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Dec 8, 2022

Dr. Derek Raghavan, president of the Levine Cancer Institute at Atrium Health, and host Dr. John Sweetenham, of the UT Southwestern Harold C. Simmons Comprehensive Cancer Center, predict the challenges oncologists will grapple with in 2023, including the cost-benefit of new treatments, how to retain the best talent, prioritizing health equity, and the future of home infusion for patients with cancer.



Dr. John Sweetenham: Hello, I'm John Sweetenham, the associate director for Clinical Affairs at UT Southwestern's Harold C. Simmons Comprehensive Cancer Center, and host of the ASCO Daily News podcast.

Today, I'm excited to welcome back Dr. Derek Raghavan, President of the Levine Cancer Institute at Atrium Health. And we'll be discussing some of the challenges that we anticipate are going to lie ahead for the oncology community in 2023.

Our full disclosures are available in the transcript of this episode, and disclosures relating to all episodes of the ASCO Daily News podcast are available on our transcripts at:

Derek, great to have you back on the podcast again today.

Dr. Derek Raghavan: Thanks, John. Great to be back with you.

Dr. John Sweetenham:  One of the issues that we believe is going to be a challenge for us in the oncology world during the coming year that you and I have discussed on a previous podcast is this issue of cost benefits of new therapies in oncology, and the need to compare new treatments against old established standard of care treatments, rather than against the most recent new treatment preceding the one that we have now if you see what I'm saying. This is clearly going to be an ongoing concern.

Why do you think we should be thinking about cost benefits of new treatments? And clearly, I think we'd all agree that this matters, but I think maybe you could expand a little on why you think it is truly important that we kind of go back and make sure we're comparing these drugs with the more established standards of care.

Dr. Derek Raghavan: You know, I think this is sort of a metaphor of modern oncology, John, because it brings in so many elements. As you've implied, the cost of cancer care and not just cancer care, I mean it's all medical care just going through the roof, and unfortunately, it's happening most particularly in the United States. And whether that's just because here the pharmaceutical industry and government seem to have a very tight relationship, or whether there's some other explanation that is not clear, but I would make the comment that a lot of the newer treatments that are horrendously expensive in the United States, may be purchased for half the cost or less in other OECD countries.

And that suggests that at some regulatory level, one of the parameters is a little off in the United States. And the reason that this is such a big deal is that it ultimately is hitting patients very hard. I think everyone has agreed, and we've discussed it in some detail in the past, everyone is identifying financial toxicity as becoming one of the governing toxicities of cancer care, and we've talked about strategies of dealing with that.

As you implied, you know, we have this sort of tendency to think that anything new is wonderful, and anything old is terrible. And often, that's true. But I think the problem is that often, we will test the brand new agent of today with last year's brand new agent, which hasn't necessarily been fully tested at the time. So, if you think about prostate cancer, you know, the Michael Hofman group tested against cabazitaxel, and I'm not quite sure why cabazitaxel suddenly became the only drug to use second-line in prostate cancer.

You know, doxorubicin has been there for a long time. Mitoxantrone has activity, even the old chestnut oral cytoxan has some activity there. And each of the drugs I've just mentioned is way cheaper than cabazitaxel. I'm not implying cabazitaxel is a bad drug, I'm simply saying it's more expensive. And I think as patients are really being harmed by the cost of care, I think one of the things that's kind of a shame, and it goes to the way we were trained, is oncologists have been trained not to think about the costs of what they're doing because the thought is that if we're thinking costs, we will withhold the best treatment because of cost considerations.

I think the other side of that coin is we need to be thinking about what is the damage to patients that the cost is doing, and if there is substantial damage, is the patient getting that much bang for the buck? In other words, say an old cheap drug gives you three months extra survival, and a brand-new, very expensive drug gives you four months extra survival, do we really want to be thinking that that somehow is a wash and we should use the newer drug? At the very least, physicians should now be trained to have that discussion with patients and raise the issues so that patients aren't embarrassed by their inability to pay.

We do know the two areas that are really hard to get patients to confess about, as it were, financial toxicity, and sexual dysfunction. And if we as physicians don't address that, we are going to be complicit in making these sorts of problems worse. So, one of the things is the costs of care.

I think one of the other issues that is a little troubling is how we're thinking about new standards of care. There is a growth industry of consensus guidelines, and the reality is that some of the consensus guidelines, I think particularly, ASCO's, are very meticulously done. I've had the privilege of being part of a couple of the panels, and they were very rigorously driven, and they were trying to identify level-1 data and trying to be honest about outcomes.

But some of the consensus guidelines are basically a bunch of good old boys getting together, and just chatting about what they do, and if they all do the same thing, then that becomes a guideline. And that can be a flawed approach, so that we've got consensus guidelines that are terrific, and some consensus guidelines that might be terrific, but may not be predicated on the best evidence.

And then finally, one of my bugaboos is this sudden emphasis on real-world data. And I tend to worry about the concept of 'garbage in, garbage out'. A lot of the real-world analyses are either looking at databases that weren't designed for the way they're being implemented, or there are very practical reports of stuff that has happened, but without the necessary scientific rigor, such as considering what are the case selection biases that have led to those sets of real-world data being produced? So, that sort of compounds the problem of the fact that we need to be focusing a little more on, "What are we doing? Why are we doing it, and how robust are the data that support our patterns of practice?"

One of the real leaders in this space is Mark Ratain, who's gone right back to torts and has started to ask questions about the pharmacology of drugs. There are dosing schedules that come out of phase I and phase II trials. There are often schedules that will be of benefit to the pharmaceutical industry but may not be fully evidence-based. So, you know, with a drug like Radium-223, which is for prostate cancer, it is said that you should give 6 doses. I'm unaware of any robust data that say that 6 is better than 5 is better than 4.

Dr. John Sweetenham: Yeah. Thanks, Derek. Great responses. And I particularly like your insight into real-world evidence. I know that there have been attempts by ASCO, and by FDA, to put some parameters around real-world evidence, and get some, I guess you'd call it quality assurance into this, but I do agree with you that it's a little bit uncontrolled at the moment, and I think if we are going to continue to use these very, very large real-world datasets as a comparator, particularly, for drug approval, as well for studies, then there's probably still significant amount of work to be done to make sure that those data are collected in a consistent and rigorous fashion.

Dr. John Sweetenham: I'm going to change gear now and talk, for just a little while, it's a huge subject and the time constraints will prevent us from saying too much about this, but of course, you know, health equity continues to be a major concern across healthcare in general, and in oncology specifically. We've now seen, for example, the replacement for the Oncology Care Model, The Enhancing Oncology Model, which has been proposed by CMMI. And not surprisingly, I think they recognize the need for addressing health equity and are introducing some health equity components into that in the next phase of Oncology Care Models from that group. But I guess my question at this point is, do you think that this kind of approach whereby health equity is at least to some extent addressed in the context of, for example, an alternative payment model, is the way ahead in terms of actually bringing about effective change, rather than just recording that there are indeed disparities?

Dr. Derek Raghavan: So, that's a complex question, and I think there are several strands to the answer. I think the first thing I would say is, it really is time for us to recognize that we are at an inflection point. And we need to move from analysis paralysis to a new paradigm, which I would call, equity of survival. I have to say, I'm really over the multiple meetings that most of the professional societies have where people seem to feel good about saying, "Yep, we've come together and we've decided there really are disparities."

We've known that there were disparities of care for probably 20 years, and some of us have done something about it and others haven't. But I think it's time to define equity of survival, and you can certainly do it. And what I mean by that is as follows: so, if I could use an example of a study from our place at the Levine Cancer Institute, Dr. Bei Hu, who is a very talented young lymphoma specialist, analyzed our outcomes for poorly insured, or uninsured, predominantly black American populations versus wealthy whites.

And she published in Cancer and also presented prior to that at ASH, the fact that we had identical outcomes for diffuse large B-cell lymphoma; our hypothesis is that we were able to improve the results by using nurse navigation to help the underprivileged patients be able to adhere to the rigorous constraints of cuff management of diffuse large B-cell lymphoma. But you know, the fact is we are able to show that survival is the same in those two population groups. So, it isn't a question of, "Did you do more? Did you spend more time?" At the end of the day, the parameter is, they lived the same, and the quality of their lives, as we've measured, it was the same. So, I think that's one piece.

I'm a bit negative about the government's new EOM. I've kept my institute out of the first OCM model because I thought that they were going to waste our time, and they played with it, and they learned very little, and then they generated a new model. I am very happy that there are health equity components in it, but of course, what we already know is government doesn't enforce those very well.

If you look at the National Cancer Institute, and from my time on the parent committee and doing reviews, I was constantly saying, "But we aren't seeing the appropriate representation of minorities." Journal editors are still allowing the NCI-designated comprehensive cancer centers to publish papers with less than 5% Black Americans. And the argument is, "Oh, that's not in our demographic." But that's nonsense because the demographic of Black Americans and Hispanics in most parts of the United States are pretty well known, and the centers that I'm thinking about have perfectly large numbers of Black American, and Hispanic, and Native American patients.

You know, I think there are two dimensions; one is government actually has to mean that they want to see things happen and enforce it appropriately, but at the same time, the idea that we're checking a box by doing yet another study of underserved populations where we're looking at demography, and their eating habits, and so on, when we're not concentrating on treatment-based survival. And the journal editors are turning down papers as being too descriptive when they report smaller studies of African American or Native American patients. All of those things have to be fixed, in my opinion.

Dr. John Sweetenham: Great, thanks. And I'm going to change gear again to another issue, which, certainly, at our center is becoming more prominent for us, and that's an issue of sites of care. So, we are increasingly becoming aware that reimbursement issues are driving where our patients receive certain components of their care, particularly their chemotherapy. At the same time, we're also seeing increasing interest, I think partly fueled by the COVID-19 pandemic towards home treatment, and specifically, home infusion. So, I'd be interested to know where you think the future lies in terms of; number one, how you think this dynamic is going to play out around payers to some extent driving sites of care. And then secondly, what you see as the future of home infusion for cancer patients and potentially the use of home chemotherapy.

Dr. Derek Raghavan: Well, you know, I tend, as you know well, to be one of your more cynical friends. I have real trouble with the insurance companies declaring publicly that they're struggling to keep up with the cost of treatment, and therefore they need to influence treatment when despite this incredibly difficult situation in which they find themselves, they're able to give seven and eight-figure bonuses to their Chief Executives every year. So, they're not doing poorly, they're just crying poor. And so, when they claim that they're doing things for the benefit of patients, I just don't believe that.

So, the first thing is, the imperative to move care from point A to point B is driven by people with self-interest rather than necessarily trying to do it for patients. Now, having said that, I actually think COVID has taught us a lot. We can do many things very effectively through telemedicine, and for example, at the Levine Cancer Institute, we surveyed our patients who are dealing with the Supportive Oncology teams, Psycho-Behavioral Medicine, and Complementary Integrative Medicine. And so, they've actually shown us that they would prefer to have video consultation, which saves them having to get dressed, jump in the car, drive into the city, or to their local branch of LCI and so on. And so, there are demands where it's quite clear that patients like telemedicine and home care, and we know that because the cancellation rate of these appointments has gone way down with the introduction of telemedicine. So, for certain things, it's really good.

You mentioned the concept of home infusion, and I think that's a terrific idea, provided that you have the necessary checks and balances. You and I both know that patients will suddenly crash with an allergic reaction in response to a drug like taxol and taxotere, or even sometimes, cisplatin, so, you don't want to have the situation where the nurse is infusing at home by herself, and trying to manage someone who's just shut down with an allergic reaction without any help. So, you need to have standard operating procedures that maximize life safety. Having said that, the idea of making it easier for patients to have their treatment and having it close to home is really, I think something that I really support.

Where I'm less enthusiastic is something that the insurance companies have started to play with, and I believe ASCO is opposing this, at an organizational level, and that's the concept of white-bagging and brown-bagging. The idea that the insurance companies will somehow supervise the preparation and distribution of drugs to their satisfaction, and then expect oncologists or hospitals to take those drugs and administer them on their behalf. There is no clear evidence of quality control; it's absolutely clear that this is being done in a fashion that will allow them to control costs, and maybe not in an appropriate fashion. And I think that should be really strenuously opposed.

Now, they're not the only culprits. What we have found is many of the largest centers declining to use biosimilars, for no particularly good reason, other than the fact that they're not that familiar with them. Well, there are good data to suggest that many of the biosimilars have equal efficacy and equal toxicity to the parent compounds, and they're way less costly. And so, we need to be thinking through a whole paradigm of, where are biosimilars available, what is the track record for their safety and utility, and so on.

So, I think there are a number of steps that we can actually be involved in that will improve the cost of care. But doing it just because the insurance companies are trying to save themselves money may not be the primary driver that would influence my thinking.

Dr. John Sweetenham: Yeah. Thanks, Derek. I'm interested in your comments on biosimilars because, you know, at our center, at UT Southwestern, we have certainly embraced biosimilar usage. And one of the points of care challenges in that regard is knowing which biosimilar is covered by an individual patient's insurance. And I know at a number of centers, that's been a challenge, and it's something that our pharmacy team has worked on in order to find a more facile way for our clinicians to be able to understand coverage. And there are significant cost savings associated with that. So, I agree 100%

And talking of costs, the final issue which we wanted to talk with you about briefly today is the issue of prior authorization. Many ASCO members in the United States spend a very large amount of time dealing with this, and in the community oncology practice, it’s estimated as much as 25% of an oncologist's time is now spent dealing with these issues, and obviously is very negative in terms of job satisfaction, physician burnouts, and so on, as well as just making things very, very difficult for our patients. Do you see a resolution to this? Do you think it will continue to be a big challenge, or do you think there are solutions available to us which will make this much easier for physicians, and save them some time as well as money?

Dr. Derek Raghavan: No, I think it's here to stay. I mean, I think it's honestly multifactorial. I think it begins with government in the sense that we've just, once again, declared war on cancer. It's the third or fourth war that's been declared during my career, and that's all well and good. But you know, the reality is that that sets expectations in the community that can often be unrealistic. And so, that puts the unfortunate community, or academic oncologist in the situation of really struggling to say to a patient, "We've done what we can, and it's time to bring in supportive oncology or hospice." So, there are unrealistic expectations in the community.

I think the second piece that relates to this is, the purveyors of computerized record systems are actually contributing more to burnout than probably anything else in the land. We've got unregulated industry where the service delivery for most of these companies is poor. And I think it all connects really with a broader issue, which is, for whatever reason, post-COVID, there is this phenomenon internationally of the so-called Great Resignation. It's partly burnout, it's partly anger about the world, I guess, at large.

But what we are finding is, one of the pivotal areas for the Great Resignation is medical and nursing staff. I've never seen as many physicians retiring early, as many nurses getting out of oncology, and either going into the pharmaceutical industry or into data management or just going into simpler types of nursing. And that reflects the resistance of the healthcare industry to recognize that there are different stresses in different types and parts of the healthcare industry, and not compensating appropriately, and putting in safety valves to help these people get off the line.

And you know, your question was, "Do I think it's here to stay?" I really do. I think the younger generation has, in many ways, a much more sensible approach to work-life balance than we did. They also have less experience. So, every time a crusty old veteran doctor, or nurse goes, they're replaced by someone with two decades less experience, and somewhat a different work ethic. I'm not saying it's a bad work ethic, but it's changing the way healthcare is delivered. So, I think this is going to be a real issue.

And then finally, you know, in terms of the actual business of prior authorization, which I view largely as a tool that the health insurance companies use to avoid payment, I think we mentioned in a previous discussion on our financial toxicity tumor board, we have a pretty standard algorithm where we call the insurance companies before starting chemotherapy or radiotherapy; check in with them that their reading of their rules allows approval, and then we document who we spoke to, and what time. That seems to be quite a good way of stopping the insurance companies denying payment at a later time based on the technicality on page 253, line 27.

While we're talking, John, what's happening at the Simmons Center and UT Southwestern? Are you seeing a change in the pattern of resignation of nurses and physicians, or have you managed to figure out strategies to avoid that?

Dr. John Sweetenham: At UT Southwestern and Simmons Cancer Center, in particular, what we've seen is very similar, I think, to the national trends. And so, I think what we've seen is three main groups affected; our nursing staff, and as you say, I think there are various reasons why that's happened, our clinical trials staff, in particular, we've had an increasing problem in hiring and have lost many to industry actually. And then, on the physician front as well, we have seen a number of our physicians move to industry, both in terms of drug companies, and also some data companies where, you know, I think there is clearly an interest in having physician leadership.

And, you know, I do agree with you, and I think part of the challenge, and there's been quite a lot of literature about this, as you’ll know, is, what are we going to do, particularly in the academic oncology community, what are we going to do for our younger faculty in terms of growth opportunities for them that keep them within academic medicine? And I think we probably really have to rethink the way academic oncology is running at the moment if we're going to retain the best people within our field. So, a short answer to your question is, yeah, we're seeing very similar trends to those that are reported nationally. We're planning interventions, but obviously, all of these things take quite a long time.

It's been great talking to you as always, Derek. I think it's good to hear your insights on the podcast, particularly, with respect to what might happen in 2023. I think as always, it's important to remember that despite the challenges, I think if you look back year-on-year, there is for sure, going to be a lot to be excited about this year. And our patients, I think, can anticipate to see continued improvements in what we do, and hopefully improvements in their lives and the lives of the caregivers who take care of them. So, despite the challenges, I think we need to just remember that it's not all bad, and there are a lot of good things going on out there.

Dr. Derek Raghavan: Yeah, I agree with that, John. One of the things we always forget, despite the fact that you and I were tasked with talking about the problems emerging, is, the most rapidly growing patient population in oncology is the long-term survivors, and we can both be justifiably proud of all the good things that have happened to create that scenario.

Dr. John Sweetenham: Absolutely. So, thanks, once again. Always a pleasure to talk with you.

And to you, our listeners, thank you for your time today. If you value the insights that you hear on the ASCO Daily News podcast, please take a moment to rate, review, and subscribe, wherever you get your podcasts.


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Dr. John Sweetenham:

Consulting or Advisory Role: EMA Wellness

Dr. Derek Raghavan:

Consulting or Advisory Role: Gerson Lehrman Group, Caris