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Future Trends with Oral Oncolytics

Peter L. Salgo, MD; Carl T. Henningson, MD; Steven L. D’Amato, RPh, BSPharm; Noa Biran, MD; and Arturo Loaiza-Bonilla, MD, MSEd, FACP, conclude the panel discussion by reviewing future trends in using oral oncolytics, including accessibility and combination therapy.
Published Online: Mar 14,2018

Peter L. Salgo, MD: How does the availability of these drugs affect treatment? In other words, are they available nationwide? Are they available only through specialty pharmacies? Can anybody get them? Can any patient who needs these drugs get these drugs?

Carl T. Henningson, MD: The availability is really financial availability. Anyone can order these drugs. But sometimes, again, patients can’t afford the co-pays—or they don’t want to pay the co-pays.

Steven L. D’Amato, RPh, BSPharm: The only ones that can’t go through in-office dispensing for all in-office dispensing programs are drugs like the IMiDs, because the drug company has a REMS (risk evaluation and mitigation strategy) program that’s restrictive. They can’t open it up across the country. There are select practices across the country that can dispense the IMiDs for that company, but others won’t be able to. So, those all need to go through specialty pharmacy.

Peter L. Salgo, MD: That implies that there are geographic areas—hot spots—where these drugs are available and others where they are not?

Steven L. D’Amato, RPh, BSPharm: Well, for in-office dispensing—they’re available all over the country. There should be no reason why a patient cannot receive an oral oncolytic for their disease, aside from cost.

Noa Biran, MD: Other than co-pay.

Peter L. Salgo, MD: And the oral parity laws. You don’t think they are having the impact that they should?

Arturo Loaiza-Bonilla, MD, MSEd, FACP: In concept, they’re very nice. They were very well intended. But, implementation wise, they could be better, for sure.

Peter L. Salgo, MD: And if we’re going to take a look at future trends here, where are we going in the future? Are we seeing the end of intravenous (IV) chemotherapeutics?
Steven L. D’Amato, RPh, BSPharm: No.

Carl T. Henningson, MD: No, I don’t think so. There’s definitely a need for IV chemotherapy. I think there’s a move toward oral drugs, but there’s a number of things that we’re going to see in the future. Again, even in our own practice, we now have a navigator that’s going to help the patient obtain these drugs, as well as our IV drugs, and get approvals. I think there are going to be more web-based programs or app-based programs, based on the ASCO plenary session, and other studies, as well, showing their benefits. And then, ultimately, hopefully, there’s going to be competition for cost between some of these drug companies that have the same class of drugs. Hopefully, that will bring down costs.

Peter L. Salgo, MD: Yes. But, in the meantime, somebody’s got to pay for this right now. This money thing is bothering me.

Steven L. D’Amato, RPh, BSPharm: It bothers me.

Peter L. Salgo, MD: As a physician, I want my patients to get the latest, greatest, and best. I want a better drug. Somebody is facing me across the table with a terrible tumor—whether this is multiple myeloma, colorectal cancer, or hepatocellular carcinoma—which is really expensive because, at some point, somebody is going to get transplanted, which is off scale. I want some large-scale analysis to integrate all of this so that somebody can say, “Sure, this is an expensive drug, but look at the alternatives.” In the long run, maybe they’re more. Who’s doing that? Who should do that? Devise me the perfect system.

Noa Biran, MD: I don’t know what the perfect system is, but I know that, in general, medicine and oncology are moving more toward bundled payment. The hospitals have already done it. And now, outpatient is going that direction. If you have a stage II, HER2-positive, ER-negative breast cancer case, “this” is the amount of money you have for that patient throughout the rest of their life. You have to use that amount of money to treat that patient. You can do whatever you want with that cost. If we don’t start to control costs now, then that’s where we will be.

Peter L. Salgo, MD: Can you imagine? You’ve got somebody who is doing well, and you just ran out of money. “Sorry, go away. Die.”

Noa Biran, MD: That’s what will happen.

Steven L. D’Amato, RPh, BSPharm: Really, it’s a global problem that needs to be addressed in other ways. I think you can offset the drug costs if you create efficiencies in the other areas that we’re wasting billions of dollars of money on. With the Oncology Care Model, value-based insurance design, and all of the things that we’re talking about—like pathway adherence—these are all an effort to decrease waste in the system. It gets into coordination of care. We need to address all of the inefficiencies in care that we have in the US—from coordination of care to scans being done inappropriately, lab tests being done inappropriately, wrong treatment, treatments given too late near the end of life, decreased hospitalizations, emergency room visits. All of those areas will decrease cost globally, and that can help offset some of the drug costs. Something has to change, moving forward.

Peter L. Salgo, MD: I have heard since 1976, when I finished medical school, that something’s got to change.

Steven L. D’Amato, RPh, BSPharm: A single-payer system?

Peter L. Salgo, MD: One payer? I don’t know. But, I’ve always heard “Well, as soon as we reduce the slack in the system—as soon as we get rid of all of this waste—then we’re going to be able to pay for these great oral oncolytics.” I’ve always been struck that somebody’s waste is somebody else’s really good care. I mean, does that make any sense to you?

Arturo Loaiza-Bonilla, MD, MSEd, FACP: Right. I heard every single part of the whole spectrum and those points. Everyone has the same vision. We need to get better. We need to improve. We need to decrease cost. But, they also say, “Well, we also want to lead innovation.” Who pays for that? Who’s going to help us to overcome that?

Peter L. Salgo, MD: He’s going to say that the minute that you reduce costs, there’s a lot more money that’s going to go into research and development, right?

Steven L. D’Amato, RPh, BSPharm: It should.

Arturo Loaiza-Bonilla, MD, MSEd, FACP: Supposedly.

Peter L. Salgo, MD: But, you can hear the screaming now: “No money for that. That’s a waste” and “More money for you.” Why don’t you 2 duke it out?

Steven L. D’Amato, RPh, BSPharm: At the end of the day, you hate to use the word “rationing.” But, at the end of the day, it’s going to be, who has the money and who doesn’t? So, to get to your point about bundled payments—“Mrs. Jones, I can only use so much here. If you want X, you’re going to have to pay for it”—that’s where you’re headed. If you really want that, you want the gold treatment that is not in the value-based framework. But you want it. You have to pay for it.

Peter L. Salgo, MD: That is so antithetical to what is expressed with the American values in health care. Someone gets the good stuff, and everybody else doesn’t.

Steven L. D’Amato, RPh, BSPharm: Studies have shown that patients don’t care about the cost of health care unless they’re paying for it.

Noa Biran, MD: It’s so true.

Peter L. Salgo, MD: But, if the cost of health care is so many standard deviations beyond what they can pay for, that doesn’t work either, does it?

Steven L. D’Amato, RPh, BSPharm: It does not. No.

Arturo Loaiza-Bonilla, MD, MSEd, FACP: It’s not sustainable. Something will happen. We are witnessing, as it moves forward, that the deficit will grow. There will be some cuts, and we will adapt. Eventually, everything goes back to the median. Right now, we’re just talking about the fringes in medicine. But, everything will get back to normal at some point, and we’ll get a better sense.

Peter L. Salgo, MD: But, in the long run, a lot of people are going to die. Yes, we may center back toward the median. But, at some point, somebody is not going to get a pill that he or she might benefit from. These are great, great drugs.

Steven L. D’Amato, RPh, BSPharm: Correct.

Peter L. Salgo, MD: These oral oncolytics are terrific drugs, right? And there’s more of them every day.

Noa Biran, MD: Yes.

Peter L. Salgo, MD: If we simply say, “Don’t worry about it. You can’t get it”—but, someday, everybody will get them—that’s a whole generation lost.

Noa Biran, MD: That’s not going to work in this country.

Peter L. Salgo, MD: It’s not going to work.

Noa Biran, MD: Nobody will accept that.

Peter L. Salgo, MD: What are your thoughts?

Carl T. Henningson, MD: One of my best friends from medical school is the chief operating officer of Kaiser, in southern California. That system seems to work very well because Kaiser is a nonprofit. It owns the hospital. It is the insurance company. The doctors work for Kaiser. They are incentivized to keep costs down and to keep patients out of hospitals. They’re paid very well. They like working for Kaiser. They get pensions and things that other physicians don’t. The greedy people that are milking the system are taken out of the system.

Peter L. Salgo, MD: Correct me if I’m wrong, but Kaiser grew out of the early socialist movement back in the mid-20th century, right?

Carl T. Henningson, MD: Yes.

Peter L. Salgo, MD: So, basically, Kaiser is in some respect the private sector’s answer to single payer, right?

Carl T. Henningson, MD: Right.

Peter L. Salgo, MD: So, are you arguing that if we adapt the Kaiser model nationally, single payer is the only way to go? Is that what you’re saying?

Carl T. Henningson, MD: Perhaps. If it works as well as it does there, perhaps.

Arturo Loaiza-Bonilla, MD, MSEd, FACP: We have to look at the mirrors of other industrialized countries, which are actually doing better in health care than we are. We have all of the innovation. We have all of the bells and whistles and drugs. But, we are not doing better in terms of outcomes. To me, what’s important is, what’s going to happen at the end? Are we actually living longer, better lives? The answer is no. So, we have to change. We need very strong-willed people that are actually going to compromise to make things happen the right way.

Peter L. Salgo, MD: Again, new therapies are expensive. I can remember when dialysis first came on that there were committees. Only so-and-so got dialysis because it was so expensive: “We’re not going to give it to you. We are only giving it to you.” Now, everybody gets dialysis. It took a while. This is a new therapy, these oral oncolytics that we’re discussing today. They are expensive but come with real benefits. Somebody is going to have to figure out a way to make them affordable for everybody and to change the silo, at the very least. What do you see, going forward, for the oral oncolytics? Are they going to enter the mainstream? Are they going to be affordable? Where do we go on this?

Carl T. Henningson, MD: I think they’re already in the mainstream. They’re very expensive right now. In the future, I think that we’re going to have multiple drugs that target the same molecule. Hopefully, there’s going to be some competition to keep the costs down. It’s already happened, for instance, at Memorial Sloan Kettering Cancer Center. There were 2 drugs for colon cancer. One of them was twice as expensive as the other, so one of the colon cancer leaders took one of the drugs off of the formulary.

Arturo Loaiza-Bonilla, MD, MSEd, FACP: We’re doing the same. At Cancer Treatment Centers of America, it’s the same thing.

Peter L. Salgo, MD: Right now, you’re looking at a drug like ixazomib for multiple myeloma. Is it a game changer? Is it a good drug? Do people like it?

Noa Biran, MD: It’s a great drug. People like it. Is it going to cure the disease? No, it’s not going to cure the disease, but it offers a long-term therapy that’s convenient. At the end of the day, everybody in the whole system is going to need to pitch in. The pharmaceutical companies will need to reduce the price a little bit. The payers will have to give in a little bit—so will the physicians and everybody across the board.

Carl T. Henningson, MD: The hospitals.

Noa Biran, MD: The specialty pharmacies—everybody.

Carl T. Henningson, MD: Up until now, it’s been the physicians and the patients.

Noa Biran, MD: That’s it.

Carl T. Henningson, MD: They have been the only ones regulated.

Peter L. Salgo, MD: The other drug that we were talking about was regorafenib, for hepatocellular carcinoma and colorectal cancer. Is it a game changer? Is this a great drug? Is everybody going to want it? Do you see it going there?

Arturo Loaiza-Bonilla, MD, MSEd, FACP: It’s a good drug. It’s prolonging survival in our patients. It’s giving an extra option for patients who have no other alternatives. It may not cure, but it may serve as a bridge until a better drug comes down the line. In some patients with certain biomarkers, because this is a dirty tyrosine kinase inhibitor—we call it dirty because it goes and attacks multiple targets at the same time—it may respond beautifully to those medications, even if they don’t have a specific marker. A patient of mine had a KDR mutation and had an amazing response to the treatment, beyond any other patient. So, those N of 1s are always the ones that make us consider trying these patients. We like getting these patients to the next level.

Peter L. Salgo, MD: I want to ask each of you to just sum up, if you can, 1 thought that you’d like our viewers to take away from this program. Dr. Biran, why don’t you start?

Noa Biran, MD: I think oral oncolytics are excellent. There are more in the pipeline. They offer patients a very convenient and effective mechanism of treating their disease. The cost is going to be an issue down the line. So, this is something we have to work on.

Peter L. Salgo, MD: Dr. D’Amato?

Steven L. D’Amato, RPh, BSPharm: From my perspective, it’s all about access. We need to have a system in place to make sure that all of our patients can access these drugs at the same cost, whether it’s an intravenous therapy or an oral therapy, and whether it comes from a specialty pharmacy or a dispensing program. At the end of the day, it’s about the patient and making sure our patients have access to the drugs.

Peter L. Salgo, MD: Dr. Henningson?

Carl T. Henningson, MD: The oral oncolytics are a major advance. They can improve quality of life for patients. They can improve survival. The cost issue is a major issue. It will need to be addressed in the future. And then, the other thing is, I think we’ll be using more technology to improve adherence, as well as help with the side effects of these drugs.

Peter L. Salgo, MD: Dr. Loaiza-Bonilla?

Arturo Loaiza-Bonilla, MD, MSEd, FACP: Well, oncolytics are here to stay. Now, we are using combinations. We are also going to use them along with immunotherapy, which is going to be even more expensive. So, we need to find a system that makes these medications accessible to everyone involved. We need to look at the right biomarker and, as you said, the right drug at the right time. I’m looking forward to seeing what the future holds for this.

Peter L. Salgo, MD: I’ll tell you, this is a complicated problem. Do you know why? Cancer is complicated. It seems to me that anything you can do to make it easier to take your therapy, with a therapy that’s effective, is a good idea. I’ve been watching the development of chemotherapeutics throughout my entire career. This is an exciting time. When we’re arguing about money, as opposed to medicine, that’s good. It means that the medicine is probably good.

I want to thank all of you for being here. I want to thank you guys for viewing. On behalf of our panel, I’d like to thank you, at home.