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Early Breast Cancer and Value-Based Care


A panel of medical experts discuss cost-effective treatment strategies.

Samyukta Mullangi, MD, MBA: Now there’s also a cottage industry of companies that specialize in patient copay assistance. TailorMed and Nexus Health are entire companies whose entire raison d’être is just to try and find assistance for patients on these medications.

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: And you’re just talking about the oral. Look at what I call hybrid patients getting IV [intravenous] therapy, going through the medical benefit. And then you have your infusion therapy where I think in Minnesota, 1 thing that we have helped, which takes us to the next point of value-based care delivery, we, with some of our payers, have been able to demonstrate the value in total cost reduction when we leverage some of our pathways, utilize pharmacists for things like biosimilar interchange where it’s easy on the provider. You just pick the regimen; the pharmacist will pick the institutional preferences. With some payers, we have what we call gold card access, which makes the whole prior authorization pretty much nonexistent. It’s like an auto approval in certain areas if you’re following pathways as such. Let’s talk a little bit about that, this value-based care model. Sam [Samyukta Mullangi], you mentioned EOM [Enhanced Oncology Model], which we’ll talk a little bit about, but Jay [Andersen]—CDK [cyclin-dependent kinases] 4/6 inhibition, does it fit into this value-based care model and what does that really look like?

Jay Andersen, MD: That’s a big bucket. What is value-based care? I would say our pathway has a lens toward that. Obviously, we’re looking at data and outcomes but our pathway also looks at cost. And there have been cases in our pathway review where data were there, maybe not super impressive, huge cost where we did not add it to pathway, but it’s on NCCN [the National Comprehensive Cancer Network], it’s an FDA-approved drug, so that’s part of our process of the value assessment. I think that is the main element that we are implementing as it relates to pathway. To your point, we use the other strategies that you reference as well. Trying to find the biosimilar if there’s equivalent data, trying to define if there is a drug that has similar outcomes but is lesser in cost, and all those interchanges there make sense. And in our pathway, we have links to outcomes and pricing. A lot of times I think oncologists aren’t aware of the price issues. I’m more aware of them now that I’m on pathways and it’s embedded in our pathway system, so you can actually click and see, that’s $19,000 a month. I think we all have to have an eye on that.

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: I think 1 of the challenges in defining pathways goes into the point of the total cost of care tied to also hospitalizations and resource allocation for these patients. You get a patient who now has QT prolongation, you’ve brought on cardiology services or you’re managing it as the oncologist and PCP [primary care physician]; it all just ties in. A while back we had OCM [Oncology Care Model]. Some people went through OCM and some people didn’t go through OCM. We’re not really sure what we got out of OCM, and now we have EOM. I know currently where all practices are. Some have submitted this application, they’ve gotten preapproval, and they’re waiting on data collection and all these different types of things. I think everybody needs to make a decision by July or something about whether or not we’re going to be part of this. Under EOM, there are 7 disease states, and you obviously have to have breast cancer as 1 of those. Walk me through that, Sam [Samyukta Mullangi]. What are the implications of EOM? What does that mean for our breast cancer patient population? How do the CDK4/6 inhibitors fit into this? One thing I do know about EOM, I don’t know the exact percentage, but I know drug prices make up about three-fourths of what’s going into EOM. Again, that’s huge, which again, on the pharmacy side and on the pathway side, you’d want to reduce the total cost of care as best as you can. Could you walk us through that?

Samyukta Mullangi, MD, MBA: I’ll start by saying that both the OCM and the EOM are total cost of care models, very different from pathways where the pathways are prescriptive. As long as you’re following pathways to some degree, you can be hands-off about thinking too hard about the total cost of care. With these models, you’re now less prescriptive. You can choose what you want to do within the context of understanding that there’s going to be reconciliation at the end of every performance period. The OCM, which ran from 2016 to 2022, was CMS’s [Centers for Medicare & Medicaid Services] first foray into cancer value-based care, and really its first foray into outpatient specialty medicine disease states. But over the course of its period, I would say that its impact was a little bit lacking. According to the analyses it was associated with almost no change in total episode payments while there was maybe some savings and how they defined high-risk cancers, and we can go into that. It was drowned out by the increase in spending on low-risk cancers as well as the monthly payments that they made to practices to fund practice transformation, and then the performance payments that came at the end of each performance period. In total, by the end of it, CMS ended up with a net $150 million loss and so they concluded that it was not a success. But I will say from the practice perspective, another big criticism of the OCM was that it relied heavily on case mix, which to some degree in cancer, which has such heterogeneous disease states within that definition, is inescapable. You have to have some degree of case mix to scale any value-based care program. But take the example of breast cancer, which is what we’re talking about today. You could have a 1.8-cm, node-negative, triple-negative breast cancer that is potentially treated with TC [Taxotere and cyclophosphamide]. That’s about $25,000 for a 6-month episode, or it could be a 2.3-cm node-negative, triple-negative breast cancer that would be treated with KEYNOTE-522 that would accumulate a $100,000 plus in a 6-month episode. So that’s a very expensive 0.5-cm increase in cancer. I would say that the case mix problem really becomes an issue for smaller practices because that can just skew very differently for a practice based on the count of cancer that you’re seeing. The EOM does a few things to correct some of these issues around the case mix. One, it just drops low-risk breast cancer entirely from consideration. And low-risk breast cancer is defined as breast cancer that is just treated with hormone therapy alone. Early-stage breast cancer that’s treated with hormone therapy plus CDK4/6 would not be low risk. That would be a high-risk cancer. That would be included in the EOM. Another thing that it does is it basically asks practices to submit clinical data to help better phenotype for CMS for reconciliation purposes. Now practices, through a data portal, will have to submit ER [estrogen receptor], PR [progesterone receptor], HER-2 [human epidermal growth factor receptor 2] data as well as metastatic cancer or no. So that can give a better count and a count for this case mix problem. And the third thing is that the novel therapy trend factor in the OCM was applied at the practice level, again, subject to all of those case-mix issues. Now that novel therapy trend factor is applied at the disease level. In the event that breast cancer has new therapeutic advances that change the cost paradigm for breast, that would ideally be reflected in the trend factor and reflected in the cost targets that practices need to meet. I think there’s a few changes now in EOM. Will it be perfect? Will we see broader participation? Hard to say, but we can look to see, 6 months from now or a year from now, we’ll see. You make a really great point that in cancer, and in breast cancer certainly, the majority of spend is coming from drug prices, and there’s very little that we can do. I would say that maybe 10 years ago there were so many areas of clinical equipoise where you could say, for example, in non–small cell lung cancer, you could just do a cheap carbo [carboplatin] taxol and that was considered equally efficacious to another more expensive platinum doublet with no loss in efficacy. I think a lot of our treatment paradigms across the board, across tumor types have evolved, and I don’t think you have that many areas of clinical equipoise anymore where you can just quickly make cheaper substitutions. So to the extent that we look at how can we not just think about categories of spend that are very high, but what are categories of spend that are impactable? I think that we are going to have to focus a little bit more on reducing acute care utilization. I would say the EOM also has additional requirements around data collection for things like electronic patient-reported outcomes and health-related social needs, which are social determinants of health. And to the extent that practices who participate in EOM don’t just do that to check a box, but really engage with it and try and proactively identify both clinical and nonclinical issues that come up with their patients and try and bring down their rates of acute care utilization if possible. That I think is probably the best step forward. Some data show that 80% of folks who are being treated with anticancer drug therapy within their first year of treatment will go to the emergency room and a full third of those convert into hospitalizations. And there was a study that actually got published in the last year that showed that 50% of ED [emergency department] visits for folks with cancer are identified as potentially preventable. For example, a full third is just related to unmanaged pain. So to the extent that oncology practices and physicians can stay on top of these things a little bit more and influence that element of the whole total cost of care, then I think that would be the way.

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: I love what you highlighted about the preventable emergency room visits. I’ve been part of 2 health systems that have rolled out initiatives with local providers and local clinics to provide simple things like fluid, electrolyte transfusions, and pain management. To some extent it’s like a value-based agreement thing to try and reduce those unnecessary or unwarranted types of visits.

Transcript edited for clarity.

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