Up-front spending on pharmaceuticals to treat colorectal cancer in the U.S. would be $7.5 bil. per year if oncologists use newly launched therapies without restrictions, Memorial-Sloan Kettering Cancer Center researcher Leonard Saltz, MD, told the American Society of Clinical Oncology annual meeting June 5 in New Orleans.

Saltz presented an economic analysis showing that it costs approximately $250,000 to treat a metastatic colorectal cancer patient today, compared to $500 per patient in 1995 (in constant dollars).

"You multiply this out over 30,000 - that's the approximate, conservative estimate for patients...and we're talking wholesale cost of $7.5 bil."

Saltz attributed the high cost of treating colorectal cancer to two inter-related factors: longer life expectancy for colorectal cancer patients (and therefore longer course of therapy); and the high price of the therapies that extend life.

The two most recently launched colorectal cancer agents - Genentech's Avastin and Bristol-Myers Squibb/ImClone's Erbitux - carry especially high prices (¹ Also see "Genentech Avastin Clears FDA; Colorectal Cancer Drug Costs $4,400 A Month" - Pink Sheet, 1 March, 2004., p. 9).

In 1995, treatment costs for colorectal cancer were low because each patient typically received only 4.5 months of 5-FU/leucovorin, Saltz explained.

Today, however, patients live much longer due to improved therapy options. Saltz' estimate of $250,000 per patient assumes that a patient receives 11 months of the FOLFOX regimen plus Avastin, followed by 4.5 months of Pfizer's Camptosar , and then 4.5 months of Camptosar plus Erbitux.

The $250,000 estimate is strictly the cost of the chemotherapy. "That's not anti-anemics. That's not growth factors. That's not antibiotics. That's not doctors' fees. That's not nurses' fees, hospital fees, pharmacy fees. That's not complications. That's just the drug," Saltz said.

Saltz, who was one of the principal investigators in the development of Camptosar (irinotecan), stressed that the issue is not the value of the therapy. "These drugs are working," he declared.

Nevertheless, "we don't have that much money in the till. It is going to require some serious thought on how are we going to do this responsibly."

"We simply aren't going to be able to make this kind of therapy available to everybody without some way to control these costs," Saltz said.

"We are going to have to be thinking of strategies of how to use these drugs more appropriately. We are going to think about strategies to use these drugs in patients who are most likely to benefit, and strategies to avoid using these drugs in patients we think are not going to benefit."

"We need to seriously look at the concept of treating for a fixed period of time or to a maximal response and then stopping therapy in patients, give them a holiday, and then resuming therapy at time of progression."

In the case where a patient has failed first-line therapy, Saltz recommended that oncologists discontinue use of Avastin with second-line therapy.

"It's tempting to say let's just continue the Avastin because it seems so relatively non-toxic compared to any drugs that we have been working with....But, it's going to have significant economic consequences and I'm not comfortable making that interpretation right now," he explained. "I don't personally continue it."

On the other hand, Saltz suggested that relying on receptor expression assays to limit therapies would be a mistake, at least for Erbitux.

"I don't believe that you should use EGFR-positivity or negativity as relevant" to treatment or payment for Erbitux, Saltz maintained. "The science supporting denying treatment to a patient because he or she is EGF-negative simply is not there."

There is also no basis for using Erbitux in non-colorectal tumors that express EGFR, he said.

Erbitux was approved in conjunction with an EGFR diagnostic, and the indication (reflecting the clinical trials) is limited to EGFR-positive tumors. However, labeling also notes that there is no apparent correlation between levels of EGFR expression and tumor response (² Also see "Erbitux Launch Benefits From EGFR Screening; 75%-80% Of Patients Positive" - Pink Sheet, 3 May, 2004., p. 13).

Colorectal Cancer Drug Costs May Force Rationing – ASCO Presentation

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