AJMCtv® Interviews, June 2019

Rick McDonough, MD, Past President of the Florida Society of Clinical Oncology (FLASCO)

Why is now a great time for people to enter the field of oncology?

One of the things that drew me to this is that it touches on so many people’s lives [and involves] so many different aspects of medicine. As we go through medical training early on, we see all the different aspects of the body, and this is a field [in which] many of these things come together, because so many things [have an] impact on cancers—how they develop, how you address them while [patients are] going through treatment….Beyond that, the advances are coming so rapidly on this that the nature of the care of cancer is evolving quickly from year to year. One of our speakers was talking [about how,] through the course of his career, just how drastically things have changed and how much longer survival has been, how patients are coping, how many more cancer survivors…we have. And that’s another thing too: looking at getting together physicians and groups from across the state to work on things like survivorship. So, how does the patient fare after they’ve completed their cancer treatment, and what are those steps for them going forward?

What are the benefits of being a FLASCO member?

In talking about education and inclusiveness, the ability to connect to your peers and people in different disciplines that touch on cancer care [is vital]. Collaboration is, I think, one of the key things in medical care, whether that’s on the small level of within an office of the team of people that are day by day helping you take care of cancer and blood cancer patients or whether that is across the broader spectrum; whether that’s a group or a hospital system [or] whether that’s an academic medical center [where] you have a large group of people who are focused on the mission of that entity.

We’ve really sought to expand that farther across the state so that we can bring together people from different geographies within the state, different settings and the way that they care for cancer patients, whether that’s a single doctor in a practice and their staff or whether that’s large institutions; whether that’s academic or even private practices that are large and spread across large areas of the state. So, by being a part of this membership, you get access to education, information, resources, [and] materials that are, hopefully, going to be helpful in the care of cancer patients [and] make sure that in making those connections, the more that we all collaborate, the better [we] can become.

Michael Kolodziej, MD, Vice President and Chief Innovation Officer at ADVI Health

Beyond that, [when] listening to, for example, 1 of the fellows who was present for [the] discussion, it was really eye opening particularly for people that are new in their career [they were] able to say, “This is information that I need to know,” —beyond just the scientific and the medical aspects of their training… they can…understand more of the big picture of what’s involved, and as this gets more and more complicated—and currently in oncology, change is so rapid in both the science and the mechanism of how we deliver care—[we can] collaborate to make those advances and continue to move this forward. What are some of the highlights from your panel on payment models?

I was fortunate enough to moderate a panel on alternative payment models [APMs]. We had a representative from Moffitt Cancer Center, a representative from the Memorial Healthcare System, and a representative from Florida Cancer [Specialists]. So that’s great, because those are 3 very different practice settings, all of [which] are knee-deep in APMs.

Two of the 3 are involved in the Oncology Care Model [OCM]. Moffitt is not in the OCM because they’re a PPS [prospective payment system]— exempt hospital and were not allowed to participate.

I think the take-home message is that overall, the OCM has been a positive experience for the 2 groups that participated. They’ve learned a lot about how to optimize care delivery. They’ve looked at where they could improve care; they looked at the opportunities to improve the patient experience and, at the same time, [were] cognizant of cost.

One of the important takeaways was that practices in the OCM would do it again, and that’s important. The second thing was that all 3 groups are participating in other APMs, and that is really good news. I think when the OCM was launched, it was somewhat disappointing that so few commercial payers chose to participate. I was at Aetna at the time, and we did choose to participate.

Thomas Marsland, MD, Medical Oncologist

Nonetheless, all 3 groups that we had on our panel today are participating in APMs, and that’s good news, because I believe that the knowledge gained—for example, in the OCM—is transferable to these other models, and our panelists said as much. Innovative therapies are being developed in cancer care, but these treatments can be extremely expensive. How does financial toxicity affect patients, and how can it be mitigated?

I think that [financial toxicity] is the biggest challenge we face. We have these great new therapies, but they come at a fairly significant cost. But I think, as one of the other speakers mentioned, [that] the cost of the drug is only one part of a spectrum of costs. You know, it’s the cost of the administration, the cost of managing the toxicities, the hospitalizations, the emergency room visits [etc]. So I think, if all you’re looking at is the cost of the drug and that drug is X versus a drug [that costs] less [that’s 1 thing]— [However], if you’re looking at it as a continuum or more of what they call an episode of care, it may be that although the drug costs more, when you look at the total spectrum of care over a period of time…the drug actually saves money.

Luis E. Raez, MD, Incoming President of the Florida Society of Clinical Oncology (FLASCO)

A couple of the medical directors from several of the big payer communities have made a point that clearly drug cost is a significant piece, but it’s not the largest piece; I mean, end-of-life care, appropriate planning—using the drug at the right time and for the right patients—I think is one way that we can help to manage that cost and allow patients to get the type of care that they need. What are some of your goals as the incoming president of FLASCO?

Stephen Grubbs, MD, Vice President of Clinical Affairs of the American Society of Clinical Oncology (ASCO)

[At] FLASCO, we have several goals. We are working with 12 industry partners in statewide projects that benefit cancer therapy outcomes and patients. For example, one of the projects I love the most because I’m a lung cancer doctor is lung cancer screening. Statewide, we screen [just] 5% of all the patients that are at risk of having lung cancer. It is our goal to increase significantly that proportion.…We have other projects regarding access to drugs, payment of drugs, [and] healthcare outcomes, [and] most of these projects involve patient care and quality care. What are the most important differences between the Patient-Centered Oncology Payment [PCOP] model and the Oncology Care Model [OCM]?

PCOP is an alternative payment model [APM] that ASCO published in May of 2015 after several years of work by our volunteers and staff. What’s interesting is [that] the OCM from CMS was actually introduced the summer of 2015 and started in the summer of 2016, and there are many similarities between the 2 even though they were independently made.

Over time, we’ve made some adjustments in the PCOP model that will be probably published this summer. We’ve taken some of the lessons learned from the OCM experience and other APMs in the oncology space and have actually refined our model some.

Initially, some of the differences were important to practices in that the OCM was requiring total cost of care in considering the calculations of how well a practice was performing in it. The PCOP model initially said, “We probably should have our physician practices responsible for the total cost of care that they were controlling.” So, some issues about the cost of drugs became an issue…[and] we’ve tried to adjust that in our new model.

The other thing that I think you’ll see different as we’ve refreshed our model—or are in the process of doing it—is [that] we’ve taken a different approach, because I think what we’ve learned is that [no 1-size] model will fit everybody in the country.…I think the OCM has [a] very sophisticated group of practices in it that we all know are really wonderful practices, but [there are] a lot of practices out there that don’t have the resources. We’re kind of designing our refresh model so that many other types of practices can perform in the new model if someone wishes to take it up and use it.

One of the big differences is [that] we’ve kind of moved our model away from [the idea that] “across the country, everybody should perform in this type of model” to more of a regional-based model because, again, care of medicine is local, and you need to make adjustments for what your local community needs and wants.…I think that’s where we’ve taken a little different [approach in how] we’ve refined our model now.

The other part of our model that I think [others] are beginning to recognize is, you have to have a certain level of a care delivery system within your practices to make any of these things run properly, and therefore we’ve put a lot of thought into what the practices will need to have in their infrastructure to be able to perform well in an APM.

Blase Polite, MD, Associate Professor of Medicine and Executive Director of Accountable Care at The University of Chicago Medicine

Those are some of the differences, and it’s still an evolution.…OCM’s changed over the last several years, too, to the credit of CMMI [the Center for Medicare & Medicaid Innovation], so I think all these things— from my perspective—are experiments, and they’re pilots, and we need to learn from them. Not any one is by itself going to get the answer right the first time around. Why did you want to focus on the state of the Oncology Care Model [OCM] at this meeting of the Institute for Value-Based Medicine?

Eleanor Perfetto, PhD, Executive Vice President of Strategic Initiatives for the National Health Council

I think we’re at an inflection point or a crossroads in the OCM right now. We know that Medicare and CMMI [the Center for Medicare & Medicaid Innovation] are looking to develop the next model, what they’re, I think, calling OCM Plus.…This is an important time, [and] those of us in the community who have had experience with the OCM and have been thinking about this for the past several years really have to start [offering] our input into what we think has worked and what we think has not worked with the OCM. So, I was hoping to bring some people who I believe are thought leaders, both…individuals who are thinking about different models that we think accomplish the same mission that CMS is trying to do and, I think, some very forward-thinking private payers who are beginning to look at how you get to value-based care in the oncology space. So, I was hoping that from this, we’ll generate some ideas that eventually the CMS folks will listen to as they put together the next version of the model. What are some criticisms of the QALY [quality-adjusted life year] measure, and what factors does the measure not take into acount that some argue it should?

Some of the limitations that the QALYs have are things like potentially being discriminatory against people who are older or people who have severe illnesses or disabilities, so those are things that need to be taken into consideration. Very often the QALY does not take into account patient views, so it’s really important that if a value assessment or a health technology assessment is going to [use] a QALY, the entire assessment should have patient input.

From the patient perspective, what are some concerns regarding the QALY, and have there been efforts to include the patient voice into these measures?

One of the concerns that patients and patient groups have about…the QALY is that it might be used to prevent access or limited access to care. So, that’s a major concern—that if a QALY is being used by someone who is making a decision, that it be used in context with other elements and not alone, and that a QALY shouldn’t be the decision maker.

Nicholas Robert, MD, Medical Director at McKesson Specialty Health

In value assessment or in health technology assessment, there have been some efforts to include the patient voice. It’s really important that it be incorporated into the entire process and not be a check-the-box exercise that only happens at one point during the evaluation.…It’s really important that patients are at the table start to finish and have their voice heard. How can real-world data be beneficial for measuring end points, particularly in rare tumor types?

With the advent of real-world data, which have really been the result of having electronic medical records, we have the ability to identify patients that have been treated in standard ways. If we have the opportunity to develop a new treatment, especially if the cancer’s a rare cancer, it’s hard to do the standard randomized clinical trial. So…that new agent can be tested in a group of new patients, and we can compare those results with a similar group treated with standard therapy, and in this way, we can advance new treatment faster. We recently did this in a very rare tumor called Merkel cell [carcinoma], and the company developed a new agent and identified certain clinical outcomes. We were able to look at those same clinical outcomes with patients receiving standard therapy, and the evidence revealed [that] this was an advance, and the drug was subsequently approved.

What challenges are posed by variability in clinical practice that might influence response measurements?

That’s a really key question. Response is really a challenge. In a standard clinical trial, response is defined; there are metrics for that, and [they] are followed to see if the drug is really improving a response. When you go to real-world data, the same criteria are not used. [When] physicians see patients that are being treated for cancer…are doing better, [they’ll describe these cases], and often they’ll include in their assessment results from scans, but not necessarily always.…We had a poster at ISPOR [2019] this year where we looked at the criteria, and 1 of the things we did [was sit] down as a group [and develop] these so-called playbook rules, where we defined certain terms like “response.” But physicians assess response, so I think when you use those terms, you have to be very careful and make sure that people understand you’re not using the same criteria that you would use in a clinical trial.

Devin Incerti, PhD, Lead Economist, at Innovation and Value Initiative

That being said, we have been able to use the metrics from a clinical trial retrospectively, and that has challenges and limitations, but there is a way to obtain at least some CT [computerized tomography]—based measurements that you would see in a typical randomized trial. So, I think the message here is to be very transparent in the limitations when you look for evidence of response. In looking at different approaches to value assessment, what lessons were learned and best practices emerged?

One of the most common ways to do value assessment is what I would call a conventional cost-effectiveness analysis. This is used particularly in Europe but really around the world, and they’ve been doing it for the last 40 years or so. What that means is that the method is very well established; we have good ways to do it, and it lets us help guide decision making. We can use it to set prices, we can use it to make coverage decisions, [and] we can assess uncertainty. If you’re a decision maker, you might not want to just make a decision; you might want to know the uncertainty you have with that decision, and luckily, those methods let us do that.

One other thing: The conventional cost-effectiveness lets us think about opportunity costs, which is, in my mind, a very important concept. If you’re introducing a new technology, it’s not free. There’s something else you could have done instead. You might have to displace a particular investment that’s already there. You might have to spend less on healthcare—or more on healthcare and less on other goods and services in the economy—and cost-effectiveness lets us do all of those things.