In a bold move to shed light on the ramifications of the ever-increasing cost of cancer drugs for patients with cancer and for the health-care system, 118 prominent oncologists came together to write a commentary in Mayo Clinic Proceedings detailing their concerns.1 To learn more about these proposals and the reaction from the oncology community to the commentary, The ASCO Post recently talked with S. Vincent Rajkumar, MD, one of the coauthors of the article. Dr. Rajkumar is Edward W. and Betty Knight Scripps Professor of Medicine in the Department of Hematology at the Mayo Clinic in Rochester, Minnesota.
In the article, the oncologists call for support of a grassroots effort to focus attention on the problem and detail solutions to mitigate the issue of the rapid rise of oncology drug prices.
“There is no relief in sight because drug companies keep challenging the market with even higher prices,” wrote the oncologists. “This raises the question of whether current pricing of cancer drugs is based on reasonable expectation of return on investment or whether it is based on what prices the market can bear.”
According to the article, over the past 15 years, the average price of cancer drugs in the United States has increased 5- to 10-fold, reaching more than $100,000 per year in 2012. The combination of escalating drug prices and requirements by insurance companies for patients to share more and more of those costs is resulting in about 10% to 20% of patients with cancer not taking the prescribed treatment or compromising it, wrote the oncologists. To stem the rise in drug prices, the oncologists proffered this seven-step plan:
Create a review mechanism—activated after U.S. Food and Drug Administration (FDA) drug approval—to propose a fair price for new treatments based on the value to patients and health care.
- Allow Medicare to negotiate drug prices.
- Allow the Patient-Centered Outcomes Research Institute to evaluate the benefits of new treatments; enable similar organizations to include drug prices in their assessments of the treatment value.
- Allow importation of cancer drugs across borders for personal use.
- Pass legislation to prevent drug companies from delaying access to generic drugs.
- Reform the patent system to make it more difficult to prolong product exclusivity unnecessarily.
Encourage organizations that represent cancer specialists and patients, such as ASCO, the American Society of Hematology (ASH), American Association for Cancer Research (AACR), American Cancer Society (ACS), and National Comprehensive Cancer Network (NCCN), to consider the overall value of drugs and treatments in formulating treatment guidelines. (See “ASCO Releases Details of Its Conceptual Framework for Assessing Value in Cancer Care” in the June 25, 2015, issue of The ASCO Post.)
Origins of the Commentary
How did the group of 118 oncologists come together to develop the seven-step plan advocated for improving the situation caused by the high cost of cancer drugs?
The background of how this article developed is that many of us have been working separately on this issue and arguing for change for a long time. I wrote a paper about the high cost of cancer drugs in 2012,2 and Hagop Kantarjian, MD [Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center], and other experts in chronic myeloid leukemia wrote about the unsustainable prices of cancer drugs in 2013,3 but we had limited impact.
When I first started pursuing this issue, I wasn’t very hopeful that we would get too many experts to sign on because there really is no personal benefit for us and we could be putting ourselves at risk with the drug companies we are criticizing. We depend on these companies for access to their drugs for clinical studies and support for research as well as for consulting and speaking opportunities.
Of course, the authors of this paper are unique. They are not just a collection of experts in oncology, but, in my opinion, they are the very best experts and true giants in the field. I am simply honored to be part of this group.
Seven Solutions
How did you arrive at the seven solutions for reducing drug costs proposed in your article?
They reflect a process of studying the problem, asking questions, and determining steps that we think would be effective. The fact that most of us are involved in clinical trials and know what it takes to bring a drug to market helped. We understand the costs involved; we know how many dollars it takes to develop a drug, the clinical trials needed to approve a drug, and how indications of the approved drug expand over time.
We take care of patients, so we know the financial consequences of these high-priced drugs. For some well-insured patients with low prescription drug copays, the personal financial burden of cancer is not great. But most patients can’t afford the high copays on drugs that cost tens of thousands of dollars and aren’t a cure for their cancer.
We considered all these issues and thought about solutions, and many of us arrived at the same list of solutions, which are all commonsense steps. For example, consider the recommendation to allow Medicare to negotiate drug prices. Here you have a situation where the largest buyer of the most expensive drugs on the market can’t negotiate with a pharmaceutical company on the price of a drug—and most importantly, on drugs that only work for a few weeks—and can’t ask the question, “Why are you charging $100,000 or $200,000 for this drug?”
We are all full-time researchers in our respective specialties. My research is in multiple myeloma. We are not economists or politicians, but we know why drug prices are so high, and we know what needs to be done to have a real impact in lowering prices, such as making it a free-market situation where the buyer and the seller can negotiate price.
Impact of Targeted Therapies
Will molecularly designed clinical trials, which may enable more drugs to be winners in the treatment of cancers with specific mutations, help reduce the cost of drug research and development and, therefore, reduce the market price of a new drug?
Absolutely not; they will have the opposite effect, because pricing will depend on what competing companies are charging for their drugs and the size of the patient population utilizing the drug. One example is panobinostat (Farydak) in the treatment of multiple myeloma. The FDA approved the drug earlier this year, but it offers no significant improvement in overall survival or patient-reported quality-of-life outcomes—yet each pill costs more than $1,000.
If targeted therapies are approved without price controls, they will be priced very, very high because there will be few patients with that specific target, and the patent on such drugs will last for many years. On the other hand, everything changes if such a drug is curative.
Imported Drugs
One of your solutions is to allow the importation of cancer drugs across borders. What are the safety implications of doing that, and who would be the watchdog to ensure the drugs are not counterfeit?
If you are instituting this kind of program as public policy, you need to have safeguards. We are not proposing that the FDA buy cheaper drugs from other countries and sell them here. We are saying that if private citizens want to take on the responsibility of assessing the risks and benefits of buying cancer drugs from other countries, they should be allowed.
You always have to look at what the alternative might be if patients are forced to go without treatment because they can’t afford it and die of their disease. Pharmaceutical companies say they have patient assistance programs to help people afford treatment, but you have to be really poor and have limited personal assets to qualify for those programs.
Early Response to Proposal
What has been the reaction to your proposal from the oncology community, including patient groups and the pharmaceutical and insurance industries?
The response so far has been mostly very positive. We did have some pushback from some oncology and pharmaceutical groups who point out that the cost of cancer drugs make up only 9% of Medicare’s budget and claim that negotiating drug prices won’t make a big difference in our overall health-care spending or fix all the inefficiencies in the health-care system.
We agree that there are many reasons our health-care costs are so exorbitant, but that doesn’t mean we should do nothing. Let’s fix one problem at a time. For example, let Medicare negotiate drug prices with the pharmaceutical companies.
We are highlighting one issue that we think is a major concern and that is unjust. Our primary allegiance is to the patients we treat and to our research, so we can find new treatments and improve patient outcomes. It would not be wise for us to take our eyes off the work we need to do. It is the responsibility of those involved in legislating public policy to address the other inefficiencies in the health-care system.
We do have to ask ourselves, why are we in the oncology community supporting these marginally effective, high-priced drugs? If we ignored them, perhaps the prices would drop. I don’t propose to have the magic bullet solution, but at least our proposal starts a dialogue to address the problem.
Next Steps
What are your next steps?
I would like nothing more than to concentrate on myeloma research and not have to worry about the high cost of cancer drugs. It is too stressful to do both. But it is important to keep up the pressure and keep writing, speaking up, and increasing the visibility of the issue. We are working with our professional organizations such as ASCO, ASH, and AACR, as well as engaging with leaders in our own institutions to develop solutions.
We are also giving our full support and voice to patient-based grassroots movements advocating against the high price of cancer drugs, such as the Change.org petition (http://chn.ge/1DCWT1M). Patients are the ones most affected by these costs, and they need to speak up.
We also need to realize that oftentimes the patients most affected by high health-care costs are the ones who are uninsured or underinsured and have no voice. We need to be their voice. ■
Disclosure: Dr. Rajkumar reported no potential conflicts of interest.
References
1. Tefferi A, Kantarjian H, Rajkumar SV, et al: In support of a patient-driven initiative and petition to lower the high price of cancer drugs. Mayo Clin Proc 90:996-1000, 2015.
2. Siddiqui M, Rajkumar SV: The high cost of cancer drugs and what we can do about it. Mayo Clin Proc 87:935-943, 2012.
3. 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.
