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ASCO in Action Podcast

American Society of Clinical Oncology (ASCO)

The ASCO in Action Podcast provides analysis and commentary on cancer policy and practice issues. The podcast is hosted by Dr. Clifford Hudis, CEO of the American Society of Clinical Oncology. ASCO in Action, the society’s internal wire-service, provides the latest news and analysis related to cancer policy. These updates provide snapshots of ASCO’s ongoing advocacy efforts, as well as opportunities for ASCO members and guests to take action on critical issues affecting the cancer community. Music provided by gmz, via ccmixter.org.
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In this interview, ASCO President Dr. Howard A. “Skip” Burris discusses why he became an oncologist, the importance of mentors in his career, the most significant changes he’s witnessed in cancer care during the past three decades, and his vision for the coming year as he serves in this top volunteer position. Dr. Burris stresses that we can’t “divide and conquer, to conquer cancer,” a message underscored by his ASCO presidential theme, “Unite and Conquer: Accelerating Progress Together.”

Find all of ASCO's podcasts at podcast.asco.org

Shannon McKernin: Hi. My name is Shannon McKernin, and I'm the host of the ASCO Guidelines Podcast series. When a new ASCO guideline publishes, we release a podcast episode featuring an interview with one or more expert panel members. Each episode highlights the key recommendations and the implications for patients and providers. You can find the ASCO Guidelines Podcast series on Apple Podcasts or wherever you're listening to this show, and you can find all nine of ASCO's podcasts, which cover a wide range of educational and scientific content and offer enriching insight into the world of cancer care at podcast.asco.org.

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 offering enriching insights into the world of cancer care. You can find all of ASCO's podcasts including this one at podcast.asco.org.

This ASCO in Action podcast is part of our series exploring policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals who care for people with cancer. My name is Clifford Hudis, and I am the CEO of ASCO as well as a host of the ASCO in Action podcast series.

For today's podcast, I am delighted to be joined by Dr. Howard, or "Skip", Burris. He's ASCO's president for the 2020 term, and if we're lucky today, we'll find out why he's called Skip. In the meantime, Dr. Burris is joining me to share his vision for his presidential year. That is what he hopes to accomplish by this top ASCO volunteer leadership position is an opportunity to leave a lasting mark on our organization and indeed the larger oncology community. Skip, welcome and thank you for joining me today.

Howard “Skip” Burris: Thank you for having me. Looking forward to the conversation.

Clifford Hudis: So, Skip, every one of us comes to oncology for individual reasons and personal motivations, and I know that's true for you as well. So before we get into the details of your current role at ASCO, I think our listeners will be interested in learning why you became a medical oncologist when there are so many places to go in medicine, so many exciting specialties, what was it that drove you to choose taking care of patients with cancer for your career?

Howard “Skip” Burris: Interesting question and story. I was driven to medicine really thinking that I wanted to do something that was meaningful, something that helped others. And I was influenced by actually a number of friends whose fathers were physicians when I was in high school. And as I initially went into the medical field, I thought surgery was so exciting, and I actually spent many of my electives doing surgical sub-specialties and in particular thoracic surgery. And it was an exciting time in the '80s with heart transplantation and bypass surgeries.

And yet I also was dissatisfied with the fact that it seemed transactional. While important, and certainly lifesaving for those patients, these were surgeries and then, quote unquote, were done taking care of that patient. And then I had a seminal moment after rounds one day when we were in the intensive care unit. And I was talking to a patient, and the team moved on. And my attending yelled at me, “hey, Burris, what are you doing?” I looked at him and he said, “Come on. He's fixed. Let's go.”

And I half smiled and I thought, well, this guy's got such an interesting story and he was terribly appreciative of the care he'd receive, but he looked at that attending as somebody had truly had saved his life. And so fast forward to fumbling through internship and trying to fi...

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Dr. Melissa Dillmon, the Chair of ASCO's Government Relations Committee, joins ASCO CEO Clifford A. Hudis to discuss improving access to clinical trials for patients with Medicaid. Medicaid covers 20% of Americans, however unlike Medicare or private insurers, Medicaid is not federally required to cover the routine care costs associated with clinical trials.

Find all of ASCO's podcasts at podcast.asco.org

Transcription Shannon McKernin: Hi. My name is Shannon McKernin, and I am the host of the ASCO Guidelines Podcast series. When a new ASCO guideline publishes, we release a podcast episode featuring an interview with one or more expert panel members. Each episode highlights the key recommendations and the implications for patients and providers.

You can find the ASCO Guidelines Podcast series on Apple Podcasts or wherever you're listening to this show, and you can find all nine of ASCO's podcasts, which cover a wide range of educational and scientific content and offer enriching insight into the world of cancer care, at podcast.asco.org.

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

For today's podcast, I am really delighted to be joined by Dr. Melissa Dillmon-- Missy-- the chair of ASCO's Government Relations Committee, and a longtime dedicated ASCO volunteer.

Now, regular ASCO in Action podcast listeners may remember that just a few months ago, I spoke with one of our colleagues, Dr. Beverly Moy, the issue of financial barriers to clinical trial participation, and we focused on ASCO's work to address those barriers to try to make it easier for patients to enroll in clinical research studies.

Today, we're going to follow up on that. Dr. Dillmon is going to join me as we drill down deeper into one of the barriers that we've touched on previously-- in this case, the lack of coverage of routine care costs that are associated with clinical trials, but very specifically, the challenges that are faced by patients who have Medicaid.

Dr. Dillmon, welcome, and thank you for joining us today.

Melissa Dillmon: Thank you, Cliff, for having me and discussing what I think is a very timely and important issue.

Clifford Hudis: Since it's something I know you care deeply about, maybe you could start off at a high level and give us a little bit of background. What is it exactly that we're talking about here, when we talk about clinical research and coverage for patients with Medicaid?

Melissa Dillmon: So Cliff, you know that in many cases, clinical trials provide the best or sometimes the only treatment option for our patients with cancer. And we live in a time when there is an incredibly rapid pace of development, with new investigational treatments that are dramatically altering the course of cancer for the better. Patients with Medicaid have a unique barrier to accessing clinical trials because Medicaid is the only payer that is not federally required to cover the routine cost of clinical trial participation.

So Medicare and major commercial payers are required to have coverage for routine costs of clinical trial participation. Medicare provided this coverage beginning in the year 2000 after the Medicare National Coverage Determination Act protected their beneficiaries. The Affordable Care Act also requires insurers to cover routine patient care costs for trials participation. But Medicaid was not specifically called out or included in this requirement.

So today, commercial payers and Medicare are paying for the routine cost of clinical trial participation, but Medicaid is not required in any of the states by the federal government to cover these costs. And we know that these patients have financial barriers to accessing basic medical care and preventative services anyway. So this lack of mandated coverage makes it even harder for some Medicaid patients to participate in potentially life-saving trea...

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Lisa Lacasse, president of the American Cancer Society Cancer Advocacy Network, speaks passionately about the critical importance of advocacy and ACS CAN’s partnership with ASCO in reducing the cancer burden, in latest AiA podcast with host ASCO CEO Dr. Clifford Hudis.

Find all of ASCO's podcasts at podcast.asco.org

TRANSCRIPT

Ad: Hi. My name is Shannon McKernin. And I am the host of the ASCO Guidelines Podcast Series. When a new ASCO guideline publishes, we release a podcast episode featuring an interview with one or more expert panel members. Each episode highlights the key recommendations and the implications for patients and providers. You can find the ASCO Guidelines Podcast Series on Apple Podcasts or wherever you're listening to this show. And you can find all nine of ASCO's podcasts, which cover a wide range of educational and scientific content, and offer enriching insight into the world of cancer care at podcast.asco.org.

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. This ASCO in Action Podcast is ASCO's podcast 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 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 have Lisa Lacasse, president of the American Cancer Society Cancer Action Network, or ACS CAN, as my guest. Welcome, Lisa.

Lisa Lacasse: Thanks so much, Cliff. It's really great to be with you today. I appreciate the invitation.

CH: Well, I'm really delighted that you could join me today for this discussion. And I think there are probably hundreds of topics that you and I could discuss. But I want to start with the big picture first. The American Cancer Society, of course, is a very well-known, nationwide organization with a mission of saving lives and leading the fight for a world without cancer. Can you tell our guests about the American Cancer Society Cancer Action Network, ACS CAN? What's the relationship with ACS itself? And what exactly does ACS CAN do?

LL: So thanks. That's a great question, Cliff. So many are very familiar with the American Cancer Society, which is a large, old organization that attacks cancer from every angle. The Society works to advance breakthroughs in research, treatment for patients, providing direction and information to help people manage their cancer care, and also mobilizes volunteers at the community level to really support patients in their fight against cancer. But we know that the fight to end cancer doesn't just happen in a doctor's office or a scientific lab. It really requires the government and all elected officials to join us to impact the disease. And so that effort to engage government requires advocacy. And that's where the American Cancer Society Cancer Action Network, ACS CAN, steps in. And we are the advocacy affiliate of the American Cancer Society. So ACS CAN simply urges lawmakers and rallies all of our community partners to lead in the fight against cancer. And together-- the American Cancer Society and the American Cancer Society Cancer Action Network-- although we're two independent organizations, we're working towards the same mission. However, ACS CAN uses different but complementary set of tools. So we obviously resemble ACS in a lot of important ways. We're both nonprofits. We are both absolutely, obviously evidence-based. And we're both supported by a vast army of volunteers. And we all focus on the ultimate goal of eliminating cancer as a major health problem. But ACS CAN advances this mission using tools that aren't fully available to ACS. One, an electoral program called Cancer Votes, which is really an effort to educate voters on important issues to cancer. And we also do a significant amount of lobbying. And that's not just in Washington DC, but in all 50 state capitals and many, many local...

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Dr. Joanna Yang and Dr. Robert Daly join ASCO CEO Dr. Clifford A. Hudis to discuss the Health Policy Leadership Development Program (HP-LDP). As former fellows, Drs. Yang and Daly provide insight as to how the program has made them better advocates for their patients.

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. This is ASCO's monthly podcast 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 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 delighted to be joined by not one, but two of ASCO's rising leaders, Dr. Robert Daly and Dr. Joanna Yang. Both Dr. Daly and Dr. Yang are recent participants in ASCO's Health Policy Leadership Development Program, formerly known as the Health Policy Fellowship Program. This is a professional development program designed to build health policy and advocacy leadership expertise among our members. It's a one-year program where fellows get practical experience working with our policy and advocacy staff and council to craft policy positions and statements, along with other educational sessions on communication, leadership, and advocacy. Starting this year, participants will be able to participate as well in ASCO's Leadership Development Program, which offers mid-career oncologists the opportunity to improve their leadership skills and gain valuable training to set them up to be future leaders in oncology. Dr. Daly and Dr. Yang, welcome, and thank you for joining me today.

Joanna Yang: Thank you so much for the opportunity.

Robert Daly: Yes, thank you so much for having us.

CH: So Dr. Yang, I'm going to start with you. You were an ASCO Health Policy Fellow in 2017-2018. And I want to kick off our discussion by talking about what brought you to the program. Why were you interested in developing special expertise in policy work?

JY: Sure. So I've always been interested in health policy. And I had the opportunity to study health policy and health economics during undergrad. But of course, studying health policy is very different than creating or influencing health policy. When I started residency, I saw many ways in which health policy on a national level or even state level affected the patients I was caring for. And I felt compelled to do more. But the issue is that there is never any clear way for me to get involved or even to learn how I could learn how to shape health policy. And that's why the ASCO program is so great. I feel like it came at exactly the right time. I was looking for a way to learn more to develop the skills I needed to influence health policy. And ASCO came out with this structured and immersive experience where I could take the things that I had studied in school, and also the things that I'd seen in practice, and use them to actually have an impact on the patients I take care of.

CH: So Dr. Daly, you as well were one of our inaugural Fellows. What prompted your interest in applying for the program, especially given I think you were the first year?

RD: Yes.

CH: Right, so you took a leap off of the ledge there and said, I'll go first.

RD: Yeah, I'm similar to Dr. Yang. I had a real interest in cancer care delivery research during my fellowship at the University of Chicago. And I was lucky enough to be mentored by Funmi Olopade and Dr. Blase Polite. And Dr. Polite was really fundamental and helped developing the ASCO Health Policy Fellowship. And so I really saw this as an opportunity to augment that training but really gain skills in leadership, advocacy, and health policy, areas that I hadn't had exposure to in the past. So this seemed like the perfect program for me at that point in my career.

CH: I have to say parenthetically that I'm jealous of both of you, because while I was personally drawn, especially in later years in my career to the policy and advocacy aspects of work with ASCO-- and it truly is the reason that I moved from my traditional academic career to this role as CEO at ASCO-- I never, of course, had the opportunity to be trained and to learn how to do this professionally as you two have. So I am in awe of your ...

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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 A. Hudis (CH): Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast, series where we explore policy and practice issues that can 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 delighted to have as my guest, Dr. Richard Pazdur, the Director of the Food and Drug Administration's Oncology Center of Excellence.

The OCE was established to expedite the review of novel cancer therapies and products by bringing together expertise from across the FDA. And we'll touch on this a little bit during our conversation. Dr. Pazdur, welcome and thank you for joining me today.

Dr. Richard Pazdur (RP): It's a pleasure Dr. Hudis.

CH: Thanks. So I want to kick off our discussion by diving right into a hot button issue, expanded access. Can you provide our listeners with some background on this, and explain what the FDA's expanded access program is, and why an oncologist might want to pursue expanded access for an individual patient?

RP: Of course. The FDA's expanded access program provides a way that patients with serious or life-threatening diseases or conditions such as cancer can try investigational medical products for treatment when no satisfactory therapies are available, and when there is no opportunity for the patient to enroll in a clinical trial. The process-- to make a request, the patient's physicians will approach the pharmaceutical company to ask for its agreement that the company will provide the medical product.

The company has the right to approve or disapprove the physician's request. Then the physician needs to send the request to the FDA. This process can be complex to navigate, particularly for oncologists or physicians who don't have experience working with the clinical trials or these types of requests.

FDA allows the vast majority of these requests to proceed. And the FDA has been working to improve the expanded access programs for a number of years, including the development of a more streamlined application process, a more streamlined form. But for many key health care professionals, especially those not familiar with the expanded access program, this process may appear confusing or somewhat burdensome.

CH: And so is this a segue to Project Facilitate, which you announced at our annual meeting a few weeks ago? Can you talk a little bit about that and, its practical implications?

RP: Yes. The Project Facilitate call center is a pilot program only for oncology that will serve a single point of contact. We have FDA oncology staff there, oncology nurses, oncology pharmacists who will assist the physician and their health care team throughout the process to submit and expanded access request for an individual cancer patient.

This is a concierge service to support the patient's medical team throughout the process. It ranges from the initiation of the FDA form 3926. The process will also provide information about IRBs, particularly central IRBs, and really will also follow up on the status of a given patient to determine if that patient has received any benefit from the therapy and if there were any adverse events that need to be reported to the FDA.

CH: So imagine that Project Facilitate works as hoped for. What's the thumbnail before and after experience? That is, how will things appear to be different to the physicians and to the patients?

RP: It should make the process easier for physicians to get information that they need to submit an expanded access request. As I said before, it's often somewhat complicated, especially for physicians don't have experience with either the drug or with the process. And it's obviously easier to talk to somebody over the phone to ask specific questions rather than just being directed to a website.

We're also working in conjunction with Reagan-Udall Foundation for the FDA, which started the expanded access navigator website to educate patients and health care professionals about the expanded access process. This navigator approach offers information provided by companies about their expanded access policy, and now inc...

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In the latest ASCO in Action Podcast, ASCO’s President, Dr. Monica Bertagnolli, FACS, FASCO sat down with ASCO CEO Dr. Clifford A. Hudis to discuss cancer care in rural America. Improving cancer care access in rural America has been a signature issue in Dr. Bertagnolli’s presidential year, during which she has held town halls in communities across the country to discuss the real-world challenges facing patients in rural America and their cancer care teams. The podcast reveals some of Dr. Bertagnolli’s learnings from her town halls, and she explains what rural cancer care in America looks like today and offers steps to improve rural cancer outcomes in the future.

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.

Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast 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 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 delighted to have with me today ASCO's current president, Dr. Monica Bertagnolli. And we're going to be talking about cancer care in rural America. Dr. Bertagnolli has long been a champion for improving access to cancer care in rural America, and it has been a signature issue for her throughout her presidency at ASCO. Indeed, she has held town halls in communities across the US to discuss the real-world challenges that face patients and the entire care team in these locations.

She shared some of those learnings recently at ASCO's State of Cancer Care in America event, which we entitled Closing the Rural Cancer Care Gap. Today, we're going to talk about what rural cancer care looks like in America and how we can take steps to improve outcomes in these many communities. Dr. Bertagnolli, welcome and thank you for joining me today to discuss this important topic.

It's great to be here, Cliff.

So, to kick off our discussion, I'm going to ask you to describe briefly some of the disparities that currently exist between patients with cancer in rural areas compared to those who live in urban or suburban areas.

Well, just imagine that you live in a town where most things are certainly like they are anywhere else, except the hospital is a very small one. The medical care is a primary care physician and maybe a general surgeon. They can do X-rays. They can diagnose most things. But if you have a need for anything beyond the basics of care, you have to drive three, four, six hours in order to reach it.

I think, throughout our country, we really do have a health care system that gets to most people. But particularly when it's an issue of specialty care, such as a cancer diagnosis, that's not always available.

Finally, there's a lot of our country that fits in this category. By the one government agency that looks at these things, the Federal Office for Rural Health Policy, 84% of the country, of the geographic area of the United States, is a rural location. And in that 84%, 18% of the population lives. So, we think, in oncology, it's very important that we understand more about the people who live in these locations so that we can figure out how to get them what they need.

So, starting in a quantitative way is an interesting mathematical representation, that about a fifth of the country in population is distributed over more than 4/5 of the landmass. And I think that's a way of visualizing the lack of density. But there are common challenges that patients in rural areas face that go beyond just distance and geography. What are some of those that you have uncovered and thought about this year?

You know, it's important not to overgeneralize, because certainly, there are people from every single socioeconomic status and walk of life that live in rural locations, no question. But when you go into big generalities, people who live in rural locations tend to have less education level. They tend to be less affluent. They tend to have more risky behaviors, more smoking and alcohol use. And some of the things that we know are associated with cancer development in general seem to be more predominant in rural locations. And finally, citizens who live in rural locations are, again, generally less likely than ...

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Welcome to this ASCO in Action podcast. This is ASCO's podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and most importantly, the patients we care for, people with cancer. My name is Cliff Hudis. And I'm the CEO of ASCO, as well as the host of this ASCO in Action podcast series.

For today's podcast, we're going to do something a little different. We don't have a guest today. Instead, we're going to spend some time going over a quick update on an important clarification issued recently by the CDC, the Center for Disease Control and Prevention, and specifically, their guidelines for prescribing opioids for chronic pain, a very topical issue.

The clarification they issued was the form of a letter from the agency to ASCO, as well as to ASH and the NCCN. And in this letter, the clarification affirmed that the CDC guideline was never intended to deny access to clinically appropriate opioid therapy for patients suffering with acute or chronic pain from conditions like cancer and sickle cell disease.

But I want to explain first why it was important that they issue this clarification and then talk about what we have to do next. Opioid abuse in the United States is clearly a very serious issue. And the tremendous toll that it's been extracting on individuals and families across the nation is well-reported. Indeed, it was one of the reasons originally given for the passage of the 21st Century Cures Act. In fact, one of the motivations had to do with addressing some parts of the opioid crisis.

And so this just makes the point that finding a solution to the problem is among the very highest priorities that government and really the general public, as well as professional societies and advocacy groups and all stakeholders, have to be working towards. However, we do have to, at the same time, be careful that we don't overreach and cause additional harm, especially to vulnerable populations, as we take steps to reduce opioid abuse. What happened before was that there was a misinterpretation of the opioid prescribing recommendations that had been issued by the CDC.

And this resulted in part in new laws and regulations, as well as third-party payment policies that severely limited essential pain medications from patients with cancer and sickle cell disease. The consequence for them was suffering and even more prolonged hospitalizations and health care expenses.

So the challenge here was to fix this mistake. As we talk about how this happened, I want to take a moment and provide a little bit of background on this. Last spring, about a year ago I think, there were papers published, at least one in particular, that highlighted seeming discrepancies-- and I emphasize the word seeming-- between opioid use guidelines that had been issued by the CDC, the NCCN, ASCO, and others.

To their credit, the NCCN, led by Bob Carlson, responded to this by reaching out to us at ASCO and asking if we would be willing to collaborate on a meeting of the minds to identify what was true and not true in terms of those supposedly conflicting guidelines and then issue some sort of a unified statement to help address the situation.

In November of 2018, hosted here at ASCO headquarters, representatives from ASCO, the National Comprehensive Cancer Network or NCCN, the American Society of Hematology, ASH, and the CDC met to discuss the similarities, as well as the differences, among our various published respective guidelines in the area of managing chronic pain. We also discussed how to more clearly communicate to all of our respective memberships how and when practice guidelines should be applied in patient care.

While discussing the CDC guideline, it became very clear to all of us that it was necessary to issue at some point a clarification on the question of where the CDC guideline applied to patients with cancer and sickle cell. And indeed, the first action item we took after this November meeting was that ASCO, ASH, and the NCCN sent a letter to the CDC asking for clarification.

We're really happy, again, to report that this collaboration worked. Very soon after they received this letter from us, the CDC responded favorably. And in their response letter, they noted that their guideline, that is, the CDC's guideline, was initially developed to provide recommendations for primary care clinicians who prescribe opioids for patients with chronic pain outside of active cancer treatment, outside of palliative care, and outside of end of life care.

So I want to pause for just a second and make very clear the aim of their original publication was primary care docs, not oncol...

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Welcome to this ASCO in Action podcast. This is ASCO's podcast series where we explore policy and practice issues that have impact on oncologists, the entire cancer care delivery team, and most importantly the individuals who 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 delighted to have as my guest Dr. Jeffrey Ward. He's the chair of ASCO's Government Relations Committee, and a longtime active member in that area. In addition to his important contributions to ASCO over the years, Dr. Ward is a medical oncologist and a hematologist at the Swedish Cancer Institute in Edmonds, Washington.

Our conversation today will focus on utilization management in cancer care, or the policies that public and private insurers use to control the use of anticancer drug therapies, such as prior authorization requirements, restrictive formularies, step therapy, or fail first requirements, and specialty specific tiers. These are all new and complex topics for some listeners. For others, there's great familiarity. And we're going to explore all of them in the coming discussion.

In September of 2017, ASCO published in the Journal of Oncology Practice a policy statement on the impact of utilization management practices specifically directed at cancer drug therapies. In that statement, ASCO outlined its opposition to payer imposed utilization management policies that restrict patient access to high quality, high value cancer care. The statement also points to high quality clinical pathways as the best first option for ensuring the appropriate utilization of anticancer drugs and the delivery of the highest quality cancer care.

So with that as introduction, Dr. Ward, I'm delighted to welcome you to the podcast, and really looking forward to hearing your thoughts on utilization management. Thank you for being here.

It's a pleasure. Thanks for inviting me.

So to get the conversation started, can you just define first exactly what we mean by the phrase utilization management? Utilization management is classically when insurers or payers put controls over what care a patient may receive. And in our case, that usually means control of the drug therapies that they're going to get. I think that utilization management more strictly could also include when providers themselves use practices that try to strive for the highest quality care at the best price.

So that already raises the possibility that there are a number of utilization management policies that payers could employ focusing, for example, on the use of specific prescription medications or other interventions. What are some of the more common utilization management practices that are being used specifically in cancer care?

Well, I think the one that we run into every day is specialty care pricing. I was talking to the MedPack folks at Congress just a couple of months ago and began telling them the contortions we go through in a practice, where in my practice, we have seven docs. We have two full-time people who their whole job is to get authorization for drugs, and then to figure out how the people are going to pay for their co-pays that can sometimes be several thousand dollars a month. It's a restriction that I suspect the drug companies actually utilize to try and market their drug by providing co-pay support.

At the same time, I think payers build it into the pricing of their insurance. So it's become a big part of what happens. And it's almost a dance between practices and payers. But it takes a tremendous amount of time and effort. And I'm not sure that it accomplishes a whole lot.

Wow. I mean, I think there's a lot that we could unpack there. And I think for some of our listeners, it would help to frame this in even more realistic terms. We shouldn't use specific drugs or drug names. But I'm curious if you could provide a more concrete example of what exactly would happen to Mr. Smith in your office when you make a recommendation for a treatment, and what then ensues in terms of this specialty tier pricing.

Sure. So Mr. Smith has prostate cancer. And he is appropriately treated with a very expensive oral medication along with his castrate therapy. And in doing so, I write a prescription. I send that prescription to a specialty pharmacy.

They then begin doing a preauthorization process, or that preauthorization process may be done from the doctor's own office. They get preauthorization for the drug, but they find out that the patient has a 20% co-pay. This drug may cost $12,000 a year, and so the patient is now responsible for the...

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Dr. Clifford A. Hudis (CH): Welcome to this ASCO in Action Podcast. This is ASCO's podcast 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 Cliff 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 delighted to have Dr. Lowell Schnipper, chair of ASCO's Value of Cancer Care Task Force as my guest today. In addition to his extensive service to ASCO, Dr. Schnipper is the Theodore W. And Evelyn G. Berenson Professor of Medicine at Harvard Medical School, Chief of the Division of Hematology/Oncology at the Beth Israel Deaconess Medical Center, and Clinical Director of the Beth Israel Deaconess Cancer Center. He is also an Associate Director of the Dana-Farber Harvard Cancer Center and a member of the Cancer Center's Executive Committee.

Now, to provide some background for our listeners, I do want to highlight a couple of related points. First, as early as 2007, ASCO, led by Dr. Schnipper, was already focusing on rising drug and health care costs. And two, as detailed in our five-year strategic plan, almost everything we do at ASCO is aimed at helping our members and all of society achieve high-quality, high-value care for all people with cancer. Examples of the latter include our Patient-Centered Oncology Payment model, our participation in the Choosing Wisely campaign, our entire CancerLinQ project, and ASCO's Quality Oncology Practice Initiative, or QOPI, which is now available internationally.

So our conversation today will focus on one longstanding project that's part of all of this effort. And this is one that's been a critical component of our efforts going back really, starting in 2007, ASCO's Value Framework. Here, I want to note that both ASCO and ESMO have developed algorithmic scales that are designed to evaluate the benefit of new cancer therapies.

Again, ASCO's is called the Value Framework. And it was developed primarily as a physician-guided tool to facilitate shared decision making by patients and their oncologists as they select among high-value treatment options for individual patients. In our framework, the clinical benefit of a specific treatment and its known toxicity are combined, and they produce a score that we call the Net Health Benefit.

So after years of building, testing, and refinement, we recently conducted an analysis that compared the output of ASCO's Value Framework against the European Society for Medical Oncology, or ESMO's tool, which they call the Magnitude of Clinical Benefit Scale.

Dr. Schnipper, you co-authored the assessment that we're going to discuss today. And that's why I'm so delighted to welcome you to the podcast. I want to thank you, in advance, for sharing your insights with us here today. Thanks for joining us.

Dr. Lowell Schnipper (LS): It's my pleasure to join you. This is a terrific opportunity to explain a bit about what ASCO is doing and put it in the context of what other groups are doing, in particular, a group like ESMO. We started this effort, as you were pointing out, approximately a decade ago, not the Value effort, but our emphasis, as a society, on the increasing cost of cancer care for our patients.

And we wrote several manuscripts detailing the importance of doctors being sensitive to cost and, of course, providing the patients with the best opportunity for high-value care. As the years evolve, and some of the initiatives that you've already mentioned, Cliff, we felt it really important to develop a formulaic way of approaching how we, as an oncology community, might assess the clinical value of the drugs we use to treat patients with cancer and convey that, then, to our patients in the context of shared decision making.

That's really the background of this effort. And the Value Framework itself has actually evolved over about three or four years in a number of iterations. And I'm hoping that as the discussion ensues, we'll be able to get into that in more detail.

That's great. So let's actually start with the main topic today, which is the comparison between ASCO's work and ESMO's. Why, exactly, did you decide to pursue this comparison and then publish it?

We became aware that ESMO was undertaking a very similar initiative, namely an attempt at developing an algorithm with which to assess the value, the clinical value, of oncologic therapies representing all of the European nations. That's about 27 nations. In parallel, but actually quite independently, we at ASCO were developing our own Value Framework.

And as one can see ...

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On September 25-26, ASCO held its 2019 Advocacy Summit, during which oncology care providers from across the United States came to Capitol Hill to urge Members of Congress to support policies that will improve access to high-quality, high-value care for people living with cancer. Listen to coverage in this new ASCO in Action podcast.

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 insight into the world of cancer care. You can find all of ASCO's podcasts, including this one, at podcast.asco.org.

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

Recently, ASCO held its 2019 Advocacy Summit. More than 130 oncology care providers from across the United States came here to Washington DC to meet with members of Congress and to urge support for policies that improve access to high-quality, high-value care for people living with cancer.

This is one of the highest impact events that ASCO holds every year. There's nothing like seeing ASCO advocates hit the halls of Congress with such passion and dedication, with the collective goal of ensuring that lawmakers focus on policy changes that will improve the lives of people with cancer and the care they receive.

ASCO president Dr. Howard, or "Skip", Burris kicked off the activities at the Advocacy Summit and spoke about why it's so important for us to be on Capitol Hill.

Dr. Howard “Skip” Burris: ASCO's on Capitol Hill today so that our members actually get to meet with their representatives and congressmen and their staff so they understand how important cancer care is to this country, and to make sure that they understand the issues that are facing our patients that we care for who are experiencing cancer.

The decisions that Congress makes, with regard to health care and cancer care in particular, is so important and powerful to cancer patients. Access to therapy, timely access to getting treatments initiated, making sure that there's appropriate coverage of new therapies, all those things are critical for us to implement the great scientific and clinical advances that we've made into the care and outcomes for our patients.

Dr. Clifford Hudis: ASCO advocates asked lawmakers for their support for legislation that will make a big difference in the lives of individuals with cancer. One of those pieces of legislation is HR 913, the CLINICAL TREATMENT Act, which would guarantee coverage of the routine care costs associated with clinical trial participation for Medicaid enrollees with life-threatening conditions, including cancer. Medicaid is the only major payer, including Medicare, that is not required to cover these care costs today, and we hope to address this.

Dr. Karen Winkfield, chair of ASCO's Diversity Inclusion Task Force, says that changing this policy is critical to improving the validity of clinical research data and to improving patient outcomes. Dr. Karen Winkfield joined other ASCO advocates in urging members of Congress to support this bill.

Dr. Karen Winkfield: So the Clinical Treatment Act is really vitally important because it will allow all patients equal opportunity to access clinical trials that would be beneficial to not only them, but also other individuals who may come from the same backgrounds, including racial and ethnically diverse populations, but also those of lower socioeconomic status. We want our clinical trial to be representative of every single individual in this country.

Dr. Clifford Hudis: The Advocacy Summit was packed with meetings with congressional lawmakers and their staff. Dr. Jason Westin, a member of ASCO's Government Relations Committee, participated in the summit and he spoke about why these direct meetings are so important.

Dr. Jason Westin: I think advocacy is very important for cancer doctors and cancer professionals to be an advocate for our patients. I think that there are so many opportunities for us to help our patients in the clinic, in the research arena. But if we're not involved in advocacy, then others are advocating in other directions that may not benefit our patients in the way that we would like.

Man...

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