We are trying to be an honest broker in helping oncologists and patients make their best-informed treatment decisions based on effectiveness and cost.
—Lowell E. Schnipper, MD
Last January, ASCO held a leadership summit in Washington, DC, with representatives from the pharmaceutical industry, insurance payers, patient advocates, and physicians to address the skyrocketing costs of new drugs and technologies used in the diagnosis and treatment of cancer. Although costs are rising throughout the health-care system, they are especially pronounced in cancer care, where new therapies include 8 of the top 10 most expensive drugs covered by Medicare. And while cancer care in total is responsible for only 5% of health-care expenditures, this is expected to grow over the next 6 years, from $125 billion in 2010 to a projected $175 billion in 2020.1
The meeting, “Summit on Optimizing High Value Cancer Care: Addressing the Cost of Drugs and Novel Technologies,” was an initial step in developing a dialogue among the key stakeholders. The ultimate goal is to find solutions that will enhance value in cancer care (optimal clinical benefit per unit cost) and increase patient access, while continuing to encourage innovation in drug and technology development.
Over the past 2 decades, ASCO has been active in promoting high-quality, evidence-based cancer care through its clinical practice guidelines and its National Initiative on Cancer Care Quality, which formed the basis of ASCO’s Quality Oncology Practice Initiative (QOPI®). Now, the Society is in the process of launching a strategic Value in Cancer Care initiative. Developed by ASCO’s Value in Cancer Care Task Force, the initiative has three goals:
1. To provide oncologists with the skills and tools needed to evaluate the relative value of interventions and use them when discussing treatment options with their patients
2. To provide patients access to information to help them in selecting high-value treatment that meets their specific needs
3. To provide all those responsible for covering the costs of cancer care with an algorithm to help define and assess the value of cancer treatment options
In a wide-ranging interview with The ASCO Post, Lowell E. Schnipper, MD, Chair of ASCO’s Value in Cancer Care Task Force and Chief of Hematology/Oncology at Beth Israel Deaconess Medical Center in Boston, talked about potential methods for reducing cancer care costs and the task force’s development of an algorithm scorecard to evaluate drugs based on their cost and value, as well as their efficacy and side effects.
Please define what value in cancer care means.
The concept underlying value in oncology really relates to what the optimal treatment for a given clinical scenario is at the lowest cost. The idea is if there are multiple choices in a treatment decision, oncologists should integrate the cost of those treatments, as well as the clinical benefit and side-effect profile into their decision-making.
What were some of the major concerns presented at the recent summit on high-value cancer care?
The issues that we talked about on the patient side had to do with the enormous need for innovative new therapies in the context of many advanced forms of cancer and the extraordinary vulnerability that many patients feel when meaningful fractions of the cost of some of the treatments we recommend are passed along to the individual through health insurance copays.
We know that medical issues contribute in a substantial way to personal bankruptcy, which often occurs not just because somebody who is sick is out of work, but also as a result of high medical cost-sharing. Patients are picking up larger and larger fractions of the cost of expensive medications, and that is an issue we have to confront. Many patients are feeling a lot of financial stress on top of the stress of their life-threatening illness, so that was one theme that resonated with the meeting participants.
From the drug manufacturers’ perspective, they recognize that they have to produce drugs that are innovative if they can, and they say that that innovation costs an enormous amount of money. In fact, nobody would dispute that the research and development costs are enormous, especially as a drug moves through the clinical trial process before it ever gets to the FDA for a decision.
Members of the pharmaceutical industry said that they have a high rate of failure for experimental drugs and that for every winner, there are many losers they have invested in, but they have no way of getting a return on that investment. The many regulatory hurdles they have to overcome are far too high, they said, and generally result in prolongation of the evaluation process, which also increases costs.
They also argued that while an effective drug may be expensive, its costs are offset by its benefit to society through fewer hospitalizations and greater worker productivity. What they are saying is that while a drug may look expensive because it has a big price tag, a high-value drug has many other downstream benefits to society.
Keeping Drug Costs Down
Were potential solutions raised for maintaining drug innovation while keeping costs down?
The pharmaceutical industry understands that better science will enable us to pick smarter drugs for people with cancer. By that I mean if we can identify biologic markers in a patient’s specific tumor type that can predict drug targets with a high degree of reliability, development costs will be lower for a given successful drug. And that lower cost should enable manufacturers to lower the pricing bar. I don’t know if they will get to the lower pricing bar; I’m just saying that’s a conceptual possibility.
Was end-of-life care discussed as being another big driver in the high cost of cancer care?
Yes, not as directly related to the cost of drugs, but in the context of cancer-directed therapy that will not do any good and might produce toxicity. The assumption is that properly done end-of-life care can—to a much larger extent than is the case now—be more home-based, with fewer emergency room visits, fewer hospitalizations, and certainly less in the way of active cancer-directed therapy in the last several weeks or months of life.
Were we to succeed in delivering more home-based end-of-life care—and we have been talking about this for a long time—it would be a way of enhancing the value of cancer care in that particular time frame. If we eliminated intensive medical interventions in the final days of patients’ lives and treated them in a more respectful humane way rather than admitting them to a hospital and subjecting them to many tests, procedures, and chemotherapies that are not likely to result in their being materially improved for a long period of time, it would improve the quality of health care we deliver.
What were the conclusions of the summit?
We all agreed that we need to lower the cost of developing drugs, and that means we need to look at streamlining the clinical trial process and discovering efficiencies that are currently escaping us. We are also hoping to figure out the real-world effectiveness of drugs on specific patients with cancer.
For example, our CancerLinQ™ initiative will help us understand exactly how valuable treatments are in the general cancer patient population as opposed to the highly controlled clinical study population. And that may give us a better sense of when to use some of these agents, which, again, are quite costly, and when not to, because I think that’s going to impact the utilization of drugs, and, therefore, the pocketbook of our patients.
What are the next steps in addressing the issues of value in cancer care?
We are still in the conceptual stage and not yet in the planning stage of a follow-up meeting, but as a series of next steps, we’ve been contemplating taking on one or two of these major issues in greater depth at our next meeting. This initial meeting was more of a general discussion of our concerns. But we feel that there is so much substance to some of these topics, we need to have subsequent meetings to fully examine them and develop possible solutions.
For example, incentivizing drug innovation and developing a cost structure for drugs that reflect the value that those drugs deliver. Those two concepts may seem irreconcilable, but the question is whether there are ways of thinking about the universe of patent law and intellectual property, so that when a company develops a truly novel cancer treatment as opposed to a similar treatment that is a bit more of a lookalike, the distinction is acknowledged sufficiently by way of reward.
We need to enhance the ability of the biotech industry to develop new treatments for us. We can’t effectively treat patients without them. They need to thrive, and we need to help them thrive. We need to respect the concept of value in cancer care and moderate the impact of our treatments on the people we care the most about: our patients.
ASCO is developing an algorithm to determine the relative value of cancer drugs. The first therapies ASCO will be evaluating for cost and effectiveness are those for advanced non–small cell lung cancer, prostate cancer, and multiple myeloma. Please explain the rating system ASCO is developing.
I can’t talk too much about it right now because the algorithm is not yet ready to be rolled out in detail. But a subcommittee of our Value in Cancer Care Task Force chaired by Nancy E. Davidson, MD [Director, University of Pittsburgh Cancer Institute], is focused on defining a value algorithm that we hope will reflect value in cancer care. It is a team effort.
We are developing an approach to defining clinical benefit that can encompass overall survival and/or progression-free survival as well as how much the patient’s quality of life is improved. We also want to consider the toll on the patient’s health caused by the treatment, how toxic or nontoxic the treatment is, and we are trying to add in the cost of administering the drug to a given patient with a specific disease.
In the cancers you mentioned—non–small cell lung cancer, prostate cancer, and multiple myeloma—we want to see if the way we are beginning to construct these categories of clinical benefit, drug toxicity, and cost makes any sense. Is it possible to come up with an answer that looks authentic and credible to a group of critical oncologists?
Once we feel that the value algorithm represents a reasonable approach to care by the oncology community, we will share the information with other stakeholders. We will demonstrate the algorithm to our patients and discuss the results with them. We would also like the health insurance payers and drug manufacturers to preview it.
Once we come up with a prototype of the algorithm over the next few months, we will then begin to share it with others and get their input.
What reaction have you gotten from ASCO members on the steps ASCO is proposing to improve value in cancer care and reduce health-care costs?
For the most part, we have shared the concepts I’m discussing here with members of our clinical practice committee and state affiliate leaders, and they all feel that this is an important challenge to undertake. Everybody recognizes the issues involved in America’s soaring health-care costs, so there is a sense that what we are proposing is quite a responsible and appropriate thing to do.
There is concern among some members that the information provided by a drug value rating system or the decisions that the value algorithm might lead to may have unintended consequences—for example, that a drug manufacturer might, in fact, raise its drug price if it has ASCO’s imprimatur. But that is a highly unlikely scenario, because if the price is greatly increased, it will get a lower score in the value algorithm.
How can ASCO help dispel the perception that examining treatment options based on both value and outcome is not health-care rationing?
ASCO is not going to recommend rationing cancer care in any sense. The final clinical pathway is always between the doctor and the patient. As a group, we have a consensus that we will never get into the space between the doctor and the patient and say, “You should do this, or you can’t do that.”
We are trying to be an honest broker in helping oncologists and patients make their best-informed treatment decisions based on effectiveness and cost. If we can define an algorithm that makes sense, perhaps it will help the physician and the patient make their best choice, based not just on how effective a specific anticancer drug may be, but on what financial impact the drug may have on the patient as well. ■
1. Marlotto AB, Yabroff KR, Shao Y, et al: Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst 103:117-128, 2011.