In a business like this where the risks are profound, you fail far, far, far many more times than you succeed. You have to look at the total economic costs associated with finding those winners.
—Newton F. Crenshaw
That the United States spends twice as much on health care than other industrialized countries—about $2.8 trillion in 2012—without reaping appreciably better outcomes1 is not news. The topic has been dissected on the front pages of leading newspapers for years and was the subject of the entire feature section of an issue of Time2 magazine in March. What is different about the debate making news now is the number of oncologists speaking out against the high cost of cancer drugs and its impact on patient care.
Last October, three physicians from Memorial Sloan-Kettering Cancer Center in New York—Peter B. Bach, MD, Director of the Center for Health Policy and Outcomes; Leonard B. Saltz, MD, Chief, Gastrointestinal Oncology Service and Chairman of the Pharmacy and Therapeutics Committee; and Robert E. Wittes, MD, former Physician-in-Chief—led the way with an Op-Ed piece in The New York Times.3 They wrote the editorial to explain their decision not to give ziv-afilbercept (Zaltrap), a new “phenomenally expensive” cancer drug, to their patients with advanced colorectal cancer. They noted that the new agent provided no advantage over bevacizumab (Avastin), which works through a similar molecular mechanism but costs about $5,000 a month—less than half of the $11,063 per month price of ziv-afilbercept. (A month after the Op-Ed appeared, Sanofi Aventis, maker of ziv-afilbercept, reduced the drug’s price by 50% for patients with previously treated colorectal cancer.)
They were taking this stand, explained the physicians, because “ignoring the cost of care is no longer tenable. Soaring spending has presented the medical community with a new obligation. When choosing treatments for a patient, we have to consider the financial strains they may cause alongside the benefits they might deliver.”
The sharp rise in the price of cancer therapies, the authors argued, means that much of the burden to pay for these expensive drugs falls to patients through higher health insurance and Medicare copayments, often driving them into bankruptcy. (A recent study4 by researchers at the Fred Hutchinson Cancer Research Center in Seattle found that, in Washington State, people with cancer were twice as likely to file for bankruptcy as people without cancer. Cancer took the greatest financial toll on younger patients who had two- to fivefold higher bankruptcy rates compared to older patients.)
Taking an Active Role
The Memorial Sloan-Kettering physicians are not the only ones now taking an active role in protesting high drug prices. In April, a group of 120 experts in chronic myeloid leukemia (CML) from around the world banded together to draw attention to the rising cost of cancer drugs, especially tyrosine kinase inhibitors for the treatment of CML. In an article in Blood,5 the authors argued that it was important to lower the prices of cancer drugs so more patients could afford them and to maintain “sound long-term health care policies.”
According to Hagop M. Kantarjian, MD, Department Chair and Professor in the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, Houston, and the corresponding author of the Blood editorial, the impetus for the article came from the realization that two of the three drugs approved by the U.S. Food and Drug Administration (FDA) last year in the treatment of CML—bosutinib (Bosulif) and ponatinib (Iclusig)—came with an eye-popping price tag of over $100,000 per year. The third drug, omacetaxine (Synribo), costs $28,000 for induction and $14,000 per maintenance course, according to the Blood article.
“We were lucky in 2012 to have FDA approval of three CML drugs,” said Dr. Kantarjian. “But when I started looking into the price of these drugs, I noticed that of the 12 cancer drugs approved that year, 11 were priced above $100,000 per year,” he noted.
“Then I looked at the price of imatinib (Gleevec), a drug I use on a daily basis,” he continued. “When imatinib was approved in 2001, it cost between $25,000 and $30,000 a year. Now, it has gone up to $92,000 a year. If you consider that imatinib’s original price included the cost of development and profits to the company, there was no reason to increase the price except that it was something Novartis, the drug’s manufacturer, could do with impunity.” According to Dr. Kantarjian, the cost of a typical cancer drug has doubled over the past decade, from around $5,000 per month to over $10,000 in 2010.
“And when you look at cost benefit in terms of prolonging life or improving quality of care or reducing toxicities, there is almost no correlation between the benefit and the price of the drug,” he added.
Cost vs Benefit
Newton F. Crenshaw, Vice President of Lilly Oncology, agrees that while drug prices at times do not correlate with long-term benefit, drug breakthroughs happen in a step-by-step process.
“If people are saying that the value of a drug should be based solely on how long it improves overall survival, that really ignores the history of drug innovation, which is often incremental and punctuated by an occasional breakthrough. And we need to reward all of those steps,” said Mr. Crenshaw. “Two decades ago, the overall survival for metastatic lung or colon cancer was a matter of months. Today, people with those diseases are living as much as 2 years longer. It’s not a cure, but having that much more time matters to patients.”
Perhaps the biggest area of contention between the cancer experts who penned the Blood article and the pharmaceutical industry is how much it actually costs to bring a new drug to market. The figure often cited by drug manufacturers is about $1.3 billion, which is based on analysis by the Tufts Center for the Study of Drug Development. Mr. Crenshaw agrees that that figure is accurate.
“In a business like this where the risks are profound, you fail far, far, far many more times than you succeed. You have to look at the total economic costs associated with finding those winners,” said Mr. Crenshaw. However, other studies6 put the cost of developing a new drug at between $60 and $90 million.
Publicity from the article in Blood is not just stirring debate among oncology specialists and drug manufacturers over the reasons for the increase in cancer therapy costs, but spiraling drug prices have also caught the attention of Congressman Stephen F. Lynch (D-MA), a senior member of the House Oversight and Government Reform Committee, who is calling for an oversight hearing to look into the “exorbitant cost of cancer drugs.”
What everyone does agree on is that health-care costs in the United States are unsustainable at their current rate.
“ASCO’s viewpoint is that all parties—medical societies, government agencies, pharmaceutical companies, insurance companies, patient groups, and health-care policymakers—need to make a serious commitment to address this problem together,” said Clifford Hudis, MD, President of ASCO and Chief, Breast Cancer Medicine Service at Memorial Sloan-Kettering. “What we don’t want to do is remove the motivation for developing new therapies.”
To confront the rising cost of cancer care and its impact on patients, ASCO established a Value of Cancer Care task force, which issued a Guidance Statement on the Cost of Cancer Care7 in 2009. The Guidance Statement offered several recommendations, including that physicians discuss with patients the cost of care and the development of patient education materials on the high cost of cancer care to help guide their decision-making regarding treatment options (visit www.cancer.net/all-about-cancer/managing-cost-cancer-care).
In the spring of 2012, as part of the American Board of Internal Medicine’s Choosing Wisely initiative, ASCO announced its list of the Top Five common costly tests, procedures, and treatments that are not supported by evidence to have a meaningful clinical benefit. The list includes the use of chemotherapy for patients with advanced cancers who are unlikely to benefit, costly imaging technologies for staging or early breast and prostate cancers, routine blood tests for biomarkers and advanced imaging tests for the detection of breast cancer recurrence, and overuse of drugs to stimulate white blood cell production in patients receiving chemotherapy.
“What I have observed so far in my area of practice is that Choosing Wisely has allowed many, many oncologists to do what they know is right—for example, to not do screening blood tests for metastatic breast cancer,” said Dr. Hudis. “That may sound like a small thing on an individual patient level, but it is the kind of thing that can add up to a lot of savings.”
In the fall, ASCO will announce the next Top Five list of high-cost procedures and treatments with limited clinical benefit and will publish details of its evidence-based recommendations.
Starting a Dialogue
While the full impact of the new stand against high drug prices some oncologists are taking is unknown, Dr. Kantarjian and Mr. Crenshaw agree that a meeting of the key stakeholders to discuss the issue and develop solutions is vital. “We are working to reach out to Dr. Kantarjian and his colleagues because we think dialogue is important,” said Mr. Crenshaw. He added that several groups of stakeholders, including pharmaceutical companies and Dr. Kantarjian, are working on plans to hold a “summit” to discuss the economics of cancer research, possibly this fall.
“Keeping patients front and center in this discussion is really
ASCO’s job,” said Dr. Hudis. “We have to figure out some way to continue and even accelerate the pace of drug discovery and development while at the same time determining how to get those advances to the broadest array of people. And we do have to incentivize real breakthroughs, not just the smaller incremental advances that sometimes are all we get.” ■
Disclosure: Drs. Kantjarian and Hudis reported no potential conflicts of interest. Mr. Crenshaw is Vice President of Lilly Oncology.
1. Squires DA: Explaining high health care spending in the United States: An international comparison of supply, utilization, prices, and quality. Issues in International Health Policy, May 2012. Available at www.commonwealthfund.org. Accessed June 25, 2013.
2. Brill S: Why medical bills are killing us. Time, March 4, 2013.
3. Bach PB, Saltz LB, Wittes RE: In cancer care, cost matters, New York Times, October 14, 2012.
4. Ramsey S, Blough D, Kirchhoff A, et al: Washington State cancer patients found to be at greater risk for bankruptcy than people without a cancer diagnosis. Health Aff (Millwood). May 15, 2013 (early release online).
5. Experts in Chronic Myeloid Leukemia: The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: From the perspective of a large group of CML experts. Blood 121:4439-4442, 2013.
6. Light DW, Lexchin JR: Pharmaceutical research and development: What do we get for all that money? BMJ 345:e4348, 2012.
7. Meropol NJ, Schrag D, Smith TJ, et al: American Society of Clinical Oncology guidance statement: The cost of cancer care. J Clin Oncol 27:3868-3874, 2009.