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$3 Million to Toss a Life Ring?

June 2010, Vol 1, No 2

Washington, DC—Three million dollars to toss a life ring? That’s what the pharmaceutical industry would charge, the director of Medical Ethics at Harvard’s School of Medicine suggested at the 101st Annual Meeting of the American Association for Cancer Research (AACR), held April 17-21 in Washington, DC.

“You are drowning and will live 30 more years if I throw you a life ring. Can I charge you $100000 per QALY (quality-adjusted life-year)—$3 million?” asked Dan Brock, PhD. “The size of the benefit does not tell us the cost,” he said. “Pharma can set any price it wants and believes it can get.”

Dr Brock and other speakers at the special session on Clinical Cancer Research as an Engine for Improving Patient Care—But at What Cost? expressed serious concerns about the impact of monopoly pricing by the pharmaceutical industry and skyrocketing costs for cancer treatments in the absence of significant gains in survival and outcome.

“Progress in the therapy of cancer continues to be incremental,” said Antonio Fojo, MD, PhD, head of the Experimental Therapeutics Section in the Medical Oncology Branch at the National Cancer Institute. “Unfortu nately, drug costs are not incremental.”

Rising Costs, Affordability, and the Question of Benefit

All but one of the 10 most expensive drugs in the United States are for cancer, said Thomas Smith, MD, professor and chairman of Hematology/ Oncology and Palliative Care at the Virginia Commonwealth University (VCU) Massey Cancer Center. Most new cancer drugs cost between $6000 and $10000 per month, with some therapies reaching the $20000 per month range, but there is little difference in overall survival between them, he indicated.

The cost of new therapies for breast and colorectal cancer has increased more than 100 times in the past decade, but the improvement in overall survival is less than 1%, said Dr Smith. The United States spends twice as much as any other country on cancer but has the same survival for most diseases, he said.

Avastin “does not ‘rescue’ the dying cancer patient,” Dr Brock emphasized. Its use for breast or lung cancer costs between $200000 and $300000 per QALY and is not covered by the National Health Service in Britain, he noted, where the company didn’t even provide data for it to be considered by that organization. “The bar for what we call significant has fallen,” said Dr Fojo. “If Avastin and cetuximab are an important part of the therapeutic armamentarium 7 years from now, we have failed miserably.”

Insurance costs have doubled in the past 8 years, meaning fewer people can afford these new treatments, Dr Smith pointed out. “One other distressing thing here ethically is the new tier that has been added to health insurance,” said Dr Brock. New fourth tier policies require a percentage copay, meaning that a 20% copay for a drug with an annual cost of $100000 results in a $20000 outlay that many patients cannot afford. Such an approach is based not on value but ability to pay.

Treatment decision makers have little incentive to weigh true costs against benefits, Dr Brock said. Most cancer patients have insurance and are concerned only with out-of-pocket costs, and some oncologists receive substantial income from using new drugs for patients. Dr Brock asserted that the US Food and Drug Administration (FDA) approved some new uses in the absence of any evidence of clinical benefit and believes this is a step in the wrong direction for value in cancer care. “We need a willingness to ration even ‘last chance’ care at the end of life” and to not cover very high-cost, marginal interventions, he said, but he also acknowledged that such a move will probably not come without a national healthcare system.

Short of this, covering last-chance therapies only in clinical trials or for registry patients and authorizing the Centers for Medicare & Medicaid Services (CMS) to negotiate drug prices may be solutions. Although the CMS is explicitly prohibited from negotiating prices, “this may change,” Dr Brock ventured. A much larger step would be transforming the new comparative effectiveness program to a cost-effectiveness program. Dr Brock acknowledged that this may be difficult to achieve because of Congress’ reluctance to pass measures that could be seen as rationing care.

Restricting active therapy to patients with a high performance status can curb costs, suggested Dr Smith, as can limiting therapies with no chance for cure and limited benefit (eg, fourth-line chemo). “Most people can learn that they cannot be cured,” he said, noting a VCU study that observed no distress in 27 such truthful patient education sessions. Fears of abandonment can be reduced with better, less costly end-of-life care such as hospice.

“It’s not going to be easy to discuss costs” with patients, Dr Smith warned, noting that physicians only discuss prognosis with patients about 39% of the time. “We have to get past the hurdle of being able to give people bad information about their disease and do it without damaging them” before discussing costs.

Instilling Efficiency in the Process

Physicians drive care costs by what they do and don’t do, with many oncologists choosing the chemo that makes the most profit for the practice and giving too much chemo near the end of life to little benefit, Dr Smith suggested. “Without chemo and supportive drug profits, oncology is a poorly paid, difficult specialty,” he said. Any solution will require realtime monitoring of physician performance and new payment models. He also called for more scrutiny of physician-owned labs, radiology, and infusion services. Dr Smith suggests getting rid of “routine” tests whose use is not supported by evidence, and said patients can be convinced they don’t need tests through discussions that a specific test doesn’t work.

“Clinical treatment and development of new treatments are inefficient,” said David Parkinson, MD, a former Tufts University clinical researcher and current CEO of Nodality, a biotechnology company developing biological characterization tests to aid in clinical decision making and drug development. Rational, “efficient” treatment requires a biological understanding of malignancy, development of targeted therapeutics, and biological characterization of individual patients, he said. Providers continue to classify tumors on the basis of morphology and size although “it is becoming increasingly clear we see enormous biological diversity” in patients.

“We have a lot to learn from car mechanics,” he said as he displayed a slide of a parking lot full of cars, every one of which has something wrong. “A mechanic would lift the hood, diagnose it, and give an individual car a specific therapy. He would not treat red cars all the same way and silver cars all the same way.” It “is necessary for us as a community to redefine malignant disease.”

Development of targeted therapies “is one thing industry can do very well. The missing element is rational ‘efficient’ treatment,” he said. There is still a lack of tools for biologically driven therapies and tests validated for real-world use.

Dr Parkinson described cultural and regulatory hurdles that must be overcome in order to achieve biologydriven clinical decision making. Diagnostic test reimbursement is “a disaster,” summarized Dr Parkinson, with uninformative lab tests and inefficient therapeutics application wasting valuable healthcare dollars.

Scientific culture focuses more on publishing papers than producing real-world products, he said, with “more biomarker meetings than there are biomarkers.” In recent years, “the FDA has been so under-resourced [and] they are just now getting resources to look at this field.” The agency has clearly indicated it is moving to regulate, a move he thinks is “quite appropriate.”

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