No Magic Bullets for Drug Price Reform:
Notes from ASH and SABCS
By Neil Canavan
ASH: The High Cost of an Unmet Need
Andrew Pollack, a journalist from the New York Times, set the 2009 ASH in motion with his front-page, opening-day article, “A Fortune to Fight Cancer”, which highlighted the record-setting price of Folotyn. Approved in September ‘09, Folotyn, manufactured by Allos, Westminster, CO, is indicated for the treatment of peripheral T-cell lymphoma. According to clinical trials, the drug is adept at shrinking tumors, and thereby extending progression-free (but not overall) survival—so, to be clear, the patient may well be more comfortable, but will not live longer. And the price? It’s roughly $30k a month.
The article appeared just as several Allos/Folotyn posters were being presented at ASH, and poster presenters hastily deferred all questions from the press to the nearby-stationed, Monique Greer, Vice President of Allos’ Corporate Communications. “Well, it did generate a lot of awareness for a small company,” Greer observed, in the sense that there’s no such thing as bad publicity. “But once we got past the headline it enabled us to get into the discussion about how rare this disease state really is, and the fact that it has a very poor prognosis.”
Greer also suggested an angle to the economics concern: the drug requires little of supportive care; it’s administered on an outpatient basis; and only requires a few minutes in an I.V. push. She further pointed out that doctors were more interested in the drug’s mechanism of action and response rates, rather than its price. What Greer says she hears from patient advocates is that they understand what’s at stake in drug development.
Judy Jones, President of the Cutaneous Lymphoma Foundation, is by no means a cheerleader for drug prices based on whatever the market will bear, but in a telephone interview she was sympathetic to certain arguments. “We’re dealing with a new treatment for a disease that has no FDA approved treatment. Until this drug came along these patients didn’t have anything. Do I wish that these [new] drugs were cheaper? Absolutely. But I don’t know how to determine how much is too much, and I don’t want to threaten new drug development.”
A day after Pollack’s article appeared in the Times, a seemingly prescient talk at ASH, titled, “The Cost of Health Care: Balancing a Patient’s Right to Care with the High Cost of Some Drugs and Procedures” suggested that the issue of drug pricing might be addressed. But that was not the case. What the speaker, economist Paul Ginsburg, President of the Center for Studying Health System Change, Washington, D.C., did discuss were those cost-drivers common to the healthcare system as a whole where, in general, many highly effective drugs are now, or soon will be, off-patent.
This is not the case, of course, for cancer treatments. “I quickly realized during the course of the meeting that in oncology, one of the biggest issues is drug pricing,” he said, and he’s wary of the competing interests in trying to bring down costs. “All spending is someone else’s income,” Ginsburg said, adding that oncologists have long standing conflicts of interest because they sell drugs directly to the patient, and are, in fact, competing with pharmacies when it comes to oral vs. I.V. medications. “In the industry these are called self-referral incentives,” he said, “like if a physician orders a CT scan, and s/he just happens to also own a CT scanner.”
SABCS: The Race Heats Up
Healthcare reforms are coming, to be sure; but just how elegant or crude the reforms will be may depend largely on the body of the reformers. “The oncology community would do itself a favor by taking this issue seriously instead of constantly excepting the idea that anything that works at any price has to be good,” said Hal Burstein, MD, PhD, Dana-Farber Cancer Institute, Boston, MA. His comments came after the SABCS presentation of promising data for a combination treatment of Herceptin (trastuzumab) and Tykerb (lapatinib) in the setting of metastatic breast cancer (Abst. #61)—a regimen that will run a minimum of $15,000 a month, for a payoff of just over four months of increased survival.
Burstein is also concerned with the very language used in the reporting. He responded to the headline-reporting of data for the so-called PARP inhibitor, BSI-201. “The Times said, ‘drug improves survival’, which is true, it improves by two months, meaning, May vs March.” But some patients misunderstood the language, thinking they now had a shot at an actual cure, which could easily drive demand for something that is only minimally effective.
Also reported at SABCS were results from Avastin’s AVADO and RIBBON trials, where success was measured, as with Folotyn, as gains in progression-free survival. Matthew Ellis, MB, PhD, Director of the Breast Health Program, Washington University and Barnes-Jewish Hospital at St. Louis, MO, said “we need to be careful about approving drugs that don’t improve survival, yet cost $50k to $60k a year.”
Gabriel Hortobagyi, MD, Director of the Breast Cancer Research Program at the M.D. Anderson Cancer Center, Houston, TX, concurs: “Multiply [that] by the number of breast cancer patients out there, and pretty soon we’re talking about real money.” And money begets money. Profits are put back into research that hopefully will lead to more drugs, and more profit. But therein lies part of the problem. “In oncology,” said Hortobagyi, “we do a huge amount of research on drugs, and very little research in biomarkers,” the biological signals that could tell you if the drug is working, or, before the drug is even given, if it even has a chance of working. He also said that “to do healthcare reform right, competitive efficiency [of treatments] has to be provided with a reasonable funding mechanism.”
As the clinicians wait for these assays to determine who might actually benefit from a given drug, the philosophical task of defining benefit must be addressed. “That is the debate to be had by everyone,” asserts Mothaffar Rimawi, MD, Baylor College of Medicine, Houston, TX. The community of physicians needs to comment on it, and the community of patients and patient advocates also need to comment on it. “What is the dollar value we put on a month gained, or the quality of a life briefly improved? This is a very sensitive discussion. Is your position that of having a loved one who is a patient, or are you a policy maker who has a limited number of dollars to stretch?”
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