechanisms than standard chemotherapy. CAR T-cells have shown incredible promise in clinical trials and now in early days standard of care. And the sky is the limit for how this could be used in the future, targeting other markers on other types of cancer and really opening up a whole new field of how we treat cancer, much in the way that immunotherapy with checkpoint antibodies has done over the past decade or so.  

Dr. Clifford Hudis: Well, that's exciting. But you just hinted at what I think is the obvious next question. Breakthrough though this may be, clearly this has, at least for some patients, fairly significant side effects. And some of them, I understand, are somewhat different from what an earlier generation of oncologists might have been trained to recognize and to treat. Can you talk a little bit about what some of those side effects are, typically at least? And how we hope to limit that in the future? 

Dr. Jason Westin: CAR T-cell side effects are certainly unique and not overlapping in the way that we think of oncology therapies side effects. The CAR T-cell therapy side effects in the short term are broken down into two main camps. The first is something called cytokine release syndrome, sometimes abbreviated CRS. Cytokine release syndrome is effectively almost like sepsis, in that it's an overwhelming immune response where the T-cells that have been manufactured and infused into the patient release an avalanche of cytokines to effectively recruit other immune cells to come help fight the cancer.  

And in doing so, induces sepsis-like phenomenon of organ dysfunction, fever, and sometimes hypertension, which can be severe. The other acute short-term side effect that we can see from CAR T-cell therapy is a significant neurologic toxicity. And this is a new diagnosis, a new syndrome that's recently been classified by a consensus group as immune effector cell associated neurologic syndrome, or ICANS, for short. 

This can range from mild slowing of speech or mild slowing of cognition all the way to status epilepticus and anything in between. The most common troubles folks have are mild slowing, but aphasias and/or seizures can certainly occur and can be quite distressing to the patient and to the family.  

Thankfully it seems that both cytokine release syndrome and ICANS, the neurologic toxicity, appear to be fully reversible in the nearly all patients, in the vast majority of patients. The late side effects of CAR T-cells are also unique and different from what we've seen from prior chemotherapy-type induced side effects. These include, depending upon what target you're going after, an effective lack of the target expression long term.  

And for CD 19 focusing therapies, this effectively means a B cell aplasia that can sometimes be for a year or longer after the one infusion of car T-cells are administered. We know from other immune therapies that depleting certain parts of the immune system is not usually overwhelming infections or other obvious toxicities, but can result in chronic infections, inflammation and need for replacement of things like intravenous immunoglobulin to replace immunoglobulin deficiency. 

So, CAR T-cell side effects are not what we typically think of in terms of chemotherapy, of cytopenias, nausea and fatigue, or immune therapies of inflammatory responses off target from the projected cancer. These are more specific toxicities related to the extreme expansion and cytokine release of these Car T-cells during the battle against cancer as well as lingering effects from these T-cells remaining active for many months and maybe even years after the infusion. 

Dr. Clifford Hudis: There are a number of barriers right now. You've highlighted some of them. First of all, we don't have applicability yet established for a large number of diseases. That's an area for research. There are special toxicities. And it sounds like, realistically, anybody starting to do this needs to be trained and needs support staff and teams, just like you described. So there's a geographic limitation. 

But beyond all of that, there's also a more conventional limitation, which is just outright cost. And as I understand it, the cost, or at least the list price for available agents, can range from $373,000 to treat an adult with an advanced lymphoma up to 475 to treat a pediatric indication. 

And further, I think these prices do not include the additional costs of hospitalization or managing side effects, and maybe other adverse events. I'm curious, do these prices matter day to day in your practice? Do your patients need assistance navigating this? Or what's the real-world experience, given this price point? 

Dr. Jason Westin: This is a major concern for us for the future of CAR T-cell therapy. The accessibility not just based on physically being able to get it but financially being able to get these therapies, as you mentioned. The cost of the actual product itself, the one-time infusion of these T-cells that are manufactured specifically for each given patient, it's a major cost. 

But in addition to that, the actual hospitalization, which is usually a significant amount of time. For most patients that receive CAR T-cell, they're hospitalized between a week to 10 days. This is not a trivial admission for observation overnight in the hospital.  

These are huge costs. Now payers, including commercial and private payers, and now government payers, are supporting this. However, as the number of patients grow, this is going to be something that's going to increasingly strain the ability of the system to support an incredibly expensive therapy. 

This is potentially home-run therapy for patients that may, in some cases, have decades of life left to go. So, the cost is not trivial for the benefit received. But it is an incredible amount that's put upon the system, put upon the payers. Right now, through payers, it's doable. But I worry about the future of this as the number of patients who can benefit from this goes up. 

Dr. Clifford Hudis: Well, I guess if it's as transformative as you're describing, it is at least plausible that it's front-loading costs, but net actually might not be particularly more expensive than traditional, long-standing, less-effective therapies. I assume those kinds of economic models and reports are being developed. Is there anything you can say about that at this point? Or is it just too soon to make those estimates? 

Dr. Jason Westin: It's still very early days. But there are absolutely analyses being done at looking at the number of quality life years gained from these kinds of treatments. And depending upon the effectiveness of the treatment, it can absolutely be a net long-term positive of somebody getting back to health and not requiring chronic therapies, or not dying at a premature age. 

So, there is no doubt that the cost of this is high, but the benefit is also very high. But if this continues long term to scale up for more and more patients, even net long-term success and long-term neutrality of a cost, if you're paying more now and getting less costs later, it can still strain the system, if the upfront cost is substantial. 

So, I think this is something that's going to have to be looked at in terms of, what is the true cost of making CAR T-cells? And potentially bringing those costs down as we try to scale up for more patients over time.  

Dr. Clifford Hudis: So, you spoke about getting approval, and it sounded like you were talking about conventional commercial payers. Last year, the Centers for Medicare and Medicaid Services, or CMS, announced that Medicare would cover CAR T nationwide and we at ASCO were really delighted with that. 

But we recognize that, while the drugs are being reimbursed, that reimbursement remains at a level well below the actual acquisition costs. So, I think this is another version of the same question, but how is that shortfall impacting patients? And how is it addressed? Or is that just something that the institutions have to eat? 

Dr. Jason Westin: It's different from different institutions, depending upon their status with CMS and if they're grandfathered into older systems, or if they're not protected in that way, it is certainly a problem. And it's something that the approval for this to be funded by CMS was absolutely great for our patients. However, the reimbursement, as you mentioned, that's proposed for that approval is quite low. 

It's not close to the price for the product as well as for the inpatient stay. And so many hospitals are treating commercial patients with the idea that they are reimbursed at a higher level to cover patients who are treated and covered by government payer systems. The government payer systems also have temporary funding that's associated with the new technology, the end-tap mechanism, where there's an initial bump in the reimbursement that's not permanent.  

This is--these add-on payments are helping hospitals who are at risk of having a net loss financially for doing CAR T-cells. But these are only usually two years in length, meaning that this is not going to be a cost assistance for those hospitals for the long future of CAR T-cells. This is short term.  

So, this is something that is new to government payers. This took quite a while after approval for CMS to make a determination on where this would be supported or not. It's all brand new. And it takes time to figure out the potential benefit, the potential long-term reimbursement levels. 

But the current reimbursement levels are not going to be sustainable from government payers to hospitals, as a modality to keep this viable therapy for patients. We've already seen some hospitals that are not able or willing to treat patients who are on a government health-care system, actually sending them to larger systems that are treating many commercial patients to try and subsidize this net loss for a patient on Medicare or Medicaid. 

This is something that is a big problem that's in addition to the cost of it. The substandard reimbursement is going to be a strain on the system in the long run. 

Dr. Clifford Hudis: Well, that's interesting. I mean before the CMS coverage announcement came out, we at ASCO actually submitted comments to the agency, and this included our perspective on both appropriate coverage and reimbursement for CAR T as well as an overarching description of ASCO's principles on approval coverage and getting the right treatment to the right patients at the right time. That's really the underlying principle that we try to rely on.  

I mention that because I know you have some familiarity with policy making in government, and then you've been--we've been--lucky, I think, that you're serving on the government relations committee right now. From the perspective of that, GRC, I wonder if you care to just expand a little bit on the importance of ASCO coming out and taking a stand on an issue like this?  

Dr. Jason Westin: I think it's essential for organizations like ASCO to advocate on behalf of our patients to try and educate policymakers and lawmakers about exciting new breakthroughs and why this matters for our country, as well as for our future. This technology is so new and so innovative. So different than what we've done before in terms of treating diseases with medications or with antibodies, that it is sometimes a shock to the system about what exactly is this CAR T-cell. What exactly does that mean? 

And having lawmakers and policymakers learn from organizations of experts like ASCO. And having policy statements and comments made on potential proposed recommendations. If we don't speak up for our patients, then our patients are going to suffer. And so, I applaud ASCO and the team at ASCO that works on these recommendations and policy statements. 

Because this really is essential for us to speak up and to be seated at the table in a way that we can advocate for our patients. It's sometimes difficult for lawmakers or for policymakers to know what to prioritize. Or if this is something that's real, or if this sounds too good to be true, and therefore we shouldn't learn much about it or pay attention to it. 

As mentioned earlier on this podcast, this is the beginning of a new era of therapy for fighting cancer. And we need to make sure that our policymakers and our lawmakers are aware this is coming, and aware that this is something that's going to be potentially transformative. And therefore, legislating and making policy in a way to allow patients dealing with cancer to have access to these incredible new treatments. 

Dr. Clifford Hudis: So, on the question, again, of access, maybe going in a slightly different direction. We've talked a good bit just now about the science. We've talked a little bit about the toxicities. And we've spoken about the geographic limitations as well as payment. But addressing the geography issue. 

Obviously with scale and familiarity, it's at least conceivable that more centers could offer this, and they might offer it on an entirely outpatient basis. What do you think about that as a near-term potential? And what do you think we have to maybe accomplish? What advances might be needed in order to facilitate that? Or you could say, I guess, not going to happen. So, what do you think is coming in that regard? 

Dr. Jason Westin: I think that the CAR T-cell delivery has such a special need for both monitoring as well as anticipation of management of troubles, that this is not something that I see the current generation of CAR T-cells being administered widely in settings that don't have experience with this, or settings that don't have experience with prior transplant-type treatments. 

This is treatment which has potential danger to go sideways in a hurry. And if you've never done this before, you may not anticipate that, and not be able to help your patients. So, there are current geographic limitations, and centers that do this and centers that don't. And I think that's probably for good reasons at this point and should not be something that we try and break down those walls and have this available at every oncology clinic until we work out ways to make this safer and less dangerous. 

So, it's been a significant challenge to try to transition the current generation of CAR T-cells from an inpatient setting to outpatient setting. We are working on that, as others are. And there are some CAR T-cell products that may lend themselves to easier use as an outpatient, either because of less toxicities or less severe toxicities projected.   

So, this is not something that's going to be a forever problem. But to the current generation of the FDA-approved products, the vast majority are administered inpatient, which is a strain on the hospital systems as well as on patients who prefer not to be cooped up in the hospital for a week to 10 days, if they don't need to be. So, I think this will change as we get better technology, as we get systems in place to monitor patients through telemedicine system as an outpatient. And hospitals have more direct lines from the hotel to the inpatient service, if you have a toxicity. That's coming, but it's been a challenge. 

Dr. Clifford Hudis: I think that's a great place for us to start to wrap this up. I have to ask though, reflecting on what we've covered, is there any area of CAR T science or clinical use that we've neglected to surface in this conversation? Or anything else you want to convey to the listeners?  

Dr. Jason Westin: I think the CAR T-cell story is an incredible advance. When I describe it to my patients, I describe it as almost a science fiction-like therapy where we're able to take your immune system, modify it in a way that it can now see the wolf in sheep's clothing, and get back and re-infuse these cells back in your body. And get them to work to effectively eliminate the cancer that they've not been able to do thus far.  

This is a therapy that works incredibly well for relatively rare cancers at this point. And so I think, as we're smarter and as we learn how to better manipulate the immune system in therapeutic ways, the sky is the limit for how we can both treat cancers and hopefully, even as we get further afield, maybe even prevent cancers from ever developing. 

If we know somebody has a genetic risk that is a high probability of developing a cancer, teaching their immune system new tricks, so that we can have the sky be the limit and really work to try to end cancer, to try and conquer cancer. This is something that is obviously a goal for many researchers and many people who focus on cancer. But this new advance of cell therapy, of CAR T-cell therapy, is a major step forward in our efforts to try and rid the world of cancer. 

Dr. Clifford Hudis: Well, I mean that's just a great way to wrap this up, I think. And I want to again thank you, Dr. Westin for taking the time to speak with me today and for providing so much clear and understandable information. I'm sure this will be useful for a lot of people. Really appreciate it. 

Dr. Jason Westin: Thank you very much for having me. 

Dr. Clifford Hudis: And I do hope that all of our listeners have enjoyed this conversation on CAR T-cell therapy, an exciting and developing area of cancer care. I hope you also see, woven through this, the way in which we are able to take evidence-based advocacy to policymakers to support the kinds of cutting-edge, scientific advances that are members and all of our listeners contributed to through their research and their study.  

And I think that this is something that highlights the connected nature, again, of all of our work and the importance of our engagement. For those of you who want to learn more about CAR T and also breaking cancer policy news, we have that for you at ASCO in action on our website. 

And again, as a reminder, that's ASCO.org/ASCOaction. And in this case, ASCO action is all one word. Until next time, I want to thank everyone for listening to this ASCO in Action podcast. If you enjoyed what you heard today, please don't forget to give us a rating or a review on Apple podcasts or wherever you listen. 

And while you're there, please make sure you subscribe, so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of our shows at podcast.asco.org. 

In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by ASCO Chief Medical Officer Dr. Richard Schilsky to discuss the recently released 2020 Clinical Cancer Advances report, which named the refinement of surgical treatments for cancer as the Advance of the Year. 

“A lot of the advances we’re seeing in surgical approaches now are driven by better systemic therapies for cancer. These systemic treatments have improved survival outcomes and quality of life for our patients, and have now begun to transform the role of surgery in cancer management by reducing the amount of surgery in some cases, eliminating the need for it in others, or, conversely, increasing the number of patients who could undergo surgery when it’s needed for treatment of their cancer,” says Dr. Schilsky.  

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Transcript

Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. 

Dr. Clifford Hudis: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network. This is a collection of nine programs covering a wide range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of ASCO's podcasts, including this one, at podcast.asco.org. The ASCO in Action podcast is ASCO's podcast series that explores policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for--people with cancer. 

My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of this series, and I'm delighted today to have as my guest the Society's Chief Medical Officer and Executive Vice President, Dr. Richard Schilsky. He's also an executive editor for the recently released 2020 Clinical Cancer Advances Report. In this report, ASCO identifies the most important clinical research advances of the past year across the full trajectory of the disease, from prevention and screening, to treatment and survivorship. The report also announces ASCO's Advance of the Year and updates our list of research priorities that have great potential to accelerate progress against cancer. Rich, welcome, and thank you for joining me today. 

Dr. Richard Schilsky: Thanks a lot, Cliff. 

Dr. Clifford Hudis: Now, starting at the beginning, this year ASCO has recognized refinement of surgical treatment of cancer as the Advance of the Year, and this is an area of clinical cancer research that has demonstrated the most significant progress in a year's time. I have to say, before we get into that, it seems almost poetic to me that this has happened this year because, one, we lost a leading surgical investigator in our field, Bernie Fisher, this year, and two, as I think about it, it came as a little bit of a surprise to me only because the mid 19th century was really the beginning of the century of surgery, and surgery for cancer dates back to Roman and Greek times, actually. So, can you tell us, in light of all of that, what was it that brought this back to the fore this year? 

Dr. Richard Schilsky: Over the years, we've seen a great deal of progress in developing the new systemic therapies for cancer, and this really, I think, illustrates the prescient work of Bernie Fisher in his seminal research on adjuvant therapy for breast cancer, because a lot of the advances that we're seeing in surgical approaches now are driven by better systemic therapies for cancer. These treatments have improved survival outcomes and quality of life for our patients, and they've now begun to transform the role of surgery in cancer management by reducing the amounts of surgery in some cases, and even eliminating the need for it in others. Or conversely, increasing the number of patients who can undergo surgery when, in fact, it is needed to help in the treatment of their cancer. 

Dr. Clifford Hudis: That's great to hear, because I was wondering at first if it was simply the fact that we just had a president who was a surgeon, and it's clearly about much more than that. What are some are the specific advances that you actually would cite as supporting this call out of surgery this year? 

Dr. Richard Schilsky: Yeah, I think there some really interesting reports that are summarized in this year's Clinical Cancer Advances that really speak to this issue. In melanoma, for example, there are two studies that examine the efficacy and safety of neoadjuvant treatments for patients with locally advanced disease. Australian researchers examined the combination of two molecularly targeted drugs, dabrafenib and trametinib, given before surgery in patients with stage 3c melanoma that has BRAF V600 mutation. Not only did 86% of patients on the trial respond by the time of resection, but almost half had a complete response, either obviating the need for or simplifying the surgical treatment. 

In another study, patients with stage three melanoma that was still treatable with surgery received ipilimumab and nivolumab for two cycles prior to surgery, resulting in a pathologic response rate of 77%. These studies are already changing practice, helping patients with locally advanced melanoma avoid surgery in many cases, or making surgery possible in patients with locally advanced disease who might not otherwise have been candidates for surgical resection. So this really is the year, I think, where we're seeing highly effective systemic therapies making surgery more possible where surgery can contribute to achieving better cure rates, or obviating the need for surgery where surgery is actually no longer necessary given the effectiveness of systemic treatment. 

Dr. Clifford Hudis: From your point of view, as you look at both our Clinical Cancer Advances for this year and also the totality of public health data, what role would you ascribe to federal funding in generating these advances? 

Dr. Richard Schilsky: Well, I think it's pretty clear that essentially every cancer advance begins in the basic science laboratory. It begins with new discovery, new understanding of biology, new description of mechanism of cancer progression, and the identification of novel cancer targets, and all of that basic research that's funded by NCI and NIH more broadly is the foundation for all the progress that we've made in development of new therapies, as well as prevention strategies and early detection strategies and so on. So, the federal funding is critical.  

This year's Clinical Cancer Advances Report highlights 10 studies that were supported, directly or in part, by funding from the NIH, so that highlights another important role for the federal funding. Not only is there the discovery work, but there is also the work through NCI-funded cooperative group studies and other clinical trials that actually is helping to translate those basic science discoveries into clinical trials, and more importantly, helping to design clinical trials that are not likely to be pursued by commercial interests, but that answer important clinical questions that directly impact the way patients are treated by their physicians. 

Dr. Clifford Hudis: This is the second year that ASCO has included with its Clinical Cancer Advances Report a specific set of research priorities. Can you tell us a little bit about the motivation for creating this so-called research agenda for the country, and then the criteria that are used to select these specific priorities? 

Dr. Richard Schilsky: Well, as you said, as much progress as we're making, there still is substantial unmet need, and so we need to continue to accelerate progress in many areas and focus our resources, so we launched ASCO's list of research priorities to accelerate progress against cancer by sparking momentum in those areas of research where the opportunity is really ripe to spur new advances. The goal in doing this is to provide the cancer community with direction, or at least insight as to where to focus their investments and resources. The research priorities represent areas that have the potential to significantly improve the knowledge base for clinical decision-making and help us address vital needs in cancer care that remain unfulfilled. 

Dr. Clifford Hudis: Now, these priorities are nominated by ASCO volunteers and clinical experts who've worked on the Clinical Cancer Advances Report and have identified not only what the big advances are for the year, but what the unmet needs are, where the opportunities still lie to continue to accelerate our research momentum. So, they were then discussed and distilled and evaluated by various groups of ASCO experts, and what's now in the report represents our best current thinking about where we have opportunities to really have a big impact. 

And I think, if I'm not mistaken, one of the hopes for results of this is to recognize that there are areas that get a lot of research. We know there are literally more than 100 I-O drugs theoretically in development right now around the world. Our goal here, I think, is to highlight some of the areas that may not be supported directly by industry necessarily, but in fact, may be dismissed as people think about high-impact targets. There are some places where we need to make progress in order to offer the most patients the greatest benefit. 

Dr. Richard Schilsky: I think the research priorities are not necessarily what might be thought of as underrepresented areas of research, but they are areas where ASCO feels that there is opportunity to have a big impact, because there's already sort of a glimmer of progress being made in these areas, and we believe that with further investment and prioritization, we can really much more rapidly accelerate progress in these areas. And the research priorities are by intention fairly broadly stated, because we're talking in the research priorities not necessarily about a specific disease or a specific target, but really a specific approach or an area where we believe we can have broad impact by focusing on a specific population or a way in which we can use therapy more effectively or with less toxicity. 

Dr. Clifford Hudis: So as an example, and just making it up, but a difficult to treat disease where there is not, again, meaningful scientific advance actually wouldn't make the list because there's not really an opportunity right now in our minds, right? 

Dr. Richard Schilsky: Absolutely. And in fact, when you look at the list, you'll see that there are no specific cancers that are called out in the list. The list is really about specific populations, specific approaches, ways in which we can better utilize available therapies or limit the toxicities of available therapies so that overall, the impact of treatment is greater for the particular patient population. 

So then why don't we just dive right in and talk about what are some of the research priorities that made the list this year. 

There are eight priorities this year. They really fall into three major thematic areas. The first of those is getting treatments to the patients who can benefit from them the most and sparing the toxicities and costs of treatment for the patients who would benefit the least. So, two priorities in that area are identifying strategies that predict response and resistance to immunotherapies. 

So these are therapies that we already know can have an enduring impact on a small proportion of patients across a variety of different diseases, and the real question is, who are the patients who are likely to receive that long-term benefit, and who are the patients who are unlikely to benefit and understand why, but also if the patients are not going to benefit from those therapies to then turn to alternative treatments with fewer toxicities. Another priority in this area that sort of echoes of the advance of the year is to further understand how to limit the expensive surgery by optimizing systemic therapy, and this really gets back to the whole concept of adjuvant therapy in many ways, where we know that many patients who receive adjuvant therapy either don't need it or don't benefit from it. And what we want to be able to do is to tailor adjuvant therapy in such a way that it has the greatest impact on the population that needs it the most. 

Now, the priorities are also focusing on improving treatment and care of special populations, emphasizing the importance of improving representation of these populations with clinical trials so that we actually have reliable data to better inform treatment approaches. A few priorities in this thematic area include increasing precision medicine research and treatment approaches in pediatric and other rare cancers, optimizing care for older adults with cancer, increasing equitable access to cancer clinical trials so that more patients can benefit from those studies, and importantly, reducing the adverse consequences of cancer treatment, particularly in long-term survivors who, in a sense, have to live with the consequences of their cancer and its treatment for the rest of their lives. 

Finally, but not least, the research priorities focus on reducing the risk of cancer and on detecting it early. So, there is a priority on reducing obesity's impact on cancer incidence and outcomes, I know that's been of particular interest of yours for many years, and then on better identifying premalignant lesions and predicting when treatment is needed. We know from the natural history of many premalignant cancers that they never will evolve to invasive cancer, and so there's a risk of over-treating people based on a diagnosis of a pretty invasive cancer. We want to better understand the biology and natural history of those circumstances so that the patients who need treatment will get it and the patients who can safely forgo it can skip it. 

Dr. Clifford Hudis: Yeah, and one can imagine in the years ahead that that will actually, if you will, leap into even low-grade, but invasive cancers and start to help us know who actually needs therapy and you can just have a cancer-- 

Dr. Richard Schilsky: Yeah, I'm sure you could do many hours of podcasting about DCIS and the controversy surrounding that type of cancer. Of course, the same is true in prostate cancer and other cancers that have a diverse natural history. There are clearly circumstances where patients who have early stage, but biologically indolent cancer may not need treatment or may not need aggressive treatment. We just have to be able to identify who those patients are. 

Dr. Clifford Hudis: Right. So, for people who are intrigued by this, and I hope you are, I encourage you to take a look at the full and detailed list of the research agenda by visiting asco.org/cca. That's asco.org/cca, and there, you can take a deeper dive into all of these items. Now, Rich, if we were to succeed and direct the right resources to these priority areas, how would you see this actually transforming patient care in the next few years? 

Dr. Richard Schilsky: Well, at a high level, I think it's-- we hope it'll dramatically change the care of cancer patients and allow more patients to get the right treatment at the right time, and of course, enabling them to live longer, fuller, better lives. It's really all about understanding the biology of each person's cancer, its likely natural history, its vulnerabilities, and then developing a treatment plan that is optimized for the care of that particular individual. 

Dr. Clifford Hudis: Now, we recognize-- and we touched on this already-- that we can't do all of this within ASCO, and we don't have the ability to specifically direct research programs. So, what is it that would satisfy us that the cancer community is responding to this goading, if you will, and is trying to make progress? What would be the indicators that you would find? 

Dr. Richard Schilsky: Well, as you said earlier, I mean, we continue to vigorously advocate for increasing federal funding for cancer research, which is the foundation of all the basic science breakthroughs that enable everything that flows from that in terms of development of new molecular diagnostics and treatments, so we want to continue to be aggressive in advocating for that improved funding. We clearly still need better prevention and screening approaches. We saw very little in the way-- other than vaccination, as we discussed earlier, and a few drugs, like some of the drugs that are approved to treat or reduce the risk of breast cancer in high-risk individuals, we saw very few effective prevention strategies. We need a lot more research on how to identify what those strategies might be and how to bring them to fruition. 

We have a lot of opportunity that can really only be supported through federal funding to do what's often referred to as comparative effectiveness research. The pharmaceutical company's job is to bring new drugs to market, not to necessarily show which drug among many is the best drug for an individual person. And yet, we know that patients and doctors are confronted with these decisions all the time, particularly when there are several approved drugs in a given indication. Which is the best one to use, which is the least toxic, which is the one that's likely to produce the best outcomes for my particular patient? Those are questions that can be answered through comparative effectiveness studies that can be funded by federal funds. 

And then finally. Breakthroughs on rare cancers. Rare cancers are not necessarily a focus for commercial drug development because they represent small markets. Now, we are beginning to see with the FDA approval of some histology agnostic drug approvals that even drugs that target very rare molecular alterations can potentially be attractive to the pharmaceutical industry. Because in the histology agnostic approval, it opens up a much broader market. But rare cancers otherwise are likely to not get the attention of commercial developers, and we need federal funding to support research in those areas, to be sure. 

Dr. Clifford Hudis: So really, our hope with these priorities is that we stimulate the entirety of the research and treatment ecosystem to think about these studies, to support them, design them, and enroll patients on them given the opportunity, right? 

Dr. Richard Schilsky: Well, that's exactly right. And the whole ecosystem has a role to play in bringing drugs from the discovery phase, through development, through ultimate commercialization, and then the effectiveness research then follows on after the commercialization so we really actually understand how the drugs perform in real-world populations, many of whom never get the opportunity to participate in the pivotal clinical trials. 

So fundamentally, this can all be understood as advocacy. And in that regard, I guess it's reasonable, or at least our listeners may wonder what steps they and ASCO members in general can take to urge Congress to support these policies and support the critical cancer research that we're highlighting. 

The easiest thing for ASCO members is to contact their members of Congress through ASCO's ACT, A-C-T, Network, which they can access at asco.org/actnetwork, and there, they can easily generate a letter advocating for federal support for cancer research to their congressmen and their senators. And I can't stress enough how important it is that all members get involved in this advocacy work. There are also opportunities for people to come to Washington to participate in ASCO's Hill days and to get involved in ASCO's other activities through the Government Relations Committee and other work that their society is doing on their behalf. 

Dr. Clifford Hudis: Well, this is great. In just about a half an hour here, we've covered a large amount of material and a lot of progress. Maybe at the risk of some redundancy, what do you think, in summary, is the takeaway that you hope that listeners and everyone reading the Clinical Cancer Advances Report takes away? 

Dr. Richard Schilsky: It's a bit hard for me to sort of grapple with this from time to time, but I've now been an oncologist for 40 years, and over the 40 years of my career, when you look at it through that broad span of time, I really feel like I've seen remarkable progress that we have made together in understanding cancer biology, developing far more effective and less toxic therapies, developing much better supportive care strategies, and we're now really beginning to see that at the population level with this substantial fall in cancer mortality rates that you alluded to earlier that's been occurring now year over year over year for at least the last two decades. And this year, as you suggested, it's being attributed, at least in part, to far more effective treatments for cancer than we've ever had in the past, particularly for lung cancer, which is still the nation's biggest cancer killer, but for which we have far better therapies than we've ever had before. All of this comes only from a sustained commitment to research, from having an ecosystem, as you suggested earlier, that's committed to making progress in every cancer type for every cancer patient. And I am remarkably optimistic as we now head into a new decade that the pace of progress is going to continue to accelerate in a very unprecedented way. 

Dr. Clifford Hudis: Yeah, I agree. I mean, it's been interesting to watch the advances I think one of the places where we have to acknowledge frustration on the part of our members and community and the patients we serve is that the advances are often very pointed because of scientific breakthroughs, and they are profound, and meaningful, and they transform disease, but the totality of the burden of cancer remains substantial. For some reasons outside the scope of this discussion, it will even continue to grow on a global level. So, we have a challenge here to celebrate real advances while respecting the fact that we have a lot of progress ahead, right? 

Dr. Richard Schilsky: Our work's not done, but it's gotten a lot easier, and in many ways, a lot more fulfilling. 

Dr. Clifford Hudis: Well, Rich, I want to thank you again, both for leading the production of this report, and for joining me today on this ASCO in Action podcast to talk about it. I encourage our listeners, again, to read the full report by visiting asco.org/cca. 

Dr. Richard Schilsky: Thanks, Cliff. This is really a fun project for me to work on every year with wonderful ASCO volunteers, and I hope our members will enjoy reviewing all the advances summarized in the report this year. 

Dr. Clifford Hudis: For those of you listening, if you enjoyed what you heard today, please don't forget to give us a rating or a review on Apple Podcast or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org. Until next time, thank you for listening to this ASCO in Action podcast. 

Disclosure: Dr. Schilsky reports serving on the board of directors for the Reagan-Udall Foundation for FDA and research grants to ASCO in support of a clinical trial from the following companies: AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Meyers Squibb. Genentech, Lilly, Merck, and Pfizer. 

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis is joined by Dr. Jeffrey Ward, a leading contributor to the society’s updated Patient-Centered Oncology Payment (PCOP) model, to discuss how PCOP can improve patient care and lower costs.   

“If we don’t find a way to bend the cost curve, we’re not going to be able to fulfil the mission to take care of our patients,” said Jeffrey Ward, MD, FASCO.  Currently the clearest way to move from fee-for-service to value-based care, notes Dr. Ward, PCOP “will invigorate our specialty and our practices” and “improve the way we give care.” 

Take the ASCO Podcast Survey and help improve our podcast program: https://www.surveymonkey.com/r/ascopodcasts 

Transcript

Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network. This is a collection of nine programs covering a wide range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of ASCO's podcasts, including this one, at podcast.asco.org.

The ASCO in Action podcast series explores policy and practice issues that impact oncologists, the entire cancer care delivery team, and most importantly, those individuals we care for-- people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series.

For today's podcast, I'm delighted to have as a returning guest Dr. Jeffery Ward, past chair of ASCO's Government Relations Committee. He's here today to talk with us about ASCO's newly updated Patient-Centered Oncology Payment model, or PCOP. This is an alternative payment model which he had a major role in authoring and developing. Dr. Ward, who in many respects could be considered a Founding Father of ASCO's payment reform initiative, is going to tell us more about the significant updates in this model, its goals, and how it could work to improve care for patients with cancer. Welcome, Dr. Ward.

Dr. Jeffery Ward: Thank you. Good to be here.

Dr. Clifford Hudis: Jeff, I'm going to dive right in. I've called you a Founding Father because you played such a critical role in shaping ASCO's more than five yearlong effort to develop a viable alternative to the current pay-for-service reimbursement system. Before we get into the updated model, can you tell our listeners a little bit about how we got here today? Why are you a Founding Father?

Dr. Jeffery Ward: Well, my recollection is that it actually began about eight years ago, but it took three years to get a work product. Through an intermediary, the Brookings Institute, they asked ASCO if we had any ideas or offerings that the Congressional Budget Office could score as savings without driving oncology out of business.

At the time, I was a brand-new CPC chair, and waiting with Rocky Morton from Iowa. We pulled together-- the CPC steering committee-- about 15 doctors, mostly from community practices, and had some fairly heated meetings focused on what has proven, over time, to be a very tall peak to climb-- alternatives to buy-and-bill chemotherapy.

At the end of the day, we told the supercommittee that we had nothing for them but promised to stay engaged. That wasn't a good feeling. It wasn't a good day. And we decided that that wouldn't happen again. So, we put together a payment reform workgroup consisting of community, hospital, and academic-based oncologists, pulled in a lot of ASCO support staff, and hired a consultant-- or mediator-- to try and keep us focused. The only prerequisite to be on this group was that you had to be reform-minded, and our task was to forget everything that existed and propose a novel reimbursement model.

Dr. Clifford Hudis: Well, that brings us right to the current day and we recently put out the update of this. The official name is the ASCO Patient-Centered Oncology Payment, which is a community-based medical home model-- or PCOP for short. But at a very high level, can you tell us, what does this updated PCOP do? What makes it unique as an alternative payment model?

Dr. Jeffrey Ward: I think at a high level, it makes the oncologists responsible for being a good steward of our cancer care delivery system-- I think, arguably, the best cancer care delivery system in the world-- without making us responsible at the same time for what the market will bear-- drug prices that are both ridiculous and entirely out of our control. So, I think it aligns what we aspire to and how we get aid into one cohesive model.

Dr. Clifford Hudis: What are the specific approaches that our PCOP uses to make sure that patients have access to high-quality care, and practices have the resources they need to provide that care? And you alluded to the tension already, but I'll clarify, maybe, even more. There are those critics who will say that doctors should be focused solely on quality of care and outcomes for individual patients. And there are many others in our community who make very clear arguments for our responsibility to society to balance benefits against costs. So how do we thread that needle?

Dr. Jeffrey Ward: Well, I don't think that that's a dichotomy. I think what you have to do is, you have to say, those two goals can and should be married into a cohesive model of both delivery of care and reimbursement. PCOP actually has two reimbursement models. It has a starter track. It'll be familiar to followers of Medicare's oncology care model demo. It takes a performance-based reimbursement system and puts it on the backbone of traditional fee-for-service. But there's one big difference, in that it doesn't hold practices responsible for drug list prices.

Then there's an advanced track that's really closer to the original payment model we first published in 2014. It transitions fee-for-service oncology to monthly bundled payments and replaces the margin on drugs with a suitable pharmaceutical management fee. Critically, both tracks then marry the reimbursement model with an oncology medical home model of care and value-based clinical pathways in an effort to hold us responsible for care management and appropriate utilization of oncologics that, I believe, broadly applied, would put downward pressure on pharmaceutical drug prices without putting practices in the middle anymore.

Dr. Clifford Hudis: I want to drill down a little bit on this oncology medical home framework. What would it actually take for a practice to engage in this, and how would a patient perceive benefit?

Dr. Jeffrey Ward: For a practice to be able to say, “we're going to do this”, they would start, probably, with the simpler track and work their way up. In the advanced track, the PCOP payment methodology actually involves three components. There are monthly payments, there is residual fee-for-service reimbursement, and then there's performance incentive payments. Practices are held accountable for providing high value, evidence-based care under three different performance categories. These three scores of equal weight then contribute to a score that, done well, improves your reimbursement. Done poorly, it lowers your reimbursement. And though it's contrary to business as usual, I think it's hard to argue that it shouldn't, particularly when you as a practice had a role in creating the parameters themselves.

Dr. Clifford Hudis: What happens-- just for people who might either be interested in this, but haven't participated, or for people that are approaching this slightly more academically, you're going about your business and you're in a practice. What triggers you to start doing this? Another is, why don't you just put your head down and keep doing things the way you have?

Dr. Jeffrey Ward: I think for several reasons. One reason is that we have a system that isn't going to be able to continue the way it is. There's no doubt that prices are accelerating in such a way that, if we don't find a way to bend the cost curve, we're not going to be able to fulfill the mission we have to take care of patients.

The second reason is that this is a pathway that actually is going to improve the way we give care. The struggle we have with fee-for-service medicine in general is that it rewards the provider for doing more. This effect is amplified dramatically when you apply it to the cost of drugs. On the other hand, value-based pathways-- what we've built into this-- that look at efficacy first, toxicity second, and cost as a tiebreaker, can reward me for using the right drug in the right patient at the right time. And a well-constructed pathway will avoid both over and under-utilization of therapies. And that helps make PCOP, I think, uniquely different from payer-mandated pathways because it's a prospective pathway agreed upon by the providers and the payers in a transparent and collaborative way. So, there's several things, I think, that we've done to try and combine both reimbursement and care into one cohesive model, instead of two separate tracks that incentivize different things.

One other aspect of this-- beyond the internal control that you have with pathways-- is, of course, that nobody practices in a vacuum. And I understand a major element of the PCOP design is its emphasis on implementation in communities that include multidisciplinary providers and practices. It also includes, at least theoretically, multiple kinds of payers-- federal and state on the one hand, and then private on the other, the latter including employers. And finally, it can include patients with some mobility and span regional health networks.

Dr. Clifford Hudis: I guess I have two questions. One, what is the benefit of this broader approach to the PCOP model? And the second is, what are some of the challenges that that brought?

Dr. Jeffrey Ward: I think one thing that's really unique in the update in the model-- it's certainly not something that we had envisioned initially, and it's why evolution, I think, of the model is important-- is the recognition that quality improvement happens slowly if you're in a silo. And so PCOP is really designed to bring together geographic communities of providers, payers, policymakers, and then it yokes them together to the patient's benefit. It allows for efficient sharing of best practices. One of the things that being involved, I think, in both the Washington State Medical Oncology Society here in my state and in ASCO at the same time has taught me that being collaborative helps our patients a whole lot more than being competitors.

Dr. Clifford Hudis: I asked this question a little bit before, but now, even thinking about networks and collaboration, I'm going to ask it again and maybe push, even, a little harder. But in practice, how do you implement PCOP? How does a practice go from, it's Tuesday morning and we're running along the way we have since 2003, and it's Wednesday and now I'm in PCOP? What actually do you do to engage?

Dr. Jeffrey Ward: Yeah, I do think that there is a bit of a hurdle there. But there are also, I believe, some natural places that this could happen and get a foothold, and that once people see how this model worked and how effective it was, that it would certainly gain in popularity. I think Medicare Advantage plans, Medicaid HMOs, some accountable care organizations in particular have really struggled with, how do we manage oncology? And one way to do it is to partner with the providers and be able to manage together, and PCOP would be a godsend for some of those payors.

Dr. Clifford Hudis: Well, I think-- not to get too inside the beltway about this-- we know for sure that the bandwidth and resources within CMS right now-- in CMMI, rather-- are limited enough that it is unlikely that they will wholesale adopt our model. And that leaves two possibilities. One is, they may take pieces of it as they upgrade the existing model. The other is that we might go it alone-- that is, outside of the Medicare system. But I think, in either case, we're really hitting on something which I wanted to get out there. It feels to me like it isn't ultimately-- narrowly-- up to the practice to adopt this. It's up to the payers to press practices in this or another direction. This is a response to pressure from payors. Do I have that right, or am I off base on that?

Dr. Jeffrey Ward: I think different communities feel pressures differently. In Washington state, I think we've been a little bit slow for our payers to step in and begin pressing us for alternative payment models. It's been more common in other places. But I do think that practices should consider this their counterproposal to some of the draconian efforts that we're seeing payers develop in other parts of the country. It's going to be a whole lot easier, I think, long-term if we're working together than if we are at odds.

And as-- this really raises two questions, a narrow one about the ideal practice setting for this, and the other is about the resources necessary to make this step. So, I guess my question is, do you think that this is targeted specifically at small community practices, or is it applicable to other types of practices? And related to that, can you talk about how ASCO itself is able to provide additional support for people that might want to do this?

I know that the concepts in PCOP can improve patient care and they can lower costs. I think it would ultimately invigorate our specialty and our practices if we were to move in this kind of direction. We know our current system is unsustainable, and ultimately won't be good for us or our patients. This represents a real opportunity that, as they say, you're either at the table or on the table.

Dr. Clifford Hudis: Well, ultimately, for this to succeed, it has to fill a need, or it has to help with something. We know that the majority of practices are dealing with a variety of meaningful, serious pain points. Our most recent ASCO Practice Census found that almost 60% of practices found payer pressures-- or cited payer pressures as their top concern. How would the PCOP reduce that pain for those practices?

Dr. Jeffrey Ward: Well, somebody's going to listen to this and they're going to think I'm a complete Pollyanna. But I really think the biggest reason for the enmity between the providers and payers is that we're playing with two different sets of rules. And PCOP allows for setting the rules for both of us. So if our focus is on the patient-- and I really do think that most payers want a patient focus of care-- I think we can find common ground around PCOP once we get together and start talking to each other instead of talking at each other.

Dr. Clifford Hudis: Do you think that this is-- or how big of a part do you think this is in the ongoing transformation from fee-to-service to fee-for-value-- in other words, the conversion to value-based care? Is this ultimately how we get there, or do you think there'll be other routes that practices can follow?

Dr. Jeffrey Ward: I'm certainly not going to say there's only one way to do anything. But I think-- I could certainly get in trouble in some circles for saying this out loud, but I think that the demise of fee-for-service medicine and buy-and-bill chemotherapy is coming. I think ASCO should take the lead in implementing the change. I think oncology as a community should take that lead and then improve on it. So, I don't think this is the end-all. I think there could be other ways to do it. But right now, I think this is the clearest way to get there.

Dr. Clifford Hudis: If you talk to policymakers and you listen to candidates on the campaign trail, health care costs in general-- drug prices specifically-- are clearly at the top of the agenda and get a whole lot of rhetoric these days. So, if PCOP were to be implemented, how do you see it actually changing the cost of care? Where would the cost savings come from? And I think, alluding back to the comment you made before regarding fee-for-service, how confident are you in the ability of the health care system to distribute high-quality providers and access to care the way we need it, to be sustained? Because that obviously is sustained in part by the fact that people can make a living doing this.

Dr. Jeffrey Ward: Yeah. Data and experience tells us that the savings available through triage pathways, proactive patient-reported outcomes, efficient use of hospital facilities to limit ER visits and hospitalizations can produce real savings. The savings that occurred in the United Healthcare demo all came out of those kinds of savings, not from changing drug prescribing habits, or at least drug costs. I think there's also sufficient evidence to believe that value-based clinical pathways do bring savings. And I think there's a lot of improvement yet to be done in that arena.

Dr. Clifford Hudis: ASCO has estimated that PCOP could bend the total cost curve for cancer care by 8%. That's huge. It doesn't try to measure the impact that widespread use of value-based pathways may have on drug prices. In my opinion, if everybody was on a value-based pathway, the only way to move up on the pathway if you're a drug company may be to lower your price, and we may see competition on list prices. That's something that's never happened in brand-name drugs today. I think that there's an opportunity, if this caught on and large numbers of practice were doing it, to actually bend the cost curve on drugs beyond just the 8% that ASCO has estimated so far.

And-- I'm just curious. You alluded already to the fact that the Center for Medicare and Medicaid Services model-- the pilot program, which was the first oncology alternative payment model, called the OCM-- that it's actually about to sunset. And you talked already about that pressure of time-- and I'm thinking about cost control, which is really their issue-- how does PCOP build on what we've learned from OCM? There must be some lessons that we can then implement in round two here, no?

Dr. Jeffrey Ward: Yeah, I think there is. And we've answered some of this in our discussion already. The amount of data that the practices have access to has really allowed them to fine-tune their practices and lead the practice transformation. Unfortunately, we've had to hire actuaries to figure it out, but that may be the price of success. We've tried to take the good-- we have OCM incorporated into our new proffered PCOP-- and leave the bad.

As we've mentioned, I really believe the Achilles heel of our OCM is that it puts drug list prices front and center and makes providers responsible for them. I know that CMMI has doubled down on this, and they believe that they can win their way into limited risk. But it still makes winners and losers based on luck of the draw-- based on who walks in your door. So, I really hope that CMMI will take a hard look at PCOP-- test as it is, or tear it apart piecemeal and use its best parts to improve OCM. It would be a shame if OCM was thrown out as a failed experiment just because it hasn't reached a point where people are ready or capable of taking two-sided risk.

Dr. Clifford Hudis: We've covered a lot, and yet we've, I think, just begun to scratch the surface. So, if a practice listening to this-- a payer, if an employer or any other stakeholder has their interest piqued by our discussion and wants to implement PCOP, or just wants to learn more, what should they do? Who should they contact?

Dr. Jeffrey Ward: Well, I think that first they can head to the ASCO website at asco.org. They can also reach out to Clinical Affairs Department at [email protected].

I think that-- for those of you that didn't get a chance to write it down, I would just urge you, clinical affairs as written as one word. So [email protected]. That's an attended email box. And frankly, by coincidence, I happened to be looking for the PCOP article this morning. And if you just Google PCOP and ASCO, one of your first few hits will be the 64-page PDF with a nice introduction from our current president, Skip Burris.

Dr. Clifford Hudis: I do encourage people to follow Jeff's lead and dig into this, and start to familiarize yourself both with the specifics, but also with the concepts. I think this is likely to be a long-standing conversation and a gradual evolution for our community. So, with that, Jeff, is there anything else you want to add? Do you think we've missed any important topics as we are closing out this conversation today?

Dr. Jeffrey Ward: I'm sure we have. I can't think of them.

Dr. Clifford Hudis: Well, I do want to thank you for joining me for this particular ASCO in Action podcast. It's always nice to have you back. And we look forward to hearing about the progress of PCOP and hearing even from CMMI what their review of it is in the months ahead.

Dr. Jeffrey Ward: It's exciting times. Thanks.

Dr. Clifford Hudis: And for those of you listening today, if you've enjoyed what you heard, don't forget to give us a rating or review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss an upcoming episode. The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org. For now, and until next time, thank you for listening to this ASCO in Action podcast.

Survey Promotion: If you like what you hear from the ASCO podcast, please let us know. Take our listener survey and help shape the future of the ASCO Podcast Network. Visit podcast.asco.org click on the Survey link. Once again, that's podcast.asco.org. The survey will just take a few minutes to complete and will help us get to know you better. Thank you so much for listening.

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis, discusses updates that will affect oncologists in the 2020 Medicare Physician Fee Schedule final rule, which outlines changes to Part B reimbursement policies and the Quality Payment Program.  

ASCO’s goal will always be “to ensure that oncologists can provide the right treatment, at the right time,” says Dr. Hudis, “and we aim to help CMS implement policies that advance that goal.” 

Take the ASCO Podcast Survey and help ASCO improve its podcast program: https://www.surveymonkey.com/r/ascopodcasts

Transcript 

Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  

Dr. Clifford Hudis: Welcome to the ASCO in Action Podcast, brought to you by the ASCO Podcast Network, a collection of 9 programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org.

The ASCO in Action Podcast is ASCO’s podcast series that explores the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for—people with cancer.

I’m Dr. Clifford Hudis, CEO of ASCO and the host of the ASCO in Action podcast series. For this podcast, I wanted to provide a quick update on an important announcement from the Centers for Medicare & Medicaid Services, which of course we refer to as CMS on this podcast.

In early November, the agency released its final rule for the 2020 Medicare Physician Fee Schedule—commonly referred as the “physician fee schedule”—and other changes to Medicare Part B reimbursement policies, including proposed updates to the Quality Payment Program.  

Just to review, the physician fee schedule is a complete listing of fees that Medicare uses to pay doctors or other providers and suppliers. It is also a comprehensive listing of maximum fees that is updated each year and used to reimburse providers on a fee-for-service basis.

At ASCO, we always review this rule closely and assess its likely impact our members and, most importantly, our patients.

The top takeaway from the rule is that CMS estimates a zero percent overall impact for the hematology/oncology and radiation oncology specialties in 2020.

Though it’s important to note that the actual impact on individual physician practices will depend on the mix of services the practice provides, and practices in certain states may see a change due to the elimination of the 1.0 threshold previously applied to the geographic practice cost indices.

CMS also finalized provisions to align Evaluation & Management (or E&M) coding with changes laid out by the CPT Editorial Panel for office/outpatient E&M visits.

This is a welcomed update that comes after ASCO and other stakeholders expressed concerns that earlier CMS proposals to consolidate E&M codes would have diminished the resources available to care for Medicare beneficiaries with cancer.

We appreciate the fact that CMS listened to our perspective and revised its plans to better serve people with cancer.

The physician fee schedule rule also finalizes updates to the Quality Payment Program for 2020 and beyond.

A key update to the Merit-Based Incentive Payment System (or MIPS)—one of the Quality Payment Program’s two tracks—is that all four MIPS performance categories will remain at their 2019 weights in 2020, but the performance threshold, which is the minimum total MIPS score needed to avoid a negative payment adjustment will increase to 45 points in 2020 (up from 30 points in 2019).

CMS also finalized its plan to establish “MIPS Value Pathways” (or MVPs) beginning in 2021.

CMS has described MVPs as a way to reduce the burden of participating in MIPS and for CMS to collect more meaningful performance data.

The MVP framework would connect activities and measures from the four MIPS performance categories that are relevant to a patient population, a medical specialty, or a specific medical condition such as cancer.

For years, ASCO has encouraged the use of high-quality oncology clinical pathways to help ensure patient access to high-quality, high-value cancer care. We are hopeful that this provision in the CMS final rule is a move in the right direction.

We have also appreciated CMS’ recent efforts to reduce administrative burden for providers. MVPs, if implemented appropriately, may help improve the quality and accessibility of cancer care. We will continue to work closely with CMS as it implements this new provision.

I hope this summary of the updates to the physician fee schedule for 2020 was helpful to our listeners.

Our ultimate goal is always to ensure that oncologists can provide the right treatment, at the right time, and we aim to help CMS implement policies that advance that goal.

To that end we will submit detailed comments on the final rule during the open comment period, to ensure CMS understands the needs of the oncology community, and the full impact this rule is likely to have.

If you’d like more information on Medicare physician reimbursement in 2020, please visit the ASCO in Action website at asco.org/ascoaction.

Until next time, thank you for listening to this ASCO in Action podcast and if you enjoyed what you heard today, don’t forget to give us a rating or review on Apple Podcasts or wherever you listen and while you are there, be sure to subscribe so you never miss an episode.

The ASCO in Action Podcast is just one of ASCO’s many podcasts; you can find all of the shows at podcast.asco.org.

Survey Promotion: If you like what you hear from the ASCO podcast, please let us know. Take our listener survey and help shape the future of the ASCO Podcast Network. Visit podcast.asco.org click on the Survey link. Once again, that's podcast.asco.org. The survey will just take a few minutes to complete and will help us get to know you better. Thank you so much for listening.