By John Leifer –Contributing editor
Providers of cancer treatment and therapeutics have learned to carefully hone their rhetoric so that it conveys a socially appropriate sense of altruism. Yet, beneath this thin veneer exists a motivation every bit as powerful as saving lives ? reaping billions of dollars in profit. That?s what?s at stake in the ongoing war on cancer? a war in which some important battles have been won, but at a tremendous cost.[1]
As the number of cancer patients grows and their treatments become increasingly expensive, we may find ourselves locked in an unwinnable war of attrition?unless reining in costs becomes as much of a priority as expanding our medical armamentarium.
…the global market for oncology drugs, including those used in supportive care, reached $91 billion in 2013?this compares with $71 billion in 2008 and $37 billion a decade ago… cancer therapies account for more than 30% of all preclinical and phase I clinical development products…
How the battlefield changed
Despite the fact that cancer incidence rates have declined for the most frequently occurring types of the disease, cancer continues to impact 40% of all Americans, and it is responsible for nearly 25% of all deaths.[2] That translates into 1.66 million newly diagnosed patients annually and nearly 600,000 deaths, according to the American Cancer Society.[3] Incidence tells only part of the story, however. More importantly, the majority of cancer patients are surviving longer.
There are currently more than 14 million Americans who have survived cancer?a dramatic increase from the 3 million survivors in 1971.[4] While much of this increase is attributable to population growth, improvements in cancer therapies have also played an essential role. As a result, for many patients, cancer has been transformed from a death sentence into a chronic disease that by definition, cannot be cured, but can be controlled for an extended period of time.
The soaring costs of care
Fifty years ago, direct spending on cancer care equaled $1.3 billion.[5] By 1995, spending had soared to $41.2 billion , and by 2010, it was an estimated $125 billion.[7] That?s an almost 10,000 percent increase in direct spending over fifty years. Add in the indirect costs of care, such as lost productivity, and the numbers almost triple.
Cancer care was not the only part of the nation?s health care bill that rose dramatically over time. In 1950, total health care costs for the U.S. equaled $12.7 billion.[8] By 2012, those costs had risen to $2.6 trillion [9] ? a 20,000 percent increase in the span of three generations.
Such costs have exacted a high price. Today, the single greatest cause of personal bankruptcy in America is medical bills. In fact, according to Mustaqeem Siddiqui, M.D. and S. Vincent Rajkumar, M.D., writing in Mayo Proceedings, ?The percentage of personal bankruptcies in the United States attributed to health care costs rose from 46.2% in 2001 to 69.1% in 2007.? [10] Such statistics come as no surprise, since patients are bearing an increasing proportion of the cost burden associated with expensive treatments. Medicare beneficiaries, who are often on a limited, fixed income are particularly hard hit.
What Lies Ahead
The estimated cost burden for the coming decades is fuzzy at best. The NIH guesstimates that the direct costs of cancer care could range anywhere from $158 billion to $207 billion.[11] A number of factors are contributing not only to cost escalation, but also to the complexity of forecasting.
We know that the projected level of growth in the 65+ segment of our population?which is the segment most affected by cancer?will result in a virtual tsunami of cancer patients. What we don?t know is how these patients will be treated, or the costs of emerging therapeutic modalities.
Furthermore, with the number of cancer survivors forecast to grow to 19 million by 2024, there will presumably be a dramatic increase in the long-term costs of controlling their disease and maintaining their well-being.
History demonstrates that the cost of cancer does not increase linearly, but rather in a manner reminiscent of Moore?s law * ? a factor that proves beneficial when describing the growing power of computers, but not the growing costs of care. Nowhere is this more apparent than in the skyrocketing costs of drug therapies.
A Pharmaceutical Gold Rush
The pharmaceutical industry has doubled-down on its investment in cancer therapeutics?a wise move, considering the increased market demand reported by industry monitor, IMS: ?The global market for oncology drugs, including those used in supportive care, reached $91 billion in 2013?this compares with $71 billion in 2008 and $37 billion a decade ago.? [12]
With demand soaring and sales burgeoning, much of pharmaceutical research now centers on beating cancer. IMS concluded, ?cancer therapies account for more than 30% of all preclinical and phase I clinical development products??[13]
It?s not just demand that is driving the soaring sales of cancer drug. It?s the manner in which drugs are priced. In the U.S., which accounts for 40% of all cancer drug sales, there are no governing rules regarding pricing, beyond what the market will bear. While most consumer products are priced based upon comparative value, the price of cancer therapeutics appears to be plucked from the ether with no relationship to the drug?s relative efficacy or toxicity.
According to an article in the Journal of Clinical Oncology, ?Of the 12 anticancer drugs approved by the FDA in 2012, only three prolonged survival, two of them by less than 2 months?yet nine were priced at more than $10,000 per month.? [14] One drug, approved for the treatment of pancreatic cancer, was shown to extend survival by a mere 10 days.
According to an article published by the Mayo Clinic, ?Last year, ipilimumab (Yervoy? Bristol-Myers Squibb, New York, NY) was approved by the United States Food and Drug Administration(FDA) for the treatment of metastatic melanoma. The benefit in survival over and above standard treatment was 3.7 months in previously treated patients and 2.1 months in previously untreated patients. The cost: $120,000 for 4 doses.? [15]
It appears that $100,000 per year has been set as the minimum threshold for introducing new cancer therapies. But it is not just the introductory pricing of drugs that is problematic. It is also the price inflation of cancer drugs that is raising costs astronomically. The price of imatinib (Gleevec; Novartis), a drug used to treat CML (chronic myeloid leukemia) increased from $30,000 to approximately $90,000 over a ten-year period.
Lies, Damn Lies, and Statistics
The pharmaceutical industry justifies what appears to be morally egregious behavior by explaining that drug costs are primarily driven by research costs. In fact, stating that the cost of bringing a drug to market now exceeds $1 billion has become almost a mantra?but it is patently invalid. [16]
Pharma?s argument regarding the tremendous costs of research was effectively eviscerated in a November 15, 2013 article in the prestigious journal Cancer.[17] Authors Donald Light, Ph.D., and Hagop Kantarjian, M.D., demonstrated that the actual cost probably approaches $125 m
illion or one-eighth of what has been claimed.
While not seeking to venerate pharmaceutical pricing models, authors Siddiqui and Rajkumar do point out factors that contribute to the escalating costs of drug therapy in cancer, including:
- The laborious and time-consuming process of completing all phases of testing required to receive approval of a new drug.
- Over the course of their disease, patients may be the recipients of multiple drugs ? for, as one drug fails, another drug may be substituted in the quest for an efficacious agent.
- When a new drug is approved and can claim enhanced efficacy or lower toxicity, it may be quickly embraced as the ?best? solution to a patient?s condition.
- In the life or death challenge of seeking to overcome cancer, the importance of costs seems to pale in the eyes of both patients and providers. [18]
You Don?t Have to Sell Drugs to Profit from Cancer
It?s not just the pharmaceutical industry that is profiting from this gold rush. Cash-strapped hospitals and health systems are lining up to ensure that cancer provides a rosy bottom line for their institutions.
Not only are facilities expanding the depth and breadth of cancer services offered, but they are now employing oncologists at an unprecedented rate. Such employment accomplishes multiple objectives:
- It locks in the physicians who control patient flow in the market, thus locking in market share;
- it allows the hospitals to increase the costs of the oncologists? services by billing them as hospital outpatient services;
- it allows hospitals to capture all the procedural revenue?imaging, radiation, and surgery?associated with these patients;
- it allows hospitals to increase profits on the resale of cancer drugs using what is known as 340b pricing. **
Numerous other parties stand to profit handsomely from the growth of cancer?including, but not limited to health information technology companies that seek to capitalize on the tremendous data-demands associated with cancer research, medical technology vendors, and even manufacturers of prosthetics.
Re-establishing equilibrium between Patients and Profits
Until payers realign incentives so that providers are rewarded based upon achieving the most efficient and effective patient outcomes over time, there will be an imbalance between the needs of patients and the pull of profits.
There are specific steps that can be taken today to achieve these objectives, including:
- Physicians must act as fiduciaries for their patients? health and well-being. As such, they must demand comparative effectiveness data that show the relative value of a cancer drug. Physicians can drive change simply through their prescribing patterns, and they must wield this power appropriately on behalf of their patients. This principle was proven effective when a group of oncologists at Memorial Sloan Kettering refused to prescribe the drug aflibercept [Zaltrap, Sanofi] because it was twice as expensive as an alternative drug yet no more effective. The manufacturer bowed to the pressure and cut the price of Zaltrap by 50 percent.
- The FDA can aid these efforts to move from ?what the market will bear? pricing to value-based pricing by establishing minimal thresholds for comparative efficacy while also factoring in the comparative toxicity of drugs under consideration.
- There must be clear and unequivocal prohibitions on any conflicts of interest that allow physicians to profit, beyond their professional fees, for the provision of cancer therapeutics?be it a chemo agent, radiation treatments, or other modalities.
- The Department of Justice must bring greater scrutiny to the acquisition of major oncology groups or other actions that may result in the creation of monopolies or oligopolies in cancer care.
- Congress must reconsider the prohibitions on governmental agencies, such as Center for Medicare and Medicaid Services (CMS), from negotiating prices with pharmaceutical manufacturers.
As a society, we must struggle through discussions of what we are willing to expend in order to extend life, while factoring in the patients? probable quality of life. Other countries, including the UK, have spent years seeking to answer difficult questions regarding the appropriate level of resources that should be deployed in efforts to save or extend a patient?s life. Since resources are, at some point, finite, the necessity of such discussions is supported on prima facie evidence. Even so, efforts to address similar issues in the United States have resulted in outrage. Panels designed to investigate such issues were derisively labelled as ?death panels.? Discussions of ?death panels? must yield to rational, albeit difficult conversations.
The Time to Act is Now
Health care providers and vendors have proven that they are incapable of being self-regulating. They have also proven that they are subject to the same moral vices as the rest of society, including greed-based pricing schemas that dramatically enhance corporate profitability, while pushing desperately needed medications beyond the reach of many patients.
While it may take decades for a new model of care delivery to evolve in the U.S. ? one that rewards efficient, longitudinal care management and dis-incents the provision of ever more expensive interventions, there needs to be immediate action to stop the profiteering off the backs of cancer patients.
Notes
* Moore’s Law refers to an observation made by Intel co-founder Gordon Moore in 1965. He noticed that the number of transistors per square inch on integrated circuits (IC) or microchip had doubled every year since their invention and that this trend would likely continue into the future. Moore?s prediction began to be frequently cited and in time,it became known as Moore’s Law. In later years, the law was modified as the pace of change slowed down a bit. Today, the definition has changed to reflect that the doubling of the number of transistors per square inch on microchips occurs every 18 months.[More info]
** The 340B Drug Pricing Program requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices. [More info]
References
[1] National Cancer Institute Seer Training Module Cancer Facts & The War on Cancer [Link]
[2] American Cancer Society. Cancer Facts & Figures 2015, [Link]
[3] Idem, 1-2
[4] Idem, 1
[5] Paulson S. The Business of Cancer Care,Texas Medicine 106, no. 9 (2010): 23.
[6] Ibid, 23
[7] K. Robin Yabroff,Jennifer Lund,Deanna Kepka,andAngela Mariotto, Economic Burden of Cancer in the US: Estimates, Projections, and Future Research, Cancer Epidemiology Biomarkers, no. 10 (2011): 3
[8] John Leifer. The Myths of Modern Medicine: The Alarming Truth About American Health Care. (Lanham, MD: Littlefield Publishers 2014: 7
[9] Ibid. 7.
[10] Mustaqeem Siddiqui and S. Vincent Rajkumar, The High Cost of Cancer Drugs and What We Can Do About It. Mayo Clinical Proceedings 87, no. 10 (October 2012): 935.
[11] Angela B. Mariotto, K. Robin Yabroff,Yong
wu Shao,Eric J. Feuer, andMartin L. Brown, Projections of the Cost of Cancer Care in the United States: 2010-2020 Journal of the National Cancer Institute (Advance Access January 12, 2011) 6.
[12] IMS Institute for Healthcare Informatics, IMS Health Study: Cancer Drug Innovation Surges as Cost Growth Moderates [Link]
[13] Ibid.
[14] Hagop M. Kantarjian,Tito Fojo,Michael Mathisen,andLeonard A. Zwelling, ?Cancer Drugs in the United States: Justum Pretium ? The Just Price, Journal of Clinical Oncology 31 , no. 28 October 1, 2013, 3600
[15] Siddiqui and Rajkumar, The High Costs of Cancer Drugs 935.
[16] Donald W. Light and Hagop Kantar. Market Spiral Pricing of Cancer Drugs. Cancer November 14, 2013, 3900.
[17] Ibid.
[18] Siddiqui and Rajkumar; The High Costs of Cancer Drugs
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