Who Shares the Maximum Risk With Innovative Treatments in Oncology?

Andrew L. Pecora, MD, CPE: If we take the premise that regardless of where you live, if you’re an American citizen, you should get the same level of care as any other American citizen and we look at the obvious inequalities of distribution of care throughout the country, and then you layer on top of that the complexity and expense of immuno-oncology, this is its own crisis flashpoint.

I’m actually a practicing immuno-oncologist. That’s what I did my research in and this is what I do every day. So, I see things I’ve never seen before. I see young people with metastatic melanoma and with brain metastases who have complete responses and they’re now 5 to 7 years out, they’re seemingly cured. It’s hundreds and hundreds of thousands of dollars to do that. It’s very complicated to give these drugs, and the side effect profiles of these drugs, if you don’t manage them right, can be deadly. So, you have this incredible, not incremental, benefit—but profoundly change-of-care benefit. And now, we have safety net hospitals that are struggling and you layer on top of that [the] alternative payment models. So, it sounds like you’re putting everything in a blender and hitting spin, right? How do you see, from your perspective, all of this tying out?

Brenton Fargnoli, MD: In the short run, a lot of the critical access hospitals, rural health clinics, and federally qualified health centers have been exempt from participation in models, such as the Oncology Care Model. In terms of immuno-oncology and combination immunotherapy, I agree: the promise and what we’ve seen with patients has been fantastic. And I think that’s the point—to key in on what it’s delivering, for certain patients, tremendous outcomes. So, there’s certainly an appetite among the various stakeholders to move toward some outcomes-based drug pricing. And [through] that lens, it then becomes quite feasible in terms of delivering tremendous outcomes for these particular patients.

The challenge becomes how to measure that in the real world. You can do clinical trials and cohort analyses and then say for this set of patients, “This is the cost.” But to efficiently and accurately do that at scale, leveraging real world data, to say, “The patient that Dr Pecora treated now is living 40 years longer,” there’s a price for that [outcome] versus, “The other patient Dr Pecora treated passed away a week later.” So, there’s an opportunity to look at different payment models, in that regard. And bringing it back to the patient will be key in terms of the outcomes the drug is actually delivering.

Rena M. Conti, PhD: I agree. I think the question is, who takes risks for those type of treatments? My view is that physicians shouldn’t be on the hook either way for patient benefit or patient costs associated with really new things, including the PD-1 (programmed cell death protein 1) inhibitors. But instead, really it’s pharmaceutical companies that should be holding some of this risk. So, moving toward paying for outcomes where pharma is providing drugs and some combination of insurers plus providers are providing data on real world outcomes (which is going to flow back to pharma in terms of payment and potentially to providers in some way in terms of some other payment) is where we’re going to go.

Those drugs are actually a great example where, frankly, we don’t really know which patients are going to respond perfectly to those treatments. And it’s entirely possible that we’re going to have to layer one drug on top of another drug in order to get durable responsivity. And so, in that case, it’s going to be very, very difficult for physicians and/or patients to be holding that risk. Someone else has to be holding the risk for that treatment, and it’s likely going to be some combination of the payers, the insurers, plus pharma.

Andrew L. Pecora, MD, CPE: That’s interesting. I agree. In our personal experience, we are now at the table with big data, precision analytics, payers, and pharma. We’re all figuring this out together. So, I think that’s going to be as transformative as anything we’ve talked about and that the pharmaceutical industry and the biotechnology industry are going to understand [that] the risk they’re taking is not just the risk of discovery and approval, it’s also the risk of efficacy in the real-world setting.