Sky's the Limit for US Cancer Drug Prices, Says Top Doc

'Havoc' Inevitable?

Nick Mulcahy

February 26, 2015

There is no price that is too high for cancer drugs in the United States because Americans just can't say no, says Leonard Saltz, MD, from Memorial Sloan Kettering Cancer Center in New York City, in an editorial published online February 17 in the Journal of Clinical Oncology.

Dr Saltz phrased it this way: "There is virtually no level above which we have been willing as a society to say, no, it does not make sense to spend that much money for that little benefit, and therefore we won't do it."

Furthermore, he says that drugs — and cancer drugs in particular — are "unlike virtually all other goods and services" because they are "above discussion of, and indeed even consideration of, cost."

Dr Saltz's comments accompany a study of the cost-effectiveness of adding bevacizumab (Avastin, Roche/Genentech) to chemotherapy for the treatment of metastatic colorectal cancer in the United States, conducted by Daniel Goldstein, MD, from the Winship Cancer Institute of Emory University in Atlanta, and collaegues.

Cost-effectiveness studies are now more or less empty gestures, Dr Saltz suggests, because the Centers for Medicare & Medicaid Services rubber stamps escalating pharmaceutical prices, and private insurers largely follow suit.

"In the current environment, cost-effectiveness research has become an academic exercise of no meaningful consequence," he writes.

Cost-effectiveness research has become an academic exercise of no meaningful consequence.

Dr Saltz, who is a high-profile long-time critic of drug prices, might be best known for cowriting a 2012 op-ed published in The New York Times that declared his institution would not pay for aflibercept (Zaltrap, Sanofi) because it is no more effective in the treatment of colorectal cancer than bevacizumab, but more than twice the price.

In his current editorial, Dr. Saltz argues that bevacizumab for colorectal cancer is a "substantial expenditure" for which there is a "relatively modest incremental survival improvement."

And the authors of the study agree, almost to the word. "Bevacizumab provides minimal incremental benefit at high incremental cost per quality-adjusted life year (QALY) in both the first- and second-line settings of metastatic colorectal cancer treatment," they write.

Talk of a Threshold in the United States

Before this study, there were no cost-effectiveness modeling analyses on the use of bevacizumab in metastatic colorectal cancer in the United States, the authors report.

The addition of bevacizumab to fluorouracil-based chemotherapy is a standard of care for previously untreated metastatic colorectal cancer, they explain. Continuation of bevacizumab beyond progression (second line) is an "accepted standard of care," based on the 1.4-month increase in median overall survival observed in a randomized trial (Lancet Oncol. 2013;14:29-37).

Using bevacizumab as first-line therapy provided an additional 0.10 QALYs (0.14 life-years) at a cost of $59,361. The incremental cost-effectiveness ratio was $571,240 per QALY, the authors report.

Continuing bevacizumab beyond progression provided an additional 0.11 QALYs (0.16 life-years) at a cost of $39,209. The incremental cost-effectiveness ratio was $364,083 per QALY.

These ratios will continue to increase, suggests Dr Saltz, because the United States has its collective head in the sand.

Other industrialized nations have drug spending thresholds.

For example, in the United Kingdom, the National Institute for Clinical Excellence (NICE) has established a maximum threshold. As of 2009, it was £30,000 per QALY. This means that the cost of a patient's drug treatment should not exceed an amount equivalent to about $55,000 for a year of healthy survival.

NICE has rejected the use of bevacizumab in colorectal cancer because it exceeds the threshold and is not cost-effective. Thus, the drug cannot be prescribed on the National Health Service and can only be accessed by private payment.

Even the controversial Cancer Drugs Fund in the United Kingdom, which provides money for specific patients for some drugs that have been rejected by NICE, recently announced the removal of bevacizumab for first-line use in colorectal cancer from its list of funded drugs (second-line use remains).

The idea of a cutoff for coverage in the United States was discussed at the recent Gastrointestinal Cancers Symposium during a session that featured Dr Saltz and representatives from NICE and the European Society of Medical Oncology.

There was some dancing around the subject of how to move forward with expensive therapies that have only marginal benefit, reports John Marshall, MD, from the Lombardi Comprehensive Cancer Center at Georgetown University in Washington, DC, in a recent posting on his Medscape Marshall on Oncology videoblog.

"What's a QALY worth in the United States? What is a QALY worth in Europe? No one was willing to answer that yet, but it is clear that that is where we are going. A value judgment will be placed on novel therapies. We are already seeing it unofficially, and the question is: Will the guidelines begin to embrace this in an official way?" says Dr Marshall.

However, in his editorial, Dr Saltz does not envision a solution to this issue.

"Havoc" could be on the way in the United States, he says, with even worse healthcare disparities and even more lack of access to care.

Some of the study authors report financial ties to industry, including Roche, the makers of bevacizumab. Dr Saltz reports ties to nine drug companies, including Roche.

J Clin Oncol. Published online February 17, 2015. Editorial, Abstract


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