COMMENTARY

Will 'Value Vehicle' Drive Cancer Costs Down?

John L. Marshall, MD; Lowell E. Schnipper, MD

Disclosures

December 29, 2015

Editorial Collaboration

Medscape &

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John L. Marshall, MD: Hello, everybody. John Marshall coming to you live from our sixth annual Ruesch Center Symposium.

Each year, we try and take a very tough topic and take it apart from multiple stakeholders' perspectives. This year, we are focusing on two very hot topics: value and outcomes. How are we going to measure value going forward? We know it's going to be our new metric. How are we going to measure it? How are we going to hold each other accountable to it, what's its impact going to be on cancer care, access—all of those things in our evolving world of healthcare and the changes that are going forward.

I can't believe the quality of the faculty we have been able to attract here to Washington for the Ruesch Symposium, and topping them all is my keynote speaker, Dr Lowell Schnipper, professor of medicine from Harvard Medical School, chair of the American Society of Clinical Oncology (ASCO) Value in Cancer Care Task Force, and the main author of one of the most important papers the Journal of Clinical Oncology has ever put out on the new position on value—around drug development, the cost of chemotherapy, and the cost of future medicines.

Lowell, thank you so much for coming down. I look forward to everything you're going to teach us today. Welcome.

Lowell E. Schnipper, MD: My pleasure. Thank you for inviting me.

Dr Marshall: Tell us about this paper. Tell us about the process and what the goal was of ASCO's charge, which you're leading. Give us the background on what this is.

Tackling the Taboo of Cancer Costs

Dr Schnipper: I'm happy to do that. We started on this journey about 7 years ago; we formed what was then called the Task Force on the Cost of Cancer Care. It was put together at a time when healthcare costs were skyrocketing; there was no such thing as the Affordable Care Act. But it was the beginning of a general awareness that Americans were going broke, and the budget of the country was under great pressure.

ASCO felt as an oncologic community, a professional organization that speaks for our physician members, we needed to tackle this issue of cost. We began to assemble a task force.

Dr Marshall: It's got to have been hard, though. There's a lot of pressure. ASCO, of course, is also about supporting community oncologists. It's a professional society. It's a profitable business. Even at the early stages, was there some pressure against this?

Dr Schnipper: In the early stages, we clearly encountered sensitivity to every one of the points that you just alluded to. Yes, 8 years ago, there was a buy-and-bill process in which oncologists were rewarded or remunerated for drugs that were administered to patients. That process was not felt to be, at least societally, in everybody's best interest, but it certainly created some tensions internally. Most oncologists in the know—and this goes for community and academic oncologists—are aware that the whole payment model is going to be reconsidered. We knew that 8 years ago, and it's happening right now. ASCO really supported us getting into this space, and it was ASCO's leadership that put this taskforce together.

 
You shall not talk about cost.
 

The first thing we did was put pen to paper and write about a taboo that most doctors embrace, which is that you shall not talk about cost.[1] In fact, we think that's really a false choice. There's no way that our patients aren't mindful of either big-time insurance policies or very substantial deductibles. If you're looking at the average American family, that is a reality. We knew it then, and we know it all the more now.

Dr Marshall: I've got a patient right now who wants a CAT scan every 3 minutes. The disease is very volatile, and I understand where he is coming from. I'm coaching him that you don't want to do CAT scans too often because you won't see whether the treatment is working. But on the other hand, if I order a scan too often, I know I'm going to get that phone call from the guy from Aetna who's going to make me justify a scan at 6 weeks or whatever. There is that tension that patients want access to all of this therapy, and they'll put up with the cost.

Dr Schnipper: My feeling is that when the exam room door closes, you are your patient's advocate, and the art and science of medicine is reduced to asking: How can I relieve this patient's suffering, both physical and psychological? The doctor has a difficult job—being a steward in some ways of society's resources, but most important, taking good care and providing what's needed to the patient right in front of them.

Taking a Second Mortgage to Pay for Cancer Care

Dr Marshall: I could see if I was a patient, if I had a premium policy and I was paying a lot for it, I'd want unlimited access. If I had gotten a cut-rate policy, then I might not be able to have all treatment options that are out there. Are you starting to see that?

Dr Schnipper: We are. Our value construct, which was published in July's Journal of Clinical Oncology,[2] was motivated by a couple of things. One is the tremendous financial pressure the country and our patients are under, but also we were really motivated to deal with the doctor/patient interface and how finances interpose themselves.

 
Our patients are making tradeoffs to receive care; there's plenty of research to tell us that.
 

We know that copays and sharing of insurance costs is now the rule of the realm. Insurance companies see the costs of drugs; they see the cost of hospital stays, they see the cost of doctor visits. They are saying, if you want a Cadillac, you're going to have to pay a chunk of out-of-pocket funds on top of the premium. We're trying to tell those people that our patients are trading off a child's opportunity to go to college debt-free or a family's need to get a second mortgage. Our patients are making tradeoffs to receive care; there's plenty of research to tell us that.[3,4,5]

Dr Marshall: I live and work in Washington, DC. I have a highly insured, highly educated patient population, so I don't see patients make that tradeoff in my world. What's the research really tell us if you look countrywide?

Dr Schnipper: Very large numbers. There was a very nice paper a few years ago in the Journal of Clinical Oncology, from Scott Ramsey's group out in Washington state,[4] demonstrating that a very large number of patients with colorectal cancer were in financial distress in the context of having gone through adjuvant or other kinds of therapy for their cancer.

Dr Marshall: Maybe not just the cost of the treatment, but work and maintaining insurance and all the other things you have to do.

Dr Schnipper: Exactly. There are costs that are direct healthcare costs, and then there are indirect ones. If a husband can't get to work because he's got to take his wife to the doctor to get chemotherapy, then he too may be losing salary. There's a telescopic impact. That's really the Energizer Bunny that stimulated us to come up with a formula that would at least begin to rationalize what we're paying for.

Dr Marshall: The group that you pulled together is a who's who of oncology. You've got every major thought leader in the arena of cost and outcomes, and lots of heavy-hitting clinicians and leaders of ASCO. This was a collective.

Dr Schnipper: We have the collective wisdom of people from the payer community, leaders in large community practice groups, some academic physicians, some specialty oncologists, and some general oncologists.

Dr Marshall: How hard was it to herd those sheep?

Devising a Scoring System to Show Relative Benefit

Dr Schnipper: It's always hard. Everybody knows what to do. They're sure of what to do.

We broke the task force into groups that were going to answer a few questions. One group had to answer the question: How would we value clinical benefit? How would we value or devalue toxicity? How would we rate it? What do we do about costs? That was the biggest elephant in the room. I'll get to that in a minute.

We decided that we needed to be evidence-based. We weren't going to basically go on a hunch or go on some sentiment of our colleagues or our patients, but rather rely on the clinical trials process. We decided number one, we wanted to look at comparative clinical trial data.

The value framework is designed to compare a test regimen against a standard of care. Then we had to pick variable degrees of improvement over the standard of care, define some scoring system or some valuation of it, and give the degree of benefit over the standard of care some numerical score.

Then we did the same thing with toxicity. How much toxicity results from regimen A as compared with regimen B? Is it more? Is it much more? Is it about the same? Is it a lot less? If it's a lot less, we added points. If it's a lot more, we subtracted points.

 
Is quality of life a measure of hope or a measure of toxicity?
 

Dr Marshall: To drill down on that, there's a famous study in the colorectal cancer world of quality of life comparing epidermal growth factor receptor [EGFR] therapy with no EGFR therapy.[6] The EGFR therapy has significantly more toxicity—diarrhea, skin reaction, and all that stuff. But when you look at the quality of life, the treatment arm was higher than the control arm because patients think they're benefitting. We're talking about the concrete metrics of toxicity and the costs associated with it, but is quality of life a measure of hope or a measure of toxicity? I struggle with that.

If you had a big magnitude of benefit, but it was also very toxic, does this scoring take that into account?

Dr Schnipper: Yes. If it was very toxic, it would detract from the overall conclusion.

Dr Marshall: What if you cured somebody, but you had to stay 10 days in the hospital?

Dr Schnipper: Good question. Because cancer care has so many different goals depending on the context, what we did at the outset was to make two frameworks. One is for the incurable patient with advanced disease, and the other is for the patient who's potentially curable—the adjuvant case. That's because for adjuvant therapy, you can tolerate a lot more toxicity because it's very likely to be reversible, not permanent. Therefore, overall survival is by far the most heavily weighted and, I think, more desirable outcome.

In the advanced disease setting, we give scores for clinical benefit, for side effects, and we give bonus points for what we feel are particularly noteworthy and desirable outcomes, such as palliation. If a study describes symptom palliation—bingo, that's going to get a bonus point.

Dr Marshall: It's worth more.

Dr Schnipper: Yes. That's the coin of the realm for palliative care. If a study compared two regimens of 9 months' duration, and one of them results in a treatment-free period of 2 years and the other one of only 6 months, we give a bonus for that 2-year treatment free period because that has to be a major improvement in quality of life.

Should Transformative Drugs Cost More?

Dr Marshall: At this meeting in 2011, Mace Rothenberg, MD, who, as you know, is the current head of Pfizer's oncology group, said that what he thought we should do is pay more, that a medicine is worth more if it is innovative—not the third VEGF inhibitor in second-line colon cancer, but something that's really transformative. Tell me about how you are crediting innovative new therapies.

Dr Schnipper: Now I'm going to take you under the hood. When this was being conceived, I proposed giving innovation points for something like a trastuzumab, for essentially a disruptive therapy. When we field-tested this among leaders from the biotechnology and pharmaceutical industry, we received many queries asking, what is innovation? One person's innovation turns out to be another person's humdrum second-line therapy.

Dr Marshall: Just a tweak of pharmacology vs a new target.

Dr Schnipper: Exactly. We got into a minefield. It was interesting. Patients said to us, "Innovation—who cares? I just care how good this drug is." At the moment we left it out, and yet the scientist in me respects innovation almost above anything else other than clinical outcome.

Dr Marshall: It would seem to me that if we set that kind of target, you could charge more for your medicine if it was really transformative. That would attract the companies to aim for it more often.

 
There are drugs we use that have marginal benefit and big-time costs. That's what we're hoping to adjudicate with a vehicle like this.
 

Dr Schnipper: I would hope so. I am really hoping that one byproduct of this move toward beginning to define value is that we get to a point where a Lexus or a Tesla will in fact, reward the maker of the Lexus or Tesla equivalent in drugs compared with the maker of a Honda. You're a cancer doctor, just as I am; we all know there are drugs we use that have marginal benefit and big-time costs. That's what we're hoping to adjudicate with a vehicle like this.

Dr Marshall: This paper comes out. There's some review, a period of feedback. Tell us about what's happened since then.

Kicking the Tires on the New 'Value Vehicle'

Dr Schnipper: What ASCO has done—I think quite wisely, because this is so controversial an area, with so many stakeholders affected—we put this out almost as a feeler. Tell us what you think is bad about it. We make no promises to listen to one party vs another, but to try to digest it.

Four hundred responses came in—some in personal letters to me and to ASCO, and some from the largest biotech companies expressing their appreciation for the effort and their hesitancy about its implications.

I think what we all tried to understand was how we can improve this framework from the one that was published. I don't think we have a definitive answer for what we're going to come out with next, but we're getting quite close.

Dr Marshall: As a closing comment, is the FDA watching this? Do you think policy might change as a result of this paper?

Dr Schnipper: It's a key question. When ASCO embarked on this, there was a general sense that the immediate focus had to do with the doctors who are doing the prescribing and the patients who are consenting to receive therapy. But we were aware of the policy implications of doing something like this. Frankly, we just felt we needed to take baby steps at first.

I was at a meeting yesterday at the American Board of Internal Medicine, and somebody else was at a meeting a few days earlier in the Department of Health and Human Services, and I was told that the ASCO framework and other similar tools were a centerpiece of discussion about constructing new payment models.

Dr Marshall: We're already starting to see scoring being combined with guidelines, such that this recommendation is given this kind of score. Do you see your scoring proposal being used every day by oncologists to discuss with patients, or is it more for use in drug development?

Dr Schnipper: It's more so in the practical end. What we're envisioning is that the final product would be taken seriously by software engineers who would come up with a nice polished piece of equipment that would be prepopulated with trial information, so that you and I in talking with our patient could essentially dial it up and show the patient that regimen A will do this for you or regimen B will do that. It will cost this much or it will cost that much—and hopefully get to that place quite quickly—and then the patient might say, "Dr Marshall, what should I do?" You could say that I understand your goals are X, and guide the patient this way or that way.

 
Do you see that brave new world where the patient is incentivized to choose a less expensive option?
 

Dr Marshall: I also could see a time when the guy from Aetna would be saying, if you pick the cheaper but very similar drug, I'll waive the copay or give the patient a kickback on their insurance. Do you see that brave new world where the patient is incentivized to choose a less expensive option?

Dr Schnipper: I hope not. It's not impossible that that will be the case, but I think that's where our job as a doctor comes in. We need to know what our patient wants, we need to know whether they want to be more comfortable in the late stages of an illness or to live long enough to see a son or daughter graduate from Georgetown, and those goals have a lot to do with what we would tell the patient is best for them.

Dr Marshall: We could go on for hours. I'm going to let you go on for an hour later on in the day. Lowell, thank you so much for coming, and thanks for contributing all that you've done and caring about this important topic and taking it forward.

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