While the overall expenditure on cancer care in general has remained relatively steady over the past 2 decades-encompassing 4.8% of the total $513 billion spent on medical care in 1987, vs 4.9% of the average $979 billion spent annually from 2001 to 2005-the cost of oncology drugs has soared past all other classes of pharmaceutical agents (Cancer 116:3477-3484, 2010). According to the marketing firm IMS Health, sales of oncology drugs have skyrocketed from $5 billion in 1998 to $19.2 billion in 2008. Most of that increase is attributable to the newer anticancer agents on the market. According to Journal of the National Cancer Institute (Fojo T, et al: J Natl Cancer Inst 101: 1044-1048), 90% of cancer-fighting drugs or biologics approved by the FDA over the past 4 years cost more than $20,000 for a 12-week course of therapy, with many offering a survival benefit of only 2 months or less.

The result of the rising cost of cancer treatment is threatening not just the financial solvency of patients-a poll by the American Cancer Society found that one in five families use up all of their savings paying for cancer treatment-but that of the country as well. With health-care spending projected to balloon to $4 trillion by 2015, outpacing the growth in the gross domestic product by 20% (up from 17.3% in 2009), health-care industry experts and government agencies are looking for solutions to rein in costs without stifling drug innovation or jeopardizing patient care.

The ASCO Post explored some of the major issues confronting those who seek to ensure high-quality cancer care while reducing costs. For this article, we talked with Lowell E. Schnipper, MD, Chair of ASCO's Cost of Cancer Care Task Force, Professor of Medicine at Harvard Medical School, and Chief of Hematology and Oncology at Beth Israel Deaconess Medical Center, Boston; Nancy E. Davidson, MD, Member of ASCO's Government Relations Committee and Director of the University of Pittsburgh Cancer Institute; Antonio Tito Fojo, MD, PhD, Senior Investigator and Head of the Experimental Therapeutics Section of the National Cancer Institute; and Peter B. Bach, MD, MAPP, Director of the Center for Health Policy and Outcomes and Attending Physician at Memorial Sloan-Kettering Cancer Center, New York, and former Senior Advisor to the Administrator of the Centers for Medicare and Medicaid Services.

Major Challenges

What are some of the greatest challenges facing oncologists in the future?
Dr. Schnipper: The key issue is how best to enable people afflicted with cancer to live as long as possible with the disease and function in the healthiest way possible. What's happened over the past 5 to 10 years is that advances in the basic biology of cancer have given us insights into how cancer cells work at a level of detail we've not had before. As a result, pharmaceutical companies and innovative scientists have been able to develop therapies targeting the various cellular circuits that seem to be abnormally activated in cancer. A few magnificent examples of success have included imatinib for CML, trastuzumab (Herceptin) for HER2-overexpressing breast cancer, and rituximab (Rituxan) for B-cell lymphomas, but we have seen very few other home runs.

That brings us to the focus on cost. The little bit of improvement patients get out of some of the newer drugs comes at an enormous cost, both emotionally and financially. Does the drug cure the patient or just give the patient a few extra months until the disease progresses again? The magnitude of the impact of the drug on the patient is not taken into consideration in pricing.

Oncologists often discuss the treatment of advanced cancer with a patient who has heard about a novel therapy that holds promise. Frequently, the medication being considered will have a minimal impact on longevity at the expense of sometimes very unpleasant toxicity and substantial financial consequences to the patient. It is the oncologist's responsibility to help patients understand the magnitude of potential benefit-small or large-and whether there are less costly but equally effective alternatives.

Seeking Solutions

What is ASCO doing to help solve the problem?
Dr. Schnipper: ASCO is taking a series of steps to alert our membership to the impact that the rising cost of cancer care is having on both patients and society. We are encouraging physicians to be very open to communicating with their patients about cost and its relationship to the quality of available treatments. Patients need to understand that "more expensive" and "newer to the market" does not necessarily equate with "better."

There is a need for oncologists to recognize the implications of cost for individual patients, understand its practical dimensions, and increasingly integrate this information into treatment discussions, such that medical decisions can be optimized.  ASCO is committed to the development and dissemination of clinical support tools to help prepare oncologists to engage in cost discussions with their patients.

ASCO's Cost of Cancer Care Task Force is identifying ways to help guide oncologists on the practical application of scientific evidence as it not only pertains to clinical benefit and risk, but also to cost.  Specifically, the Task Force is identifying how oncologists can obtain access to up-to-date, comprehensive information about the clinical benefit, toxicity, and cost of the treatment regimens they prescribe such that they may integrate this information into their discussion with patients.

Dr. Davidson: I helped establish ASCO's Cost of Care Task Force with ASCO's CEO Allen Lichter, MD, and it is based on a several-point plan. The first point is to put the cost of cancer care into the conversation we have with our patients. Talking about the cost of their care is the same as talking about other kinds of side effects of care that we provide. We need to make that a routine part of the conversation.

The second part of the plan is to stress that oncologists need to be engaged in generating the kind of evidence we need to make good health-care decisions. And then we need to put that information into evidence-based guidelines. The last part of this plan is to encourage a conversation that we all have to engage in, both as oncologists and as citizens, about what our priorities are and what we want to do as a society regarding health care.

The issue of cost isn't just about high-priced drugs; it's also about the very expensive devices we use as well as the cost of general health care. We have to consider end-of-life health care and how we can use resources most wisely to make sure that individuals in that situation are comfortable and get all the care they need but are not overtreated.

Our obligation as physicians is to talk about all aspects of care with our patients. These days, that means the economic consequences, including the cost of drugs and costs in terms of time-for example, time away from work. All aspects of care should be part of the dialogue.

There isn't any one part of the system that is responsible for driving up the costs of care. I think that we're all equally responsible, so it behooves all of us to try and carry out the high-quality research that's necessary to establish the value, or lack thereof, for new therapies. We also need to figure out how best to apply them and then police ourselves so that we use these new therapies appropriately.

At the University of Pittsburgh Medical Center, we've put a pathways program in place, in which a large consortium of academic and community practitioners work together. We have self-assembled into a dozen or more disease-specific groups. On a regular basis, each group reviews the existing medical literature for its disease and then puts together pathways that can help physicians and patients understand the most appropriate therapy for a particular disease, at a particular stage.

Practical Considerations

How can the cost of cancer drugs be reduced while still providing the most effective care for patients, and without limiting drug development innovation?
Dr. Fojo: I don't have the answers, but I'll give you my bias. A big deal has been made regarding personalized medicine, but unfortunately this has yet to become a full-fledged reality. We're heading there, but we're not there yet, not even close. When we do get there and can identify the small percentage of patients who benefit from a specific drug, then the problem of drug costs will basically solve itself. And by that I mean that practically every drug that is tried and every drug that is approved has activity in some patients. When you think about all the rigor that goes into drug development, when the drug "fails" to bring benefit to patients in a clinical trial, it's a disappointment and also in many ways a surprise. Usually it has been demonstrated to have activity in too few patients to be considered a valuable option. But, in fact, the majority of drugs do have some activity, and the challenge is to find the individuals in whom that drug is effective.

Once drug development is linked hand-in-hand with biomarkers and we are able to determine whether a patient's tumor will or will not respond to the drug, then we'll be able to narrow down the number of patients we give these expensive drugs to by identifying those in whom we know the agetns will be effective. At that point the drugs won't look so expensive.

When you charge $80,000 for a drug that gives a patient an average of 1.2 months survival advantage, that just doesn't make sense. At some point, we should become smart enough to identify that small percentage of patients in whom the drug would be really effective. Then we'll be giving these expensive drugs to patients who are getting not 1.2 months, but at least 1 to 2 years' benefit from them.

The other thing that should worry us is that these drugs aren't harmless. We refer to many of our "novel agents" as "targeted therapies." The implication here is that they target the tumor and not normal tissues. But it turns out that every target these drugs have is also present in normal tissues. Consequently, they all have toxicities, often as bad or even worse than those of cytotoxic agents. So we're giving these drugs to too many patients, including many patients who experience no benefit, and we are in fact causing them harm. We have to reprogram ourselves and recognize that these agents are like all our previous drugs-they have side effects that we need to think about. We can't expect that a patient will either have benefit or suffer no consequences. It actually comes down to benefit or harm. And the harm can either be a case of no activity and some level of toxicity or, as we are finding in an increasing number of examples, these drugs may actually worsen the disease they are intended to treat.

The solution in the long term is to know ahead of time the tumor's genetic and epigenetic composition and whether it is likely that a given drug will work. As a medical community, we've got to stress that 1.2 months is a marginal benefit. Furthermore, we ought to recognize that a majority of patients are not deriving this marginal benefit but are nevertheless suffering toxicities and are thus being harmed. We ought to say as a community to pharmaceutical companies, "We were all hoping your drug would perform better, but, unfortunately, it has not, and a 1.2-month survival benefit just isn't worth $80,000."  It is also not worth conducting additional large trials to extend the indications for these drugs. We need to move forward. We need to do better for our patients. We need better drugs.

Whys and Wherefores

Why is the cost of cancer drugs so high?
Dr. Bach: It's pretty simple, actually. The drug manufacturers in the United States essentially have no downward pressure on the cost of cancer drugs. They can choose to charge whatever they like. There's been this long period where manufacturers are getting increasingly bold in terms of the prices they're willing to charge. One of them comes on the market with a drug with a high price, and no one flinches. Then the next one has no hesitation to charge a similar price. So we see this almost lockstep progression in the rise of the cost of cancer drugs and no check on that.

With our medical care system as it works today, can anything really be done to substantially lower the cost of cancer care?
Dr. Bach: There's no question that the challenges ahead are sizable. But the reality is that anything that drives down the cost of drugs or decreases utilization will decrease the incentive for innovation, and if the incentives are decreased, it will tamp down on the total amount of beneficial innovation. That's the expectation at least. How big an effect that will have in a negative direction, or how large the changes have to be to reimbursement, payment, and costs to really suppress pharmaceutical innovation, and even technologic innovation- that's harder to know, but that is one tension here.

Everyone would agree that the rising cost of health care is economically unsustainable in the United States. Whether cancer is itself the big problem or a little problem is hard to know. I can't look at the problem in isolation. I actually think that the cost problem we have in cancer care is just a reflection of the broader ills we have in our health-care system. ■

Financial disclosure: No potential conflicts of interest were reported by Peter B. Bach, MD, MAPP; Nancy E. Davidson, MD; Antonio Tito Fojo, MD, PhD; and Lowell E. Schnipper, MD.

Editor's note: Several pharmaceutical companies declined to be interviewed for this story when contacted by The ASCO Post.