Rationed or Rational: The Future of Cancer Medicine

Disturbing news from Britain’s Health Service on Monday, January 12, described the National Health Services’ decision to “delist” 25 of the nation’s 84 currently available chemotherapy drugs from their formulary. Citing the rising cost of cancer therapy Professor Peter Clark, chair of the Cancer Drug Fund said that the CDF, originally established in 2011, had already exceeded its annual budget. From ₤280 million in 2014 the costs for 2015 are projected to rise to ₤340 million. In defense of the policy Dr. Clark said the delisted drugs “did not offer sufficient clinical benefit.”

avastinAn examination of the delisted drug should raise concern for medical oncologists. Among those delisted are Bevacizumab (Avastin) for colorectal cancer, Eribulin (Haloven) and Lapatinib (Tykerb) for breast cancer and Pemetrexed (Alimta) for advanced lung cancer. Additionalhalaven deletions include Bendamustine (Treanda) for some non-Hodgkin’s lymphoma, Bortezomib (Velcade) for relapsed mantle cell lymphoma and Waldenström’s macroglobulinemia. Bortezomib will also be limitedvelcade_MP_thumb in some cases of myeloma, while Cetuximab will be unavailable as second or third line treatment in colorectal cancer. For American oncologists these agents have become standards of care.

Many physicians in England are outraged. Mark Flannagan, executive chief of the Beating Bowel Cancer Fund described this as “bad news for bowel cancer patients” suggesting that 65% of patients with advanced colorectal cancers will confront the risk of an earlier death. Despite these draconian measures physicians may still have the opportunity to request delisted drugs under what is described as “exceptional cases.”

The breadth and scope of the drug restrictions are surprising. After all, Pemetrexed is one of the most widely used treatments for advanced lung cancer, Bevacizumab has become an established part of colorectal cancer management and Eribulin is a favored salvage regimen in recurrent breast. The withdrawal of Bortezomib, an active agent in mantle cell, Waldenström’s and myeloma, will not be suffered lightly by patients in need.

Are the problems confronting the UK an early harbinger of the same for the American medical system?

With aging populations in western societies and increasingly sophisticated medical technologies, the cost of medical care, particularly cancer care may soon become unmanageable. UK’s centralized medical care delivery through the National Health Service, a single payer system, was designed to save money. Despite its high-minded intentions, the NHS appears to be failing. While spending more money each year the dissatisfaction with medical delivery only grows. A nearly 12% increase in health care per person expenditures in England between 2009 and 2013 (₤1712 to ₤1912) was met with an 18% increase in patient complaints.

Among the problems are progressive layers of middle management that add cost without providing care.  Physicians find it more difficult to do their jobs while people inexpert in the delivery of medical care have been given decision-making power. As the English population has come to look upon health care as a right, some overuse medical services, even ER’s, for non-serious conditions. Reformers have suggested the solution may lie in charging fees for appointments or requiring an annual membership fee. In today’s political milieu however, few elected officials are likely to relish policies that end “free health care” in England.

What might solve this dilemma for medical oncology? An obvious solution is to apply resources where they are most likely to benefit patients, e.g. personalized care. While this seemed a pipe dream 20 years ago when we first introduced the concept, a growing chorus of scientists now embraces the idea. With their focus almost exclusively on genomics this new cadre of clinical investigators describe a future where each patient gets exactly the right treatment.

We applaud this thinking and fully agree. However, we must be prepared to use all platforms to achieve this worthy goal. To fill the current void phenotypic analyses offer substantive benefits. By capturing cancer biology at a functional level, these studies identify true “driver mutations,” and have the capacity to examine synergy and sequence-dependence, both beyond the scope of genomic analyses.

As human tumor primary culture analyses (such as EVA-PCD) have already been shown to double objective response rates and improve one-year survival, it is time for government officials and policymakers to re-examine the benefits of drug selection technologies that are available today.

Will the future of cancer medicine in the UK and the US be rationed under the duress of rising costs, or rational, through the application of available technologies capable of making intelligent cost- and life-saving decisions? That remains to be seen.

About Dr. Robert A. Nagourney
Dr. Nagourney received his undergraduate degree in chemistry from Boston University and his doctor of medicine at McGill University in Montreal, where he was a University Scholar. After a residency in internal medicine at the University of California, Irvine, he went on to complete fellowship training in medical oncology at Georgetown University, as well as in hematology at the Scripps Institute in La Jolla. During his fellowship at Georgetown University, Dr. Nagourney confronted aggressive malignancies for which the standard therapies remained mostly ineffective. No matter what he did, all of his patients died. While he found this “standard of care” to be unacceptable, it inspired him to return to the laboratory where he eventually developed “personalized cancer therapy.” In 1986, Dr. Nagourney, along with colleague Larry Weisenthal, MD, PhD, received a Phase I grant from a federally funded program and launched Oncotech, Inc. They began conducting experiments to prove that human tumors resistant to chemotherapeutics could be re-sensitized by pre-incubation with calcium channel blockers, glutathione depletors and protein kinase C inhibitors. The original research was a success. Oncotech grew with financial backing from investors who ultimately changed the direction of the company’s research. The changes proved untenable to Dr. Nagourney and in 1991, he left the company he co-founded. He then returned to the laboratory, and developed the Ex-vivo Analysis - Programmed Cell Death ® (EVA-PCD) test to identify the treatments that would induce programmed cell death, or “apoptosis.” He soon took a position as Director of Experimental Therapeutics at the Cancer Institute of Long Beach Memorial Medical Center. His primary research project during this time was chronic lymphocytic leukemia. He remained in this position until the basic research program funding was cut, at which time he founded Rational Therapeutics in 1995. It is here where the EVA-PCD test is used to identity the drug, combinations of drugs or targeted therapies that will kill a patient's tumor - thus providing patients with truly personalized cancer treatment plans. With the desire to change how cancer care is delivered, he became Medical Director of the Todd Cancer Institute at Long Beach Memorial in 2003. In 2008, he returned to Rational Therapeutics full time to rededicate his time and expertise to expand the research opportunities available through the laboratory. He is a frequently invited lecturer for numerous professional organizations and universities, and has served as a reviewer and on the editorial boards of several journals including Clinical Cancer Research, British Journal of Cancer, Gynecologic Oncology, Cancer Research and the Journal of Medicinal Food.

3 Responses to Rationed or Rational: The Future of Cancer Medicine

  1. Shaker Farhat, MSc, PhD(c) says:

    Why are cancer drugs so obscenely expensive, that “in 2012, 12 of the 13 new drugs approved for cancer indications were priced above $ 100,000 per year of therapy”? A recent analysis proposes some tangible solutions:
    http://jop.ascopubs.org/content/early/2014/05/06/JOP.2013.001351.full.pdf+html

    • There are many reasons for high drug prices in the US oncology market. The article referenced describes several. The authors note Joseph Stiglitz. I believe that the fundamental problem is a lack of market forces. As we have separated the consumer from the producer, by interposing layers of bureaucracy, regulation and managed care, the decision to purchase a drug for given a purpose at given price has been removed from the patient and put into the hands of disinterested third parties. In keeping with Stiglitz’s principles these are externalities that fundamentally reshape the supply and demand curve. However, contrary to Stiglitz, the market does exist and does work, if it is allowed to do so.

      No drug company could possibly hope to sell a drug to the consumer at $12,000/ month and expect more than a handful of people to step up to the check out line. Instead they use the “externalities” of clinical trial Phase II & III data and FDA approval to literally force disinterested third parties to pay these fees. Since there is no “market” to drive the price down, the only respite for the payers is to deny coverage and ration care. Everyone makes decisions with their own money that reflect their personal choice to allocate resources toward one expense over another. Food, transportation, clothing, homes all reflect our allocation choices. Medical care, despite protestations to the contrary, is also driven by choice.

      We have foolishly abdicated the most important choices of all, those that influence our health, to (dare I say) disinterested third parties. The overcharges, shortages and rationing that then occur all reflect our unwillingness to allow the invisible hand to define the “just price”. It is regrettable that we seemed to have forgotten a lesson first taught to us in 1776 by Adam Smith.

  2. hphblog1 says:

    Reblogged this on Hope Practiced Here and commented:
    Disturbing news from Britain’s Health Service on Monday, January 12, described the National Health Services’ decision to “delist” 25 of the nation’s 84 currently available chemotherapy drugs from their formulary. Citing the rising cost of cancer therapy Professor Peter Clark, chair of the Cancer Drug Fund said that the CDF, originally established in 2011, had already exceeded its annual budget.

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