In Conversation With ASCO President Peter Paul Yu

On August 13, 2014, Peter P. Yu, MD, FASCO, the 2014—2015 president of the American Society of Clinical Oncology (ASCO), sat down with The American Journal of Managed Care at their headquarters in Alexandria, VA, to discuss some of the “value” prospects that ASCO has brought to the table when discussing cancer care.

American Journal of Managed Care

: How is ASCO defining value in cancer care?

Peter Yu, MD:

“Value” is important to talk about in cancer care as it feeds into concerns regarding both the sustainability of and access to cancer care. ASCO’s initial framework for evaluating value in oncology is defined by three key components: clinical benefit, toxicity, and cost.

American Journal of Managed Care: How is ASCO helping both providers and patients navigate today’s changing healthcare landscape?

Dr Yu:

The cancer patient is bombarded during a time of high emotional stress. There are a lot of discussions occurring within a short period of time—treatment options, side effects to anticipate, prognosis, etc. Layering it with a discussion of cost of care makes it even harder on the patient. Yet if these conversations with the provider do not happen before treatment begins, patients will surely realize the cost burden after the fact: the cost of care, the co-pays, and the unaffordability of it all. This can impact the success of therapies, compliance, and other issues. ASCO is endeavoring to develop a framework that can form the basis to initiate the value discussion. The approach is to look at different kinds of cancer treatments, assess their clinical benefit in terms of quality of life and survival, the economic cost, and the toxicity cost, in a way that can be compared with alternative treatments. This can help compare different regimens on a relative basis without trying to rank-order treatment, based on a single value judgment. We want to establish a basis to conduct a discussion on choosing treatment options, not to restrict patient or physician choice. Outlooks, of course, will vary—for some patients, certain side effects may be intolerable, while others may accept any degree of side effects as long as there is a significant survival benefit. So it’s not possible to state a single right answer for every patient—that’s for the doctor and the patient to decide together. But if we can provide a basis for having a consistent discussion across patients and providers, it’d be a significant benefit.

American Journal of Managed Care:

Can you elaborate on the Choosing Wisely campaign and the role that ASCO seeks to play?

Dr Yu:

It’s the first part of a broader effort across the house of medicine to discourage use of therapies or diagnostic tests that have no proven value. This is an effort across medicine to foster a culture for doctors to evaluate the downstream consequences of the things we order. A generation ago, most oncologists ignored the broader considerations of treatment decisions; they did not believe it to be their responsibility. They thought, “My job as a patients advocate is to do everything I can to have the patient survive a day longer—end of story. Anything else is not my responsibility.” They also believed it was unethical for a physician to consider both financial and clinical toxicity cost.” However, with medical events triggering a quarter of US personal bankruptcies, most physicians today recognize that it’s their responsibility to

discuss the relative value of the treatments that they are recommending to their patients. We would like to instill a sense that we need to be mindful of this conversation.

American Journal of Managed Care:

Can you provide us an overview of CancerLinQ?

Dr Yu:

We are rapidly moving to a world of digital heath. All aspects of our lives are captured electronically in a way that can speed communication, enhance coordination

of care and allow discovery of patterns of care that can speak to quality and best outcomes. It’s often hard to gauge correlation from a small patient sample—the disease is complex as is the patient, and a small sample size will have a lot of bias. Physicians are often biased from personal experience as well. However, when we aggregate results from across thousands of patients, we can gain insights or trends on patterns that may not be visible from a smaller number of patients or an individual doctor’s experience. Consider the example of side effects or toxicities. When the FDA approves a drug, there’s been a solid evidence-base to the decision which is founded on clinical trial data. Post-approval, patient exposure now increases by a 1000-fold and you could learn things that were perhaps missed in smaller trials. CancerLinQ will allow us to amass, aggregate and analyze data and learn from it. This information, when returned to the doctor at point-of-care, will allow physicians to make choices based on rapidly available information that can improve treatment decisions.

American Journal of Managed Care:

Were there any barriers with CancerLinQ? How does ASCO plan to take stewardship of the information?

Dr Yu:

There are a lot of issues in all aspects of modern life—electronic data, security, identity theft, etc., which we hear about in the press all the time. Add on top of that our special sensitivity to, and need for, privacy of data in healthcare. HIPAA is a set of laws governing the use and distribution, as well as obligations for privacy and security around, personal health data. However the greatest barrier to overcome is resistance to sharing data. Both the economic and the learning benefit of health data are more fully realized when we share our data sets and make them available. ASCO has set up a data governance structure to ensure that patient data is secure and that

data analytics are performed only in deidentified data sets by ASCO staff. Raw data are not released.

American Journal of Managed Care: Could you discuss some of the cost barriers of cancer therapies.

Dr Yu:

We feel cost should be linked to the value. Common sense dictates that when something is more valuable, we pay more for it and vice versa. But costs of drugs and pricing of new therapeutics in the market don’t necessarily have any bearing to actual clinical benefit. ASCO believes we need to tie clinical benefit, toxicity and cost together in terms of defining value. It is the basis of our value framework to determine the true value of a therapeutic. ASCO, of course, will not participate in pricing decisions, but if a doctor and a patient feel that a drug has high value in that patient’s case, they’ll use it even if expensive. However, if they decide that there’s another

regimen that’s equally effective but less costly, the discussion should entail using the less costly drug.

We are also looking at clinically-meaningful benefit for new therapies. ASCO’s March policy statement addressed what constitutes a meaningful benefit in survival in the opinion of four expert panels that evaluated the treatment of diseases such as triple-negative breast cancer and pancreatic cancer. Starting by defining what current standard of care treatments deliver in improved survival, the panel debated what improvement in survival beyond this would be considered a meaningful step forward. Estimates ranged from 2 to 6 months based on baseline treatment and 20% or more in actual survival improvement. The objective was not about providing recommendations to the FDA for approval; rather, it was to raise the bar and expectations that clinical research trials aim for improvements if they want to establish

a new standard of care. When the industry develops a new drug, it should target a certain improvement level in the drugs being developed.

American Journal of Managed Care:

What is the value of speaking at meetings such as AJMC’s Patient Centered Oncology Care, which will be held on November 13-14, in Baltimore, and where you’ll be delivering a keynote?

Dr Yu:

EBO

We have a complex ecosystem in healthcare—and that complexity means multiple stakeholders who are often not together at the same table having the same conversations. We need to engage all stakeholders in the system. In January, ASCO convened a summit that brought together payers—both private and Medicare—the pharmaceutical industry, patient advocates, and provider groups, to talk about value and to come to an agreement that we are all responsible for improving value of care. We need to reduce the cost of conducting research; the regulatory burdens, which add to cost of care delivery, should be moderated; payers need to pay for things that are high-value, which in turn should reduce copays; and physicians need to choose wisely. Essentially, the entire healthcare system needs to contribute to the conversation. So the value of speaking at a conference like AJMC’s Patient Centered Oncology Care is that it’s a diverse group of stakeholders—a wider audience—and that’s where this conversation has to take place.

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