CancerNetwork: Most of the really expensive oncology drugs are those for metastatic disease at the end of life, and many of these treatments only incrementally benefit either progression-free survival or overall survival. So do you think there will be, like you said, more scrutiny in evaluating the value of these drugs?
Dr. Helft: So that process has been taking place already for the past 10 to 12 years as new targeted and very expensive agents have come into general practice. There were questions raised even as very sensitive targeted therapies were brought online in the late 1990s and early 2000s about the overall cost-benefit ratio of these therapies. So that is going to receive more scrutiny.
There is a great deal of evidence that there is overtreatment of advanced cancer patients at the end of life. For example, chemotherapy given within 30 days and 2 weeks of death, and referral into hospice programs taking place with a median of about 20 days now, and those sorts of outcomes are clearly aligned with some patients’ preferences, but there are data to suggest that they are not aligned with many patients’ preferences. So one of the incentives, in a sense, lines up well with good medicine—that is, we should be treating patients at the end of life in ways that are consistent with their values and preferences. I certainly think that is going to receive a lot of scrutiny and focus in this context.
Dr. Eagle: I agree with Dr. Helft that those issues he pointed out need greater focus. The paradox of the law is, in a sense, it doesn’t really do that directly. Under the current CMS system, drugs are approved based on efficacy, the cost of the therapy is not really included in the approval process and CMS is obligated to pay for any FDA label for its use. The independent payment advisory board is an important part of the cost-control measures of the law, but by statute it is really not allowed to address benefit design or what Medicare beneficiaries receive. It can only look at payment amounts for providers and therein lies the problem, because there is only so much you can achieve by looking at payment amounts of providers.
I think this is kind of the paradox of the law, that despite its being such a sweeping, comprehensive law, it is incomplete. At its heart it is a coverage act. The details in terms of how it is going to achieve cost control are really going to be decisions that are going to have to be made in the future and Massachusetts is struggling with this now. So I think that what Dr. Helft described is really going to be the hardest part of all of this. How do we actually do these things? The law doesn’t really explicitly say how we are going to do these things, and I think those are going to be the difficult decisions that lay ahead.
Dr. Helft: What a terrific point Dr. Eagle just made because this is the part—as both an oncologist and an ethicist I struggle with the most—and that is in a sense, the statute puts pressures on organizations to limit cost, but really, the limitation of cost will take place in the clinic office, right? When we sit down with patients or when we see them in the hospital. So doctors and nurses who deal with patients in these situations, I would argue, we are very unequipped to have these kinds of conversations about cost effectiveness, about the burdens and benefits of treatment. We do that to a large extent now but we leave out this whole dimension of cost. And certainly patients and families and the populous at large are not at all prepared to have those discussions. So I totally agree with Dr. Eagle on that.
CancerNetwork: Along the same lines, what do you think that this will mean for oncologists who serve a lot of low income or underinsured patients? Will this help ease some of the financial pressures for these practices?
Dr. Eagle: I think that to an extent the answer is yes. The more patients that can become insured vs completely uninsured, that is a good thing. I think what we may see is a rising phenomenon of underinsurance, and Medicaid can sometimes be an example of that. For instance, in North Carolina, in 2009, they changed the fee schedule for drug reimbursement to where probably more than half of the chemotherapy drugs were reimbursed by Medicaid for a price of less than what I can purchase them for, and that just doesn’t allow me to treat those patients in a lower-cost office setting. We figured out work-arounds for that, but it creates a new set of issues, so thorny issues will still be there. There is an underlying cost of providing care and even an insured patient, if the payment amounts are lower than the cost of the expenses of providing the care, you do get issues of figuring out how to manage those patients, so that is something that can happen with or without insurance.
Dr. Helft: I agree with every point that he made. There is also the sheer issue of the fact that as we bring more and more people into the healthcare system, which I am all in favor of. We practicing oncologists are about 11,000 in number across the United States. If you think about that up against the sheer number of cancer cases and those who will have greater access to care, I think there is a man and woman power issue that is going to be operative. That is operative now, by the way, but perhaps in new ways it will become operative.
CancerNetwork: I wanted to follow up and ask whether this act will help flood the system and whether we will need many more community oncologists. Many of the baby boomers are also getting older, so the elderly population is also increasing quite a bit.
Dr. Eagle: I think the demographic changes alone will drive that. The aging populations—if you just look at cancer incidence and prevalence, it is going up. Both because we have an aging population, but also because cancer patients are doing much better. A colon cancer patient with metastatic disease, 15 years ago, the median survival was 8 months, and now it is approximately 2 years. So there are just more patients that are receiving more intensive therapy for longer periods of time.
CancerNetwork: As a final question, what do you see as the biggest questions that both oncologists and patients will be asking in the context of patient care and this new law? Dr. Helft let’s start with you.
Dr. Helft: I guess I would go back to the issue that is related to what we talked about and that is we have not really been asked as a society and as a medical care system to bring rationally driven treatment limitation decisions to bear. The few experiments that the United States has tried in those areas to limit treatment have actually not worked. So we have very limited experience at limiting treatments, especially on the basis of measures of cost and effectiveness together. The best example would be organ transplant patients where we do clearly allocate resources based on medical needs, but that is an example of an absolutely scarce resource. So we do not have enough donor livers to transplant into all of the patients who need a liver transplant, and so we have had to ration them. But we have not faced those kind of allocation decisions to any extent really, and I think we will be struggling with those for years to come.
CancerNetwork: Dr. Eagle, do you have anything to add?
Dr. Eagle: I completely agree. I think it is how we tackle this difficult issue of containing the cost. Anytime there is a renaissance of new and effective therapies, ready to come to market, I think that is going to be the central issue. And there are different ways to do that. Most other countries have health policies and agencies such as England’s NICE that looks explicitly at these types of things and we do not do that. I think there is some appeal potentially, to have physicians do this at the bedside because oncology patients’ circumstances can be very unique, and their wishes can be very unique, but at the same time not all oncologists see the value of treatment the same way.
In addition to that, we really don’t have any authority over the pricing of the therapies either, so there is probably some disconnect between what we feel our obligations to our patients are, in terms of giving them what will help them. Provenge, for metastatic prostate cancer, might be an example of that, because we really don’t have any authority over the pricing of therapies so it seems that perhaps we are not in the best position to withhold treatment if it looks like it would benefit our patients. I think those are some of the issues we are going to struggle with: what are the mechanisms to control costs and what is a fair way to do that at the societal level.
CancerNetwork: Thank you both so much for joining us today!
Dr. Eagle: Appreciate it, thank you!
Dr. Helft: Thank you!