An interview with Jonathan Wilcox, co-founder and policy director, Patients Rising, Washington, DC
In an effort to address rising health care costs, a number of organizations have spearheaded the development of frameworks that seek to assess the value of different treatment options available to patients who present with a variety of diseases. However, the proliferation of these resources has also raised concerns among health care stakeholders about the transparency of their development, the parties they serve, and the limited evidence with which they are created.
Even the American Society of Clinical Oncology (ASCO), the world’s leading organization for physicians and oncology professionals caring for people with cancer, drew criticism after the release of its own Value Framework in June 2015.1 In a letter to the editor published in the Journal of Clinical Oncology, Jeffery S Weber, MD, PhD, Laura and Isaac Perlmutter Cancer Center, New York, NY, contested that the primary measures used in ASCO’s Value Framework, such as median overall survival and progression-free survival, do not adequately summarize the true benefit of some oncology drugs.2 Similarly, authors of another article claimed that the Net Health Benefit Score used in ASCO’s guidelines may represent an arbitrary measure that distracts patients and oncologists.3 Even as ASCO addressed these issues in an update to the guidelines released this year,4 questions about the effectiveness of this framework and others like it have remained.
In early May, the Institute for Clinical and Economic Review (ICER), a nonprofit organization that evaluates the value of medical tests and treatments, released a report on their assessment of the value of new treatments for multiple myeloma, which was determined based on ICER’s Value Assessment Framework.5 Authors of the report wrote that all of the treatment options in the report exceeded common cost threshold measures and proposed limiting treatment options they deemed ineffective at their current price.5 This assessment immediately received criticism from organizations who claimed that limiting treatment options on the basis of price could set a dangerous precedent and do more harm than good for patients with multiple myeloma. The International Myeloma Foundation was one such organization to come out against ICER’s value assessment, saying that, under the current framework, patients would have to “fail first” on lower priced medications before they could receive more effective drugs that may have worked from the start.6
Another organization that has come out strongly against the ICER Value Assessment Framework is Patients Rising, a Washington, DC-based nonprofit that focuses on patient advocacy. In their own response to the report, representatives from Patients Rising said that the value framework poses a significant risk to patients by limiting spending on new, innovative treatments for cancer while also limiting patient access to needed medications.7
Journal of Clinical Pathways spoke with Jonathan Wilcox, the co-founder and policy director of Patients Rising to get his take on how the recent ICER report and other value frameworks are affecting patient care.
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First, can you tell us more about Patients Rising and the primary objectives of your organization?
Patients’ Rising is a patient advocacy nonprofit organization. We are an aggressive advocate for patients and their rights. We focus broadly and specifically on the challenge of ensuring patients have access to the medications they need and deserve. We are aggressive in telling the truth about health care, which we believe includes public policy, regulations, and the need for critical reforms. And I would add that that includes changes to the entire sector; I don’t believe reforming any one part of health care is going to fix the whole thing, nor do I believe we should be going after one area or sector. We’re going to have to examine and answer all of these questions, which I don’t believe is what’s happening right now.
Patients Rising recently came out against the ICER Value Assessment Framework that was used to assess treatments for myeloma. Can you explain why you think the initiative is such a threat to patient safety and a deterrent to high-quality care?
Value frameworks as a general theory are something that we have concerns about. They place what we see as a disproportionate focus on cost, which is a challenge, but not our only challenge. That gives patients an inaccurate picture of the totality of their health care challenges as well as the system’s challenges.
In addition to that, I look at value frameworks being proposed by ICER—specifically the [Final Evidence Report and Meeting Summary reviewing the comparative clinical effectiveness and value of treatments for multiple myeloma]5—and say that we have fundamental concerns that put us at a real crossroads with the initiative, from a quality and philosophical standpoint.
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I have had some conversations with members of ICER that have been long, open conversations. These were good talks, and I would say we disagreed without being disagreeable—I have nothing personal against the people at ICER—but on the merits of the program, this is simply not going to work for us, or for patients. My fundamental and unmovable, unshakeable dispute with ICER’s Value Assessment Frameworks is that they seek to cap treatments and slash investments in medicines as a way of addressing health care economics, and that is just going to threaten patients. That’s really all there is to it.
I think I know what they believe, and I know that this is a part of the health care conversation now, but it has run well off the rails. I am all for creative ideas to address cost and economics and for new ways of looking at this. That includes long-term solutions and involvement from different stakeholders so we can have a good give-and-take. However, that isn’t what we’re getting here. We’re getting: “Drug prices are too high, patients are too expensive, so we have to cut.” That’s the impression I’m getting from reading this. That’s why I ask the question, “Has this think tank stopped thinking?”
Are there concerns that the Centers for Medicare & Medicaid Services (CMS) could adopt this framework?
Oh, yes. We are very concerned and consider it to be a leading reason why, in May 2016, we went to [the meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC)] in St Louis, where ICER’s value framework for multiple myeloma was discussed, because we felt that a fundamental threat to patients was in St Louis. While I dispute the proposals of ICER, they carry with them the threat that these proposals may be made into larger policies by the government or the insurance industry, which we cannot allow to happen.
Recent actions from CMS have also been met with criticism from provider and patient organizations. Do you think policy makers are stressing cost management over quality patient outcomes?
Well, I think that’s what I’ve been saying. If you look at these materials, some of what is inside is of the most technical science, the most detailed health economics data, but it is all only one part of the conversation. The aspect I have found to be truly disturbing about ICER and its misplaced priorities are its heated assertion that patients and their medications are a threat to society itself. In one of their materials they ask the question: “Medicines or the social good?” I think that is outrageous. Let’s study the access models that are working. The Medicare Part D program is liked by patients, and it is saving money—$500 billion dollars to the Medicare system from 2011 to 2015.
Secondarily, the chief operating officer of ICER, Sarah K Emond, MPP, said [at the Financial Times US Healthcare & Life Sciences Summit] in New York, “If we pay for hepatitis C drugs, we will have to layoff teachers and close schools.” For one, this belies a total lack of understanding about government funding. But it also does something a lot more sinister for me, which is that it sets up the politicking premise that we have a choice between sick people and young people, education and innovation, and I think that really crosses a line. That is why we have called them out on it. I want to stress that I have never even heard anything like this. It is one thing to hear this from another source, but this is the chief operating officer of a self-proclaimed, widely respected source for clinical and economic review that has been cited by the government? That is a dysfunction in ICER that will need to be addressed. If they truly believe this, I think that is a disqualifying factor.
I reiterate: if that’s what ICER believes, then it is time to turn away from ICER. It is a statement that reflects such cynicism and inaccuracy that I don’t see how it resolves itself. And that is something that isn’t being talked about. At this meeting, people quickly brought up points about tumor biomarkers and genetics, and I wanted to stand up and ask: “Did you hear what was just said? That sick people threaten the future of this country. That sick people are taking schools away from kids.” I just feel like those kinds of comments are opening up new, disturbing fronts in this conversation. If it was careless hyperbole, that’s one thing; but I want it addressed. If it is something deeper—and I believe that it is—we want a retraction.
What has the response been from other organizations about the report?
We certainly aren’t alone. In fact, I would say that ICER is pretty isolated in the patient community for sure and from the innovation district as well. That is certainly what I saw at the meeting in St Louis.
Do you share these concerns in regards to other frameworks such as the ASCO Value Framework and the National Comprehensive Cancer Network (NCCN) Evidence Blocks as well?
That is a really good point. I was directly involved in raising questions about the development of these frameworks, specifically ASCO’s. We were with another organization before we started Patients Rising, but my dispute with the ASCO [Value] Framework is of a similar nature. To me, we have seen two fundamental problems with the value frameworks from ASCO, NCCN, and especially ICER: they are cost obsessed, and they exclude the patient voice.
If you go back and read when ASCO rolled out their draft and look at their executive summary—which I will point out did not have a single patient advocate involved in it—the first sentence of the first page is that the cost of patients on medications threaten not just the health care system but the future of this country. This statement, for one, is demonstratively false and, two, reflects a certain bias that has to be challenged. And one of the major reasons for this is that, institutionally, the patient voice is often a last resort, not a first option. And that is too bad, because I think patients should be added not only from a point of fairness but also because they have something of great value to add. And I will make a third point, which is that, as an organization, we believe that patients also have a responsibility in all of these endeavors.
“A responsibility”—what do you mean by that?
First, I think patients have to make sure they are as knowledgeable as they can be, which will be helpful to both them and their doctor. A recent study that I found very compelling said that, as part of an overall strategy, if patients were to pay just slightly higher copays or slightly higher out-of-pocket costs for visits, it would inject billions and billions of dollars into the system. And I have always been intrigued by that, as a part of the conversation that hasn’t been looked at as much.
This comes back to my problem with value frameworks—that they levy a disproportionate attack on medicine. And what I mean by that is, if ASCO and ICER and other organizations are concerned about downward financial pressure on the system, we should be looking at all the ways of trying to alleviate that pressure. To me, the extreme would be to deny patients their medicine. Yet, I see no ideas about sky-rocketing insurance premiums or mass hospitalization costs. All I hear is, let’s cut medicines for patients.
There’s something fundamentally dishonest there that really leads us to wonder about how much of a good-faith gesture these really are. Look at all of the progress that has been made in the last 20 years in the treatment of illnesses like chronic myeloid leukemia and human immunodeficiency virus (HIV). The cost of treating these illnesses is dramatically reduced as a result of broad access to novel, innovative medicines. And these specialty medicines represent only 4% of the total pie.
The US federal government has previously projected that approximately $100 billion in health care spending goes toward the costs of administering private health insurance. Now, I’m not attacking the insurance industry for that; my view is that this is an enormous and complicated system that has to do a lot of detailed work. It is going to have its challenges. But why aren’t we working together to try and address them to make the system better for everybody? Nobody is asking that question though.
Do you believe clinical pathways are addressing patients’ needs more than value frameworks are, or do clinical pathways raise the same issues?
Well, it’s a fundamental question, so I’ll give you a fundamental answer: I am against anything that, in any way, blocks the clinical judgments of the doctor-patient relationship. To me, that is unacceptable. Clinical pathways and value frameworks will be destructive to the doctor-patient relationship and the judgment of those individuals. I think that clinical judgments influenced by cost management are something very troubling. We need to stop having our health care decisions made by those who know the cost of everything, but the value of nothing.
I will give you an example. On a conference call last week, Steven D Pearson, MD, MSc, FRCP, the founder and president of ICER, provided an analogy. He said, “If I were treating a patient and I identified two medications of equal clinical benefit to the patient, I would feel a moral obligation to the system and the patient to prescribe the less expensive one.” (I should clarify that he no longer practices medicine, which I believe is a fair distinction, although I accept his medical knowledge.) I told him that I accepted that, but I also asked him if the corollary was also true: “In your clinical judgment, if a more expensive medication was thought to have a greater benefit to the patient, would you still feel a moral obligation to prescribe that one?” It is a question he has yet to answer.
So would you prefer that all costs be removed from the conversation?
Certainly not. Of course costs are a concern. But we have simply come at the problem the wrong way. We want people to start looking at ways to address cost and inefficiencies in more considerate ways. Patients are ready to engage in a more meaningful dialogue to address these concerns. All I am saying is that, if the only suggestion is to cut patient access and reduce drug development, that isn’t going to work. We need to try something else.
References
1. Schnipper LE, Davidson NE, Wollins DS, et al. American Society of Clinical Oncology statement: A conceptual framework to assess the value of cancer treatment options. J Clin Oncol. 2015;33(23):2563-2577.
2. Weber JS, Drakeman DL. Comment on the American Society of Clinical Oncology value statement [Published online ahead of print June 13, 2016]. J Clin Oncol. doi:10.1200/JCO.2015.64.3692.
3. Angelis A, Kanavos P. Critique of the American Society of Clinical Oncology Value Assessment Framework for cancer treatments: Putting methodologic robustness first [Published online ahead of print June 13, 2016]. J Clin
Oncol. doi:10.1200/JCO.2015.64.9673.
4. Schnipper LE, Davidson NE, Wollins DS, et al. Updating the American Society of Clinical Oncology Value Framework: Revisions and reflections in response to comments received [Published online ahead of print May 31, 2016]. J Clin Oncol. doi:10.1200/JCO.2016.68.2518.
5. Ollendorf DA, Chapman R, Khan S, et al. Treatment options for relapsed or refractory multiple myeloma: Effectiveness, value, and value-based price benchmarks. ICER web site. https://bit.ly/2ayqJSr. Published May 5, 2016. Accessed August 9, 2016.
6. International Myeloma Foundation (IMF) says controversial drug cost report could limit patient access to optimal treatment [press release]. North Hollywood, CA: PR Newswire; May 24, 2016.
7. Patients Rising, Aimed Alliance and the Center for Medicine in the Public Interest challenge proposed “value frameworks” from ICER as a threat to patients’ lives and health [press release]. St. Louis, MI: Business Wire; May 24, 2016.
