Value.
A simple word with lots of meanings, all of which depend on the context of the moment. Value in health care — especially in cancer care — is certainly no exception. What is undeniable is that we are seeing an increasing clamor about value in cancer treatment. And one person’s value is clearly another person’s concern.
At the crux of the debate is the question of whether we will continue to see improvements in cancer care that are meaningful, and whether we will be able to support the very innovation that, in no small part, holds such great promise for the future of making cancer a chronic disease for many and even finding a cure for some.
A recent Washington conference sponsored by the Turning The Tide Against Cancer coalition is an excellent case in point.
Conference organizers brought together experts from around the country who are vitally concerned about the progress we are making, and must continue to make, in elevating personalized (or precision) medicine as a key part of advancing cancer research and cancer care. The agenda included a number of presentations about not only how to make personalized medicine more relevant to all of us, but also how to address the question of “value.”
The right therapy for the right patient at the right time
As we look across the landscape of medical practice, value for many is focused on how we make certain we give the correct and most appropriate treatment to our patients at the right time. Avoiding unnecessary tests and procedures is a key part of this work, as reflected in the increasingly highlighted “Choosing Wisely” campaign from the American Board of Internal Medicine Foundation and many related organizations. Then there are the payment initiatives from a number of health insurers and most prominently the Medicare folks at the Centers for Medicare and Medicaid Services, who are focusing on what they call “value-based care,” meaning care of high quality and (possibly) lower cost.
For cancer patients and the clinicians who care for them, all of these “value” initiatives are important. But even more important, and more immediate for many, are the high costs of newer cancer drugs — particularly targeted and immunotherapy agents — that have come to market recently. Using these novel therapies has driven the costs of treating a patient far beyond what any of us could have imagined. Even drugs that have been on the market for over a decade have seen significant price increases.
Which brings us to the questions that were very much front and center during the Turning The Tide conference: Yes, these drugs are expensive. But in a value-proposition based world, do they meet the fundamental test of bringing value to our patients? Do they make enough of a difference that their cost is justified? And if we limit the cost of the drugs, do we run the risk of limiting innovation in cancer care? Would we reduce the opportunity to create even newer and more effective drugs that could make a real difference in the outcomes for many patients with cancer, who face dire and life-threatening consequences if we don’t make that progress?
All are important questions. All have impact. And all are centered on the question of “value.”
So how does value play out in cancer treatment?
The many definitions of value
For the drug companies, value is interpreted in many ways. The costs of drugs must reflect the cost of research, production, failed drug development and clinical trial efforts, and perhaps, most of all, incentives to continue innovation. Then comes what I am beginning to think of as a large elephant in the room: The claims by the companies regarding the value their new drugs bring to society.
What is value to society? As expressed by some of the speakers at the Turning the Tide conference, it has to do with the basic tenet that if we reduce pain and suffering, and hopefully extend life, then that is a real value to society. And, of course, they note, it is an incredible value to the individual patients, their families, their communities, and economically to their productive lives. We should be willing to pay for that value.
But think about this: I have heard in the past and am hearing once again that value should be extended to the procedures, tests, treatment costs, and so on that are avoided by a successful treatment.
To me, that “bucket” of value is theoretically almost endless in its calculation.
From my personal perspective, the company that creates a new drug is entitled to a fair return for its innovation and contribution to improving the quality and duration of our patients lives. But avoided future medical care costs? Maybe that argument would float for me if the companies in question had been on the hook for those costs before the drug was developed. But they weren’t. We were. We paid the premiums, the companies we work for paid the premiums, our hospitals offered charitable care, our governments paid for care — and sometimes even the fundamental research. So I have to say from my seat that this component of value is a stretch.
And if you are thinking that the calculation of such large numbers is easy, it isn’t. Several speakers noted that computations of value in this situation rarely are able to enumerate all of the elements that may go into a value equation, including the arcane economic science of considering what are called “hedonistic values,” such as the pleasure of seeing a sunset free of pain or physical or emotional concern.
For many of us — doctors and patients alike — value relates to the cost and benefit of a particular medication. There are formulas for that, and it is pretty clear that the costs of new cancer drugs are pushing the envelope when it comes to meeting that test. When a new targeted therapy for pancreatic cancer gets approval from the Food and Drug Administration and extends life about 2 weeks but costs lots of money, most of us would agree there isn’t much value. But what about a drug that increases median lifespan by 3 months, or 6 months? Or reduces pain scores by half? Are the high costs justified in those circumstances?
There has been a lot of discussion about new drugs to treat hepatitis C and hopefully eliminate its progression to hepatocellular carcinoma. But what about the new immunotherapy drugs that are just getting approved and have a price tag of $150,000 a year in some cases? Yes, these drugs offer treatment where no treatment has been very effective before. And they appear to have benefits beyond the cancers that would have been predicted. So they clearly have value. But at what cost?
The cost component of value
And cost is the issue for many patients and their doctors and the people who pay the bills, namely government programs and private insurers. Seeking value is becoming the new buzzword. Numerous programs have cropped up around the country that try to focus on the value of cancer treatments. Sometimes they do, but sometimes patients and physicians consider them rationing (rationalizing?) programs in disguise. Some consider just cost for year of life gained. Others are tackling the more tricky question of how to include a calculation for reducing the costs of administering the therapy, as well as the benefits from treating fewer side effects, which can include hospitalization at the more extreme end of the spectrum — as well as the increased productivity of patients able to continue working for whatever period of time.
We are clearly at a moment in time where we are entering a nationwide debate on the topic of value in cancer care. For some, there should be no limit on what we are willing to pay. This is, after all, a life-threatening and debilitating illness for far too many people. For others, what we pay must be balanced by the expectations of what we get in return for our dollars. And there is a rising tide of criticism from clinicians and patients alike that we simply are being asked to pay too much, that the prices on these drugs are simply not justified by any rational explanation.
Obviously, none of us — except the companies that make the drugs and determine their costs — have the direct insight to answer the questions at hand. These drugs are complicated to develop and complicated to manufacture. But it is not clear — because we don’t have real competition in some of these markets — whether the prices we are seeing are justified. And I must add that many of these companies have outreach programs to help those who otherwise could not afford the drugs, which also have their own costs.
No easy answers
There are no easy answers to the question of value. We can offer — and will undoubtedly see — many point/counterpoint discussions on the topic. However, it is clear that we are in the middle of a great debate, and how that debate is resolved may well hold the answer to whether we will be able to invest in innovation or become static.
The promise of personalized medicine will require that we look carefully at many aspects of how we provide cancer care and develop new treatments. We are going to have to make choices that at times will be difficult. The issue of value in new cancer drugs is just one of the early and more difficult issues that we will have to confront if we are to unlock that promise. And obviously there will be no easy answer.
Hopefully we will be granted the wisdom to make the best choices in what is obviously a very contentious discussion with high passions on both sides — with special impact for our patients and their families whose very lives may hinge on the outcome.
J. Leonard Lichtenfeld is deputy chief medical officer, American Cancer Society. He blogs at Dr. Len’s Cancer Blog. This article originally appeared in MedPage Today.
