Wednesday, July 1, 2009

The $440 Billion Question for the Value of Cancer Treatment Such As Erbitux Gets More Complicated

It seems the contrast between the often staggering cost of treatment and the modest yield in life expectancy caught the attention of the editors and academics over in the Journal of the National Cancer Institute (JNCI). The DMCB thanks them for confirming an issue raised previously in this blog. How so, you ask? Read on.

Erbitux (generic name cetuximab) is one of several manufactured proteins that in turn bind to a protein component found on various human cell surfaces that regulate growth (called, appropriately enough, ‘growth factors’). When combined with standard chemotherapy for cancers such as lung or colon, Erbitux has been shown to modestly increase life expectancy. Unfortunately, Erbitux is a very sophisticated product that required years of expensive testing and development, demand for the drug is very high, setting prices for medications is very arcane and the manufacturer has a patent.

As a result, it’s not unusual for a treatment course consisting of several IV infusions of Erbitux to cost tens of thousands of dollars. When projected over the number of persons that would qualify for treatment, authors Tito Fojo and Christine Grady apparently (access to the full text is restricted) determined that the total cost to our nation’s health care system could add up to a whopping $440 billion per year.

In our age of printing up trillions in dead Presidents, that’s not necessarily the problem. The addition of Erbitux, according to summary news reports, results in a paltry average of 1.2 months of added life expectancy. This poor value proposition troubles the authors, who recommend that expected cost and life expectancy should be used as a criteria for the funding of future cancer treatment research.

According to the Wall Street Journal, actual patients may disagree. They point out that today’s expensive advance will be cheaper tomorrow, big breakthroughs lead to other breakthroughs, persons can use the 1.2 months as a bridge to other treatments and, well, it’s only money.

For the record, the prescient DMCB raised this issue just hours before the JNCI release and believes Drs. Fojo and Grady are confirming that stomping out ‘waste’ and ‘medical mistakes’ pale in comparison to our need to reconcile the high cost of technology versus the actual yield. The issue has been around for a long time. One old example is this comparison of the expensive clot buster tPA versus cheap clot buster streptokinase for heart attack. As for our chances of reconciling high cost vs. modest yield: good luck, even in today’s reform-minded environment.

However, while the mainstream media have focused on the validity of the $440 billion price tag, the contrarian DMCB thinks ‘1.2 months’ is statistically unfair and does a poor job of reflecting the real issues faced by cancer patients. Check out this real life clinical trial that is available on line. It showed Erbitux resulted in a median survival of 12 months with a confidence interval ranging from about 8 ½ to just over 15 months versus just over 9 months of survival with a confidence interval extending from about 7 ½ months to just under 12 months without Erbitux.

Most scientific studies report confidence intervals to give you an idea of the distribution of the results. In other words, there is a 'plus minus' ‘spread’ around the average in how any population of patients will respond to treatment. That is determined by myriad clinical factors but, once the numbers are added up, it acts in typical random 'Gaussian' behavior. This means the real bottom line in this trial is that getting Erbitux may result in a life expectancy as high as 15 months versus a life expectancy as low as 7 ½ months without Erbitux.

Depending on the real price of a course of Erbitux, that may place it within reach of the standard threshold of cost effectiveness. Put another way, if you were told your life expectancy could double to 15 months for, say, 20 grand, would you go for it? Saying yes at an individual and policy level is not that unreasonable. The DMCB says the JNCI editors' failure to recognize that real world calculus is unreasonable.

Oh, and one more thing: the JNCI authors suggest that ‘oncologists must offer clear guidance for the conduct of research, interpretation of results, and prescription of chemotherapies.’ The DNCB’s experience dealing with oncologists and their drugs as a medical director in a highly regarded health plan taught it otherwise. So does some peer review literature. The JNCI authors are not only also unreasonable, they're being naive.

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