January 2016 Edition Vol.11, Issue 1

2016 Forecast Series – Assessing Value and Clinical Benefit with Lowell E. Schnipper, MD

2016 Forecast Series—Lowell E. Schnipper, MD, Chair, ASCO Task Force on Value in Cancer Care 

Dr. Lowell E. Schnipper is Professor of Medicine at Harvard Medical School and Chief of Hematology/Oncology at Beth Israel Deaconess Medical Center.

OBR: We’ve known about the ASCO Value in Cancer Care Task Force for a number of years now, but 2015 seemed like a bigger year than usual because of the launch of the Value Framework. Is that a correct assumption?

LS: In a way, the framework is evolutionary. In the past, we’ve published a number of papers relating to the general issue of cost, emphasizing how important it is for oncologists to begin to develop real awareness of the financial challenges their patients are confronting. We've also tried to give oncologists an orientation to what the drivers are that are promoting/escalating cost.

OBR: How did the Value Framework come about?

LS: The Task Force recognized that value in any area of health care is a broad, almost all encompassing term that has many dimensions, including hospital costs, physician costs, employment costs, and pharmaceutical costs. Since we are medical oncologists, we focused on costs of medical therapies for cancer, so our definition is narrower than some might like. The legitimacy of what we’re doing is emphasized by the fact that the most rapidly escalating element of cost within health care is related to drugs; in particular, oncologics, which are increasingly targeted towards rather small populations and range upwards of $8,000 to $11,000 per month.

Thus, we began to ask ourselves, “How would one define quality for a given clinical scenario?” We then devolved the framework by dividing the Task Force into smaller units to begin to think about what we would include in a definition of clinical benefit, negative aspects of cancer treatments such as side effects, and think about how we should address the issue of cost. Essentially, we developed an algorithm that attempts to quantify how much better new treatment ‘X’ is from standard treatment ‘Y', as determined in a well designed clinical trial.

And so, step 1 was to establish what clinical benefit means. In doing this, we identified prospective, randomized trials – in which a standard of care was compared against an experimental arm – that used overall survival as the endpoint. We chose overall survival because most people with a fatal disease care most about how long they’re going to live, but we also include progression free survival as a surrogate parameter when overall survival is not measured.

After coming up with a numerical score for clinical benefit, we focused on toxicities. If a new drug regimen is much less toxic than a comparator, we add points to the clinical benefit score. If it’s comparable, we do nothing. If it’s worse, that detracts from the clinical benefit. Thus, we have arrived at a graded addition or subtraction of points based on the comparative toxicity of the test regimen to the standard. Finally, we add those points together with bonus points, which are given for certain outcomes that we understand to be important to patients (e.g., symptom relief, length of time off treatment, longer survival for a significant minority of the population on the test regimen), and create a Net Health Benefit Score. If 130 points, for example, represents the ideal treatment for a given scenario, the Net Health Benefit Score is going to be some fraction of those possible 130 points.

We’re hoping that once the framework is finalized, it can be rendered in the form of a software application that will be pre-populated with results of clinical trials. Such a tool will enable the Value Framework to reveal the net health benefit for any test regimen (viewed with respect to the control they were compared against).

OBR: You mentioned segmentation of the Task Force. Does everybody involved influence the Net Health Benefit Score or the toxicity score?

LS: Yes. In terms of coming up with a final product, it was discussed with the entire Task Force, which is about 25 to 30 people.

OBR: Did you find it hard to get consensus?

LS: Occasionally, but I think that this has been a long time coming, and we understand that it’s important. We’ve had numerous live meetings and conference calls, and I think the Task Force is quite comfortable with what we’ve produced.

OBR: It’s a big project to have a health benefit score for all the different regimens for all the different cancer types. Is that one of the Task Force’s ambitions going forward?

LS: Yes. We met as a Task Force in November 2015 and discussed this course of action. But first we plan to publish a paper that will attempt to explain the basis for making a few revisions to the framework in response to some of the comments we have received from interested stakeholders. 

OBR: You’re in the comment period right now, right?

LS: The comment period is over. We’re now digesting the comments, taking a little bit of “Alka-Seltzer” each day in order to get through it, and we’re going to write up what changes we feel we should make.

OBR: Do you know when you’ll be coming out with the next publication?

LS: The paper will come out in the Journal of Clinical Oncology in a few months. I just wrote a draft of it, which I’m sharing with my colleagues. As alluded to earlier in our conversation, with this revised framework we’re going to ask software developers, in the form of a request for a proposal, to begin to think about how to develop a tool. It will probably take a year to develop.

OBR: How do think physicians will use the Value Framework in the future to help guide treatment decisions?

LS: We hope to create a library of all the clinical trials that are relevant for the most prevalent cancers and pre-populate the tool. Ideally, we’ll have a mechanism that could be at the doctor’s/patient’s fingertips when they’re discussing what to do next.

OBR: Is cost being incorporated into the Value Framework?

LS: We elected not to have cost contribute to a final score. We felt that the clinical attributes of an application or regimen should stand on its own, based on the clinical benefit to the patient minus the side effects. At the same time, we felt that it would be important for a patient to be aware of cost, which we will be able to present to the patient with the net health benefit. But, these won’t be rolled out in platinum, gold, silver, bronze, or tin categories. We’re just not there yet.

OBR: Step by step, huh?

LS: (laughs) Maybe it will go faster. This is a pretty hot area. We have been resolute in focusing on the physician-patient dialogue surrounding care. It’s no secret that payers are looking for tools like this to help them sort out what’s good quality medicine without breaking the bank, and Medicare in particular is moving in this direction with upcoming changes. In 2017, we’re going to begin to see more and more reimbursement for care compensated by quality metrics, consistent with a move away from fee-for-service.

OBR: Speaking of quality metrics, how do you envision incentives associated with clinical pathways, medical homes, or alternative payment models changing the way patients with cancer are treated in the future?

LS: I see many of these ideas as actually pregnant with possibility – good possibility. If you’ve ever been a patient, you realize how complex the health care system is and how much room for error there is. Sometimes people fall through the cracks. Initiatives, such as a medical home, for example, have the potential to coordinate care and integrate care in a better way than what we’re currently doing. The fee-for-service system is definitely something worth replacing with something that will function better. Quality is a metric used to guide, if it’s definable. Unfortunately, it’s often in the eyes of the beholder, not a mathematical truth. Nonetheless, if there can be a consensus among the relevant stakeholders about what we mean when we say quality, then I think reimbursement on that basis is reasonable. That being said, delivery of quality cancer care is so complicated that the reimbursement system, whatever it is, must be sufficient to provide for an infrastructure that is equal to this task.

OBR: Is the Value Framework 90% of what you do or are there other functions the Task Force performs?

LS: Well, it’s become the focal point in the past year, but we will continue to run a variety of educational sessions at every national meeting. This year we’re doing one that’s going to have an international flavor. There’ll be specific forays into different arenas of cancer medicine that are evolving, like immuno-oncology, and there’ll be some discussion – an educational session or symposium – about considerations of value as we think about costly, but potentially very effective therapies. We also participate in the construction of the national meeting program because we’ve resolved increasingly to incorporate value considerations as we talk about the science that’s evolving.

OBR: That’s sort of the crux of it – science and innovation – but do you feel cost is outpacing innovation?

LS: Since we struggle with this in the Task Force, I could legitimately ask you what you mean by innovation. There were several innovations in breast cancer years ago, one of them being the development of Herceptin. That was real innovation because it was a game-changer of a finding. But we now have many other antibodies directed against targets and cells. I would call that innovation with a lower case “i” rather than a capital “I”. So there is a lot of innovation going on if you mean the former. The breakthrough stuff is rarer.

My own personal thought – and this has nothing to do with ASCO at all – is that there ought to be a way of identifying true innovation, meaning game-changing discoveries, and somehow develop a system that rewards that in a big way for the companies or the people that put skin in the game to make that happen. I’m not wise enough to know exactly how to do that, but I think it’s important to protect the innovators and encourage more innovation.

Value should be a dynamic concept. When something rises to the level of really being a very impactful medication in a given disease setting, I believe there needs to be a way to recognize that.

OBR: Finally, do you think precision medicine is going to play an increasing role in establishing value scores?

LS: I hope so. When we looked at a clinical trial that compared a lung cancer treatment directed against the EGFR mutation with chemotherapy for a patient with that mutation, not surprisingly, we came out with a higher Net Health Benefit Score. So I do think that precision medicine, meaning use of a drug proven to inhibit an appropriate target that then leads to improvement in a disease process, is going to help us identify treatments for the narrow spectrum of people who have this disease causing alteration. These mutations are often rare, but when the drugs targeting them get to the right person, some of these will prove to be highly effective and measure as being valuable in the ways that we and others are defining the term.

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