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The Price of Personalization

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Adam Voorhes

But a number of new cancer drugs have price tags comparable to Gleevec’s, or higher, despite offering more modest benefits. Consider Xalkori (crizotinib), a drug designed for approximately 3% to 5% of patients with advanced non-small-cell lung cancer who have fused EML4 and ALK genes, which produce a protein that drives tumor growth. MGH thoracic oncologist Alice Shaw and colleagues compared Xalkori with standard chemotherapy in patients with ALK-positive NSCLC and found that it tripled the number who responded to therapy, and more than doubled the length of time patients remained cancer-free, from slightly more than three months to almost eight months. Though there was no difference in overall survival because of the fact that patients randomized to receive chemotherapy were allowed to “cross over” to receive crizotinib, the trial showed significantly greater improvements in quality of life with crizotinib compared with chemotherapy.

Last year, Xalkori was labeled “not recommended” by the United Kingdom’s National Institute for Health and Care Excellence. NICE deemed the drug not cost effective at a price that could run as high as £51,579, or about $86,500, for a course of treatment.

A number of other new cancer drugs—some, though not all of them, targeted therapies—cost between $8,000 and $10,000 a month, and are only incrementally better than traditional chemotherapy, says Lowell Schnipper, chief of oncology and hematology at Beth Israel Deaconess Medical Center in Boston, and chair of the American Society of Clinical Oncology’s Task Force on Value. A few extra months of life may be extremely valuable to a patient, Schnipper acknowledges. But he says the “financial impact” of high-priced medications can be devastating to patients and their families, to the point of being the primary cause of declaring personal bankruptcy. Even those who have health insurance may face huge co-payments. “We talk about the medical marketplace, but there isn’t one,” Schnipper says. “If there were, patients wouldn’t pay the same for a curative therapy as they do for something that gives them only a couple of extra months.”

Cancer drugs don’t have a monopoly on sticker shock. “We’re turning out too many super-expensive drugs that have marginal benefits,” says health economist Joshua P. Cohen of the Tufts Center for the Study of Drug Development. Cohen cites Soliris (eculizumab), which treats a rare chronic blood disease called atypical hemolytic uremic syndrome, at a cost of about $500,000 per year; and Juxtapid (lomitapide), for patients with homozygous familial hypercholesterolemia, at $250,000 per year.

Yet Cohen believes the health care system can afford targeted drugs if they work well. “This is not just about the pharmacy budget,” says Cohen, noting that someone treated with an effective targeted therapy may require fewer office visits or trips to the emergency room because of serious drug-induced side effects. A person on a targeted drug may cost the system less than a similar patient taking conventional medications.

Some research suggests that personalized approaches can benefit both patients and health care budgets. For example, a preliminary 2011 study at MD Anderson Cancer Center in Houston found that using biomarkers to select drugs likely to help particular patients resulted in better responses to treatment. In a non-randomized trial, researchers at the hospital’s Clinical Center for Targeted Therapy identified 175 patients with various forms of advanced cancer whose tumors had molecular abnormalities that could be matched to specific targeted oncology drugs. More than 25% of patients responded to treatment with those drugs, compared with just 5% of those who got conventional cancer therapies. Patients who received targeted therapies also remained in remission and survived longer.

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The Trouble with Targeting Treatments

Researchers are working to develop diagnostic tests to determine who is eligible for targeted therapies, but red tape and limited expertise stand in the way.

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1. Me Medicine vs. We Medicine: Reclaiming Biotechnology for the Common Good, by Donna Dickenson (Columbia University Press, 2013). A medical ethicist argues that the promise of personalized health care has been overstated and that focusing on the individual distracts from the importance of proven public health interventions, such as vaccination programs.

2. “Towards a Balanced Value Business Model for Personalized Medicine: An Outlook,” by Christof Koelsch et al., Pharmacogenomics, January 2013. To bring down the high cost of personalized medicine, drug developers need to adopt new strategies, such as shorter, smaller clinical trials, Koelsch and colleagues argue, stating that “not all targeted therapies must inevitably cost a fortune.”

3. “Can Genomics Bend the Cost Curve?” by Katrina Armstrong, JAMA, March 14, 2012. Like most medical innovations, targeted therapies and companion diagnostic tests add to health care costs. However, Armstrong argues that personalized medicine has the potential to improve the value of health care by reducing the use of ineffective treatments.

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