ASCO 2014: Blending Clinical Innovation with Therapeutic Parsimony

plenary

Physicians and scientists from the University of Chicago Medicine will play major roles at the American Society of Clinical Oncology’s 2014 Annual Meeting. The annual conference, once again at Chicago’s McCormick Place, is one of the largest medical gatherings in the United States, drawing nearly 30,000 oncology professionals for four and a half days of scientific presentations and education.

High-profile topics this year include multiple studies of new chemo-immunotherapy protocols and novel targeted therapies. The plenary sessions focus on large phase III trials in breast, prostate and colon cancer.

But much of the chatter this year is likely to focus on a scientifically tangential question: who’s picking up the tab? Not for dinner, after each day’s sessions, but for increasingly expensive anti-cancer drugs.

It is “our duty to present and report on the latest clinical advances, but we also must examine the ‘value’ these therapies provide to society as a whole,” according to the Chair of ASCO’s Cancer Education Committee, Gini F. Fleming, MD, professor of medicine at the University of Chicago. “What is the real benefit of two months of additional survival in a certain cancer type? What are the toxicities and costs associated with those two months of additional survival? Such questions should be integrated into every discussion that we have of every new therapy presented.”

In the United States, the cost of health care is rising faster than the gross domestic product. The cost of cancer care is rising faster than the cost of health care, and the cost of new cancer drugs is rising faster than the cost of overall cancer care.

It’s “the good, the bad, and the ugly,” said health economist Rena Conti, PhD, assistant professor of pediatrics at the University of Chicago.

The good: cancer survival is significantly higher in the US than in Europe and it continues to increase. About 20 percent of those gains can be attributed to treatment advances, including targeted therapies that have steadily replaced more toxic chemotherapies.

The bad: overuse and misuse of the newer cancer drugs is not uncommon. Most off-label use is supported by the evidence, Conti said, but a substantial amount is not.

Which brings us to ugly. The price of cancer drugs has gone through the roof. The single biggest predictor of the price of a new drug, according to Conti, “is the cost of the new cancer drugs that came out last year. They tend to creep up by 5 to 7 percent each year.”

The only check on the system, according to George W. Sledge, former president of ASCO, quoted in New York Magazine, “is corporate chutzpah.”

The poster child for precisely targeted therapies, and drug prices, is Gleevec, a drug that transformed chronic myelogenous leukemia from a deadly disease, with five-year survival rates around 30 percent, to a chronic disorder with nearly 90-percent survival.

It cost $30,000 when it came out in 2001; by 2012 that had risen to $92,000. Patients take it for the rest of their lives, unless their disease develops resistance. If it does, there are now “sons of Gleevec,” newer, nearly identical medications that are effective against Gleevec-resistant disease. These cost more than $100,000.

Those prices may be headed for a correction next year, when Gleevec goes off patent, Conti predicts. Some drug makers are already encouraging physicians to bypass anticipated generic versions of Gleevec, because of the possibility for resistance. They suggest starting new patients on the newer, more costly, alternatives.

Misuse? Maybe. Ugly? Definitely. But not necessarily evil.

High prices for desirable products are “the backbone of innovation,” Conti said. Greater reliance on generics, more thoughtful prescribing, and improving the incentives of hospital and doctor reimbursement could help.

But it’s important to keep in mind that cancer treatment, driven by genuine altruism combined with substantive incentives, is improving at a rapid rate. “Who would trade that for the stagnation we see in other health fields, like antibiotics,” Conti said.

Some patients might have moments when they would gladly make such a trade, suggests Jonas de Souza, MD, an oncologist specializing in head and neck cancer.

He has been refining a new measure to assess ‘financial toxicity,’ the side effects not of taking cancer drugs but of paying for them. A recent survey found that 70 percent of patients reduced leisure activities, 48 percent withdrew savings and 18 percent sold belongings. Concerns about costs also can affect quality of life and treatment compliance.

De Souza and colleagues have argued for rethinking how health insurance is configured. Their approach, known as value-based insurance design, encourages the use of services “when the clinical benefits exceed the cost, and likewise discourages the use of services when the benefits do not justify the expenditure.”

But who makes the call when a patient desires, and might—or might not—benefit, from a costly therapy that could meet his needs but runs counter to the needs of society?

Well, “not me,” suggests Daniel Sulmasy, MD, PhD, the Kilbride-Clinton Chair in Medicine and Ethics in the Department of Medicine and Divinity School and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. “Rising health care costs now threaten to crowd out other social goods,” he said, but the notion that physicians should engage in bedside rationing, is “misguided.”

Patients must be able to trust their doctors, he insisted. For a physician to unilaterally decide to withhold care that a patient might want could “undermine trust and disrupt the balance between profession, market and state.”

It also is likely, he adds, to be “idiosyncratic and unjust.” Instead, our society should engage in a “messy and uncomfortable but absolutely necessary conversation” about how much health care we can afford and how to distribute access to health care justly. This is “for all of us to decide as a society.”

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