New Colorectal Cancer Therapies Foster New Discussions on the Value of Medications

May 2010, Vol 1, No 1

New chemotherapies for metastatic colon cancer have improved life expectancy, but at a significant cost, say the authors of a study that explores the value of medications including bevacizumab (Avastin, Genentech), capecitabine (Xeloda, Roche Laboratories), cetuximab (Erbitux, Bristol-Myers Squibb), irinotecan hydrochloride (Camptosar, Pfizer, Inc), and oxaliplatin (Eloxatin, Sanofi-Aventis LLC).

The team of researchers, from Emory University in Atlanta, constructed a sample of patients aged 66 and older who were diagnosed with stage IV colorectal cancer between 1995 and 2005 and were treated initially with chemotherapy. The sample was broken down into 5 groups by diagnosis date, and those dates were organized by time periods coinciding with the introduction of these new drugs. The researchers calculated actual survival and projected survival rates from short-term survival data, and calculated lifetime medical costs, breaking these costs down by the phase of care (ie, initial costs, ongoing costs, and end-of-life costs).

The final patient sample contained 12473 members, of whom 4665 (37.4%) were given chemotherapy within 6 months of diagnosis. Among the patients receiving chemotherapy, median survival time increased by 4.5 months, and costs in the 2 years following diagnosis increased by $17800. Survival increased steadily during the course of the study, with 19.1% of patients in the last time period surviving at 3 years postdiagnosis, compared with 11.7% in the first time period. The projected life expectancy and lifetime costs, respectively, were 6.8 months and $37100 for those receiving chemotherapy. The implied cost-effectiveness ratio was $66200 per life-year gained; after discounting and controlling for variables, the incremental cost per quality-adjusted life-year was $99100.

The authors note that other studies modeling cost-effectiveness of colorectal cancer therapies have found similar or larger cost-effectiveness ratios, but that the $37100 increase in lifetime costs for patients treated with new chemotherapeutic agents is less than the figures often quoted in the media or journal commentaries.

These new agents, the authors conclude, “have been singled out as examples of high-cost/low-value medical care” that would “receive close scrutiny if Medicare and other payers were to consider cost-effectiveness in coverage decisions.

“Continuation of Medicare’s open-ended coverage policy for new chemotherapeutic agents and other expensive technologies will prove difficult to sustain as costs for the program continue to rise,” they warn.

In a follow-up e-mail interview, lead author David H. Howard, PhD, summed up 2 main messages from the paper. First, “the new drugs for colorectal cancer aren’t ‘too bad’ in terms of cost-effectiveness” and second, “the drugs are not as costly as initially advertised.” Their cost-effectiveness can change, however, if the drugs are used for other tumor types, he pointed out.

“Traditionally payers haven’t considered cost-effectiveness when deciding whether to cover new drugs,” Dr Howard noted, “but some of the new chemo drugs are really pushing the envelope. While it is unlikely that a payer would completely deny coverage for a new, effective chemo drug, I think they will start to scrutinize use of these costly drugs much more carefully and try to limit their use.”

In discussing the larger issues raised by the study, Dr Howard put forth the following: “Should Medicare continue to cover effective drugs without regard to cost, even if they are cost-effective? The federal debt is such a big problem [and] we can’t afford business as usual. And we must face the tradeoff that if we spend money on new chemo drugs, we are going to have less for education, roads, bridges, and other priorities.”

A Potential for Collaborative Research

Yu-Ning Wong, MD, MSCE, an assistant professor at Fox Chase Cancer and adjunct senior fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania, both in Philadelphia, PA, echoed the importance of this “bigger picture” perspective.

“We should consider value when making any decision, whether it’s a consumer product or a medication,” she argued. “What is important, however, is to consider the value of an expensive cancer medication in its clinical setting, not just its price. Does it increase the cure rate so that more patients live their lives without cancer? Or does it just extend life by a few months? In addition, certain drugs may become more ‘valuable’ if we are able to better identify the patients who are most likely to benefit from them.”

In Dr Wong’s eyes, this study is important “because it supports clinical trial experience that we are improving the life expectancy of patients with metastatic colorectal cancer. It’s important to demonstrate this improvement in ‘real world’ patients, not just clinical trial patients.” The study also shows how quickly new drugs have been adopted in clinical practice, she pointed out.

Dr Wong, who is an editorial board member for Value-Based Cancer Care, also cautioned that because the study period ended in 2005, the cost of more recently treated patients is unknowable.

In addition, “We don’t have data on the patients who originally had localized disease but developed metastatic disease.”

Nevertheless, the study suggests new areas of potential cooperation, Dr Wong concluded.

“Payers should realize that medical oncology is a rapidly evolving field. New drugs are being introduced and tested in a variety of tumor types across a variety of clinical settings. Clearly, this is an important opportunity for clinicians to work with insurers to determine which treatments are appropriate to cover and which should involve more scrutiny,” she said. But “it would be helpful to have more claims data available, like this Medicare database, so we can see how patients are treated in the real world. This is an important opportunity for the insurance industry to pair with academia to do these studies.”

The study appeared in the Archives of Internal Medicine (2010;170[6]:537-542. Epub 2010 Mar 16).

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