The framework is meant to provide a standardized approach to assist physicians and patients in assessing the value of a new drug treatment based on efficacy, toxicity, and cost compared with the standard of care.
—Lowell E. Schnipper, MD
Drugs represent only a small part of the overall problem, but they happen to be the component that is rising most rapidly in cancer care and also a part of the problem that affects patients greatly due to insurance copays.
—Lowell E. Schnipper, MD
Defining and ensuring the delivery of high-value oncology care has been one of ASCO’s major goals for more than a decade. In 2007, ASCO formed the Task Force on the Cost of Cancer Care, now called the Value in Cancer Care Task Force, to identify the drivers of the increasing costs of oncology care (which are estimated to be rising from $125 billion in 2010 to $158 billion in 2020).1 The Task Force was also charged with developing policy positions to ensure greater access to high-quality care, educating oncologists about the importance of discussing the cost of recommended treatments, and empowering patients to ask questions about the potential costs of their treatment options.
Five years later, in response to the Choosing Wisely® campaign launched by the American Board of Internal Medicine Foundation, ASCO identified five common clinical practices that were not supported by scientific evidence to have clinical value and that contributed to the rising cost of cancer care.2 In 2013, ASCO developed another Top Five list of tests, procedures, and treatments that are not supported by available evidence.3
Later that year, ASCO’s Board of Directors charged the Task Force with developing a framework for comparing the relative clinical benefit, toxicity, and cost of oncology treatments. The result of that effort is the “American Society of Clinical Oncology Statement: A Framework to Assess the Value of Cancer Treatment Options,” published online in the Journal of Clinical Oncology on June 22 for public comment.4
At the clinical level, the framework is meant to provide a standardized approach to assist physicians and patients in assessing the value of a new drug treatment based on efficacy, toxicity, and cost compared with the prevailing standard of care to calculate a net health benefit. Because clinical concerns and decisions vary depending on disease prognosis, two versions of the preliminary framework have been developed—one for advanced cancer and another for potentially curative disease.
The ASCO Post talked with Lowell E. Schnipper, MD, Co-Chair of ASCO’s Value in Cancer Care Task Force, Theodore W. and Evelyn G. Berenson Professor in the Department of Medicine at Harvard Medical School, and Clinical Director of the Cancer Center and Chief of Hematology/Oncology at Beth Israel Deaconess Medical Center, Boston, about the development of the value framework and its projected impact on oncology care.
Determining Net Health Benefit
Please describe the purpose of ASCO’s value framework and how the framework works.
By 2020, the costs associated with caring for people with cancer are projected to become astronomic, largely because there will be a lot more people with cancer due to an aging population and because cancer is increasingly becoming a chronic illness for which very costly medications are being used for long periods of time.
This effort was borne out of the imperative to improve cancer therapies and the awareness that many new treatments offer only small increments of benefit, sometimes with added side effects.
That said, the associated costs for these new agents are enormous. While patients need good therapy, they are becoming increasingly vulnerable to insurance copays, which are becoming larger and larger as insurance companies share more of the costs of these highly expensive agents with patients. Patients and their families often suffer financial harm and/or devastation paying for medicines that might only provide small degrees of survival gain, perhaps just a few weeks or months.
We felt a framework was needed that could put these elements—clinical benefit, toxicity, and cost of new agents when compared with the standard of care—into context so that the doctor and patient could talk about the available options for treating a specific cancer and come up with a sense of how much benefit the patient is expected to derive, based on the patient’s treatment goals. Using the framework, physicians can take this composite of the clinical impact of treatment, such as the survival benefit or how long disease progression is delayed, and either add or subtract points depending on whether the treatment is less or more toxic than the current standard of care to generate a net health benefit.
From Concept to Physician-Guided Tool
Currently, the framework is in the form of an algorithm that physicians can use to calculate a drug’s net health benefit. Will the framework eventually become part of a software program physicians can use on their mobile devices?
Right now, the initial version of the value framework is available for public comment. After we get commentary from all stakeholders and the details of the framework are finalized, we plan to convert the information into a software application that will calculate a regimen’s clinical benefit, toxicity, and cost. It will then be at the physician’s and patient’s fingertips when they have discussions about treatment options. We envision that it will ultimately be a physician-guided tool for use in the clinical setting.
Consistent Treatment Evaluation
How is ASCO defining “value” in cancer care?
The value that we are defining is expressed in terms of a new drug’s net health benefit. So some regimens that we have included in our article show a very small net health benefit or almost none when you add up the clinical benefit and the toxicity. Others have a rather substantial net health benefit, like the adjuvant treatment for breast cancer. ASCO is essentially trying to help the patient and the doctor arrive at a consistent way of thinking about different treatments they might choose utilizing the regimen’s net health benefit assessment in addition to information on cost.
Most patients will say “I don’t care what the treatment costs—my life is being threatened,” and, of course, that consideration trumps just about everything else and it should. Using the algorithm, patients can actually see that the benefits of some treatments will be very small and the cost impact might be very large. Some may choose the drug no matter what the cost or degree of benefit, and others might choose the less expensive drug that looks to be just as efficacious but has a much lower degree of financial toxicity, which may be important to them.
What has been the reaction from physicians about ASCO’s value framework concept?
Some physicians are quite forward-thinking on this issue and see the discussion as a responsibility that is not to be shied away from, but rather, to be engaged in thoughtfully and empathetically. However, some physicians feel quite committed to the notion that it is not ethical for a doctor to be thinking about cost.
My response is that I respect that sentiment to the nth degree. Nevertheless, within that general perspective of worrying primarily about our patients’ well-being—which I and all of our Task Force members agree is the central motivating factor—it is important for patients to be able to consider the cost factor when making their treatment decisions.
I want to go on record as saying that while we are talking about drug regimens and their relative value as assessed by clinical trials, we are doing so because ASCO is primarily a society of medical oncologists. However, if you look at cancer care costs more broadly, it is fair to say that there are many factors contributing to the rising cost of health care other than medications, including soaring hospitalization costs and new surgical and radiologic interventions.
There is a tendency to make drug manufacturers the fall guys for the skyrocketing costs. Drugs represent only a small part of the overall problem, but they happen to be the component that is rising most rapidly in cancer care and also a part of the problem that affects patients greatly due to insurance copays. Even so, if there weren’t any copays, insurance premiums would still be rising because of the confluence of factors I mentioned.
For complete details of the ASCO statement on its value framework, visit the Journal of Clinical Oncology website at jco.ascopubs.org. The period for public commentary on the framework will close on August 21, 2015. To provide feedback, go to asco.org/value. ■
Disclosure: Dr. Schnipper is Co-Chair of ASCO’s Value in Cancer Care Task Force.
1. Mariotto 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.
2. American Society of Clinical Oncology: 2012 Top Five list: Choosing Wisely—ASCO identifies five key opportunities in oncology to improve value of patient care. Available at www.asco.org/practice-research/2012-top-five-list. Accessed June 9, 2015.
3. American Society of Clinical Oncology: ASCO’s 2013 Top Five list in oncology. Available at www.asco.org/practice-research/ascos-2013-top-five-list-oncology. Accessed June 9, 2015.
4. Schnipper LE, Davidson NE, Wollins DS, et al: American Society of Clinical Oncology statement: A framework to assess the value of cancer treatment options. J Clin Oncol. June 22, 2015 (early release online).