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ASCO in Action Podcast

Updated about 1 month ago

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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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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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iTunes Ratings

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Average Ratings
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Cover image of ASCO in Action Podcast

ASCO in Action Podcast

Updated about 1 month ago

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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.

Rank #1: ASCO Chief Medical Officer Highlights Top Clinical Advances and Nine Research Priorities to Accelerate Progress in New Podcast

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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 can impact oncologists, the entire cancer care delivery team, and those individuals we care for, people with cancer. My name is Clifford Hudis, and I'm the CEO of the American Society of Clinical Oncology.

I serve as the host of the ASCO in Action podcast series. And today, I am really pleased to have as my guest Dr. Richard Schilsky. He is ASCO's senior vice president. And chief medical officer, and Rich is here to talk about our new clinical cancer advances report, which was just released. In clinical cancer advances, ASCO identifies the most important clinical research advances of the past year across the full range of cancers, and from prevention to screening to treatment and survivorship.

The report also announces what ASCO has identified as our advance of the year. And for the first time in this year's report, we will debut what we believe are the research priorities with greatest potential to advance progress against cancer. Rich, welcome and thank you for joining me today.

Thanks, Cliff. Great to be back.

now let's start with what we always do. Every year, we announced the advance of the year, the one area of clinical cancer research that has demonstrated the most significant progress in a year's time. And we've seen tremendous progress in the treatment of rare cancers, earning it the 2019 advance of the year recognition. Rich, can you talk about why this area was chosen? Why is this particular line of research so important for individuals with cancer?

Well, first, let me start with a definition of what we mean by rare cancers. And generally, what we're talking about are cancers that are diagnosed with a frequency of less than six cases per 100,000 cancer diagnoses each year. Collectively, though, because there are many kinds of rare cancers, overall rare cancers comprise about 20% of all new cancer diagnoses every year.

But those numbers may not even tell the full story, because as we learn more and more about the molecular subtyping of cancer, what we're learning, of course, is that there are many very, very rare mutations and fusions and other genomic alterations that occur in a very small proportion of even common cancer diagnoses. So the patient with lung cancer, who has a RET fusion that occurs in about 1% of all lung cancer cases, that begins to become a very rare subset, even though it's overall a common disease. So we're going to be dealing more and more with this general area of rare cancers. But the reason that it's so important to single this area out, of course, is because historically, we haven't been able to learn very much about these rare cancers, simply because they are rare. There aren't very many of them that occur each year. Therefore, they're difficult to study. It's difficult to complete clinical trials. It's difficult to find patient samples to be able to understand the underlying biology of these diseases.

And yet, many of them are refractory to standard treatments. Many of them have a very aggressive clinical course. And for patients who are affected by one of these rare cancers, they desperately need new treatments. And this year, we're seeing, for the first time, some real progress being made in a number of these rare cancers. I'll give you some specific examples that we called out in the report. So for example, although thyroid cancer is a very common form of cancer, anaplastic thyroid cancer represents only about 2% of all thyroid cancers. And of those anaplastic thyroid cancers, about 16%-- so now we're talking 16% of 2% have a BRAF mutation. But it's clear now that treatment with BRAF directed therapy produces a very high response rate in this rare group of individuals who have BRAF mutant anaplastic thyroid cancer.

Another example, take the drug we're all familiar with, trastuzumab. We know now, of course, that trastuzumab is effective not only in breast cancer, but also in gastroesophageal adenocarcinoma that's HER2 amplified. And there's emerging data that HER2 directed therapy may be active in other tumor types, where the HER2 gene is amplified. And one of those is uterine serous carcinoma. So uterine serous carcinoma is a rare subtype of endometrial cancer. And about 20% or 30% of those patients have a HER2 amplified gene driving their tumor. And trastuzumab has been shown to be an effective therapy in those patients as well. Last example I'll give you right now. A tumor that most oncologists probably will never confront in their practice, tenosynovial giant cell tumor. This is a very rare soft tissue tumor that occurs in the joints, typically of young adults, typically is refractory to all standard known cancer treatments. And yet, this year, we saw very promising results reported for a new class of anticancer drug, a CSF 1 inhibitor, called pexidartinib, that produced a 40% objective response rate in patients with these advanced tumors, compared to a placebo treated control group.

So we're starting to make real progress in treating these rare cancers, particularly when we can begin to understand their underlying biology, and develop a therapy that's directed at the key drivers.

It sounds to me-- I mean, in listening to that wonderful list of successes, that we've rolled up a process and an approach to drug development and science into a category that is appropriately called rare cancers. Because when you think about the way you presented it, which I think is lovely, first, rare cancers, as a group, aren't rare is what you said. Two, rare cancers cross from the rare histologies to include some of the common histologies.

But the underlying theme, if I think about the way we present this, is a deeper understanding of the driver mutations, allowing us to move a little bit off of histology towards genomics to define these diseases. And that's not to say that genomics is the only way we're going to make progress. But the unifying theme in these cancers is probably that shared trait of an alteration and a driver mutation and an available drug. And that's the advance that's helping us with rare cancers. Is that a fair roll up of that?

I think that is very fair. And you can think about it in terms of a common histology, like lung adenocarcinoma, having a large number of rare genomic subtypes, each of which comprises a rare cancer, if you will. Alternatively, you could think about it as in the trastuzumab example, of saying, well, if you look at the universe of HER2 driven tumors, those HER2 driven tumors comprise a whole bunch of different histologies. But they all are responsive to HER2 directed therapy.

And so you know, as we understand the underlying biology of cancer much more clearly, it's moving us away from the long held view that the way you diagnose cancer is looking under the microscope. And if you see something that you see only very rarely, you say it's a rare cancer, to we're not going to interrogate the cancer if we see a rare genomic alteration that occurs infrequently in the population of cancer patients. That's what we're going to call a rare cancer.

Yeah, I just say think it's almost like an introduction or a preview of an interesting future where more and more of the cancers we treat may be selected on this basis, rather than their conventional light microscopy appearance, right?

To be sure. I mean, we know still that context is important. Not all of these molecular drivers behave in the same way in every tumor type. We already have examples where not all the targeted therapies work equally well against the same alteration, again, in every tumor type. But slowly, but surely, I think the science is moving us toward a day where we will be identifying cancers, primarily, if not exclusively, by their genomic profile.

It may not be a single driver. It may be a signature. But that is ultimately is what we use to direct therapy.

So to some degree, this is a fulfillment of a multi-year view that we've had about where to invest in cancer research, and the fruits, I think, are obvious. But this wasn't the only advance that we reported on last year. It's the one we named as the advance of the year. But what were some of the other advances that we called out for recognition?

So as in the last several years, where we named some aspect of immunotherapy as the advance of the year, this year we continue to see progress in immunotherapy of cancer, particularly with extending the range of indications for many of the immune checkpoint inhibitor drugs, as well as new indications for CAR T cell therapies. So that continues to be a rapidly emerging area where there's a lot of progress continuing to be made. We continue to make progress how with the introduction of second and third generation targeted therapies.

We've come to understand, of course, that many targeted therapies although they work well for a period of time, cancers ultimately develop resistance, patients need additional treatment options after the first line of targeted therapy. And of course, the science has responded by giving us the insight as to the mechanisms of resistance, which has led to the development of second and third generation inhibitors that can effectively overcome the treatment resistance.

We're seeing this particularly in lung cancer, particularly with drugs recently introduced like osimertinib, which is effective against the T790M mutation, the common resistance mutation in EGFR mutated non small cell lung cancer. And interestingly, some of these drugs are also now showing much greater effectiveness in treating or even preventing the onset of brain metastases in lung cancers that commonly spread to the brain.

So this has opened up actually a whole new area of research on effectively treating and preventing brain metastases in those tumor types, where there's a high propensity for such metastases to occur. The last thing I'll mention as another area of continuing progress is the continuing development of new biomarker strategies to help us refine the way in which we select patients to receive treatment. And certainly, this last year, the big news were the results of the so-called TLRX trial in breast cancer, a test, a gene expression profiling test, that clearly indicates that there is a substantial proportion of women with hormone receptor positive early stage breast cancer who can safely forego treatment with adjuvant chemotherapy with no detrimental effect.

And this type of test I think is now going to really move us even further down the road of precision medicine, because it's allowing us to identify those patients who are most likely to benefit from adjuvant chemotherapy. They should get treated, and they will certainly benefit. But it also is allowing us to identify those patients for whom adjuvant chemotherapy is unnecessary, and who can be spared both the physical toxicity and the financial toxicity of adjuvant treatment.

The more of those tests that we can develop, going forward, the better we'll be able to refine prognosis, the better we'll be able to apply adjuvant therapy in the future.

I think one of the subtleties here is this highlights something we almost touched on before, which is precision medicine doesn't have to be only about gene rearrangements. There are multiple paths towards some degree of precision in treatment selection for individual patients. And this is, I think, a good example of that. It also is a good example of the fact that precision medicine is not actually just about treatment selection. It's about risk assessment, risk stratification, assessment of prognosis, identifying early recurrence, as well as directing patients to the right therapy at the right time, based on the biological characteristics of their cancer. So one of the things that we've done this year, and it's a first for us, is to announce a set of research priorities. These represent areas that our leading volunteers and others have identified as needing urgent attention. They are areas where the progress is promising, but not fulfilled completely. Can you talk a little bit about the motivation for creating this kind of a research agenda, as well as a criteria for actually selecting the specific research priorities? So obviously, you know, our field is advancing very rapidly. But there are still very many unmet medical needs. There are many clinical conundrums that oncologists face every day in practice. And we felt that given all the potential directions that research could take, ASCO is in a strong position to be able to at least begin to describe those areas, where we thought the potential benefits in patient care would be greatest, and could be realized soonest. ASCO, because we are the physicians who treat patients with cancer, we have a pretty good sense as to what the unmet medical needs of our patients are, what the lack of evidence is that our doctors struggle with every day in making clinical decisions with patients, where the field needs to continue to grow and to develop new information, to help fill those evidence gaps.

So we felt that we could take a stab at setting a research agenda, and putting out there where we thought the unmet needs, where we thought the opportunities were ripe for investment in research, and trying to articulate how, if we were successful in fulfilling those research needs and priorities, the field would ultimately be transformed. So that's what we've done with the nine research priorities that we are offering this year.

So the nine priorities that's important for readers in a moment, if they go look at this or pick up our publication to recognize, they're not rank ordered. They just happen to be nine. Maybe next year, there'll be fewer or more. And the second thing is in no particular order, as I understand it, we've divided them into a couple or maybe three big buckets.

One is essentially the issue of who really benefits from IO, the advance that you already talked about, as a multi-year call out from us. The second is really a little bit about health care disparities and precision medicine all rolled up in the concept of special populations. And related to that is access to research itself.

And then the third is something which we always worry about, but have, I think struggled with as a field for decades, and that is reducing cancer risk, along with screening, which is surprisingly still controversial in many settings. We'll talk a little bit more about some of the specifics, but I would just remind everybody listening that you can find a list of these nine research priorities if you go to our website asco.org/cca.

So Rich, as you think about the nine areas that are rolled up in those three broad areas, can you talk a little bit about how specific research would potentially transform patient care? And you've set a relatively short timeline for results in introducing this. And what kind of resources might these projects need?

If you take the first area, for example, of essentially getting the right treatment to the right patient at the right time, you know, we've touched on some of these themes already. Look at the results so far with immune therapy for cancer. It's remarkable that a significant, although still small fraction of patients across multiple tumor types, who receive an immune checkpoint inhibitor, will have prolonged disease control, 20% or so of patients apparently surviving, without disease progression, or even disease free for many, many years in melanoma and diseases that previously were death sentences for patients.

The question is why is it only 20%, and who are they? Because these drugs are toxic. They're expensive. And what we'd like to be able to understand is, what are the characteristics of the tumor or of the host or of the treatment that makes the treatment so effective in a proportion of patients, so that we can then learn how to increase its effectiveness in those groups of individuals, where it has so far been less effective.

The same is true, as we touched on a moment ago, regarding adjuvant post-operative therapy. If you think about solid tumors, broadly speaking, roughly 50% of patients with a newly diagnosed solid tumor are cured by surgery alone. They don't need and can't benefit from adjuvant therapy. Of the remaining group, who are at higher risk of recurrence. Many of them will not benefit from whatever adjuvant therapy they might receive. So what we observe in most clinical trials of adjuvant therapies are relatively small absolute improvements in say disease free and overall survival for the entire population of patients treated. But of course, what that likely represents is a substantial benefit for a small proportion of that population. So what we are suggesting in this research priority is additional research, similar to what we saw presented this year with the TAILORx study, that allows us to understand the biology, the biomarkers, the testing that can be done to identify the patients most likely in need of and those who will most likely benefit from adjuvant therapy.

And then the third area within this general theme goes back to immunotherapy and the enormous promise of CAR T cells, which so far, has been realized almost exclusively in patients with hematological malignancies. So that's wonderful. And we want to extend that benefit as far as it will go.

But the question is, can those treatments be effective in solid tumors, which generally have a much more complex biology than many human hematological malignancies, and how do we develop CAR T cell therapies that can be effective in the solid tumor setting, that can be delivered to a solid tumor patient population, and ideally, and this may still be a bit of a pipe dream, can we develop CAR T cell therapies then that can be developed and administered off the shelf, so that they don't have to be custom made for each individual patient, which drives up the complexity and the cost of treatment. So those are the key elements of this initial theme.

And in a similar way, we would have similar, or we would have short term plans for the other areas that we haven't gone into detail here. And again, I would remind listeners that they can go through our whole list of ideas in terms of areas of focus at asco.org/cca. Right?

Absolutely. And when they do that, what they'll find are that we are calling for increased research in precision medicine and pediatric cancer. We're calling for increased research that's necessary to optimize the care of older adults with cancer. We're calling for research on how to ensure more equitable access to cancer clinical trials, so that all patients can benefit from those studies, and we can make progress more quickly.

And then finally, of course, we're very interested in learning more about how to reduce the long term consequences of cancer treatment. The pediatric oncologists have actually been quite successful at this, because first of all, they've been very successful at curing children. And now, they've been able to show that they can begin to pull back on certain components of therapy in a very thoughtful and well studied way, so as to not diminish the chance of cure, but to diminish the risk of long term side effects of treatment. We, of course, want to have more research done, addressing the challenge of obesity in this country and its link to cancer risk, cancer progression, and cancer treatment, and then finally, to identify strategies to better understand the biology of so-called pre-malignant lesions, so that we can understand which pre-malignant cancers are the ones that are destined, in fact, to become invasive cancer.

That latter touches on a theme we could talk about another day which is the building, the emerging drive to rename some of those cancers, as something less than cancer, because of their lack of at least acute life threatening potential, right?

We could talk about that another day, and we should. Yes. So one of the things that I think is always important to point out is we can do all of this work, but of course, we are part of society, and we're dependent upon various sources of funding and other resources in terms of public policy. We are dependent on government ultimately for support, as well as private support. And I think this clinical cancer advances report highlights that there are policies that would help us improve and accelerate clinical cancer research.

Some of them are obvious. We talk about them in other podcasts, increasing access to clinical trials, covering the routine quest of care for trial participants, and indeed, increasing overall federal funding, not in an unpredictable way, but in a steady way, that allows us to make multi-year plans across our community. Given all of that, what steps do you think ASCO members, specifically, could take to support us? And I would take it a step further. What should they be telling their representatives in Congress in terms of these policies? What should they be telling them in terms of supporting these critical areas of cancer research and how can they make an impact? It's clear that essentially all progress that we make in developing new treatments for cancer ultimately gets linked back to federally funded support for basic science research. All of the insights that we've developed in terms of what causes cancer, how it progresses, which are the high risk populations, so much of that information comes from data sets and other basic laboratory studies, funded by the NIH or the National Cancer Institute.

Of course, the NCI has in place a robust national clinical trials network publicly funded that supports clinical trials that would never be done by a commercial sponsor. In fact, three of the rare cancer studies that I mentioned earlier during this podcast were done with support from federal funding.

Those studies, because they are rare cancer, small populations are not studying tumors that represent a large market for a new pharmaceutical product. They're not going to be done by a commercial sponsor. We need federal support. And we need our members to point out these kinds of examples when they go to talk to their representatives in Congress. And I would urge our members to not only go to talk to your representative, but to bring a patient with you.

The patient tells a story far better than we can. And having the patient at your side and having the patient tell their own story about how they benefited from federally funded research is very powerful. In order to reach your member of Congress, ASCO's trying to make that as easy as possible, and you can do that by going to ASCO's Act network at asco.org/actnetwork. That's great. I mean, we've covered a lot of exciting progress, I think, this year. And readers who take the time can dive far more deeply into this discussion with our publication. But what would you say is the main takeaway, the thematic takeaway that you hope people will get from this year's clinical cancer advances report? To me, I think what we continue to see this year, and we have seen in recent years is that the more deeply we understand cancer biology, the more that will quickly lead us to new therapeutic approaches that will be far more effective, and hopefully, less toxic, and maybe most importantly, more enduring than the common therapies that we've had available to us in the past.

Our field is clearly moving to a day when immunotherapy will be central to cancer care, when every patient will have their cancer genotype well understood, and where therapy decisions will be informed by that deeper understanding of each patient's biology. So you almost did this, but I'm going to push you a little more. In the same way that we're now calling for what should be done next in terms of research, if you could actually look into the future, what areas of progress against cancer would you expect or maybe hope to see, just 12 months from now, when we do this report again? I hope that one of the things we'll see is rapid progress in developing, not necessarily novel biomarkers as unique tests, but novel biomarkers signatures. I think it's becoming increasingly clear that in order to select patients optimally to receive immunotherapy, and even to select patients to receive certain precision medicines, that a single biomarker is not necessarily the optimal selection strategy.

For immunotherapy, we may need to see a signature that represents some characteristics of the tumor, some characteristics of the patient, maybe even some characteristics of that patient's microbiome in order to figure out who is most likely to be susceptible to which immunotherapy approach, and the same is going to be true, I think, for even the now common precision medicine approaches with small molecules. We're trying to understand how molecular pathways and networks work inside the cell can suggest to us not which single targeted therapy to use, but which combination of targeted therapies to use for each individual person.

This kind of work is on the horizon. It's complicated, involves lots of complex algorithms. But my hope is that this will move us to a future where we can take the results of a test on a patient's tumor and integrate information of various sorts and come out with a more precise estimate of what's likely to be the best treatment for that person. And you think that we could see some of those results even as soon as just 12 months from now, or is this a longer term hope? I think we will begin to see some of these types of approaches appearing at an ASCO meeting in 2020.

Well, that's really exciting. I think it's really both uplifting, and I think challenging to hear where we are, because of course, as is always true in science, every answer begets many more questions. And in our world, every bit of progress identifies new challenges. And I think that's what's summed up in a lot of what's in this report now, right?

Absolutely. But you know, I think for the first time, you know, ASCO is trying to articulate where we see the greatest opportunity. And we hope to be able to do this each year in the coming years. As you said earlier, it may not always be nine research priorities. Some of that might even be repeated year to year, because we won't solve every one of these in a year from now.

But we will modify these. We will improve upon them, and they will change as the science advances, as the questions evolve, and as the opportunities continue to develop.

Well, rich I want to thank you for joining me today for this ASCO in Action podcast. I'll remind everybody, we have a mission at ASCO to conquer cancer through research, education, and promotion of the highest quality cancer care. And this clinical cancer advances report really does help us meet that mission, by increasing awareness of the progress we're making, but also, as you point out, identifying the critical importance of the entire community's engagement in research and high quality care. That is pointing out just how important all that is in terms of delivering on the promise of all of our progress.

I encourage listeners, again, to read the full report by visiting asco.org/cca. And until next time, I thank everyone for listening to this ASCO in Action podcast.

Feb 12 2019
32 mins
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Rank #2: What Right-to-Try Legislation Means for You and Your Patients

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With Congress having recently passed federal “right-to-try” (RTT) legislation, the latest ASCO in Action Podcast features ASCO Senior Vice President and Chief Medical Officer Dr. Richard Schilsky, FACP, FASCO, FSCT, who examines the issue and explains the difference between RTT and the Food and Drug Administration’s (FDA) expanded access program with podcast host and ASCO CEO Dr. Clifford A. Hudis.

May 29 2018
35 mins
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Rank #3: What Oncologists Need to Know about Biosimilars

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Dr. Gary Lyman, MPH, FASCO, FRCP, joins ASCO CEO Dr. Clifford A. Hudis to discuss biosimilars and ASCO’s recent statement on biosimilars published in the Journal of Clinical Oncology

May 15 2018
25 mins
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Rank #4: Medicaid Work Requirements Could Negatively Impact Cancer Care Access, Increase Cost Burden on Patients

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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 most importantly, of course, the patients we care for, people who have 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. And for today's podcast, I am really delighted to have with me Dr. Manali Patel, chair elect of ASCO's health equity committee. Dr. Patel is here as our guest today to talk about some interesting issues for that committee and for all of us in ASCO.

Our conversation today is going to focus on ASCO's recent position statement on Medicaid waivers. For those of you who aren't following this or have been tuned out for a little while, there are several states that have recently submitted waivers to the Centers for Medicare and Medicaid Services-- what we generally call CMS-- asking for the agency to approve changes to the Medicaid program in their state individually that would make eligibility, continued coverage for care, cost sharing, and other program benefits dependent on the beneficiary's work status. Some state waivers have also requested the authority to cut coverage for beneficiaries based on them not paying premiums, on eligibility re-determinations, and on other work requirements. Simply put, these are challenges because they could restrict some access to care, and they put ability to work into the mix for oncologists to consider.

So here at ASCO, we're concerned. We're concerned especially that Medicaid work requirements may hinder patient access to essential cancer care services. They may reduce the already limited time that physicians have available to spend with their patients, because they will require, in some cases, doctors to do work related to assessing employability. And our position statement, therefore, recommends that federal and state policymakers take very specific steps to ensure that new Medicaid requirements do not harm patients with cancer.

So to dig deeply into this, Dr. Patel has joined us. And I welcome you, Dr. Patel. And thank you for coming on this discussion today.

Well, it's an honor and a privilege to be here today. Thank you.

So I want to start with a little more background on the type of waivers that we're talking about here. And there's always a nomenclature that's confusing to the outside world. These are called 1115, 1-1-1-5 waivers. What is their intended purpose in the Medicaid program?

Section 1115 of the Social Security Act gives the secretary of health and human services essentially the authority to waive particular provisions of the Medicaid program in hopes to further the Medicaid program's objective. 1115 waivers provide states an avenue to test new approaches in Medicaid that can potentially improve their programs but that may differ from what the federal program rules currently are. These 1115 waivers are subject to public comment. They must be budget neutral for the federal government. And while there is great diversity in how states have used these waivers over time, generally these waivers reflect the priorities that are identified by the states and the current administration.

And just out of curiosity, who submits the terms or the concepts that are being considered in these waivers? Do they bubble up from the state? They come down from the federal government? Do they come from some other source?

What's interesting about these waivers is that they do come from the states themselves. However, there is great encouragement by the administration in terms of what waivers they would encourage states to apply for and which waivers they would approve. The secretary of the health and human services is the one that makes the authority for approving the waivers themselves. But the states themselves are the ones that submit the waiver provisions in hopes that it will align with what the administration's goals and encouragements are.

And just, again, for background, historically, before we get to the present, has it typically been the case that there's heterogeneity in these programs around the country, or is this something new in terms of these waivers encouraging local experimentation and variation?

Historically, most waivers have been very small in scope until the 1990s. There are still a wide range and great diversity in how states have used these waivers over time. But there's been homogeneity in terms of the wide range of purposes for which they've been used. Most of these are to expand eligibility and to help to simplify Medicaid enrollment processes, all with the goal to help improve the Medicaid program.

Historically, many states have applied for waivers to reform care delivery and present an opportunity for states to institute reforms that go beyond just routine medical care, but that focus on providing evidence-based interventions that have an opportunity to improve health outcomes for this particularly disparate patient population. For example, Oregon used its waiver to establish a partnership between managed care plans and community providers to provide behavioral health and oral health services for its Medicaid beneficiaries.

In 2012, the enactment of the Affordable Care Act allowed a new category of low-income adults to become eligible for Medicaid. And therefore, several states in 2012 applied for demonstration waivers from the Obama administration to test different approaches to expand eligibility and recently included the introduction of premiums and co-payments. Most recently, in 2017, the Centers for Medicaid and Medicare Services encouraged new approval processes, including the potential for many states to obtain a 10-year extension. Previously these were five-year extensions.

In January of 2018, states were encouraged by the administration to apply for waivers to make employment, volunteer work, or the performance of some other service a requirement for Medicaid eligibility, as you discussed earlier in the podcast, and to impose premiums and increases in cost sharing. Now, this is different. A number of states now have waivers that have been approved, as well as ones that have been pending, that include these provisions that have not previously been approved in the past. And also, that includes drug screening and testing, eligibility time limits for patients, and lock-out periods if beneficiaries cannot pay for their premiums or cost sharing.

So there are a couple of concepts that your introduction raises. And I think it may even come as a surprise, at least to some of our listeners, that Medicaid beneficiaries have any premiums. And I want to make sure we're all clear. Are we talking about dollars coming out of the pocket directly of Medicaid recipients in the form of premiums?

We are. And we're also talking about cost sharing in terms of patients being now required to provide cost sharing for services that they are receiving through Medicaid.

And can you expand on each of those areas about what we mean? What kind of dollars would a Medicaid recipient be paying in premiums? And what kind of cost sharing dollars might they be at risk for in a typical program?

The concern now is that Medicaid is state by state. So in any individual state, these premiums and cost sharing can vary greatly. In some cases, it's 50% of cost sharing of the services provided. In other cases, it's less than that. In other states, there are waivers for the premiums or cost sharing and have never been imposed.

So to answer your question, it varies widely. And it can be as great as the premiums and cost sharing that we're seeing in Medicare and patient populations that are enrolled in Medicare. But it can also be as great as the premiums and cost sharing that we see in private health plans.

It will be surprising, I think, to many people to hear this, because I think for most people there's at least a perception that Medicaid represents insurance and access of nearly last resort and is not for people of means. So the idea that there's a cash flow out of the beneficiaries into this program or into their care in this program, I suspect is not something that's widely known.

Right. I would agree. It's not widely known. And it comes as a shock that we would expect patients that would be eligible for Medicaid, given the provisions of what Medicaid has been there to serve and was enacted to serve, that we're seeing patients experience the financial toxicity perhaps even more so than patients that may be in public health plans.

Yeah, that's interesting. And it relates at least tangentially, I'm sure, to some of the recent data that's come out of ASCO addressing the rate of financial toxicity in the form of choices around spending and choices, unfortunately, to go into debt that we've heard from the general population. It's got to be presumably even tighter in this population, right?

Right. And with costs rising at an unsustainable rate for cancer care delivery services, what I think is also a shock to the public is understanding that all of those costs eventually are coming back to the patients themselves to bear the burden of the cost that we're seeing. Every year, my own health care premiums and health insurance premiums are rising. Benefits are being cut in these private health plans. And we're seeing the same occurring for the limited services that are available in Medicaid programs.

And because states have the authority to make these programs reflect what its state's priorities are, there's wide variation in the same way that there is wide variation between each individual public and private health plan outside of these states. Within the states, there's a significant degree of diversity in terms of what services states are providing through Medicaid.

And I guess one last question before we move on is-- it sounds like you've answered this already, but I want to be clear-- the program really is taking shape right now, right? This is not the way it's been historically. Is that a fair roll-up of what you've said?

That is extremely fair. I think prior, as early as the 1990s, these waivers were really to expand eligibility. And they were meant to improve the program for its objectives to increase access, equitable access, to high-quality medical care. And now what we're seeing are provisions that are directly inhibiting this access.

Yeah. This is amazing. So turning now to the current reality and our response to it, we have concerns, as we've already alluded to, specifically regarding the work requirements, in two directions, I would say. First, of course, we're concerned about the direct impact on patients. But I think in addition to that, we're worried about the impact on the system as a whole. And my question to you is what would you like our listeners to know about how these waivers might have an impact on people with cancer?

Right, so I'm deeply concerned about the waivers failing to promote the intended objectives of the Medicaid program, as I've discussed previously in our conversation today. These waivers directly inhibit access to high-quality cancer care. These new provision to waivers can be extremely detrimental by restricting access to coverage for those not only with an ongoing cancer diagnosis, but restricting access to services that can help to prevent cancer. And patients that are enrolled in Medicaid are those patients that may be at highest risk for developing cancer.

Disruptions in care, delays in treatment, dis-enrollment in coverage-- all of these gaps in care delivery have been shown to directly adversely impact cancer care outcomes. And to think that these disruptions are now being imparted and imposed into Medicaid eligibility requirements is quite concerning. Many patients have to stop working entirely. Many are dramatically reducing their work hours to comply with evidence-based treatments. Many have debilitating side effects that prevent them from working and are at risk for life-threatening infections and illnesses when their blood counts may be low.

These worse outcomes also affect patients that are cancer survivors, who face long-term effects and increased health risks related to their cancer. So the imposition, also, of lifetime limits and lock-out periods are detrimental to ensuring that patients have equitable access to cancer care.

And you know, one of the other areas that isn't obvious at first-- I had to look into this as well-- is the downstream impact on the clinicians caring for these patients. Can you explain to our listeners, why would a doctor even become aware of this? How would this take time from the doctor, these kinds of work requirements?

Well, when I think about my own practice and how I spend-- and I think studies have also validated that we spend over 50%, or up to 50%, of our time in front of the computer with administrative paperwork burden. These restrictions, in terms of these new restrictions for Medicaid, will increase the requirement for additional paperwork. And that paperwork is going to have to directly come from the oncology practices and the providers that are seeing these patients. These restrictions and requirements that will be imposed on us are going to exacerbate our already limited time.

Do you think that the assessment of ability to work would also fall to the oncologist? That's a concern, I think, that it might drive our docs to find themselves in a funny relationship, an uncomfortable one, with their own patients?

Oh, certainly. I do believe firmly that it will come to the providers providing care for these patient populations. We are already required to provide disability placards and make that assessment in our clinics. And it does make it-- it interferes with a therapeutic relationship with our patient population.

And you alluded to this already, the fact that many patients diagnosed with cancer ironically have to stop working, both because of the time and effort it takes to get treated, but also because they're just not well. So I've heard, at least, the comment that these work requirements technically might not apply very much to cancer patients because of the-- again, the technical work requirements would be waived for patients who are sick. Do we have any sense, in real-world implementation, how this plays out?

It's unclear if states will be able to make those exceptions. And if you have an exception for patients with cancer, I can list several other terminal illnesses as well as curable illnesses that may similarly have exemptions. And it's unclear if these exemptions will be adhered to. One concern, and I think one of our recommendations have been that if there will be requirements for work requirements, that at least they not occur for a minimum of a year after a patient has undergone active treatment and that caregivers of patients should be seen in a similar light.

But to answer your question, it's really unclear if there will be provisions made and exemptions made for patients with cancer. I do certainly hope that to be the case. And that's certainly why advocating for this and advocating against these work requirements for our patient population is this especially important from all stakeholders.

Well, that's a perfect segue for us to turn to ASCO's recommendations. That is what we're advocating for. And I wonder if we could start, if we think about the recent ASCO position statement on Medicaid waivers, what are the specific recommendations that you want us to know about in terms of what we want policymakers to do? What's our focus?

Our main focus and the underlying mission of ASCO's recommendations are, again, to ensure that all patients have equitable access to high-quality cancer care. And the main focus of these recommendations are that waivers really should not create delays or barriers to receipt of timely and appropriate cancer care. Secondly, states should consider patients that are in active treatment exempt from any work requirements for the reasons that we've discussed and consider the primary caregivers in a similar light.

There should not be lock-out periods or lifetime limits or elimination of retroactive eligibility for at least a year after a patient's last treatment. And additionally, these uncompensated burdens on providers really should not be posed on providers. ASCO also recommends that waiver applications and amendments be open to a full and transparent public comment period.

So that last point, it seems like that's an obvious one for all of us wanting good government, and even in our daily lives. What is it that we're worried about with this transparency? Why is it so important that these 1115 waivers be handled in a transparent way? And I'm almost embarrassed to ask that question, because it's hard to see the argument against transparency. Why do we have to make that argument?

Right. Well, it's key. Transparency is key. We have to make this argument all the time in many other facets of health care as well.

But it's key to ensuring that we all understand what the implications of these waivers have on our patients, on our practices, but also on our personal lives, and that we have a chance to comment publicly on the waiver. I think states may look at each other's waivers and begin to make provisions for their own waivers or apply for waivers based off of what another state has been approved to demonstrate or to test. And so I think it's extremely important that we all have a chance to publicly comment on these waivers and to understand what's in the waivers themselves prior to them being approved.

So I guess in addition to our public statement on the waivers and the position statement and then hopefully having the opportunity to address these in public, are there any other next steps that we need to be taking formally as ASCO? Is there anything else that's on the agenda for us?

ASCO is currently conducting and helping state affiliates develop letters and comments to their own state officials as they design and submit the waivers. I think it's extremely important that we continue to advocate. ASCO's advocacy team from the state level is keeping an eye on waivers and opportunities to partner with state affiliates on problematic waivers that may be coming from their own states. But beyond analysis and these comment letters, ASCO is also coordinating meetings with state affiliate leadership and with state policymakers to discuss concerns about ongoing and the current Medicaid waivers as well as ones that may come up.

So it's just another plug for our regular listeners for engagement through, for example, our Hill Day and our ACT Network and so forth to keep the pressure on and the awareness up with our legislators, right?

Right. Certainly. This is a topic that will continue to evolve, and so it's extremely important that we're keeping ourselves up to date and that ASCO is helping us to keep abreast of what new developments may be occurring on these waivers on a state-based level.

Well, that's great. I don't think there is, but is there anything else that we've left out that listeners should know about the current state of the Medicaid play for us?

Well, I don't think so. I think we covered most. But as we all know, Medicaid is currently evolving. It's always evolving, and currently more so in a direction that I would have never assumed we would be evolving into. The concerns that are always raised are legislative cuts, caps to the program, uncertainty about revenues, federal legislation that may have an effect on state actions on Medicaid. And now there are growing concerns about substance use disorder and opioid epidemic use that may make Medicaid play a larger role in these issues than we had previously considered.

There's a lot to chew on there. I want to thank you, Dr. Patel, for joining me today for this "ASCO in Action" podcast. I hope our listeners find this clear and informative. I think it raises really important issues for all of us.

I want to remind everybody that ASCO's position statement on Medicaid waivers is just one of our many that address policymakers in various ways. Our overall goal is to preserve and enhance access to high-quality care for all Americans. I'll remind you that our 2014 policy statement on Medicaid reform called for major changes to the Medicaid program to ensure access to high-quality cancer care for all low-income individuals. And then, our 2017 principles for patient-centered health care reform called for access to affordable and sufficient health care coverage regardless of income or health status, the point being, this is a long-term commitment by our leadership and our volunteers. And this is something that clearly is going to remain at the top of our agenda.

If you're interested, and I hope you are, you can read the complete ASCO position statement online. It's available at ASCO.org/medicaid-waivers. And this is, again, made available to you on the web. And I hope that this is informative. With that, until next time. I want to thank everybody for listening to this "ASCO in Action" podcast.

Sep 18 2018
23 mins
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Rank #5: Expanding Opportunities in Precision Medicine

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ASCO President Bruce E. Johnson, MD, FASCO, joined ASCO CEO Dr. Clifford A. Hudis in the latest ASCO in Action Podcast to discuss the opportunities and challenges with precision medicine.

Mar 05 2018
27 mins
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Rank #6: What Practices Need to Know and Do for QPP in 2018

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In a new ASCO in Action Podcast, ASCO Vice President of Clinical Affairs Stephen Grubbs, MD, FASCO, joins ASCO CEO Dr. Clifford A. Hudis, FACP, FASCO, to break down the Quality Payment Program (QPP) and discuss the reimbursement changes coming to oncology practices in the United States.

Mar 20 2018
27 mins
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Rank #7: Congressional Advocacy

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Chair of ASCO’s Government Relations Committee Robin Zon, MD, FACP, FASCO, and ASCO CEO Dr. Clifford Hudis discuss Congressional advocacy, the role it plays in shaping cancer-related policies, and how direct advocacy can have a significant impact.

Feb 12 2018
27 mins
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Rank #8: Are Pharmacy Benefit Managers Putting Personal Profits Ahead of Patient Access?

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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, and, most importantly, 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 delighted to welcome Dr. Ray Page who's chair of ASCO's clinical practice committee as our guest today. Ray was recently awarded the prestigious ASCO Advocate of the Year Award for his exceptional efforts to shape health care policies to have a direct impact on our ability to provide high-quality cancer care for our patients. Our conversation today is going to focus on one of those policy-related issues that Ray has spent so much time on, and it's an area of growing concern to all oncology practices, that is, the emergence of pharmacy benefit managers in the cancer care delivery system.

Now some of you will know that ASCO recently released a position statement on pharmacy benefit managers, or PBMs, as they're known, specifically focusing on their impact on cancer care. And as a little bit of background on this, in terms of policy work, ASCO has a formal process for vetting and adopting the society's policy priorities. Typically, we will develop and release a position or policy statement when we learn about an issue or a development that is impacting, or may, in the future, have an impact, on the delivery of and access to cancer care.

We determined that a position statement was necessary on PBMs because serious concerns were being raised by our members through our state affiliate council, our clinical practice committee, and in direct conversation with other ASCO leaders. So as we often do, we analyze the issue carefully. We gather evidence, such as is available.

We describe the issue. And, then, most importantly, we identified steps that could be taken to at least begin to address the challenges. The result was the ASCO position statement on "Pharmacy Benefit Managers and Their Impact on Cancer Care." So with that as background, I want to turn and welcome Dr. Page. And thank you for joining me today to discuss this important topic. Welcome.

Thank you, Cliff, for having me here today.

Great. So I want to start off with a level set, Ray. Some who may be listening today may not be familiar with PBMs, what and who they are, or what purpose they serve. Can you give a general overview of pharmacy benefit managers? How do they work?

Sure, Cliff. In its simplest form, a pharmacy benefit manager, or PBM, is a middleman company that was originally utilized by payers as a third-party manager of prescription drug claims. Why did these companies ever come into being in the first place? Well, this largely developed out of the Medicare Modernization Act of 2003 and when the Medicare Part D program for oral drugs was implemented in 2006.

Cliff, I believe that they had good original intent, as their primary objective was the simplification of the transactions between pharmacies and health plan sponsors. However, over time, they have evolved to where they now include a variety of new business functions in an effort to better manage drug benefits and reduce the overall drug spending cost for plan sponsors. They claim that they're controllers of cost but, in reality, they have created huge and extremely complex business relationships to where they now have put personal profits before patients.

So how extensive is the PBM system? And has it increased in the last few years? And if so, why?

Yeah. Today, PBMs are ubiquitous. They were involved in the transaction of several hundred billion dollars of drugs across the United States. PBMs control the pharmacy benefits of over 253 million Americans. What is concerning is after numerous acquisitions and consolidations, and this is often called horizontal integration, there are now only three behemoth companies that control 85% of the prescription drug benefit transactions in this country.

These three companies are familiar to all of us. They are CVS Health, Express Scripts, and OptumRx. So one may ask, what's wrong with those guys? They're all reputable pharmacies that are managing and distributing drugs. Well, they've grown to be far more. CVS, for example, started out as a drugstore.

But now they are a PBM, specialty pharmacy, a mail-order pharmacy, an insurer, a benefit plan sponsor, and now they have medical clinics and own doctors. So part of the perversity that arises is when PBMs vertically integrate with the sponsors, the insurers, the pharmacies, and clinics all into one big package to now they have complete control of the patients and the flow of all their prescriptions.

Then may make transactional relationships between these entities and the drug manufacturers, distributors, and providers to where they generate enormous profits off the management of these drugs, yet none of these profits are ever passed on to the patients. Practicing oncologists and ASCO have concerns that some of these utilization management policies can have an adverse impact on our nation's most vulnerable patients, which are our cancer patients.

Well, last year, ASCO released a policy statement on utilization management strategies. And these are payer-imposed practices that may, in some cases, restrict access to, or deny coverage for, selected treatments. The major concern, at that time, was that certain payer practices, such as prior authorization, step therapy, specialty tiers, and restricted formularies, all of these could hinder access to high-quality cancer care.

The question we have, I think, with regard to PBMs is whether we share these same concerns when we turn to PBMs. And if that's so, can you explain some of the practices that PBMs might

use and what that might mean to the cancer patient, specifically with regard to access to most appropriate therapies?

Yeah, Cliff. There's several concerns that I have with the PBMs managing drugs that could adversely impact our cancer patients. And let me just describe a few. As cancer doctors, we always want to give what we think is the best personalized drug for that individual patient for the right diagnosis at the right time. I may prescribe a cancer drug that is not on a preferred formulary of the PBM because, perhaps, they have negotiated a better price with another manufacturer that gives them more profit.

So they recommend replacement with another drug. This is called a step edit. And, oftentimes, your preferred drug cannot be prescribed until there is a fail-first policy with an alternative drug. So for such things as nausea and vomiting control with highly emetogenic chemotherapy, I would prefer to have no vomiting with a preferred drug rather than dealing with nausea with a fail-first inferior drug.

Second, we have PBMs that want to deliver storage sensitive toxins, chemotherapy drugs, and injections to the patient's doorstep and then have them brown bag these drugs to our office for administration, although we have no record of the pedigree and the accountability of those dangerous drugs.

Third, we now have PBMs refusing to give such things as IVIg infusions in our office. And for some of our patients, they have to go to the street corner CVS box and get their IVIg at the CVS infusion center. Yet I am accountable for the outcomes of that patient.

Lastly, and worst, we're seeing cost shifting onto the patients. Based on their packaging and dispensing methods, the patients often have to pay multiple huge co-pays because of partial fills of oral chemotherapy drugs.

So if I understand you correctly, while PBMs did not end step therapy, specialty tiers, and restrictions and formularies, they're using these previously recognized tactics as a way of notionally controlling costs, but at least having a downstream effect of potentially restricting access to what is oncologist-driven best care. Is that a fair summary?

That is correct. So it is those utilization management techniques that create significant administrative burdens and impairments on getting patients appropriate, and timely, and affordable access to care.

Well, you must see this firsthand, right? You're in private oncology practice at the Center for Cancer and Blood Disorders in Aledo, Texas. And I know that you have an active practice and you see a large number of patients. I'm wondering if you've had, yourself, firsthand experience of PBMs and what you've seen it has meant for your patients to have their care influence that way. And what it's meant for you and your colleagues as you work to provide highest quality care. Are there vignettes or aspects of this that come to mind?

Yes. In my private practice in Fort Worth, Texas, I have firsthand experience with PBMs every day. What it means for our patients is an interference in the physician-patient relationship, pushing of care outside our Cancer Center, creating an impact on our ability to provide value-based care in an oncology medical home, causing delays in care, alterations in treatment plans, potential increases in toxicities, and more out-of-pocket costs for the patients.

So let me give you a quick case of a patient that I have. Tom was diagnosed with a stage 3 rectal cancer and I recommended capecitabine and radiation therapy. I prescribed, for him, capecitabine 500 milligrams, three tablets BID, on the days of radiation therapy, which would be 180 pills, which he went down to my pharmacy to get. At my pharmacy, he was told that he was out-of-network and he would have to get this through CVS Caremark.

So I saw the patient in his third week of treatment. And I found out that they had filled 120 of the 180 pills. And they told the patient that they only packaged the capecitabine in 120-pill bottles. So his first co-pay, for that first three weeks, was $400. So then he got a second bottle of 120 pills and paid a second co-pay of $400.

And that was a prescription of excess pills. And so CVS, they told him just to throw away the extra 60 pills that he did not use. Now this was financially impactful for both the patient and my practice. The drug cost, if a single script was given through my practice, would have been $3,900.

The drug cost for the two scripts with the extra unused pills was $7,200 through the PBM. Now under the new MACRA, MIPS payment model that we're all subject to, or under the Oncology Care Model, which is an alternative payment model, this kind of thing negatively impacts our resource use. So this process is completely out of my control, yet I get peened for not being a good steward of drug utilization.

Well, that's a pretty compelling example. And I assume there are others, right?

Yes, there is. There's many.

Well, I think if we turn a little bit to one of the points you raised already, it was about the in-office pharmacy in your practice. Can you, for people who might not be familiar with this, can you briefly describe how it works to have an in-office pharmacy? Is this something that all oncology practices have? And how have the PBMs impacted its operation in your experience?

Yes, Cliff. Most all cancer centers across the country have their own retail pharmacy, regardless of whether they're an academic center, a hospital-based practice, or an independent community practice. The impact of the PBMs affects the delivery of cancer care no matter how small or great your cancer center is. More and more cancer centers, as well as large hospital systems, are trying to get specialty pharmacy status to be able to combat some of the PBM tactics of being out-of-network, or having direct and indirect remuneration DIR fees, rebate clawbacks, and gag clauses.

So let me just say that PBMs may be a place for managing common drugs for diabetes, and heart, and thyroid, and infectious diseases. But there are reasons that cancer centers prefer to have complete control of the cancer therapies that we prescribe. In general, cancer drugs not only have the risk of substantial physical toxicities that need close pharmacy management, but they also have tremendous financial toxicities for the patient that we help manage with our pharmacy staff and in which those resources do not exist within the PBMs.

So it's highly preferable that cancer patients get their prescriptions through a highly-trained oncologic pharmacist at the Cancer Center who has access to their full electronic health records and drug lists and who knows them, personally, by name. Our pharmacy staff has resources to educate the patients, to work on foundation and financial assistance, and to be immediately available, by name, to triage further questions or symptoms. It is what is best for the patient.

Unfortunately, PBMs are redirecting our treatments from our pharmacies to theirs, and they are trolling for other drugs that we have historically prescribed to our patients. So this loss of prescription authority and drugs to the PBMs is at a rate that's increasing at about 10% a year to where, currently, 60% of our prescriptions go outside our pharmacy to the PBM.

I see. And, presumably, that has not only concerns raised for you in terms of business, but quality of care. Is that right?

That's exactly right. So there's always a business aspect to the management and control of the drugs. But, most importantly, is that value-based quality care that we feel provides the safest, highest quality, most affordable care to our patients when they have access through our own individual pharmacies at the cancer centers.

Well, at ASCO, as you know, we, last year, spent some time and, ultimately, we declared core values-- evidence, care, and impact. And what derives from that, for us, is we do not write papers or issue statements simply to check a box and say we did that. Instead, what we want to do is go beyond identifying, and analyzing, and reporting on a problem to, in fact, contributing to solutions.

And so, to that end, what we frequently have to do is initiate conversations with stakeholders, propose ideas that might affect real change, and have a positive impact on cancer care and our patients. ASCO's recommendations on health care system changes are often sent directly to Congress. We present them to government agencies.

We speak to payers, certifying bodies, and, really, everybody across the entire health policy environment and health care spectrum. So given that our desire is to make a difference, to have an impact, to effect change, can you, Dr. Page, can you outline some of the recommendations that ASCO has described as a path forward and a way to address the issues that our discussion has raised?

Sure. ASCO has several suggestions. And these can get very complex and have nuances, but I'll just try to make these suggestions as simple as possible. But several things that ASCO has recommended is that PBMs and the payers, in order to address quality of care concerns related to

cancer patients that they serve, they should assure that changes to prescribe therapies for the patients with cancer are made only in the context of prior consultation and approval of their physician.

So, in other words, if I write a prescription for a set number, and duration, and dosing schedule for a patient, it should be given that way. And the PBM should not be making alterations in my prescription, like I gave in my example. Pharmacies should not be prevented from sharing, with the patients, their most cost effective options for purchasing needs of medications.

So in other words, there's gag causes that PBMs have to where there could be a drug that the PBM is going to charge the patient $180 a month for, but the local pharmacy can prescribe that same drug for $30. But they are prohibited from disclosing that they can actually distribute that drug to them cheaper outside the PBM. CVS should leverage its regulatory authority to number one, require that PBMs provide detailed accounting of these DIR fees and instruct contractors and PBMs to use measures and standards that are more appropriate to the specialty.

CMS should also enforce its any willing provider provisions in Medicare Part D preventing PBMs from excluding qualified provider-led pharmacies from its networks. So we, at ASCO, really desire that any cancer center that has a pharmacy would have the opportunity to be included in the PBM network and be able to prescribe the drugs within that network on site. And then, CMS should maximize the accountability of drug waste through the PBMs. Lastly, pharmacy and therapeutic committees of the PBMs should include full and meaningful participation by oncology specialists.

So one issue that was raised in the ASCO statement, and we haven't directly touched on it yet, is simply the lack of transparency, that is, the opaque nature of PBM practices and their policies. How do you think that issue, specifically, can be addressed?

Yeah, Cliff, the transparency issues are being addressed nationally at several legislative levels. There are several federal bills that are in support of the Trump blueprint to address drug costs. And they have to do with safe harbor laws that the PBMs are taking advantage of. They have to do with undoing the gag causes that I previously mentioned. And, also, to examine the fiduciary status of the PBMs. At the state level, there's dozens of bills going after the PBMs, state by state, on all fronts.

And, lastly, as an ASCO delegate to the AMA, a few months ago, we submitted a resolution that we got accepted into AMA policy that requests that our AMA gather more data on the erosion of the physician-led medication therapy management in order to assess the impact of the pharmacy benefit manager tactics that they may have on the patients' timely access to medications, patient outcomes, and the physician-patient relationship, and that the AMA examine issues related to PBM-related clawbacks and those DIR fees to better inform existing advocacy efforts. And so I think it's always good to have the weight of the AMA behind our ASCO advocacy efforts to assure that our cancer patients can continue to get the best, affordable access to care.

Well, that's really great to hear. You've covered a lot, both in terms of background and explanations, the history of the development of the PBMs, and what challenges have now

emerged. Are there any additional steps ahead that ASCO should be taking that you know about? Is there anything else, for example, that listeners should know about pharmacy benefit managers that we've not yet touched on?

Yeah. I think I just want to emphasize that this is really a David and Goliath scenario. It is very difficult to control a rapidly growing, unregulated, complexly integrated $300 billion industry that is benefiting three gargantuan companies more than our patients. And ASCO will continue to partner with fellow like-minded advocates to optimize the affordable delivery of cancer care and conquer cancer.

Well, that's certainly an upbeat-sounding ending. And I'm sure with you fighting the good fight, this effort will go on and will make good progress. That seems clear. I want to thank you, Dr. Page, for joining me today for this ASCO in Action Podcast. I want to remind everybody that at ASCO, we are committed to preserving and enhancing access to high-quality cancer care for everybody with cancer.

This statement on PBMs is just one of many in which ASCO's voice, and the collective voice of our members, is helping to shape the future of cancer care for everybody and refine the delivery system. I encourage our listeners to read the statement, and other policy and position statements, all of which are available on the policy and advocacy pages of our website at ASCO.org. And until next time, again, thanking Dr. Page for joining all of us, I want to thank all of you for listening to this ASCO in Action Podcast.

Oct 09 2018
24 mins
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Rank #9: Increasing Patient Inclusion in Cancer Clinical Trials

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In the latest ASCO in Action Podcast, Dr. Edward Kim, Chair of the Department of Solid Tumor Oncology at the Levine Cancer Institute, joined ASCO CEO Dr. Clifford A. Hudis to discuss eligibility criteria for cancer clinical trials.

Jun 26 2018
28 mins
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Rank #10: ASCO CEO Discusses Striking Findings from National Cancer Opinion Survey

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Subscribe through iTunes and Google Play.

Hello, and welcome to this edition of ASCO in Action. This is ASCO's podcast series where we explore policy and practice issues that are important to oncologists, the entire cancer care delivery team and, most importantly, the patients we care for, people with cancer. My name is Clifford Hudis, and I serve as the CEO of ASCO and the host of the ASCO in Action podcast series.

For today's podcast, I do not have a guest. Instead, I am personally going to share key findings from ASCO's 2018 National Cancer Opinion Survey. We conduct this survey yearly, and we always hope to find interesting information that can help us as we talk to patients, policymakers, and all of the stakeholders in cancer care. This year was no different. Perhaps, the most striking and concerning finding for us this year was this.

Nearly 4 in 10 Americans believe that cancer can be cured solely through alternative therapies. Over the next few moments, I'm going to explore this observation in a bit more detail and then consider some other notable findings from this year's survey. Thanks for listening in. Now, by way of background, ASCO just recently released the results of our second annual National Cancer Opinion Survey.

We conducted the survey in collaboration with the Harris Poll to help us better understand the views held by the US public regarding cancer research and cancer care. One reason that ASCO established this annual survey was our view that by tracking the American public's perceptions of cancer, over time we might be able to better identify opportunities to add useful information and insights that could positively influence public policy.

Therefore, the survey is designed to collect high quality objective data that can be used to understand what the public does and does not know about cancer. We then use this research to help guide ASCO's educational policy and advocacy efforts. This year's survey was conducted online for a one month period. This was between July and August of 2018. Nearly 5,000 US adults over the age of 18 responded to our survey.

This included about 1,000 individuals who currently have cancer or have had cancer in the past. And, as I noted, it always amazes us that we find interesting tidbits in these kinds of surveys, and this year was no exception. I'm going to highlight three areas in particular. These include the role of alternative therapies, access to pain management, and the continued financial burden of care. ASCO's core values, as many of you will know, include evidence, care, and impact. Given that, we start with evidence, and one of the most surprising findings for us is that nearly 4 in 10 Americans believe that cancer can be cured solely through alternative therapies. And I note that given that research has shown that the sole use of alternative therapies for cancer is actually associated with a much higher mortality rate when compared against patients treated with standard evidence based approaches.

Now for clarity, I want to point out that when we say alternative medicines, what we mean specifically are interventions like acupuncture, diet, so-called enzyme therapy, massage, medical marijuana, meditation, vitamins, herbs, and other supplements. All of that and more, perhaps, in this context, we're referring to them as the sole therapy for cancer, not as complementary treatments where they have arguably different roles and different impact. It's this potential reliance on them as the sole therapy for cancer that is so concerning. Now even with direct experience with cancer, respondents don't report a very different perspective. For example, even among those who have had cancer, either themselves or have been close caregivers as a family member, for example, a sizable proportion expressed the belief that cancer can be cured solely through alternative medicine.

Younger people, those age 18 to 37, and, to a slightly lesser extent, those aged 38 to 53, are most likely to believe that cancer can be cured through alternative therapies. Clearly, given this, we have a great opportunity in front of us to help our patients, families, legislators, and everyone understand the real limits and the reality of scientifically valid evidence based treatments. And we have an obligation, given the association with improved overall outcomes, to highlight this.

We cannot ignore this widespread belief. Now I want to turn to another issue that's been getting a lot of attention these days, the opioid crisis, and explore what Americans are thinking about the use of opioids for pain management in cancer care. Our survey found that nearly 75% of Americans do not agree that there should be limits on access to opioids for people with cancer. Specifically, most Americans believe that cancer patients should not have their access to opioids limited at all.

Yet the survey shows that accessing opioids right now for cancer pain is difficult for many patients. From the small survey sample that we had of patients with direct experience, 40% of those with cancer who had used opioids within the past year to manage pain or other symptoms reported trouble accessing them. If opioids are an important part of maintaining quality of life and palliating cancer symptoms, then this obviously is an active and real problem. Highlighting the importance of providing optimal palliative care, we also learned that most Americans support alternative methods of managing pain. And, again, I want to emphasize, in this case we're talking about alternative therapies as complements not as the sole approach. 83% of respondents supported the use of medical marijuana among people with cancer, for example. Here again, however, there is an issue with access.

In a small sample of patients who have reported using medical marijuana within the past 12 months, nearly half, 48%, reported difficulty obtaining it. For those patients with cancer or who have had cancer, who are interested in using medical marijuana, almost 60% of them wish that there was more information available about its benefits for symptom relief. This is clearly a research opportunity for our community. We believe these views are likely to be heard both federally and at the level of state houses. And we think, therefore, it's important for you, our listeners, to be aware of this widespread point of view. Finally, I want to turn to one of the biggest and longest standing issues, as well as fastest growing issues in health care in general in cancer care specifically, and that is finance. We find that the financial burden is a specific worry for Americans confronting cancer. On a percentage basis, our survey respondents said they are just as worried about the financial impact of cancer as they are of dying of cancer. Now this doesn't mean that the depth or level of an individuals anxiety is the same, but it does mean that it's on the minds as about as many people. Probing this a little more, if faced with a cancer diagnosis, 57% of Americans say they would be most concerned about the financial impact on their families or about paying for treatment.

And that compares to 54% who said they'd be most concerned about dying or about suffering with pain. So I think this just highlights how central worries about financial toxicity and cost of care have become. Among people who have had cancer, or who have survived it, more than 40% say that they've had barriers. They've experienced barriers accessing care because of health insurance, with deductibles and co-pays specifically being their biggest hurdles.

And what's interesting, as well, is that patients bear a significant burden here, but so too do family caregivers. In fact, among caregivers responsible for paying for cancer care, 3/4 say that they are concerned about affording it. More than half of caregivers say that they or another relative have had to take some kind of an extreme step to help pay for their loved one's care. Examples include working extra hours, postponing their retirement, or taking on an additional job, even, in some cases, selling family heirlooms. Clearly these findings are in line with other research that has shown that financial toxicity is a growing and very real concern for people with cancer and for their families. And, again, we think it's important for our listeners to be aware of these issues since our sense is that some of these don't necessarily come up, at least not overtly, during routine clinical encounters. The bottom line is, more of our patients are suffering degrees of financial distress than we may recognize during our busy clinical days, and we need to be both aware of this and help take steps to address it. So with that, I want to thank you for listening in today. As the world's leading organization for oncology care professionals, ASCO believes that it is critical to understand what the public, including individuals with cancer, think of, expect, and need from the nation's cancer care delivery system.

As I mentioned earlier, this year's findings will help inform ASCO's future educational, policy, and advocacy efforts. And we need all of our members to help, as well. Keeping informed is one critical first step, of course. Looking ahead, please know that ASCO's National Cancer Opinion Survey is scheduled to be conducted again next year. And this will give us one more opportunity to drill down even deeper into findings from this year and explore other emerging issues while tracking potential changes in the focus and concerns of the general public we serve.

If you would like more information about the survey, please visit ASCO's website at asco.org and search for National Cancer Opinion Survey. Until next time, thanks again for listening to this ASCO in Action podcast.

Nov 13 2018
11 mins
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Rank #11: ASCO CEO Addresses Concerns with 2019 Medicare Physician Fee Schedule and Quality Payment Program Proposed Rule

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In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis discusses the recently released Medicare Physician Fee Schedule (MPFS) proposed rule. The MPFS is a complete listing of all fees Medicare uses to reimburse doctors and other providers and suppliers under a fee-for-service payment system.

Aug 07 2018
7 mins
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Rank #12: Exclusive Interview: FDA Commissioner Talks Drug Pricing, Expanded Access, and Tobacco

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

"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 take care of, people with cancer. My name is Clifford Hudis, and I am 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. Scott Gottlieb, the commissioner of the United States Food and Drug Administration.

The FDA of course plays a critical role in the delivery of high quality cancer care by reviewing and approving cancer treatments. This continues to generate discussions about the pace of scientific advances, and indeed the regulatory role of the FDA. Given that, we are really lucky to be able to talk today with Dr. Gottlieb about the FDA's efforts to increase overall efficiency by updating or modernizing aspects of our clinical trials conduct and expediting the end to end drug development process.

I will admit that I'm going to take advantage of this opportunity to also ask how his agency is tackling the issue of tobacco control for the next generation of tobacco products, another area of deep concern from our community and others. Dr. Gottlieb, welcome and thank you for joining me today.

Thanks for having me here.

Great. Now as a professional society, we are very focused on the intersection of science and society. Given that, and noting that you've been at the FDA for more than a year following a long career in public service and in private industry, I have to start by asking, for you, has your current experience changed or evolved your view of the FDA's role or functions, and if so, how.

I've been at the agency three previous times. I had a good sense of what the agency's public health mandate was and what its mission was. I think that the nature of the market and the science that we're grappling with has certainly forced or compelled the agency's mandate to evolve. I think what we're seeing right now is, I feel like we're at the inflection point with respect to a lot of new opportunities from technology.

We look at things like gene therapy and cell-based regenerative medicine. Those fields largely didn't exist last time I was at the agency, and now we're an inflection point where we're going to see gene therapies approved to the market, and we saw three CAR-T's approved already, that are going to fundamentally transform the treatment of disease.

When I was last here, we were talking about the ability to advance genomically derived drugs and have more targeted approach to the treatment of patients where you can get the right drug to the right patient at the right time with sort of a drug diagnostic system, yet seeing some early examples of that. But now that is a much more routine development pathway.

With respect even to tobacco, you mentioned tobacco at the beginning, we're at a point right now where we have the opportunity to use new technology potentially to help currently addicted adult smokers transition away from combustible tobacco products onto products that we presume don't have all the same risks associated with them.

And so using new authorities we have to regulate tobacco, including regulate nicotine levels in combustible cigarettes to render them minimally and not addictive, and allowing for a regulatory pathway that puts some of the new technologies like e-cigarettes through an appropriate series of regulatory gates, we have the opportunity to transition adult smokers off of combustible tobacco with all their morbidity and mortality associated with combustible tobacco use more rapidly than we did in the past.

And so across the board, I think we're seeing technological inflection points. Digital health tools are another example that are not only creating significant new opportunities, but I think compelling the agency to rethink its traditional approach to regulation in order to accommodate the opportunities that these new technology platforms create.

So is it fair to sum all that up as, the agency is recognizing that technology in many domains is defining and driving the need for new regulatory frameworks, and in turn, we have to educate Congress and others to make sure that the agency actually has the appropriate authorities. Is that the virtuous cycle you're describing, you think?

I think that's exactly right. I think that there are areas of profound technological change where the traditional approach to regulation doesn't apply well. Digital health tools, probably a very obvious example where you can have sort of practical incentives, where you have a digital health tool, you might evolve it almost on a daily if not weekly basis in the marketplace. It's a medical product that's a digital health tool, like a medical lab, for example.

And a regulatory process that requires you to come in and file for premarket approval every time you want to make a modification or have to file a 510(k) supplement, that is antithetical to the rapid cycle of innovation and evolution that those kinds of products undergo.

So we had to think of a new regulatory paradigm for how we would treat these products, and that's where we move towards the Pre-Cert model, where effectively what we're doing is validating the underlying architecture of the platform, of the software platform, and validating the SOPs, how good is the company at certifying its own software and validating its own software products, and then we would allow them after an initial approval to come to market with modifications as well as subsequent approvals without having to seek premarket clearance from the FDA every time.

And we would shift toward the postmarket regulatory regime for subsequent products. So basically, instead of regulating the individual products, in essence we're regulating the firm and taking a firm based approach. That's an example of where we've had to rethink our regulatory model in order to accommodate a much different approach to innovation.

Another example is with cell-based regenerative medicine, where we have very clearly said that we think that there's a lot of opportunity with cell-based regenerative medicine, but we also see a lot of clinics promulgating products based on what we think is incomplete if not poor science and creating substantial risk of patients using cell-based products intrathecally, or for injections into the eye, where they're creating substantial risk and don't have really a scientific basis to argue that there's convincing evidence of a benefit.

And these products are clearly subject to FDA regulation. They cross the line between what is and isn't regulated by FDA, but subject to enforcement discretion of the agency over many, many years. Prior to when I came in here, the agency didn't actively regulate these products. We have said very clearly, we're going to actively step in to regulate this field. In fact, it's going to take a number of enforcement actions, and we'll be taking others. At the same time, we also recognize that a lot of these technologies are being promulgated by small developers, and there's a lot of promise here. And so we've had to again come up with a more accommodative approach. But how do we regulate a field where a lot of the really interesting innovations are being brought forward, for example, by academic investigators working in small clinics. And so what we've said in that case is that we'll allow investigators to pool their data so long as they follow common manufacturing protocols that are doing similar things with cells. And it can file a common BLA, common Biologics License Application. And then we'll give individual licenses to the individual institutions or individual investigators. That's a much different approach to regulation than what we've traditionally done where you think of, we regulate companies, we regulate a biotech or a pharmaceutical company. We had to ask ourselves, how do we regulate small clinics or even institutions, academic investigators in institutions, who want to promulgate these technologies. And we've come up with an approach to do that.

So at the same time that we've said we're going to be taking more enforcement action to make sure patients aren't being put under duress, we're also going to take a more accommodative approach to allow for regulatory approval for products that are being, in many cases, promulgated by smaller entities and individuals.

So that actually lets us pivot, I think, to an area of traditional focus for at least a large group of our members at ASCO. And that would be drug development. And it's clear that you've made it a priority to streamline how new drugs specifically are reviewed and approved. And I think as part of that effort, recently you announced a new office. It's the office of Drug Evaluation Science. And my understanding is the goal is to centralize performance metrics like biomarkers, patient reported outcomes. How do you see this new office specifically helping to support this goal of a more standardized and ultimately more efficient and faster review process?

Well, the Office of Drug Development Science, the goal there is to create an infrastructure here that will help better validate scientific tools that are being used to help advance drug development, like patient reported outcomes, like bioinformatics. What we've seen is that these tools now, there's a lot of hard science behind these tools. And they've become much more commonly used in drug development programs.

And so we need an infrastructure here that not only provides for a more standardized approach to assessing these modalities when they're incorporated into applications, but also helping to advance the science of how to use these tools. I compare it to what happened in 2003 with modeling and simulation. And I was here during the time period.

What we were seeing over that time period was we were seeing more drug developers starting to use modeling and simulation as a component of their overall drug development programs. And we saw modeling being included in applications. Early on, it was often used for dose finding because you wanted to give the dose finding trials. But then you wanted to use the data that you derived from the dose finding trials to simulate what would happen if you picked a dose in between the two doses that you might have tested. And so we said to ourselves, well, this is very interesting. This could really help inform drug review better, give us more information about safety and benefit. We need some standard approach to how we're going to both evaluate these tools as well as help develop them into a harder science so it could be more rigorously used in drug development.

We created a Modeling and Simulation Office when I was here. Mark McClellan was involved in doing it. He helped recruit the guy who stood it up, him and Janet Woodcock. It was Larry Lesko. And it started as a two-man office.

Now, we've got probably 30 or 40 people in the Modeling and Simulation Group in Cedar. And well more than 95% of all applications that we get for new drugs contain a component of modeling and simulation. It's now a routine part of drug development. And we have a rigorous approach to evaluating these components of the applications as well as helping to evolve the field through multiple guidance documents that we've put out. I see the Drug Science Office, this new office that we created within the Office of New Drugs, working in a similar way where it's going to be a holding office, if you will, for new areas of science that can help improve tools used to inform us about the risks and benefits of new products.

So I want to pivot from that to one of the big societal issues. And you and I have been discussing this informally, I think, for more than a year-- drug price. The Trump administration has made it a priority to address the cost of drugs, price specifically. And I guess the question from many will be how confident can we be that ultimately a faster and more effective drug development process will itself actually and favorably impact the costs of drugs. What's your feeling about that, knowing everything that you're doing that's supportive in that way?

Well, I see my role in the drug price debate to be focused around creating product competition. You have price competition. But you can't price competition without product variety and product competition. And we're focused on creating the product competition by facilitating entry into the market of generic drugs, but also, facilitating a pathway that allows for follow on innovation within categories.

And what we've seen-- and we've analyzed this. We're going to be publishing this data soon. But what we've seen over time is that second to market innovation within a category is coming to market much more slowly. We looked at a cohort of approvals from the early 2000s. And then we looked at a more recent cohort of approvals over like a five-year period. And it's very clear that when you look at areas of unmet medical needs, orphan drugs, first in class drugs and oncologies, the second to market innovation is taking much longer to come to market and more categories of drugs are remaining sole source drugs in perpetuity. So to the extent that you're not getting that second to market innovation for new drugs, that is thwarting the opportunity for price competition within those categories. Because you do see price reductions. Oftentimes those price reductions come in the form of rebates that aren't transparent to the consumer. But there are price reductions or discounting nonetheless when you have a second and third to market drug within a category.

And the hepatitis C category was the best example of that. We saw a very dramatic price reductions in negotiations once you had multiple entrants in that category. So we're focused on that. And we're asking questions about why it's become harder to bring second to market innovation to patients. And I think that there are some very specific reasons and there's things we can do to help address that, to make it less costly to bring second to market innovation in an area of unmet medical need.

If the trials are onerous or very costly to bring that second to market drug to the market, sometimes the economic opportunity might not be robust enough after this one entrant, especially when you're talking about very narrow niche categories of unmet medical need, they're might not be enough economic opportunity to incentivize that second to market innovation.

I think where-- just to sort of close, I think where this might be most evident is in some of these inherited diseases. You've seen this play out in gene therapy, for example, where once you come to market with a treatment and you treat the prevalent population, the people who already have the disease, the incidence population, the number of people who are going to get it on an annualized basis, that might not be a big enough market to support a second entrant that's going to split the market with the first in class product. And so I am quite literally seeing investors pull out of these opportunities which we see what we think are applications being slowed down. We see people pull out if they think they're going to be third to market. And that's ultimately bad for patients. Because it's not just robbing patients of product competition, but it's also robbing them of potential product variety. And we know not every patient responds to a treatment the same way. So you want differentiation in the market.

And also if there's a horse race between being first, second, third to market and the third to market pulls out because they don't think they're going to be first or second, sometimes the first or second doesn't pan out. And then you're stuck with nothing. So this is not a healthy development. And if there's things we can do to make the development process more efficient to create more entrants, that's something we're focused on.

So that's great. You raised at least two issues that I want to pursue a little further. Let's start with the first one, which is technology based. Recently you announced specific plans to keep pace with the influx of applications for selling gene therapies. And you've referred to that already in your comments.

But you've raised concerns specifically around, I think, if I understand it, reimbursement environment for CAR-T therapies and a fear that that reimbursement challenge may, in fact, stifle innovation that's needed. Is there more to say about that? Or is that pretty much the issue right there?

Well, I think that that's one of the issues. I think the issue, obviously, is-- and many people who are in this space are acutely aware of this-- is that there's different pay structures on the inpatient and the outpatient side to the extent that some of these products are being labeled for use in inpatient only. The reimbursement on the inpatient side is much lower and more difficult than reimbursement on the outpatient side right now. So that's an unusual situation and something that's artificial. I mean, a drug shouldn't be reimbursed diametrically differently just because it's delivered in one setting versus another and the reason why you're pushing it into an inpatient setting is for safety considerations. And so I think it's something we need to address. We can't allow that sort of artificial differentiation to persist.

There's a lot of late stage CAR-T development. But we're not seeing a lot of early stage CAR-T development. And if you talk to people in the field, they'll say, well, it's because CAR-T hasn't demonstrated its ability to really potentially be effective in solid tumors. And a lot of the liquid tumor opportunities are already being pursued. I'm not sure that's true. I think that there is a reluctance. At least part of it is a reluctance to make significant investments right now because the reimbursement environment is so uncertain for these products. So that ultimately needs to be resolved by others, including CMS. But I think that there are things we can do as well here at FDA.

So for example, we say that a product should be labeled for inpatient use because we believe that with certain risks associated with the delivery of some of these products-- and you're very familiar with those risks and so are all your listeners-- require the ability to deliver intensive care or significant medical services if a patient does have a reaction on an infusion of this product. But that doesn't necessarily mean that you need to be in an inpatient facility. What it means is you need to have within a reasonable period of time-- and you can define that period of time-- access to significant supportive care. I know institutions where the inpatient infusion center is further away from the medical intensive care unit than the outpatient infusion center. So that makes no sense. Why would you say it has to be in an inpatient setting when the inpatient setting actually is further away from the kinds of medical resources that we want accessible to the patient?

So really what we should be considering is defining and labeling the kinds of services that need to be available within a certain period of time, and not necessarily inpatient or outpatient. Because there are a lot of outpatient infusion centers that are adjacent to academic institutions where you can have a significant amount of supportive care delivered very quickly. And the patient is very accessible to a medical intensive care unit if they do have an adverse reaction. So we're rethinking that, how we label these products. But that's a-- it might solve the proximate challenge. But ultimately, I think you need a fundamental solution to the pay structure so there's not an artificial divide between the inpatient and the outpatient with respect to these products.

So just in the interest of time, I want to make sure we cover the monetization of clinical trials because that's the other issue, I think, rightly raised. And you've for a while made this a priority, I know. And I'll just jump ahead and say, and I think if I remember correctly, your agency the FDA issued two draft guidance documents on innovative trial design within the last year. The first focused on master protocols. And the second on specific advice in terms of design and conduct for adaptive trial designs. That's a compressing approach in terms of the phases of traditional studies. Can you talk a little bit about why this is important and what kind of savings you think this could actually deliver as a practical matter?

I think it's important because, first of all, I think a lot of the drugs that are being put into development can't be developed efficiently with the traditional approaches to drug development. So for example, you think of a drug where it's targeting molecular change that's apparent in multiple disease states. This is most obvious in cancer where you have tissue agnostic approvals where you might want to do a basket trial where you test a drug in multiple tumor types where what's driving the tumor is the same genetic alteration, molecular change.

And you want to be able demonstrate that it works across multiple tumor types, especially with rare tumors where you might not-- if you said, well, you have to prove it first in lung cancer and then you go on and prove it in liver cancer. But it might be such a rare genetic change that you're not going to be able to efficiently enroll just in lung cancer and liver cancer. So you want to pool the data across multiple tumor types to demonstrate statistically significant evidence of benefit.

I think because more drugs are being designed that way, we have to rethink how we allow sponsors to conduct clinical trials, structured clinical trials. And so things like basket trials and master protocols and tissue agnostic approvals become very important in this paradigm.

It also can allow for a lot more efficiency. A master protocol can allow you to test multiple drugs within the context of the same trial. If you have a situation where you're looking at targeting a rare disease or a rare subpopulation of a disease, where it's hard to recruit people, if you have a master protocol set up, you can test multiple drugs in the same population much more efficiently. So as we develop drugs that are targeting smaller and smaller populations and delivering, in many cases, outsized benefit and demonstrating earlier evidence of benefit, we need to rethink how we structure trials to take advantage of those opportunities. I think one of the-- we approved a record number of novel drugs this year by a long margin, 59 approvals. The second best year, which was last year, in modern times, I think was 46. We approved 19 new NDA and BLA products focused on cancer and had 38 supplements this year.

If I was to point to one thing that's driving that innovation, it's the fact that more of the drugs, many more of the drugs that are being put into development now not only have a very plausible biologic rationale for why they're going to deliver benefits, but they're so well targeted, so the underlying disease state is so well understood, that we're seeing much more significant benefit much earlier in drug development in much more compelling disease situations. And so, proof of concept is established very early. And you can establish statistically significant evidence of benefit in a very small series. And that's accelerating these products through development. And more of these cases are situations where you're targeting such significant unmet medical needs that even if there is uncertainty around the full scope of the safety profile, the outsized benefit in that clinical setting overwhelms any of that uncertainty. And so you can move these products through development much more efficiently. That's the nature of the science that we're seeing right now. And I think it's going to be the way we see the field move forward, at least for the foreseeable future.

You know, one of the issues that this raises is the issue of targeting and niche subpopulations which you've referred to. We've tried to deal with this within ASCO by launching TAPUR, which takes next gen sequencing, by and large, and matches patients who are theoretically scientifically appropriate for off label use with drugs that are in the market but where the indication doesn't include their histology. And I know your agency is familiar with it.

But that, in turn, generates prospective evidence. The vast majority of patients, as you know, in the United States simply don't have the opportunity for various reasons to participate in clinical research. And that has raised questions about the utility of so-called real world evidence and real world data.

You know that the FDA has been working closely with ASCO, especially with our big data project CancerLinQ, so that your agency has access to our growing big data repository. And that in turn, we all hope, will inform certain aspects of regulatory review, I guess mostly in the area of label extensions.

So your agency recently released a framework providing detail on how the FDA is going to develop guidance for real world data in drug regulation. And we're especially excited by this. We're invested in this, in a sense. And we look forward to working on it as it rolls out.

How do you see this framework being implemented specifically? How is it going to benefit patients?

I think it's going to address one of the things you said right up at the top, which is patients don't have access to clinical trials. I think as we make more rigorous use of real world evidence in the development process and in the regulatory review process, that's hopefully going to open up the opportunity for data collection and clinical trials to move out into the community.

Real world evidence isn't just evidence collected after the fact. You can have real world evidence collected in randomized settings. You can have real world evidence collected in prospective settings where you have large, simple registries and other kinds of constructs. And so, as we're able to make more rigorous use of these kinds of data constructs, I think it's going to push clinical data collection further out into the community so more patients are going to be able to access experimental protocols where the evidence is being generated that's going to help inform regulatory review, either in the pre- or post-market setting.

And we're clearly making widespread use of real world evidence in post market setting, particularly for confirmatory studies post approval. And you're seeing situations where it's also informing decisions on the premarket side as well.

So I guess, since we're talking about access, one has to at least address the question of very ill patients and access to investigational drugs outside of the clinical trial system, what's been called expanded access. And this has been a topic of great discussion and debate for the last couple of years. Can you talk about some of the specific changes that the agency is making and how you see this helping patients and physicians navigate the new expanded access program?

Well, the one that we announced recently is that we're going to create a service here at FDA where we're going to staff it. Initially it's going to be sort of a pilot. And we'll focus it on oncology where we'll help patients navigate the expanded access process soup to nuts where effectively they will be able-- if someone identifies an expanded access protocol that they want to get entry into with their physician, their physician is going to be able to call FDA. And FDA is going to help guide them through the process, soup to nuts. FDA will have people who will make the outreach to the sponsor and do the interface with the patient and provider to make sure the documentation is done in a timely fashion.

This is also going to have the advantage of allowing us to be on the phone with the drug sponsor to understand why drug sponsors might not give access in certain settings. And so what we find is, in some cases, we're willing, we approve the ability for a patient to get access to a product, but the drug sponsor might turn it down. And so this is going to allow us to collect more information about why it might be turned down.

It's also going to allow us to identify situations where there might be a lot of requests of one drug company so that we can intervene to help encourage the development of a true expanded access protocol. If there's a lot of compassionate use requests, for example, of a single sponsor or a single drug, those are situations we might pick up the phone and say, hey, we're approving or we're getting requests for a lot of compassionate use. Why don't you think of starting an expanded access protocol? We can work with you on that.

So I think that having FDA be an interface there is not only going to make it more efficient for the patient and provider to access the system, but hopefully will also allow us to interface better with sponsors to sort of create the conditions where drugs can be made more widely available under appropriate conditions. And just for clarity, I assume that there is a 800 number or web URL for that. Is that right?

Well, we stand it up. It's still in process. So it's something that we're going to do soon. But yeah, this will be widely disseminated to folks.

Great. So the last thing I want to talk about, which brings us in some ways back to our roots, is tobacco. And I said at the top of this that we would touch on this. This is an area where our field saw slow but ultimately critical progress starting in the 1960s. And all of this feels like it might be jeopardized by a recent and alarming uptick in tobacco use in children, essentially kids and young adults. And this is just setting off, as I say, alarm bells across our field. I think there's data from the FDA and the CDC that in 2018, 3.6 million students were e-cigarette users. And this was compared to just 1.5 million about a year earlier.

Now there's still not a lot of research on Electronic Nicotine Delivery Systems or so-called ENDS. But there is at least some reason to believe that they might increase the likelihood of nonsmokers or former smokers converting to combustible tobacco with their known risks.

So last year, I know that the agency announced the Youth Tobacco Prevention Plan to address this alarming trend. And it'd be great if you could talk a little bit about the plan and what you intend to do and update it, as I know you've been talking at least on social media about this issue in particular.

Well, we think that the non-combustible products like e-cigarettes provide a potential opportunity for currently addicted adult smokers to transition off of combustible tobacco onto modified risk products. These products, the e-cigarettes, need to be put through an appropriate series of regulatory gates. But I've said many times, if we can transition every adult smoker off of cigarettes, traditional cigarettes, onto e-cigarettes, that's going to provide a significant public health advantage, public health opportunity.

The e-cigarettes are certainly not risk free. Those risks need to be properly defined through a regulatory process. But there is an opportunity there. And what we announced early on last summer of 2017 was that we are seeking to-- and we've advanced the rulemaking to do this. We're seeking to regulate nicotine levels in combustible cigarettes to render them minimally and not addictive so they can no longer sustain addiction.

At the same time, we allow the e-cigarettes to remain on the market while we put them through an appropriate series of regulatory gates with the notion being that if regular cigarettes no longer have nicotine, smokers would more rapidly migrate off of traditional cigarettes, hopefully off of nicotine altogether. But if not off of nicotine, onto either medicinal nicotine products, the safest form of nicotine delivery. Or if they want inhaled forms of nicotine delivery, onto e-cigarettes.

Again, recognizing that e-cigarettes aren't risk free. But on a risk continuum, nicotine exists on a risk continuum, they are lower risk than combustible tobacco. But what I said all along was that that opportunity and that policy framework couldn't come at the expense of addicting a whole generation of young kids onto nicotine through these same products. And that's, in fact, what we're seeing. We are seeing an epidemic growth. And this is what we spoke to last fall in the use of e-cigarettes by children with fully a 78% rise among high school aged kids in e-cigarettes in over one year, from 2017 to 2018. And really no indication that it's going to abate very quickly in the coming year.

So what we set out to do was implement a series of regulatory steps to try to address the access and appeal that these products have to kids. So we are putting in place significantly heightened age verification requirements for the purchase of products in convenience stores. We're particularly targeting the flavored products because we think the flavored products are a primary vehicle by which these products are appealing to children. At the same time, we launched a series of public education campaigns that we think are very effective to try to educate youth about the risks of e-cigarettes. But I'll say in conclusion that if these actions don't have a very immediate effect on these trends-- and you're not going to reverse these trends overnight. These trends are underway. This has become sort of a fashionable item among kids. You're not going to just reverse that overnight.

But if we don't see this growth leveling off and starting to reverse, I think that this is an existential threat for the entire e-cigarette industry. You know, I find myself stuck in conversations where I'm debating with them the merits of selling cherry flavored e-cigarettes at convenience stores or gas stations where it's readily accessible to a kid. And I think what they really should be contemplating is, boy, if these trends go up another year, my entire product's going to be taken off the market.

Because that is the cold, hard reality. We are going to-- whether it's FDA acting to change its enforcement policy or it's Congress stepping in, if you see another year of 50%, 60% growth in e-cigarette use among minors and you see fully 45% of American kids using some form of tobacco products and you see combustible smoking rates trying to go back up again, that's going to be a public health catastrophe. Nobody is going to have patience to tolerate that for another second. And there is going to be dramatic steps taken.

And so I think that the industry ought to wake up to that fact. We've certainly woken up to that fact and recognized it. And it would be a shame. It would be a shame because the e-cigarettes do represent an opportunity for currently addicted adult smokers in a properly regulated market. We don't want to foreclose that opportunity entirely. And we don't want to impede adults unnecessarily from getting access to these products.

But we are not-- collectively, we haven't done all we can and all we should to address the youth use. You're going to see us take more steps going into this year. We have more enforcement activity underway. But the manufacturers also need to stop fighting some of these steps. And they need to start addressing this more seriously. And, you know, it's one big manufacturer in particular that's driving a lot of the youth initiation on these products.

Well, it's great to hear the vigor that is being brought to bear on this. And I know that in our community there's tremendous support for threading this needle just right, as you describe. So thank you for that.

I want to just take a moment now and say, in general, to Dr. Gottlieb, thanks for joining me today for this ASCO In Action podcast. We are really grateful at ASCO for the strong collaboration that exists between us, the entire oncology community, and the FDA. And we look forward to continuing our work together to make sure that patients with cancer have access to safe and ever more effective treatments.

As a reminder to listeners, you can follow Dr. Gottlieb on Twitter @sgottliebfda. That's one word. You can follow me, a little less exciting I think, @cliffordhudis. And you can follow ASCO @asco. To stay connected with the latest updates on the FDA's work, visit fda.gov.

And as always, we will continue to provide here updates on relevant FDA activities at asco.org/ascoaction. Until next time, thanks again to Dr. Gottlieb and thanks to all of you for listening to this ASCO In Action podcast.

Jan 29 2019
37 mins
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Rank #13: Caring for Every Patient, Learning from Every Patient: A Closer Look at ASCO President Dr. Monica M. Bertagnolli’s Vision as She Assumes Leadership Position

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ASCO President Monica M. Bertagnolli, MD, FACS, FASCO joined ASCO CEO Dr. Clifford A. Hudis in the most recent ASCO in Action Podcast to discuss her presidential theme and the vision she has for ASCO this coming year.

Jul 10 2018
20 mins
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Rank #14: ASCO Podcast Coming Soon: Exclusive Interview with FDA Commissioner Scott Gottlieb

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Don’t Miss: Exclusive interview with FDA Commissioner Dr. Scott Gottlieb by ASCO CEO Dr. Clifford A. Hudis on the next ASCO in Action Podcast, coming January 29.

Jan 25 2019
1 min
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Rank #15: How Can Financial Barriers to Patient Participation in Clinical Trials Be Addressed?

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Welcome to this ASCO in Action Podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact on 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'm really delighted to have Dr. Beverly Moy joining us. Dr. Moy is a medical oncologist at the Massachusetts General Hospital who specializes in breast cancer care. She's also an Associate Professor of Medicine at the Harvard Medical School and a longstanding and dedicated ASCO volunteer. She led the ASCO roundtable on addressing financial barriers to clinical trials, and she was one of the authors ASCO's policy statement providing recommendations to address this important issue. So our conversation today will focus on the existing financial barriers to patient participation in clinical trials and how policymakers, trial sponsors, institutional review boards, and other stakeholders can help remove and overcome those barriers Dr. Moy, welcome and thank you for joining me today.

I'm so glad to be here.

By way of background for our audience, only a small percentage of patients with cancer ever participate in clinical research. And yet, we know that certain groups, especially people from low socioeconomic status are underrepresented even in those trials. To give a little bit of shape to that, no more than 3% or 4% of adults with solid tumors participate in research studies. And even then, that number over-represents certain higher socioeconomic groups and underrepresents others. Can you tell us why this issue is important to be addressed, and, furthermore, how we might improve the diversity of clinical trial participation?

So I think it's incredibly important that to improve clinical trial participation among underserved groups. When I think about how we can provide the highest quality cancer care, we really can deliver three basic things-- the best possible standard cancer therapy, the best possible supportive and palliative care, and the best possible novel or experimental therapy. So we know that clinical trials are crucial to the advancement in cancer care. And in the current genomic era, sometimes these trials may even represent the best possible treatment option for some of our patients with cancer. We also know from the medical literature that patients who participate in clinical trials tend to do better and sometimes even live longer.

So when access to the best possible experimental therapy is threatened, optimal cancer care becomes impossible due to financial barriers. And this is an example of social injustice, where poor or underserved patients are being deprived of quality cancer care. So I think that improving the diversity of clinical trial participants is also critically important.

When we determine a new treatment's effectiveness, the cancer clinical trial participants really should reflect the general population of patients with cancer. So as you already said, just a small percentage-- no more than 5%-- of all adult cancer patients in the United States participate in clinical trials, most of whom are white and are from a higher socioeconomic class. That means that the results of our clinical trials are less generalizable, and we need to do better.

So I think that's a longstanding issue, and I know that many listeners are appreciative the efforts to address it. But it raises a question about the underlying reason for this. And one of them, I think, is financial, that is financial barriers to participation, financial barriers to care, and what is now called financial toxicity. As an aside, we recently conducted a national cancer opinion survey-- we do this every year-- and one of the striking observations this year was that 57% of Americans say that if they received a cancer diagnosis, they would be most concerned about financial impact or paying for treatment. And that was compared to 54% who said they'd be most concerned about dying or suffering from the diagnosis. I think it's a remarkable statement that at least a large proportion of people think first and most profoundly about the financial implications of a cancer diagnosis as think about the health consequences.

So if we think about that and then turn back to the clinical trial situation, it is, I think, true that most clinical trial participants will have to face even more additional costs that may prevent them from participating in trials. Can you provide us with an overview of what some of those additional costs are that participants face when they consider a clinical research setting?

So Cliff, I think you're absolutely right and. You know, you're talking about the general financial burden that any cancer patient faces is incredibly high. And I actually would reference listeners to listen to your podcast that you did after the ASCO Quality Symposium, where you actually talked about a few studies looking at really the high rates of financial burden that patients just generally diagnosed with cancer faces.

When you add the complexity of participating in a clinical trial, not only do you have that general financial burden that a cancer patient has, but you add additional potential financial costs that become prohibitive for our poor and underserved patients. So I think of these additional costs related to clinical trials falling into really two basic categories. One is gaps in insurance coverage, and then the second is medical out-of-pocket costs.

So picking the gaps in insurance coverage policies category, we know the Affordable Care Act was passed in 2010, and it does require coverage of routine health care costs for patients participating in clinical trials. But these protections do not extend to patients with Medicare or Medicaid. It's only for patients with private insurers, and there are even restrictions there, which we can go into later. That means our poorer or older patients are more vulnerable to not having these protections.

These potential costs could consist of things like investigational care costs, such as this specific therapeutic drug under investigation, or more likely the cost of additional services that would not have been required if the patient was receiving standard therapy. These services could be things like extra blood draws for safety data or imaging studies that fall outside of the routine staging exams. So these extra services have the danger of either being billed to the patient or forcing the patient to pay more towards their insurance premium due to policies that increase cost sharing to patients in the modern era.

A second important cost category, which is just as important, if not more important, would consist of non-medical out-of-pocket costs resulting from clinical trial participation. So these costs include travel and lodging expenses, or costs due to lost wages because they have clinical trial visits, or the need to pay child care because they have to come into the hospital or the cancer center more often. So patients participating in clinical trials often have far more frequent visits than standard therapy, perhaps at centers that are farther away from their home. If they participate in early phase first in human trials, they could require longer days of things like pharmacokinetic testing that might even require overnight stays in hotels. So these out-of-pocket costs can be considerable, and prohibitive, and make it impossible for poorer patients to enroll into clinical trials. I know that-- and I'm sure many of our listeners know that-- you're actually a day-to-day clinician. You see breast cancer patients, as well as do research at MGH. And I'm interested in the practical ways that you might have seen these costs directly affect your patients. Do patients ask about trial costs when you're talking to studies with them, talking about studies with them? Have you ever had patients hear about a study and then declined to enroll because they thought it would be too expensive? So I think that's a really interesting question, Cliff. And I think, in the past, when we've presented clinical trials to patients, the idea of costs never really came up maybe because it was something that patients didn't feel comfortable bringing up to their physicians. But now, either costs are becoming more considerable, or it's being raised into awareness that I think that patients are much more comfortable talking about it, maybe not at first, but maybe towards the end of the process.

So in my own practice, I've seen people bringing it up more, and more, and more, usually even during the consenting procedure when you're talking about all the extra visits and studies that the patient may need to have to undergo the clinical trial. I've also seen patients who've actually enrolled in trials, and they're on study, and they consider even coming off trial because they didn't anticipate some of the costs that might happen.

So, for example, recently, I treated a young woman with high risk breast cancer on an adjuvant CDK4/6 inhibitor trial. And this trial requires more frequent medical visits and blood testing because of potential toxicities. And she found that the extra co-pays and financial costs toward her insurance deductible were completely prohibitive. And despite conversations, she actually prematurely dropped out of the trial after only about nine months of therapy. And this is a single mother of two young kids. That's really not acceptable that a financial reason was the reason why she couldn't continue on the trial.

So I think patients are asking more and more for financial guarantees even before signing consent for clinical trial screening, and I'm afraid we really can't provide financial guarantees because that's really not possible for us to do.

So one of the reasons that we bring together volunteer groups like you've participated in and then publish results at ASCO is not merely to identify, name, and describe the problem, but in fact to offer solutions or at least potential solutions. So I want to turn and talk a little bit about the recommendations that you've made in the policy statement and through your work.

The most recent policy statement on financial barriers to clinical trial participation focused, as I understand, on three key objectives. One was transparency in terms of clinical trial costs and these gaps in coverage that you've been describing. The second is reducing concerns about inducement, that is making sure that whatever we do does itself in an unreasonable way lead to the perception or reality of induction onto the trial. And finally, improving data in the course of participation in trials. That is studying this scientifically like we do other aspects of care.

So let's start with the first objective, transparency. What are some of the ways that lack of transparency has affected participation in trials? And how can clinical trial sponsors, or sites, or investigators help us address the issue of transparency?

So I think that transparency is a very, very critical issue here. And one of the potential problems is that lack of transparency about who is responsible for the specific costs of clinical trial participation can lead to uncertainty from the patient's part about what he or she might be responsible for paying in the end. So often, insurance payers and research sponsors, whether it be industry or other, they might disagree about who is responsible for which costs. They might argue about what really constitute truly safety assessments, what's really routine costs, so generally the research sponsor covers the costs of additional or more frequent services that the insurance payer may disagree about what services are truly additional or more frequent. You know, what is really standard?

So if a health plan denies coverage for the entire trial or individual services within a trial the sponsor considers routine, this could be problematic. So without transparency or protections the patients run the risk of being billed directly for these services. So these costs need to be addressed specifically so that the financial burden doesn't land on the patients in the end.

One of the reasons for the costs being a barrier, of course, is that clinical research is often very expensive, and at least some of the recommendations focused on clinical trial design is a way to reduce costs. What changes do you think sponsors might make to clinical trials that could directly bring down the costs for patients? And I would add, especially with regard to those traditionally facing greater barriers, the populations we're talking about today.

So clinical trial design is really important because we have to be very cognizant that what this means to the patient and how we're burdening them. So clinical trials really need to be more aware of the financial implications of their study design. So, for example, excessive follow up medical visits, or additional laboratory draws, throwing on more imaging studies, or other procedures that are not absolutely critical to the study really ought to be eliminated because these costs add up. And if they're not critical, they really shouldn't be done. There are costs associated with every test or visit performed. So we really need to reduce the excessiveness of what's required of patients on clinical trials.

So in addition to that-- and I mentioned this earlier-- one of the concerns on the other side is about what happens ethically if we pay patients directly to defray these out of pocket costs? This is referred to as an inducement. And around clinical trials, there's really a high degree of, I think, appropriate concern for inducing patients on to studies. What are some of the concerns? Do you think that they're well-founded or overblown? Is there anything that we can do to remove or address those concerns while defraying the course of participation?

So I could talk about the ethics about this issue all day long, but I'll try not to. But I think the theoretical concern that I've heard often is that financial compensation or reimbursement of clinical trial expenses could represent a form of inducement or coercion to enter into a clinical trial. And this probably stems from FDA and OHRP regulations that clinical trialists should minimize the possibility of coercion or undue influence on patients. There may also be a potential hurdle from CMS that the Social Security Act specifies criminal and civil penalties for offering financial remuneration to a Medicare or Medicaid beneficiary that influences the selection of their medical provider.

So I'm not a lawyer, but I think these concerns are fairly ludicrous because first, coercion, as a principle, is completely irrelevant here. From an ethical perspective, coercion involves a threat that makes a certain choice irresistible, and that is not relevant in the case of cancer clinical trials. Undue inducement is also irrelevant because we have multiple examples in the medical literature that large payments do not disproportionately affect patients' willingness to do medical tasks, for example even donating a kidney.

There was actually even a recent article published in JAMA Oncology, written by some bioethicists from UPenn, that argues that the worry that offering inducements to participate in research is inherently wrong. The authors even go so far as to discuss paying patients for cancer clinical trial participation to make participation more attractive to a wider population of patients. And that's really important for both social justice and trial completion issues. So the idea of paying patients for trial participation was something that was brought up even by the patient advocates who participated at our ASCO roundtable on this subject. The patients thought, if we're doing this to advance science, shouldn't we be paid for it? So to remove these concerns, ASCO's partner in our roundtable, the Lazarex Cancer Foundation who helps fund our roundtable, they worked with the state of California to sign into law identifying trial-related expenses to be reimbursed and are currently working with several other states to do the same, such as Pennsylvania and even my home state of Massachusetts, and Texas, Florida, Ohio. But I do believe that we need federal regulations to remove the specter of inducements and coercion out of this field because it simply doesn't belong. So I guess that's my long-winded way of saying that ethical concerns about paying patients for out-of-pocket costs associated with trial participation are completely overblown. I see.

Sorry if I went on for a while, but I feel pretty strongly about that. I was going to say, do you have an opinion on the matter? But one of the other areas called out in the paper relates to the economic burden on trial participants versus non-trial recipients and says that this economic burden data is more than 20 years old, that is it's not modern. And so it recommends that organizations should, therefore, pivot and support the building of an evidence base, research, on the true costs of patient participation trials now in the current era. So what exactly is the kind of data that we need and, how would better data, in turn, allow us to reduce barriers to participation? So I think that, like all research and data issues associated with cancer equity in general, we need more data about effective interventions that reduce the financial and economic burden of clinical trial participation. We also need data in the modern health care era about how burdened our clinical trial participants really are. This data is starting to come in from various single centers across the United States, but we really need a concerted, comprehensive, and collaborative effort to examine this important issue nationwide. But mainly, I do think we need research about interventions that work to help our poor underserved patients enroll into cancer clinical trials.

So with all of this said, what do you think ASCO's next steps on this issue should be? What do you propose? Or what does your group recommend that we do in a concrete way next?

So I think, first, I want to say that historically I've been extremely proud to have worked with ASCO because ASCO's really been a leader in improving access to care for all patients with cancer. And given ASCO's leadership in the oncology community, ASCO's really in the unique position of being able to convene this roundtable that led to this policy statement. And there are multiple stakeholders at this roundtable, including researchers, clinicians, industry, insurance payers, the NCI, FDA, Biden, Moonshot, ethicists, patient advocates, you name it. And ASCO, as a leading clinical cancer society, really can push this issue forward based on its leadership here.

I think ASCO ought to demand change through federal regulatory policy fixes, and disseminate, and possibly even fund relevant research that we just described earlier today. I think what we're doing today with this podcast is that we're increasing awareness of this issue, which is also something that ASCO is doing, and no one can do better. I would want listeners to become really more aware of this issue.

The most underserved patients the United States are being deprived of one of the most important types of cancer treatment options. This is a social injustice that absolutely needs to be corrected, and we need the oncology community to be united in solving this problem.

And that's a really great summary of, I think, the motive and the ethical drive underneath our work in this. Is there anything else you'd like listeners to know about the ASCO recommendations? Are there any parts of this that we've skipped over or failed to mention? No, I think that the recommendations are kind of a multi-pronged group of recommendations to try to attack this problem, and it's really a first strike in this really important issue. But I think that what our listeners really should understand is that no patients should be denied access to a clinical trial for financial reasons. And no patients should be harmed financially because of their contributions to the advancement of science. So if we're united in this belief, then we really can move forward together.

Well, I love the way you've wrapped that up. And I want to thank Dr. Moy for joining me today for this ASCO in Action Podcast. I want to remind everybody that at ASCO, as you've heard, we are committed to preserving and enhancing access to high-quality cancer care for all individuals with cancer. Our statement on financial barriers to clinical trial participation is just one of many, where ASCO's voice and the collective voice of our members, we hope is helping to share and shape the future of the cancer care delivery system.

I encourage our listeners to read this statement, as well as our other policy and position statements. They're all available on the policy and advocacy pages of our website at asco.org and, in this case, through the JCO. Until next time. I want to thank everyone for listening to this ASCO in Action Podcast and thank Dr. Moy for joining us today.

Dec 04 2018
23 mins
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Rank #16: ASCO CEO Discusses New Studies on Patient Financial Toxicity and Opioid Use Risks

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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 may impact oncologists, the entire cancer care delivery team, and the quality of care they provide. But most importantly, of course, the patients we care for. My name is Clifford Hudis. And I'm the CEO of ASCO and the host of this ASCO In Action podcast series. For today's podcast, I'm going to share with you some highlights from the research that was featured at this year's recent Quality Care Symposium.

So ASCO is the host and sponsor of the Quality Care Symposium, an annual meeting that brings together oncology leaders, and all of the members of the cancer care team, to share strategies and methods for improving the measurement and the implementation of quality and safety activities in oncology. The recently held 2018 symposium presented a wide range of scientific abstracts, focused on initiatives that aim to improve the quality of care for patients with cancer, and, also, new research in this field.

Today, I want to highlight five of these abstracts from the Quality Care Symposium. These are abstracts that deal with issues I know are of particular concern to ASCO members, financial toxicity for the one and opioid use for the other.

Now, turning first to financial toxicity. As everybody knows, oncologists see the impact of high treatment costs on our patients, many of whom are not taking all of their prescribed medication because of cost. They are drawing down their savings, when they have savings. And they're often not paying their other household bills or taking other drastic measures because the cancer treatment that they have to receive has become so expensive. This distress is now broadly defined as financial toxicity.

Three different studies were presented at the Quality Care Symposium that put a spotlight on this issue. In the first study, by Wheeler, et al, we saw results of a national survey of more than 1,000 patients with metastatic breast cancer drawn from 41 states. What we saw here, was that in these individuals, especially those who are uninsured, there really was significant financial distress. A full third of these patients were uninsured and more often they reported refusing or delaying treatment because of the cost of care. They also reported that they were contacted by collection agencies because of unpaid bills, again, for their cancer care.

The study also found that insured respondents were not immune to financial toxicity. Those with health insurance reported having higher cost-related emotional distress, being stressed, themselves, because they weren't sure about the cost of their treatment, as well as spending a lot of time-- as well as having, I'm sorry, a lot of financial stress placed on their families because of cancer.

The second research study by Arastu, et al, related to the cost of care. And this showed that nearly one in five older patients-- and these patients were defined as age 70 and above-- who had advanced cancer, were experiencing financial difficulties, again, due to the costs of their treatment. They noted that these difficulties negatively affected their care, their quality of life, and mental health. In this study, patients experiencing financial toxicity had a prior higher

prevalence of severe anxiety and depression, poor measured quality of life, than patients who did not report financial hardship.

And finally, there was a third study by Greenup, et al, in which 600 women with a history of breast cancer were surveyed. The majority of them said that they would prefer to discuss the cost of care before beginning treatment, but few of them recalled having such conversations about treatment costs with their cancer care teams. In this survey, fully 79% of these women said that they preferred to have a full understanding of the costs of care prior to starting, but 78% of them said they never actually discussed costs with their cancer care team.

The findings of these three studies, I think, are important. They're a reminder that financial toxicity is real, that it represents a particularly harsh reality for many of our patients, and that we, as oncologists, are expected to initiate and guide conversations about the cost of care with our patients, although it doesn't happen very much yet.

A very good starting point for this seems to be to direct our patients to resources and help our patients prepare for these discussions. So ASCO offers an array of these materials on its patient information website. You can look that up at cancer.net.

Now, the other big area of focus, and, again, one that's been covered in the late news extensively in the last years, is, of course, the opioid crisis. At the Quality Care Symposium there were several aspects of the opioid issue that were addressed. I'll point out in background that although there's evidence clearly available that shows that patients with cancer may be at lower risk for abusing opioids than the general population, we also are aware of the fact that opioids are a controlled substance and they can be addictive. And patients with cancer are not immune to addiction either.

So understanding the size of the problem within the arena of cancer care, and then learning what the best practices are to help control the use of opioids to the most appropriate usages, especially after surgery, are very important matters for us. There were two studies presented during the symposium that provide some important insights on both of these matters.

The first by Chino, et al, was a retrospective study conducted over a 10-year period that comprehensively explored the risks associated with opioid use among cancer patients and compared that to the general population. They analyzed death certificates. And they found that deaths attributed to opioids, in cancer patients, were about 10 times less than in the general population. Although the incidence of opioid deaths had increased significantly in the general population, that increase, again, attributed to the opioids among patients with cancer was much, much smaller. Deaths from opioid use were highest in patients with lung, GI, head and neck, hematologic and GU cancers.

The second study by Stevenson, et al, looked at how oncology care team members could use a two-prong approach to achieve a reduction in opioid use-- in this case, it was 46%-- among cancer patients who underwent a variety of urologic surgical procedures. And they accomplished this without increasing pain or anxiety.

The first part of their strategy involved developing new processes for post-operative pain control that focused on non-opioid medications and therapies. These were interventions provided first line as pain management. Patients could still be prescribed opioids, but when they got these prescriptions, they were at lower doses and dose escalation was only performed if necessary.

The second prong of their two-pronged attack involved post-operative conversations with patients. Talking to them. Rather than having nurses routinely ask patients whether they wanted any pain medication or not-- and this was often a direct reference to opioid medications, specifically-- the nurses, instead, discussed current non-opioid medications that the patients were receiving for pain, along with their frequency and dosage, asked whether these medications were sufficient and discussed their potential side effects, along with the side effects of opioids. The opioids were never withheld, but they were no longer the reflexive standard, thanks in part to this two-pronged approach.

Now, from an ASCO point of view, we are really supportive of efforts to address opioid misuse and abuse. And we counsel our members to discuss the benefits and the risks of opioids with their patients. And then, of course, to prescribe pain treatment for patients responsibly and especially paying attention to those patients who have risk of addiction. At the same time, we keep our primary concern on adequate pain control for cancer patients. This has been a long-term issue for us. And it's an important one. So taking all this into account, we are working continuously with policymakers to ensure that both federal and state initiatives that are implemented do not impede cancer patients access to essential pain medication.

Now in closing, I want to say, again, thanks to all of you for spending some time with me today to learn about ASCO's Quality Care Symposium. The meeting provides a great forum for the entire cancer care delivery team to learn about evidence-based strategies and methods for evaluating and reporting on patient outcomes, provider efficiency, and quality and safety in cancer care. And the abstracts that we've highlighted today point that out nicely, I think.

In the end, all of this is about evaluating which approaches work best and how to continuously improve them so that we can do our best to ensure that every individual patient with cancer continues to receive the highest quality care that's possible. If you would like more information on the research that was presented at this year's Quality Care Symposium, please come to our website, abstracts.asco.org. And until next time, thanks again for listening to this ASCO In Action podcast.

Oct 23 2018
10 mins
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Rank #17: What You Need to Know About the Final 2019 Medicare Physician Fee Schedule and Quality Payment Program Rule

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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 an impact on oncologists, the entire cancer care delivery team, and most importantly, 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'm going to give our listeners a quick update on an important announcement from the Centers for Medicare and Medicaid Services. In an August podcast, I outlined the proposed Medicare Physician Fee Schedule and the Quality Payment Program Rule for 2019. This is commonly referred to as the Physician Fee Schedule. Today, I'm going to provide an update on where we are with this for next year. I have to say in passing, it's probably a good day for me not to have a guest, because I'm here with a terrible cold.

So what is the 2019 Medicare Physician Fee Schedule? This is a fee schedule which consists of a complete listing of all of the fees that Medicare uses to pay doctors or other providers and suppliers. It's a comprehensive listing of the maximum fees. And it's updated each year and then used to provide reimbursement to physicians and other providers working on a fee-for-service basis.

Now at ASCO, we, every year, review this rule very closely. And we try to determine and predict the impact that it will have on our members, and of course, on our patients. There are three provisions in particular that we want to highlight today. The first of these is related to care provided in calendar year 2019. And CMS estimates that there will be, overall, a 1% reimbursement cut for hematology and oncology, as well as radiation oncology specialties. It is important to note, however, that the actual impact on any individual physician or physician practice will depend on their mix of services-- that is, what it is they exactly provide and bill.

Now the administration has publicly stated its aim to reduce the growing administrative burden that we've all been noting and complaining about for the last few years. And the second item we want to point out is there is some evidence of their sensitivity to this issue in the 2019 fee schedule. They intend to reduce the documentation required for evaluation and management services, frequently referred to as E/M.

What CMS did is finalize provisions that consolidate E/M payments. And ASCO had expressed concerns about this previously, which the agency acknowledged, along with other stakeholders, by revising the proposal. And, if fully implemented, they believe that the impact will be delayed-- that is, it will not impact providers until 2021.

But by that time, CMS plans to consolidate what has historically been Levels 2, 3, and 4 into a single billing level, and then to pay for Level 5 E/M services separately. So overall, this represents a simplification. And it fulfills one of their stated aims, again, of reducing some of the administrative burden that practitioners face.

Finally, the third area that I want to highlight is a new rule starting in 2019 that refers to the amount of reimbursement you will receive for new Medicare Part B drugs. Currently, those drugs in Part B are reimbursed at wholesale acquisition cost plus 6%. They will, going forward, be reimbursed at wholesale acquisition cost plus 3%. It's critically important to emphasize that this relates only to those new drugs that are introduced into the supply chain this year.

This new provision will also apply to drugs that have not yet reported an average sales price. But the point is it will not apply to drugs that have already been in use. So it only applies to new drugs, meaning that its reach is going to be relatively limited. However, what you can imagine going forward with each new year and new drugs being introduced is that the percentage over wholesale acquisition cost will translate into more and more absolute dollars. And therefore, this may be a growing concern for practices.

I want to switch our attention and talk about the Quality Payment Program, or QPP. In the final rule, there is an update to QPP for 2019. The final 2019 payment adjustment for Merit-based Incentive Payment System, or MIPS, practices and providers will become plus or minus 7%. And it will have adjustments to maintain budget neutrality, as well as to reward exceptional performance.

Other noteworthy changes will include an increase in the MIPS performance threshold from 15 points, which is where we were in 2018, up to 30 points for 2019. CMS also finalized two new optional opioid-related measures that MIPS providers can use to report on under the Promoting Interoperability category. These measures will give providers an opportunity to earn bonus points and therefore potentially boost their overall MIPS score.

These are the two measures specifically. One allows for checking a prescription drug monitoring program, or PDMP, prior to submitting an electronic opioid prescription for any individual patient. And the second is an attempt to verify an existing opioid treatment agreement with the patient receiving the prescription.

So I hope that this summary of the updates to the Physician Fee Schedule for 2019 is helpful to our listeners. Ultimately, our goal is to make sure that oncologists can provide the right treatment to the right patient at the right time. And we aim to help CMS implement policies that will advance that goal. ASCO will continue to work closely with the administration to ensure that CMS understands the needs of the oncology community and the full impact that the rule is likely to have.

I would encourage you, if you need more information on the Medicare Physician Reimbursement Plan for 2019, to visit ASCO in Action's website. That's at ASCO.org/ASCOaction. And ASCOaction is written as one word. We have a link to the final rule there. And we also have a helpful, I think, webinar that explains the final rule schedule and QPP rule in greater detail. So hoping this is helpful. Until next time, I want to thank you all for listening to this ASCO in Action podcast and hope you don't catch my cold.

Jan 08 2019
8 mins
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Rank #18: The ASCO Delegation to the American Medical Association Discusses Policy Priorities and Process

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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

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, of course, the individuals we take care of, people with cancer. My name is Clifford Hudis, and I am 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 as my guests - and you heard that right, plural - Doctor Ed Balaban, one of ASCO's delegates to the American Medication Association House of Delegates and Doctor Kristina Novick, an alternate delegate to the AMA House of Delegates. Both Dr. Balaban and Dr. Novick recently represented ASCO at the AMA House of Delegates meeting where they advocated for cancer policy priorities. During our conversation today, we'll get an update on the AMA meeting, we'll hear more about some of the key issues that we discuss, and then we'll spend some time talking more broadly about ASCO's role at the AMA. Dr. Balaban and Dr. Novak, welcome, and thank you for joining me today. Now, let's start with a general overview of the AMA House of Delegates, what this governance body is and why, as a medical specialty society, ASCO should care about its activities. Dr. Balaban, you have served for many years as an ASCO delegate to the AMA House of Delegates, and I want to take this opportunity first to thank you for that service. But second, I want to ask you what exactly is the role of the House of Delegates? And how does it influence what the AMA actually does?

Dr. Edward Balaban

So Dr. Hudis, thank you very much for inviting both Dr. Novak and myself to speak for a moment about this because it is something that I don't think that the general membership really understands or appreciates. So the AMA House of Delegates, it's an amazing collection. It's also known as the House or the HOD, and it turns out to be the principal policy-making body of the AMA. It is in a democratic forum that represents views and interests of a number of member physicians and, in fact, represents close to 170 or so societies. We meet twice a year, and the whole idea of meeting is to eventually establish policy in medical, professional, and governance matters that have to do with the AMA business activities and principles of the AMA.

Dr. Clifford A. Hudis

And how many members are there? And exactly how are the members selected?

Dr. Edward Balaban

So the delegates right now-- and I say right now because it does change based on the number of AMA members within each representative society. But right now, the delegates number around 620, I believe. ASCO, right now, we have six delegates. Three of them are full delegates and three are alternate delegates.

Dr. Clifford A. Hudis

All right. So ASCO has three delegates who are appointed plus three alternate delegates. Is that right?

Dr. Edward Balaban

That's right. The full delegates are voting delegates. And we'll get into the details of that, I'm sure.

Dr. Clifford A. Hudis

So what actually happens? You have 620 delegates get together. I assume you're in a big ballroom at a hotel in Chicago. And what exactly goes on in that meeting room?

Dr. Edward Balaban

So, again, we meet twice a year. We meet shortly after the ASCO annual meeting in June and spend a fair amount of time in Chicago then. And then we meet once again in November at another site. The meeting itself, each time, lasts maybe three or four days but the preparation for the meeting goes on for months. And in fact, Dr. Novak and myself and the rest of the delegation are beginning to think about November's meeting now. So the way this goes-- the way it all happens is a bit complicated, but it's fairly straightforward nevertheless. We as representing ASCO and I guess medical oncology come to understand some of the more important issues that are facing practice, no matter what setting it might occur in. Those issues then lead to crafted resolutions that are presented eventually to the House of Delegates. We go over them based on ASCO policy as well as the interests that lie within the delegation itself and frankly what we hear from the different committees within ASCO. As we're putting together resolutions, the other societies-- and again, there are a number of societies, 170, 180 societies. They're putting together their resolutions, too. In addition to that, problems that had been discussed in the past at the AMA that have made their way to the board or various committees, those reports are being formed.

Dr. Edward Balaban

And so there is a gathering of all those resolutions and all of those board reports that become available perhaps a month, six weeks, maybe eight weeks prior to the beginning of the meeting itself. Each one of those resolutions and board reports that are then reviewed in our case by ASCO and a staff. And oh, by the way, I should say right off the top that ASCO staff is superb, and nothing happens without their help. But we review each resolution that's pertinent to the world of medical oncology. We develop our own resolutions as best as we can. We start to share them with other societies that we feel might be interested. And then eventually, those are all submitted to the AMA and then we gather. The first day in Chicago or wherever we meet is usually sort of the time to start to politicking. And it really is in the truest sense that. We review those resolutions. We review our thoughts. Others meet us in hallways and meeting rooms and committee spaces that want us to participate and/or get our thoughts on different problems. Those resolutions then make their way to a panel where we testify for them. Either Cristina or myself or one of the delegation stands up and says, "This is what we have our concerns with from ASCO. We would like the AMA House of Delegates to think about this." Those resolutions are then thought through by a committee that is an aside committee. It's made up of maybe five or six people. And again, this occurs the day before the actual House itself meets in that big ballroom that you just mentioned.

Dr. Edward Balaban

That committee then decides, "Well, that resolution that Dr. Balaban just presented, that is already AMA policy," or, "That does hold some water," or, "We need to think about is whether we want to go forward with that or not." The following day, that is when we met in that big ballroom, a whole bunch of us. And it's all the voting delegates, the 600 and so, alternate delegates. There's usually a number of international organizations there. Press is there. Observers from around the country are there. And each one of these resolutions that need to be talked about are then brought forth. The debate sometimes can be very quick but sometimes, it could be fairly contentious and confrontational sometimes but fortunately, that's not always the case. It's done in a very structured, Parliamentarian way. And then at the end of all that, there is a vote that the AMA House of Delegates either accepts or rejects the particular resolution that, in our case, ASCO has presented or reaffirms it into data and/or policy that the AMA already has or wants to re-look at it and send it down the road to be looked at, again, at the board level or at some committee level to come back.

Dr. Edward Balaban

It all sounds terribly complicated. The business of the House of Delegates can spread over two or three days. It is always an amazing process with so many folks with so many different ideas. And you would think that at the end of all that that there has to be great chaos, but year after year, meeting after meeting, I'm always impressed how we walk away from there with a consensus. And it may not be exactly like you wanted but it makes sense at the end of all that meeting. So it is a complicated process. It's a difficult one to explain. It's a bit of a learning curve to be part of it but once you see it happen, you understand that something good has taken place.

Dr. Clifford A. Hudis

Well, that's great. We're going to come back a little bit maybe and talk about execution or implementation, what all of this leads to. But maybe first, I want to ask Dr. Novick-- first of all, I want to say thank you for joining us again today. Your role in all of this is as an ASCO alternate delegate. So tell us, what exactly does that mean?

Dr. Kristina Novick

Well, thank you very much, as well, for having me today. So I think as Dr. Balaban has explained is that ASCO's allocated three delegate positions and three alternate delegate positions. And together, we make up what we call the ASCO Delegation to the AMA. Being an alternate delegate allows me to participate in the House of Delegates and support ASCO's activities. We work together as a group often several months before the meeting to try to create a list of priorities that we can then formulate into resolutions. During that time, we're often working with other specialty societies that have similar priorities. We try to gain their support for our objectives. And likewise, they reach out to us to gain support for their objectives. We then create this list of resolutions that we submit for the meeting. And often, we end up reviewing probably over 100 to 200 resolutions just for each meeting. With the help of ASCO staff, we review these resolutions and we come up with position statements for the resolutions, especially when some of them are related to ASCO's priorities and policies. So as an alternate delegate, really, what I get is pride in being part of the medical oncology community and being an ASCO member. We're a small but mighty delegation. We only make up 0.5% of the delegates but we find that we have friends not only in the cancer caucus but also within other organizations that have similar priorities. And then we have the respect of the House representing our patients who are vulnerable in terms of their cancer diagnoses.

Dr. Clifford A. Hudis

So maybe you could expand a little bit and talk about what some of the policy priorities that we actually worked on to advance in the June meeting. Are there any specific ones that come to mind that you think our listeners should be aware of? I mean, I guess, for example, PBMs or 340B or opioids. Are any of those issues that you could illuminate for us?

Dr. Kristina Novick

We had a number of resolutions that we submitted this year. The ones that really do come to mind are, first of all, the pharmacy benefit managers resolution. We found that there was a lot of interest, not only from our organization and the experience that we've had within oncology with pharmacy benefit managers but also other specialties have also expressed frustration as to what has occurred with their involvement over time. In particular, ASCO's resolution asked for data gathering on the impact of the pharmacy benefit managers, on clawbacks in direct and indirect remuneration fees. The House of Delegates agreed with us on this and also wanted to gather data on the top 25 medical pre-certification requests with exploration as to what percentage of those ultimately were approved after physician appeal. I thought this resolution was really important because we know that pharmacy benefit managers, they end up controlling the drug benefits for over 210 million Americans, many of which are Medicare Part D participants as well. In addition, there were other resolutions that were focused on pharmacy benefit managers such as the state of Michigan was concerned about the regulation of compounded medications by pharmacy benefit managers and requested that the FTC and FDA get involved with increased regulation. And the board of trustees as well further outlined AMA's efforts to combat restrictions that were created on prescription and dispensing of opioid analgesics by pharmacy benefit managers and requested that we oppose their control of dose or duration limits on our prescription and on dispensing.

Dr. Kristina Novick

In addition, we also looked at the 340B program. I think that there's going to be a lot of interest in this as we try to further control drug costs. The 340B program, for those that aren't familiar with it, was a program that was actually created decades ago in an effort to try to increase the affordability of supporting patients who are underinsured or uninsured and have their access to medications that often can be quite expensive which is something that our patients in oncology experience quite often. Over time, the program's been used especially by large hospital systems as a way to try to increase the reimbursement that they receive for medications that they dispense to their patients. And we had questions as an ASCO delegation as to whether this was really going to the benefit of the population that it was originally intended for. So our resolution asked for increased transparency and oversight of the program. We believe that you need to use those savings in order to help the patients that are underinsured and most need that support. Ultimately, the AMA supported this but they also wanted to investigate our request that we no longer use the disproportionate share hospital adjustment to determine the eligibility. So we'll hear back from them in the fall of 2018 as to what the conclusions are of that report.

Dr. Clifford A. Hudis

So I think it sounds like these resolutions and some others that we were promoting were received favorably. I hinted though with this question a moment ago, with them passed, can you tell our listeners exactly what this means? How does the passage of one of these resolutions actually lead to a practical change in our environment? What happens next to make this part of our new reality?

Dr. Kristina Novick

So resolutions typically are either new policy or directives that take action. Essentially, new policy can be used to support further action by the AMA as issues arise within the legislature, within courts, within allocation of resources by the AMA which is a very large organization. They can also be used to help coordinate efforts by other organizations. The directives that take action are more specific, and the AMA will report back as to what actions they have done and also what they've achieved in response to those directives. So essentially, the House of Delegates, because it meets twice a year, directs these directives and the activities of the AMA. And in between the meetings themselves, the board of trustees acts as the body that will make the recommendations as to what the AMA needs to do to achieve the directives if there's any question in that regard. So what will happen from here is the board of trustees will be reviewing the resolutions that have been passed and then create the list of priorities and objectives to pursue over the next year. And the AMA has a tremendous amount of advocacy that it's able to do. But I think the most important thing that it can do is help coordinate these efforts across states, societies, across specialty societies which is something that we wouldn't be able to do just on our own.

Dr. Clifford A. Hudis

So the real boots on the ground as it were amounts to advocacy at the state and national level, talking to legislators, talking to regulators, talking for that matter I guess to other stakeholders in the healthcare ecosystem and trying to influence practical rules and regulation and policy. Is that a fair summation when it's all said and done?

Dr. Kristina Novick

I think that's a great way to summarize. Essentially, if you go meet with a legislator, it's very easy for them to dismiss you although we do have a lot of clout, I think, coming from the oncology perspective. But still, it's easier to divide us up into different specialties and say, "Well, psychiatrists want this and dermatologists want that." But when it turns out that we all share common objectives, we can approach them and say, "The medical community, this is what we want. This is what is best for our patients." It's a lot stronger, I think when it comes from that perspective.

Dr. Clifford A. Hudis

That's great. So before you go and I turn back to Dr. Balaban, I'm just curious as to what your perspective is on the fact that we have this very exciting, new milestone for the oncology community at the last AMA meeting and that was that Dr. Barbara McAneny was sworn in as the president of AMA. She's the first oncologist to serve in that role. What do you think that role means for ASCO and the oncology community?

Dr. Kristina Novick

We are very excited about Dr. McAneny taking over as president of the AMA. She certainly brings not only a medical oncologist perspective to the leadership of the AMA but she also brings the perspective of a physician who is taking care of underserved populations, who is a patient advocate before all else. And I think we're all going to benefit from that leadership that she's shown over the years in that regard. She's also been very good at being a role model in terms of how to practice medicine in a sustainable fashion which is something that we need. So I am incredibly excited about her leadership and her accomplishments of rising to this position within the organization. A lot of leaders within the AMA will come from large delegations. And as I said, we're not a large delegation. We're a specialty society that has three delegates spots, three alternate delegate spots. But the fact, I think, that we have now also as our advocate the president of the AMA, I think that there's going to be a lot of potential opportunities for medical oncology to get additional help from the AMA on our key issues and to be more involved as well. So I think it was very exciting to see her take that position.

Dr. Clifford A. Hudis

So Dr. Balaban, I know you've known Dr. McAneny for many, many years. And I was really touched and I thought it was a thought-provoking comment during her inauguration where, if I remember correctly, she made a plea to move away from the term providers. And I think it was a plea to focus really on physicians. I don't know if I'm misremembering that, but it struck me that it was an important semantic distinction. Knowing her, knowing her passion, knowing her years of service to the community, to ASCO, to her patients, what's your perspective on how she'll be different as an AMA president?

Dr. Edward Balaban

Like you mentioned, she's been involved with the AMA in every facet of the AMA, oh, my gosh, for years. And as Cristina mentioned, this is almost precedent-setting. Neither she nor I can remember a specialty society having a successful campaign for presidency. Barb did say exactly that. She moved away from the idea of provider because to her-- and I shouldn't speak for her but she has shared enough with me and with the AMA. Provider's sort of a tone of a definition that's part of the system. And when I say the system, I mean as it currently is in the medical community. Well, the one thing that she has proposed is that she would like to fix this system. And she'd like to readjust it, reset it, rethink it, re-personalize it that we are just not providers. We are the physicians. We are the people that drive it. We are the people that make those decisions that will make it flounder or be successful. So she has tried to reroute this, and she can do it because she does relate. As Dr. Novak said, she can communicate so well, whether it's the Navajo Indians in New Mexico or with the CEOs in Chicago. She has traveled all those different areas.

Dr. Edward Balaban

And she does not mince ideas or words. She'll say very effectively what needs to be done. And Barb and I, as with most people on the planet, we'll go back and forth on a number of things. But I could tell you that we're all very pleased to be, in a sense, on her coattails. But let me just add to that that when it comes to oncology patients, I have come to learn at the AMA that our patients and our problems tend to be first and foremost almost Barb will say a canary in a coal mine. Maybe it's with the expensive and difficult drugs that we use and the difficult diseases that we face and the multitude of problems that we do run into with each and every one of our patients, whether it's physically or economically or socially or whatever, we tend to run the tip of the iceberg. And so other societies, other world within AMA will come to see what oncology thinks. And Barbara represents a huge spokesman in that area.

Dr. Clifford A. Hudis

Well, that's really great. And I think that we're all excited by this turn of events and the unique opportunities that the year ahead will bring, and also I think the lingering impact in the years that follow we'll be able to have on the AMA. So with that, I want to again thank both Dr. Balaban and Dr. Novak for joining me today for this ASCO in Action podcast. For the listeners, I'd like to remind you that you can always learn more about ASCO's work with the AMA, and you can continue to follow ASCO in Action for news and updates. You can visit ASCO Connection to read great recaps of the meetings that are usually written by Dr. Balaban himself. And you can find them online at connection.asco.org searching for Balaban, and that's B-A-L-A-B-A-N. So until next time, thank you all for listening to this ASCO in Action podcast.

Aug 28 2018
26 mins
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Rank #19: ASCO CEO Invites Oncology Community to Join “I Live to Conquer Cancer” Campaign

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In a new ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis highlights the newly launched ASCO campaign, I Live to Conquer Cancer, and discusses how ASCO members and the cancer care community can get involved. To join the campaign, visit asco.org/live-to-conquer-cancer.

Jul 24 2018
5 mins
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Rank #20: Making a Difference through State Advocacy

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Melissa Dillmon, MD, chair of ASCO’s State Affiliate Council, joins ASCO CEO Dr. Clifford A. Hudis in the latest ASCO in Action podcast to examine current cancer-related policies that state lawmakers are considering and discuss how ASCO members can get involved.

Apr 17 2018
22 mins
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